Ansels Pharmaceutical Dosage Forms and Drug Delivery Systems 10th Ed PDF

APPENDIX A Definitions of Selected Drug Categories A Alkalinizer, Systemic: a drug that raises the inter- Abortifacient: an agent that will induce an nal body pH; it i...

APPENDIX A Definitions of Selected Drug Categories A Alkalinizer, Systemic: a drug that raises the inter- Abortifacient: an agent that will induce an nal body pH; it is useful in restoring normal abortion. pH in patients with systemic acidosis (sodium Abradant: an agent that removes an external bicarbonate). layer, such as dental plaque (pumice). Alkylating Agent: an antineoplastic drug that Absorbent: a drug that takes up other chemicals attacks malignant cells by reacting covalently into its substance; it is used to reduce the free with their DNA (chlorambucil). availability of toxic chemicals (polycarbophil, Alpha Glucosidase Inhibitor: a drug that blocks gastrointestinal absorbent). the digestion of carbohydrates into simple sug- ACE Inhibitor: see Angiotensin-Converting ars that will increase blood sugar levels (oral Enzyme Inhibitor. diabetic drugs). Acidifier, Systemic: a drug that lowers the inter- Alpha Receptor Agonist: a drug that activates nal body pH; it is useful in restoring normal sympathetic nervous system alpha receptors, pH in patients with systemic alkalosis (ammo- for example, to induce vasoconstriction (nor- nium chloride). epinephrine). Acidifier, Urinary: a drug that lowers the pH of Alpha Receptor Antagonist: a drug that reacts the renal filtrate and urine (sodium dihydro- asymptomatically with sympathetic nervous gen phosphate). system alpha receptors and prevents their Adrenergic: a drug that activates organs innervated endogenous activation, for example, to induce by the sympathetic nervous system; a sympath- vasodilation (phentolamine). omimetic drug (epinephrine, norepinephrine). Alpha Reductase Inhibitor: a drug that decreases Adrenocorticosteroid, Anti-Inflammatory: an the levels of available 5α-reductase prior to tes- adrenal cortex hormone that regulates organic tosterone's binding with the enzyme, reducing metabolism and inhibits inflammatory response; levels of dihydrotestosterone. a glucocorticoid (prednisolone, prednisone). Amebicide: an agent used to treat amoebozoa Adrenocorticosteroid, Salt-Regulating: an adre- infections (metronidazole). nal cortex hormone that regulates sodium/ Anabolic Steroid: an androgen analogue with potassium balance in the body; a mineralocor- relatively greater anabolic activity; it is used to ticoid (desoxycorticosterone acetate). treat catabolic disorders (methandrostenolone). Adrenocorticotropic Hormone: a hormone that Analeptic: a central nervous system stimulant, stimulates the adrenal cortex to produce glu- sometimes used to stimulate respiration during cocorticoids (corticotropin). severe central nervous system depression (dox- Adsorbent: a drug that binds other chemicals apram, modafinil). onto its surface; it is used to reduce the free Analgesic: a drug that suppresses pain perception availability of toxic chemicals (kaolin, gastro- (nociception) without inducing unconsciousness intestinal adsorbent). (morphine sulfate, opioid analgesic; aspirin, Agonist: a drug that reacts with and activates nonopioid analgesic). physiological receptors and induces the asso- Androgen: a hormone that stimulates and main- ciated biologic response (morphine, opioid tains male reproductive function and sex char- receptor agonist; isoproterenol, beta-adrenergic acteristics (testosterone). receptor agonist). Anesthetic, General: a drug that eliminates pain Alcohol-Abuse Deterrent: a drug that alters physi- perception by inducing unconsciousness (ether, ology so that unpleasant symptoms follow inges- inhalation anesthetic; thiopental sodium, intra- tion of ethanol-containing products (disulfiram). venous anesthetic; midazolam). Aldehyde Dehydrogenase Inhibitor: a drug that Anesthetic, Local: a drug that eliminates pain blocks the conversion of acetaldehyde to acetic perception in a limited body area by local acid by aldehyde dehydrogenase (disulfiram). action on sensory nerves (procaine, lidocaine). 753 754 APPENDIX A Anesthetic, Topical: a local anesthetic that is effec- atorvastatin, rosuvastatin calcium; simvasta- tive upon application to mucous membranes tin; ezetimibe). (tetracaine). Anticholinergic: a drug that inhibits response to Angiotensin-Converting Enzyme Inhibitor: a parasympathetic nerve impulses and choliner- drug that inhibits biotransformation of angio- gic drugs; a parasympatholytic drug (ipratro- tensin I into vasoconstricting angiotensin II; pium bromide). it is used to treat hypertension (captopril, Anticholinesterase Antidote: a drug that reactivates ramipril). cholinesterase enzyme after its inactivation by Anorexiant: a drug that acts on the brain to organophosphate poisons (pralidoxime). reduce the appetite. Anticoagulant Antagonist: a drug that opposes Anorexic: a drug that suppresses appetite, usually overdosage of anticoagulant drugs (phytona- by elevating mood (phentermine, sibutramine). dione, supplies vitamin K to oppose vitamin Antacid: a drug that neutralizes excess gastric K–antagonist anticoagulants). acid (calcium carbonate). Anticoagulant, for Storage of Whole Blood: a Antagonist: a drug that reacts asymptomatical- nontoxic agent added to collected blood to ly with physiological receptors and prevents prevent clotting (anticoagulant citrate dextrose their endogenous activation (naloxone, opioid solution). receptor antagonist; propranolol and metopro- Anticoagulant, Systemic: a drug administered to lol, beta-adrenergic receptor antagonists). slow the clotting of circulating blood (warfarin Anthelmintic: a drug that eradicates intestinal sodium). worm infestations (mebendazole). Anticonvulsant: an antiepileptic drug adminis- Antiacne Agent: a drug that combats the lesions tered prophylactically to prevent seizures, or of acne vulgaris (isotretinoin). a drug that arrests convulsions by inducing Antiadrenergic: a drug that inhibits response to general central nervous system depression sympathetic nerve impulses and adrenergic (phenytoin, antiepileptic prophylactic; diaze- drugs; a sympatholytic drug (phentolamine, pam, central nervous system depressant anti- alpha adrenergic antagonist; metoprolol, beta- convulsant). adrenergic antagonist). Antidepressant: a centrally acting drug that induces Antiamebic: a drug that kills or inhibits proto- mood elevation, useful in treating mental zoan parasites such as Entamoeba histolytica, depression (amitriptyline). causative agent of amebiasis (metronidazole, Antidiabetic: a drug that supplies insulin or stimu- intestinal antiamebic; chloroquine, extraintes- lates the secretion of insulin; it is useful in treat- tinal antiamebic). ing diabetes mellitus (insulin injection, supplies Antiandrogen: a drug that inhibits response to insulin; glipizide, stimulates insulin secretion; androgenic hormones. pioglitazone HCl, exenatide). Antianemic: a drug used to treat anemia; see Antidiarrheal: a drug that inhibits intestinal peri- Hematopoietic, Hematinic (ferrous sulfate). stalsis; it is used to treat diarrhea (diphenoxyl- Antianginal: a coronary vasodilator useful in pre- ate; bismuth subsalicylate; loperamide HCl). venting or treating attacks of angina pectoris Antidiuretic: a drug that promotes renal water (nitroglycerin). reabsorption, thus reducing urine volume; it Antiarrhythmic: a cardiac depressant useful in is used to treat neurogenic diabetes insipidus suppressing rhythm irregularities of the heart (desmopressin). (amiodarone HCl; procainamide). Antidote, General Purpose: a drug that reduces Antiarthritic: a drug that reduces the joint the effects of ingested poisons (or drug over- inflammation of arthritis (anakinra, celecoxib, doses) by adsorbing toxic material (activated ibuprofen). charcoal). Antibacterial: a drug that kills or inhibits Antidote, Specific: a drug that reduces the effects pathogenic bacteria (penicillin G, systemic of a systemic poison (or drug overdose) by a antibacterial; nitrofurantoin, urinary antibacte- mechanism that relates to the particular poi- rial; bacitracin, topical antibacterial). son (dimercaprol, specific antidote for arsenic, Antibiotic: a drug originally of microbial origin mercury, and gold poisoning; flumazenil, com- used to kill or inhibit bacterial and other infec- plete or partial reversal of the sedative effects tions (clarithromycin, penicillin, levofloxacin). of benzodiazepines). Anticholesterol Agent: a drug that lowers Antieczematic: a topical drug that aids in control plasma cholesterol level (cholestyramine resin; of chronic exudative skin lesions (coal tar).  APPENDIX A 755 Antiemetic: a drug that suppresses nausea and Anti-infective, Topical (or Local): a drug that vomiting (ondansetron hydrochloride). kills or inhibits pathogenic microorganisms Antineuritic: a drug that aids in control of bed- and is suitable for sterilizing skin and wounds wetting (enuresis) (imipramine). (povidone iodine liquid soap). Antiepileptic: a drug that prevents epileptic sei- Anti-inflammatory: a drug that inhibits physio- zures upon prophylactic administration (val- logical response to cell damage (inflammation) proic acid; topiramate). (prednisolone, adrenocorticosteroid; ibupro- Antiestrogen: a drug that inhibits the action of fen, nonsteroid). estrogenic hormones (tamoxifen). Antileishmanial: a drug that kills or inhibits Antifibrinolytic: a drug that promotes hemosta- pathogenic protozoa of the genus Leishmania sis by inhibiting clot dissolution (fibrinolysis) (hydroxystilbamidine isethionate). (aminocaproic acid). Antileprotic: a drug that kills or inhibits Antifilarial: a drug that kills or inhibits pathogenic Mycobacterium leprae, the causative agent of filarial worms (diethylcarbamazine). leprosy (dapsone). Antiflatulent: a drug that reduces gastrointestinal Antilipemic: an agent that reduces lipid levels in gas (simethicone). the blood. Antifungal, Systemic: a drug that kills or inhibits Antimalarial: a drug that kills or inhibits pro- pathogenic fungi (fluconazole). tozoa of the genus Plasmodium, the causative Antifungal, Topical: a drug applied externally to agents of malaria (chloroquine). kill or inhibit pathogenic fungi (tolnaftate). Antimanic: a drug that suppresses the excitement Antiglaucoma Agent: a drug that lowers intraoc- phase (mania) of bipolar disorder (lithium ular fluid pressure; it is used to treat glauco- carbonate). ma (methazolamide and acetazolamide reduce Antimetabolite: a drug that attacks malignant fluid formation; isofluorphate promotes fluid cells or pathogenic cells by serving as a non- drainage). functional substitute for an essential metabolite Antigonadotropin: a drug that inhibits anterior (fluorouracil, antineoplastic antimetabolite). pituitary secretion of gonadotropins; it is used Antimigraine Agent: a drug that reduces inci- to suppress ovarian malfunction (danazol). dence or severity of migraine vascular head- Antigout Agent: a drug that reduces tissue depos- aches (sumatriptan). its of uric acid in chronic gout or suppresses Anti–Motion Sickness Agent: a drug that sup- the intense inflammatory reaction of acute presses motion-induced nausea, vomiting, and gout (allopurinol for chronic gout; indometha- vertigo (dimenhydrinate hydrochloride). cin for acute gout). Antimuscarinic: an anticholinergic drug that Antihemophilic: a drug that replaces blood clot- inhibits symptoms mediated by acetylcholine ting factors absent in the hereditary disease receptors of visceral organs (muscarinic recep- hemophilia (antihemophilic factor). tors) (atropine sulfate). Antiherpes Agent: a drug that inhibits replication Antinauseant: a drug that suppresses nausea and of herpes simplex virus; it is used to treat gen- vomiting; an antiemetic (ondansetron). ital herpes (acyclovir). Antineoplastic: a drug that attacks malignant Antihistaminic: a drug that antagonizes hista- (neoplastic) cells in the body (chlorambucil, mine action at H1 histamine receptors; it is alkylating agent). useful in suppressing the histamine-induced Antiparasitic: a drug that eradicates parasitic symptoms of allergy (chlorpheniramine male- arthropods, helminths, protozoa, etc. (perme- ate; cetirizine, fexofenadine HCl). thrin for scabies, mebendazole for intestinal Antihyperlipidemic: a drug that lowers plasma worms, metronidazole for amebic dysentery, cholesterol and lipid levels (atorvastatin). malathion for head lice). Antihypertensive: a drug that lowers arterial Antiparkinsonian (antidyskinetic): a drug that blood pressure, especially the elevated diastolic suppresses the neurologic disturbances and pressure of hypertension (metoprolol; atenolol). symptoms of parkinsonism (levodopa). Antihypocalcemic: a drug that elevates plasma Antiperistaltic: a drug that inhibits intestinal calcium level; it is useful in treating hypocalce- motility; an antidiarrheal drug (diphenoxylate mia (parathyroid injection). hydrochloride). Antihypoglycemic: a drug that elevates plasma Antiplatelet Agent: a drug that inhibits aggre- glucose level; it is useful in treating hypogly- gation of blood platelets; it is used to prevent cemia (glucagon). heart attack (aspirin; clopidogrel bisulfate). 756 APPENDIX A Antiprogestin: a type of hormone antagonist that Antiviral: a drug that kills or inhibits viral infec- antagonizes or suppresses the actions of pro- tions (idoxuridine, ophthalmic antiviral). gesterone (mifepristone). Antiviral, Prophylactic: a drug useful in pre- Antiprotozoal: a drug that kills or inhibits patho- venting (rather than treating) viral infections genic protozoa (metronidazole). (amantadine, prophylactic for influenza). Antipruritic: a drug that reduces itching (pruri- Antixerophthalmic: a drug with vitamin A activ- tus) (trimeprazine, systemic antipruritic; men- ity; it is useful in treating vitamin A deficiency thol, topical antipruritic). and xerophthalmia (vitamin A). Antipsoriatic: a drug that suppresses the lesions Anxiolytic: a drug that suppresses symptoms of and symptoms of psoriasis (methotrex- anxiety (diazepam; alprazolam). ate, systemic antipsoriatic; anthralin, topical Astringent: a drug used topically to toughen and antipsoriatic). shrink tissues (aluminum acetate solution). Antipsychotic: a drug that suppresses the symp- Astringent, Ophthalmic: a mild astringent suit- toms of psychoses of various diagnostic types able for use in the eye (zinc sulfate). (haloperidol). Antipyretic: a drug that restores normal body B temperature in the presence of fever (acetamin- Barbiturate: a sedative–hypnotic drug that con- ophen). tains the barbituric acid moiety in its chemical Antirachitic: a drug with vitamin D activity; it structure (phenobarbital). is useful in treating vitamin D deficiency and Belladonna Alkaloid: a plant principle derived rickets (cholecalciferol). from Atropa belladonna and related species, Antiretroviral: a group of drugs used to treat infec- with anticholinergic action (atropine). tions caused by retroviruses, especially HIV. Benzodiazepine: a sedative–anxiolytic–mus- Antirheumatic: an anti-inflammatory drug used cle relaxant drug that contains the benzo- to treat arthritis and rheumatoid disorders diazepine moiety in its chemical structure (indomethacin). (diazepam). Antirickettsial: a drug that kills or inhibits patho- Beta Receptor Agonist: a drug that activates genic microorganisms of the genus Rickettsia sympathetic nervous system beta recep- (chloramphenicol). tors, for example, to induce bronchodilation Antischistosomal: a drug that kills or inhibits (isoproterenol). pathogenic flukes of the genus Schistosoma Beta Receptor Antagonist: a drug that reacts (oxamniquine). asymptomatically with sympathetic nervous Antiscorbutic: a drug with vitamin C activity; it system beta receptors and prevents their is useful in treating vitamin C deficiency and endogenous activation, for example, to oppose scurvy (ascorbic acid). sympathetic stimulation of the heart (atenolol, Antiseborrheic: a drug that aids in the control metoprolol, propranolol). of seborrheic dermatitis (dandruff) (selenium Bisphosphonate: also called diphosphonates, are sulfide). a class of drugs that are used to prevent the Antisecretory: an agent that acts to reduce or loss of bone mass. inhibit gastric secretions. Bone Metabolism Regulator: a drug that slows Antispasmodic: a drug that inhibits the motility calcium turnover in bone; it is used to treat of visceral smooth muscles (atropine). Paget disease (etidronate). Antithyroid Agent: a drug that reduces thyroid Bronchodilator: a drug that expands bronchi- hormone action, usually by inhibiting hor- olar airways; it is useful in treating asthma mone synthesis (methimazole). (albuterol and isoproterenol, adrenergic bron- Antitreponemal: a drug that kills or inhibits chodilators; oxtriphylline, smooth muscle relax- Treponema pallidum, the causative agent of ant bronchodilator). syphilis (penicillin). Antitrichomonal: a drug that kills or inhibits C pathogenic protozoa of the genus Trichomonas Calcium Channel Blocker: an antianginal drug (metronidazole). that acts by impairing the function of trans- Antitubercular: a drug that kills or inhibits membrane calcium channels of vascular smooth Mycobacterium tuberculosis, the causative agent muscle cells (verapamil). of tuberculosis (isoniazid). Carbonic Anhydrase Inhibitor: a drug that Antitussive: a drug that suppresses coughing inhibits the enzyme carbonic anhydrase, the (dextromethorphan hydrobromide). therapeutic effects of which are diuresis and  APPENDIX A 757 reduced formation of intraocular fluid (acet- Contraceptive, Transdermal: topically adminis- azolamide). tered drugs that prevent conception (norelge- Cardiac Depressant, Antiarrhythmic: a drug that stromin/ethinyl estradiol). depresses myocardial function; it is useful in Contraceptive, Vaginal: intravaginal ring insert- treating cardiac arrhythmias (procainamide). ed releasing drugs that prevent conception Cardiac Glycoside: a plant principle derived from (etonogestrel/ethinyl estradiol). Digitalis purpurea and related species, with car- Corticosteroid: an agent that includes the steroid diotonic action (digoxin). hormones naturally produced in the adrenal Cardiotonic: a drug that increases myocardial cortex; it includes cortisol (hydrocortisone) contractile force; it is useful in treating conges- and others. tive heart failure (digoxin). Cycloplegic: an anticholinergic drug used topical- Catecholamine Synthesis Inhibitor: a drug that ly in the eye to induce paralysis of accommo- inhibits the biosynthesis of catecholamine dation (cycloplegia) and dilation of the pupil neurotransmitters such as norepinephrine (cyclopentolate). (metyrosine). Cathartic: a drug that promotes defecation, usual- D ly considered stronger in action than a laxative Decongestant, Nasal: an adrenergic drug used (bisacodyl). orally or topically to induce vasoconstriction Caustic: a topical drug that destroys tissue on in nasal passages (phenylephrine HCl; pseu- contact; it is useful in removing skin lesions doephedrine HCl). (toughened silver nitrate). Demulcent: a bland viscous liquid, usually Cauterizing Agent: an agent that “burns” off a water based, used to coat and soothe dam- part of the body to remove or close it off (silver aged or inflamed skin or mucous membranes nitrate). (methylcellulose). Centrally Acting Drug: a drug that produces Dental Caries Prophylactic: a drug applied to its therapeutic effect by action on the central the teeth to reduce the incidence of cavities nervous system, usually designated by the (sodium fluoride). type of therapeutic action (sedative, hypnotic, Dentin Desensitizer: a drug applied to the teeth anticonvulsant, etc.). to reduce the sensitivity of exposed subenamel Cephalosporin: an antimicrobial drug that con- dentin (potassium nitrate). tains the cephalosporin moiety in its chemical Depigmenting Agent: a drug that inhibits structure (cefotaxime; cefdinir). melanin production in the skin; it is used Chelating Agent: a complexing agent that binds to induce general depigmentation in cer- metal ions into stable ring structures (chelates); tain splotchy depigmented conditions (e.g., it is useful in treating poisoning (edetate calci- vitiligo) (hydroquinone). um disodium, chelating agent for lead). Detergent: an emulsifying agent used as a cleanser Cholelitholytic: a drug that promotes dissolution (hexachlorophene liquid soap, antiinfective of gallstones (ursodeoxycholic acid). detergent). Choleretic: a drug that increases bile secretion by Diagnostic Aid: a drug used to determine the the liver (dehydrocholic acid). functional state of a body organ or to determine Cholinergic: a drug that activates organs inner- the presence of a disease (peptavlon, gastric vated by the parasympathetic nervous system; secretion indicator; fluorescein sodium, corneal a parasympathomimetic drug (neostigmine, trauma indicator). systemic cholinergic; pilocarpine, ophthalmic Digestive Aid: a drug that promotes digestion, cholinergic). usually by supplementing a gastrointestinal Chrysotherapeutic: a drug containing gold; it is enzyme (pancreatin). used to treat rheumatoid arthritis (auranofin). Disinfectant: an agent that destroys microorgan- Coagulant: see Hemostatic, Systemic. isms on contact and is suitable for sterilizing Contraceptive, Oral: an orally administered drug inanimate objects (formaldehyde solution). that prevents conception. Currently available Diuretic: a drug that promotes renal excretion of oral contraceptives are for use by females electrolytes and water; it is useful in treating (norethindrone acetate and ethinyl estradiol generalized edema (furosemide, loop diuretic; tablets). hydrochlorothiazide, thiazide diuretic; triam- Contraceptive, Topical: a spermicidal agent used terene, potassium-sparing diuretic). topically in the vagina to prevent conception Dopamine Receptor Agonist: a drug that acti- (nonoxynol 9). vates dopamine receptors, for example, to 758 APPENDIX A inhibit anterior pituitary secretion of prolactin of contractions in the small intestine or mak- (bromocriptine; pramipexole dihydrochloride; ing them stronger, without disrupting their ropinirole HCl). rhythm. Glucocorticoid: an adrenocortical hormone that reg- E ulates organic metabolism and inhibits inflam- Emetic: a drug that induces vomiting; it is useful matory response (betamethasone; prednisone). in expelling ingested but unabsorbed poisons Glutamate Inhibitor: a drug that will block the (ipecac syrup). action of glutamic acid/glutamate. Emollient: a topical drug, especially an oil or Gonadotropin: a drug that supplies the gonad- fat, used to soften the skin and make it more stimulating actions of follicle-stimulating hor- pliable (cold cream). mone (FSH) and/or luteinizing hormone (LH); Endothelin Receptor Antagonist: a drug that it is used to promote fertility (menotropins blocks endothelin receptors for treatment of contain FSH and LH; human chorionic gonado- a number of diseases, including pulmonary tropin has LH-like activity). arterial hypertension. Growth Hormone, Human: a drug that dupli- Enzyme: a molecule that catalyzes a chemical cates endogenous growth hormone; it is used reaction. in children to treat growth failure due to the Epidermal Growth Factor: a growth factor that lack of growth hormone (somatrem). stimulates cell growth, proliferation, and dif- ferentiation by binding to its receptor EGFR. H Ergot Alkaloid: a plant principle derived from Heavy Metal Antagonist: a drug used as an anti- the fungus Claviceps purpurea grown on rye or dote to poisoning with toxic metals such as other grains (ergonovine, uterine contractant; arsenic and mercury (dimercaprol). ergotamine, migraine therapy). Hematinic: a drug that promotes hemoglobin Estrogen: a hormone that stimulates and main- formation by supplying iron (ferrous sulfate). tains female reproductive organs and sex char- Hematopoietic: a vitamin that stimulates the acteristics and functions in the uterine cycle formation of blood cells; it is useful in treating (ethinyl estradiol). vitamin-deficiency anemia (cyanocobalamin). Expectorant: a drug that increases respiratory Hemorheologic Agent: a drug that improves the tract secretions, lowers their viscosity, and pro- flow properties of blood by reducing viscosity motes removal (guaifenesin). (pentoxifylline). Hemostatic, Local: a drug applied to a bleeding F surface to promote clotting or to serve as a Fecal Softener: a drug that promotes defecation clot matrix (thrombin, clot promoter; oxidized by softening the feces (docusate sodium). cellulose, clot matrix). Fertility Agent: a drug that promotes ovulation in Hemostatic, Systemic: a drug that stops bleeding by women of low fertility or spermatogenesis in inhibiting systemic fibrinolysis (aminocaproic men of low fertility (clomiphene). acid). Fibrinolytic Proteolytic: an enzyme drug used Histamine H1 Receptor Antagonist: a drug used topically to hydrolyze the exudates of infected to combat the histamine-induced symptoms of and inflammatory lesions (fibrinolysin and allergy; an antihistamine (diphenhydramine desoxyribonuclease, bovine). hydrochloride). Histamine H2 Receptor Antagonist: a drug that G inhibits histamine-mediated gastric acid secre- GABA Agonist: a drug that acts to stimulate tion; it is used to treat peptic and duodenal or increase the action at the GABA receptor, ulcers (famotidine). producing typically sedative effects, and may HMG-CoA Reductase Inhibitor: a drug that inhib- cause other effects such as anxiolytic and mus- its the rate-controlling enzyme of the meva- cle relaxant effects. lonate pathway, the metabolic pathway that Galactokinetic: a drug used to initiate lactation produces cholesterol and other isoprenoids. after childbirth (oxytocin nasal spray). Hormone: a drug that duplicates the action of a Gastric Acid Secretion Inhibitor: a drug that physiological cell regulator (hormone) (insu- inhibits the secretion of gastric acid, as shown lin, estradiol, thyroxine). by the proton pump inhibitors. Hydantoin: an antiepileptic drug that contains Gastroprokinetic: a drug that increases gastroin- the hydantoin moiety in its chemical structure testinal motility by increasing the frequency (phenytoin sodium).  APPENDIX A 759 Hydrolytic, Injectable: an enzyme drug that Leukotriene Receptor Antagonist: a drug that promotes the diffusion of other injected drugs inhibits leukotrienes or fatty compounds through connective tissues (hyaluronidase). produced by the immune system that cause Hyperglycemic: a drug that elevates blood glu- inflammation in asthma and bronchitis and cose level (glucagon). constrict airways. Hypnotic: a central nervous system depressant Lipase Inhibitor: a drug used to reduce the activ- used to induce sleep (eszopiclone; flurazepam, ity of lipases found in the intestine secreted by zolpidem tartrate). the pancreas when fat is present. Hypoglycemic: a condition of low blood sugar. Loop Diuretic: a diuretic with renal site of action in Hypotensive: see Antihypertensive. the thick ascending loop of Henle (furosemide). Lung Surfactant: a surface-active lipoprotein com- I plex (phospholipoprotein) formed by type II Immunizing Agent, Active: an antigen that alveolar cells. induces antibody production against a patho- genic microorganism; it is used to provide per- M manent but delayed protection against infec- MAO Inhibitor: see Monoamine Oxidase Inhibitor. tion (tetanus toxoid). Metal Complexing Agent: a drug that binds metal Immunizing Agent, Passive: a drug containing ions; it is useful in treating metal poisoning antibodies against a pathogenic microorganism; (dimercaprol, complexing agent for arsenic, it is used to provide immediate but temporary mercury, and gold). protection against infection (tetanus immune Mineralocorticoid: an adrenocortical hormone globulin, rabies immune globulin). that regulates sodium/potassium balance in Immunoglobulin: antibody protein derived from the body (desoxycorticosterone acetate). blood serum; it is used to confer passive immu- Miotic: a cholinergic drug used topically in the nity to infectious diseases (see Immunizing eye to induce constriction of the pupil (miosis) Agent, Passive). (pilocarpine). Immunosuppressant: a drug that inhibits immune Monoamine Oxidase Inhibitor: an antidepres- response to foreign materials; it is used to sup- sant drug that inhibits the enzyme monoamine press rejection of tissue grafts (azathioprine). oxidase, thereby increasing catecholamine Inotropic Agent: a drug that increases the con- levels of neurons (isocarboxazid). tractile strength of heart muscle; a cardiotonic Monoclonal Antibody: a highly specific immu- (digoxin, digitoxin, dopamine). noglobulin produced by cell culture cloning Ion Exchange Resin: a drug in the gastrointesti- (muromonab CD3, inactivates T lymphocytes nal tract that takes up ions present in a toxic that reject tissue grafts). amount with an equivalent release of nontoxic Mucolytic: a drug that hydrolyzes mucoproteins; ions (sodium polystyrene sulfonate, takes up it is useful in reducing the viscosity of pulmo- potassium ions with the release of sodium ions). nary mucus (acetylcysteine). Irritant, Local: a drug that reacts weakly and non- Muscle Relaxant, Skeletal: a drug that inhibits specifically with biologic tissue; it is used top- the contraction of voluntary muscles (cyclo- ically to induce a mild inflammatory response benzaprine HCl, dantrolene, succinylcholine). (camphor). Muscle Relaxant, Smooth: a drug that inhibits the contraction of visceral smooth muscles K (aminophylline). Keratolytic: a topical drug that toughens and Mydriatic: an adrenergic drug used topically in protects skin (compound benzoin tincture, the eye to induce dilation of the pupil (mydri- salicylic acid). asis) (phenylephrine). L N Laxative: a drug that promotes defecation, usual- Narcotic: a drug that induces action by reacting ly considered milder in action than a cathartic with opioid receptors of the central nervous (psyllium mucilloid, bulk laxative; mineral oil, system or a drug that is legally classified as a lubricant laxative; sodium phosphates oral narcotic with regard to prescribing regulations. solution, saline laxative; bisacodyl, irritant Narcotic Antagonist: a drug that reacts with opi- laxative). oid receptors asymptomatically; it is used to ter- Leprostatic: see Antileprotic. minate the action of narcotic drugs (naloxone). 760 APPENDIX A Neuraminidase Inhibitor: a drug in a class of anti- Pigmenting Agent: a drug that promotes melanin viral drugs targeted at the influenza virus, which synthesis in the skin (trioxsalen, oral pigment- works by blocking the function of the viral ing agent; methoxsalen, topical pigmenting neuraminidase protein, preventing the virus agent). from reproducing by budding from the host cell Plasma Volume Expander: a substance that can (oseltamivir). be transfused to maintain fluid volume of the Neuromuscular Blocking Agent: a drug that blood. paralyzes skeletal muscles by preventing Platelet Growth Factor: contained in platelet-rich transmission of neural impulses to them plasma that is a blood plasma that has been (succinylcholine). enriched with platelets, different growth fac- Nonsteroidal Anti-Inflammatory Drug: an anal- tors, and cytokines. gesic, anti-inflammatory drug that inhibits Platelet-Reducing Agent: a drug that slows down prostaglandin synthesis (ketoprofen). platelet production in the body (anagrelide). NSAID: see Nonsteroidal Anti-Inflammatory Drug. Posterior Pituitary Hormone, Antidiuretic: a hormone that promotes renal reabsorption of O water; it is useful in treating diabetes insipidus Opioid: see Narcotic. (vasopressin injection). Opioid Antagonist: see Narcotic Antagonist. Potassium-Sparing Diuretic: a diuretic that does Ovulation Stimulator: a drug that is similar to not induce systemic potassium depletion as a estrogen and binds to the estrogen receptor side effect (triamterene). causing a negative feedback that stimulates Potentiator: an adjunctive drug that enhances the the release of gonadotropin releasing hormone action of a primary drug, the total response that activates the pituitary gland to release being greater than the sum of the individual follicle-stimulating hormone and luteinizing actions (hexafluorenium, potentiator for suc- hormone with resultant release of an egg. cinylcholine). Oxytocic: a drug that stimulates uterine motility; Progestin: a progesterone-like hormone that stim- it is used in obstetrics to initiate labor or to con- ulates the secretory phase of the uterine cycle trol postpartum hemorrhage (oxytocin). (norethindrone). Prostaglandin Synthetase Inhibitor: a drug that P inhibits prostaglandin synthesis and prosta- Parasympatholytic: a drug that inhibits response glandin-induced symptoms such as inflamma- to parasympathetic nerve impulses and to tion; a nonsteroidal anti-inflammatory drug parasympathomimetic drugs; an anticholiner- (ibuprofen). gic drug (atropine). Prostaglandin: a drug from the classes of cell- Parasympathomimetic: a drug that activates regulating hormones cyclized from arachi- organs innervated by the parasympathetic donic acid (alprostadil, maintains ductus arte- nervous system; a cholinergic drug (metoclo- riosus patency in newborn infants pending pramide HCl; neostigmine). corrective surgery for congenital heart defects). Pediculicide: an insecticide suitable for eradicat- Protease Inhibitor: is a drug used to treat or pre- ing louse infestations (pediculosis) (malathion; vent infection by viruses, including HIV and permethrin). hepatitis C. Penicillin Adjuvant: a drug that extends the Proteasome Inhibitor: a drug that blocks the systemic duration of penicillin by inhibiting its action of proteasomes, cellular complexes that renal excretion (probenecid). break down proteins Phenothiazine: an antipsychotic or antidepressant Protectant: a topical drug that provides a phys- drug that contains the phenothiazine nucleus ical barrier to the environment (zinc gelatin, in its chemical structure (chlorpromazine, anti- skin protectant; methylcellulose, ophthalmic psychotic; imipramine, antidepressant). protectant). Phosphate Binder: an agent that reduces the Proteolytic, Injectable: an enzyme drug for injec- absorption of phosphate when taken with tion into herniated lumbar intervertebral discs meals and snacks. to reduce interdiscal pressure (chymopapain). Photosensitizer: a drug that increases cutaneous Prothrombogenic: a drug with vitamin K activity; response to ultraviolet light; it is used with it is useful in treating the hypoprothrombin- ultraviolet light to treat certain skin diseases emia of vitamin K deficiency or overdosage (e.g., psoriasis) (methoxsalen). with a vitamin K antagonist (phytonadione).  APPENDIX A 761 Proton Pump Inhibitor: a drug that inhibits gas- Smoking Deterrent: a drug that serves to mini- tric acid production. mize the desire to smoke. Psychedelic: a drug (especially a street drug) that Somatostatin Analog: a hormone chemically and induces vivid sensory phenomena and halluci- functionally similar to somatostatin. nations (mescaline). Specific: a drug specially adapted in its indicated Psychotherapeutic: a drug used to treat abnormal use, usually because of a functional relation- mental or emotional processes (chlorpromazine, ship between drug mechanism and disease haloperidol). pathophysiology. Stimulant, Central: a drug that increases the R functional state of the central nervous system, Radiographic Agent: see X-Ray Contrast Medium. sometimes used in convulsive therapy of men- Radiopaque Agent: a drug used to help diagnose tal disorders (flurothyl; modafinil). certain medical diseases. Stimulant, Respiratory: a drug that selectively Radiopharmaceutical: a drug containing a radio- stimulates respiration, either by peripheral active isotope; it is used for diagnostic or initiation of respiratory reflexes or by selective therapeutic purposes (iodinated albumen with central nervous system stimulation (carbon 125 I or 131I). dioxide, reflex respiratory stimulant; ethami- Rauwolfia Alkaloid: a plant principle derived van, central respiratory stimulant). from Rauwolfia serpentina and related species, Stool Softener: a drug used to soften the stool by with antihypertensive and antipsychotic actions enhancing the incorporation of water to ease (reserpine). evacuation. Resin, Electrolyte Removing: see Ion Exchange Sulfonylurea: an oral antidiabetic drug that con- Resin. tains the sulfonylurea moiety in its chemical Respiratory Stimulant: a drug which serves to structure (glimepiride, glipizide). increase the action of the respiratory system; it Sunscreening Agent: a skin protectant that increases breathing. absorbs light energy at wavelengths that cause Retinoic Acid Derivative: a derivative of vitamin sunburn (paraaminobenzoic acid, PABA). A (retinol). Suppressant: a drug that inhibits the progress of Reverse COMT Inhibitor: a drug that inhibits the a disease but does not cure it. action of catechol-O-methyltransferase. Sympatholytic: a drug that inhibits response to Rubefacient: a topical drug that induces mild sympathetic nerve impulses and to sympatho- skin irritation with erythema; it is used as a mimetic drugs; an antiadrenergic drug (phen- toughening agent (rubbing alcohol). tolamine, alpha sympatholytic; propranolol, beta sympatholytic; clonidine, alpha2 sympatholytic; S doxazosin mesylate, alpha sympatholytic). Salt Substitute: a sodium-free alternative to Sympathomimetic: a drug that activates organs sodium chloride used for flavoring foods innervated by the sympathetic nervous sys- (potassium chloride). tem; an adrenergic drug (epinephrine). Scabicide: an insecticide suitable for the eradica- Systemically Acting Drug: a drug administered tion of the itch mite Sarcoptes scabiei (scabies) so as to reach systemic circulation, from which (crotamiton). the drug diffuses into all tissues, including the Sclerosing Agent: an irritant drug suitable for injec- site of the therapeutic action. tion into varicose veins to induce their fibrosis and obliteration (morrhuate sodium injection). T Sedative: a central nervous system depressant Thiazide Diuretic: a diuretic that contains the used to induce mild relaxation (phenobarbital). benzothiadiazide (thiazide) moiety in its chem- Selective Estrogen Receptor Modulator (SERM): a ical structure (hydrochlorothiazide). compound that acts on the estrogen receptor to Thrombolytic: an enzyme drug administered par- selectively inhibit or stimulate estrogen-like enterally to solubilize blood clots (enoxaparin action in various tissues. sodium, urokinase, warfarin sodium). Serotonin Agonist: a compound that activates Thyroid Hormone: a hormone that maintains serotonin receptors, mimicking the effect of the metabolic function and normal metabolic rate neurotransmitter serotonin. of tissues (levothyroxine). Serotonin Antagonist: a drug used to inhibit the Topically Acting Drug: a drug applied to the action at serotonin receptors. body surface for local therapeutic action. 762 APPENDIX A Toxoid: a modified antigen from an infectious Vasoconstrictor: a drug that narrows arterioles, organism used as a vaccine (tetanus toxoid). usually to elevate blood pressure. See Trace Element: a chemical element required by Vasopressor. living organisms in minute amounts. Vasodilator, Coronary: a drug that expands blood Tranquilizer, Minor: an old term for an anxiolytic vessels in the heart and improves coronary drug. blood flow; it is useful in treating angina pecto- Tranquilizer: a drug (such as antipsychotic) used ris; an antianginal drug (nitroglycerin). to suppress an acutely disturbed emotional Vasodilator, Peripheral: a drug that expands state (trifluoperazine, antipsychotic). peripheral blood vessels and improves blood Tricyclic Antidepressant: an antidepressant that flow to the extremities of the body (minoxidil). contains the tricyclic phenothiazine nucleus in its Vasopressor: an adrenergic drug administered to chemical structure (amitriptyline, imipramine). constrict arterioles and elevate arterial blood Tuberculostatic: see Antitubercular. pressure (norepinephrine). Vesicant: a blistering agent or blister-producing U agent. Urea Cyclic Disorder Agent: a drug used to treat Vinca Alkaloid: a plant principle derived from a severe disease of newborns in which ammo- Vinca rosea and related species, with antineo- nia is not correctly metabolized in the liver. plastic action (vincristine). Uricosuric: a drug that promotes renal excretion Vitamin: an organic chemical essential in small of uric acid; it is useful in treating chronic gout amounts for normal metabolism; it is used (probenecid). therapeutically to supplement the vitamin con- Urinary Acidifier: an agent used to adjust the tent of foods (ascorbic acid, thiamine HCl, pH of the urine to be more acidic (ammonium pyridoxine HCl). chloride). Uterine Contractant: an obstetric drug used after X placenta delivery to induce sustained uter- Xanthine Alkaloid: a plant principle chemically ine contraction to reduce bleeding (methyler- related to xanthine, with central nervous sys- gonovine). tem stimulant, smooth muscle relaxant, and Uterine Contraction Inhibitor: a drug that inhib- diuretic actions (caffeine). its uterine muscle contraction; it is used in Xanthine Oxidase Inhibitor: a substance that preterm labor to prolong gestation (ritodrine). inhibits the activity of xanthine oxidase, an enzyme involved in purine metabolism. V X-Ray Contrast Medium: a drug opaque to X-rays Vaccine: an antigen-containing drug used to that assists visualization of an internal organ induce active immunity against an infectious during radiographic examination (barium disease (hepatitis B vaccine, rabies vaccine). sulfate, iopanoic acid).  APPENDIX B Glossary of Pharmaceutical Terms and Dosage Forms A Blocks: large veterinary products intended to be Active Ingredient: the ingredient or ingredients licked by animals and containing API(s) and of a pharmaceutical product responsible for nutrients such as salts, vitamins, and minerals. its pharmacologic activity (also medicament, Bolus: a large, long tablet intended for adminis- drug substance, active pharmaceutical ingre- tration to animals. dient [API]). Aerosol: a dosage form that is packaged under pres- C sure and contains therapeutically active ingredi- Caplet: tablet dosage form in the shape of a ents that are released upon activation of an appro- capsule. priate valve system. A dosage form consisting Capsule: a solid dosage form in which the drug of a liquid or solid preparation packaged under is enclosed within a hard or soft soluble con- pressure and intended for administration as a tainer or shell. fine mist. The descriptive term aerosol also refers Capsule, Delayed-Release: a coated capsule or to the fine mist of small droplets or solid particles more commonly encapsulated granules that that are emitted from the product. may be coated to resist releasing the drug in the Aerosol Foam: a dosage form containing one or stomach because the drug will irritate gastric more active ingredients, surfactants, aqueous mucosa or gastric fluid will inactivate the drug. or nonaqueous liquids, and the propellant; if Capsule, Extended-Release: a capsule that is for- the propellant is in the internal (discontinuous) mulated in such a manner as to make the con- phase (i.e., of the oil-in-water type), a stable tained medication available over an extended foam is discharged, and if the propellant is in the period following ingestion. external (continuous) phase (i.e., of the water- Capsule, Film-Coated Extended-Release: a solid in-oil type), a spray or a quick-breaking foam is dosage form in which the drug is enclosed discharged. within either a hard or soft soluble container Aerosol, Metered: a pressurized dosage foam or “shell” made from a suitable form of gel- consisting of metered-dose valves, which atin; additionally, the capsule is covered in a allow for the delivery of a uniform quantity of designated film coating, which releases a drug spray upon each activation. (or drugs) in such a manner to allow at least Ampul: a final container that is all glass in which the a reduction in dosing frequency as compared open end, after filling with product, is sealed by to that drug (or drugs) presented as a conven- heat (also ampoule, ampule, [French] carpule). tional dosage form. Aromatic Water: a clear, saturated, aqueous solu- Capsule, Gelatin-Coated: a solid dosage form in tion of volatile oils or other aromatic or volatile which the drug is enclosed within either a hard substances. or soft soluble container made from a suitable Aseptic: lacking disease-producing microorgan- form of gelatin; through a banding process, isms; not the same as sterile. the capsule is coated with additional layers of Aseptic Processing: manufacturing dosage forms gelatin so as to form a complete seal. without terminal sterilization. The dosage Capsule, Liquid-Filled: a solid dosage form in form is sterile filtered, aseptically filled into which the drug is enclosed within a solu- the final package, and then aseptically sealed. ble, gelatin shell, which is plasticized by the Aural (Auricular): for administration into, or by addition of a polyol, such as sorbitol or glyc- way of, the ear. erin, and is therefore of a somewhat thicker consistency than that of a hard-shell capsule; B typically, the active ingredients are dissolved Bead: a solid dosage form in the shape of a small or suspended in a liquid vehicle. sphere. The dosage form generally contains Capsule, Soft-Shell: a solid dosage form in which multiple beads (also pellet). one or more active ingredients, normally in 763 764 APPENDIX B solution or suspension or in the form of a Dosage Form: a formulation that typically con- paste, are filled into a one-piece shell. tains the API(s) and excipients in quantities Chewable: attribute of a solid dosage form that and physical form designed to all the accurate is intended to be chewed or crushed before and efficient administration of the API to swallowing. the human or animal patient. Coated: attribute of a solid dosage form that is Douche: a liquid preparation intended for the irri- covered by deposition of an outer solid that is gative cleansing of the vagina; prepared from different in composition from the core material. powders, liquid solutions, or liquid concentrates. Collodion: a liquid preparation composed of Dressing: the application of various materials for pyroxylin dissolved in a solvent mixture of protecting a wound. alcohol and ether and applied externally. Drops, Oral: a solution, emulsion, or suspension Colloidal Dispersion: an attribute of a prepara- that is administered in small volumes, such as tion or formulation in which particles of col- drops, by means of a suitable device. loidal dimension (i.e., typically between 1 nm Drug Delivery System: modern technology, dis- and 1 μm) are distributed uniformly through- tributed with or as a part of a drug product out a liquid. that allows for the uniform release or targeting Concentrate: a liquid preparation of increased of drugs to the body. strength and reduced volume, which is usually Dry Powder Inhaler: a device used to administer diluted prior to administration or use. an inhalation powder in a finely divided state Concentrate for Dip: a preparation containing one suitable for oral inhalation by the patient. or more active ingredients usually in the form of a paste or solution; it is used to prepare a E diluted suspension, emulsion, or solution of the Effervescent: a dosage form containing ingredi- active ingredient(s) for the prevention and treat- ents that rapidly release carbon dioxide when ment of ectoparasitic infestations of animals. in contact with water. Conventional-Release: descriptive term for a Elixir: a clear, pleasantly flavored, sweetened dosage form in which no deliberate effort has hydroalcoholic liquid containing dissolved been made to modify the release rate of the active ingredients intended for oral use. API. In the case of capsules and tablets, the Emollient: attribute of a cream of ointment indi- inclusion or exclusion of a disintegrating agent cating an increase in the moisture content of is not interpreted as a modification. the skin following application of bland, fatty, Cream: a semisolid dosage form containing one or or oleaginous substances. more drug substances dissolved or dispersed in Emulsion: a two-phase system in which one a suitable base. An emulsion dosage form often liquid is dispersed throughout another liquid containing more than 20% water and volatiles in the form of small droplets. A dosage form and/or containing < 50% hydrocarbons, waxes, consisting of a two-phase system composed of or polyols, as the vehicle for the API. Creams at least two immiscible liquids, one of which are generally intended for external application is dispersed as droplets (internal or dispersed to the skin or mucous membranes. phase) within the other liquid (external or con- tinuous phase), generally stabilized with one D or more emulsifying agents. Delayed-Release: a type of modified-release dos- Enema: a rectal preparation for therapeutic, diag- age form. A descriptive term for a dosage nostic, or nutritive purposes. form deliberately modified to delay release of Enteric-Coated: descriptive term for a solid dos- the API for some period of time after initial age form in which a polymer coating has been administration. For example, release of the API applied to prevent the release of the API in the is prevented in the gastric environment but gastric environment. promoted in the intestinal environment; this Excipient: an ingredient of a dosage form other term is synonymous with Enteric-Coated or than an API. Gastro-Resistant. Extended-Release: descriptive term for a dosage Dental: descriptive term for a preparation that is form that is deliberately modified to protract applied to the teeth or gums for local action. the release of the API compared to that observed Dermal: a topical route of administration where for an immediate-release dosage form. The term the article is intended to reach or be applied to is synonymous with prolonged or sustained the dermis. release. Many extended-release dosage forms  APPENDIX B 765 have a pattern of release that begins with a Gel, Metered: a gel preparation, with metered-dose “burst effect” that mimics an immediate release valves, which allow for the delivery of a uni- followed by a slower release of the remaining form quantity of gel upon each activation. API in the dosage form. Globule: also called pellets or pilules, are made of Extract: a concentrated preparation of vegetable pure sucrose, lactose, or other polysaccharides. or animal drug obtained by removal of the They are formed into small globular masses of active constituents with suitable menstrua, by various sizes and are medicated by placing them evaporation of all or nearly all of the solvent, in a vial and adding the liquid drug attenuation and by adjustment of the residual mass or in the proportion not less than 1% (w/v). After powder to the prescribed standards. shaking, the medicated globules are dried at temperatures not to exceed 40°C. F Granules: a preparation of dry aggregates of Film: a thin layer or coating. A term used to powder particles that may contain one or more describe a thin, flexible sheet of material, usu- active ingredients with or without other ingre- ally composed of a polymer. Films are used in dients. They may be swallowed as such, dis- various routes of administration including as persed in food, or dissolved in water. Granules a means of oral administration of material in are frequently compacted into tablets or filled a rapidly dissolving form. The term may also into capsules, with or without additional be used as an attribute when applied to solid ingredients. oral dosage forms for taste masking, product Gum: a mucilaginous excretion from various identification, and aesthetic purposes. plants. A dosage form in which the base consists Fluidextract: a liquid preparation of a vegetable of a pliable material that, when chewed, releases drug containing alcohol as a solvent, preserva- the API into the oral cavity. tive, or both and so made that unless otherwise Gum, Chewing: a sweetened and flavored insolu- specified in an individual monograph, each ble plastic material that, when chewed, releas- milliliter contains the therapeutic constituents es a drug substance into the oral cavity. of 1 g of the standard drug. Gum, Resin: natural mixture of gum and resin, Foam: an emulsion packaged in a pressurized usually obtained as exudations from plants. aerosol container that has a fluffy, semisol- id consistency when dispensed. An emulsion H dosage form containing dispersed gas bubbles. Hard-Shell Capsule: a type of capsule in which For Solution: a product, usually a solid, intended one or more APIs, with or without other ingre- for solution prior to administration. dients, are filled into a two-piece shell. For Suspension: a product, usually a solid, intend- ed for suspension prior to administration. I Immediate-Release: descriptive term for a dosage G form in which no deliberate effort has been Gas: one of the states of matter having no definite made to modify the API release rate. In the shape or volume and occupying the entire con- case of capsules and tablets, the inclusion or tainer when confined. exclusion of a disintegrating agent is not inter- Gastro-Resistant: descriptive term for a solid dos- preted as a modification. age form in which a polymer coating has been Implant: see Pellet. A small sterile solid mass applied to prevent the release in the gastric consisting of a highly purified drug with or environment. without excipients made by compression or Gel: a semisolid system consisting of either a molding and put in place by injection or incision. suspension of small inorganic particles or large Infusion, Intramammary: a suspension of a drug organic molecules interpenetrated by a liquid. in a suitable oil vehicle; intended for veterinary It may contain suspended particles. It may use only. contain a gelling agent to promote stiffness. Inhalant: a special class of inhalations consisting Gel, Dentifrice: a combination of a dentifrice of a drug or combination of drugs that by vir- (formulation intended to clean and/or pol- tue of their high vapor pressure can be carried ish the teeth and which may contain certain by an air current into the nasal passage where additional agents) and a gel. It is used with they exert their effect; the container from a toothbrush for the purpose of cleaning and which the inhalant generally is administered is polishing the teeth. known as an inhaler. 766 APPENDIX B Inhalation: a route of administration for aerosols M characterized by dispersion of the API into the Modified-Release: a release pattern of the active airways during inspiration. ingredient from the dosage form that has been Injection, Liposomal: an injection, which either deliberately changed from that of the conven- consists of or forms liposomes (a lipid bilayer tional form. It includes accelerated release, vesicle usually composed of phospholipids, delayed release, extended release, pulsatile which is used to encapsulate an active drug release, and targeted release. substance). Molded Tablet: a tablet that has been formed by Injection: a preparation intended for parenteral dampening the ingredients and pressing them administration or for constituting or diluting into a mold, then removing and drying the a parenteral product prior to administration. resulting solid mass. A route of administration of a liquid or semi- Mouthwash: an aqueous solution used to rinse solid deposited into a body cavity, fluid, or the oral cavity. tissue by use of a needle. Insert: a specially formulated and shaped non- N encapsulated solid preparation intended to Nasal: route of administration (mucosal) charac- be placed into a nonrectal orifice of the body, terized by deposition in the nasal cavity for where drug is released, generally for localized local or systemic effect. effects. Intraocular: a route of administration to deliver a O sterile preparation within the eye. Ocular: route of administration indicating deposi- Intrauterine Device: a device inserted and left in tion of the API within the eye. the uterus to prevent effective conception. Oil: an unctuous, combustible substance that Irrigation: a sterile solution intended to bathe or is liquid, or easily liquefiable, on warming flush open wounds or body cavities. and is soluble in ether but insoluble in water. Such substances, depending on their origin, J are classified as animal, mineral, or vegetable Jelly: see Gel. oils. Ointment: a semisolid preparation intended for L external application to the skin or mucous Liniment: an alcoholic or oleaginous solution membrane. A semisolid dosage form, usually or emulsion applied by rubbing on the skin containing < 20% water and volatiles and more for treating pain and stiffness of underlying than 50% hydrocarbons, waxes, or polyols as musculature. the vehicle. This dosage form generally is for Liposomes: microvesicles composed of a bilayer external application to the skin or mucous and/or concentric series of multiple bilayers membranes. separated by aqueous compartments formed Ophthalmic: a route of administration character- by amphipathic molecules such as phos- ized by application of a sterile preparation to pholipids, which enclose a central aqueous the external parts of the eye. compartment. Ophthalmic Ointment: a sterile ointment intend- Lipstick: a waxy solid, usually colored cosmetic, ed for application to the eye. in stick form for the lips. Ophthalmic Preparation: drug in a dosage form Liquid: a dosage form consisting of a pure chem- intended to be applied to the eye. ical in its liquid state. This dosage form term Ophthalmic Solution: a sterile solution, essential- should not be applied to solutions. ly free from foreign particles, suitably prepared Lotion: a fluid emulsion applied to the surface and packaged for application to the eye. of the skin. See Solution or Suspension. The Ophthalmic Strip: a sterile single-use container term has also been applied to suspensions and or sterile impregnated paper strip containing solutions. the drug to be applied to the eye. Lozenge: a solid preparation that is intended to Ophthalmic Suspension: a sterile liquid prepa- dissolve or disintegrate slowly in the mouth. ration containing solid particles dispersed in Lyophilization: removal of water or other sol- a liquid vehicle intended for application to vent from a frozen solution by sublimation the eye. caused by a combination of temperature Orally Disintegrating: a descriptive term for and pressure differentials (also called freeze a solid oral dosage form that disintegrates drying). rapidly in the mouth prior to swallowing. The  APPENDIX B 767 API is generally intended for gastrointestinal Premix: a mixture of one or more drug substances delivery and/or absorption. with a suitable vehicle. Oropharyngeal: a route of administration charac- Prolonged-Release: see Extended-Release. terized by deposition of a preparation into the Pulsatile Release: a release pattern of the active oral cavity and/or pharyngeal region to exert ingredient from the dosage form modified to a local or systemic effect. release aliquots of the total dose at two or more Otic: a route of administration characterized by time intervals. deposition of a preparation into, or by way of, the ear. Also referred to as aural. R Otic Solution: a solution intended for instillation Radiopharmaceuticals: “radioactive pharmaceu- in the outer ear. ticals,” or substances labeled with radioisotope Otic Suspension: a liquid preparation containing and used for diagnostic imaging or therapy. micronized particles intended for instillation Each name specifies the substance, the isotope, in the outer ear. and the dosage form. Rectal: a route of administration (mucosal) char- P acterized by deposition into the rectum to Paste: a semisolid dosage form that contains one provide local or systemic effect. or more drug substances intended for topical Rinse: a solution used to cleanse by flushing. application. It generally contains a high con- centration of solids (20% to 50%) and has a stiff S consistency. It is intended for application to the Salve: a thick ointment or cerate (a fat- or wax- skin, oral cavity, or mucous membranes. based preparation with a consistency between Pastille: an aromatic preparation, often with a an ointment and a plaster). pleasing flavor, usually intended to dissolve Semisolid: attribute of a material characterized in the mouth. by a reduced ability to flow or conform to its Patch: a drug delivery system that often contains container at room temperature. A semisolid an adhesive backing usually applied to an does not flow at low shear stress and generally external site on the body. Its ingredients either exhibits plastic flow behavior. passively diffuse from or are actively trans- Shampoo: a solution, emulsion, or suspension ported from some portion of the patch. used to clean the hair and scalp. Pellet: see Bead. A small solid dosage form of Soap: the alkali salt(s) of one or more fatty acids. uniform, often spherical, shape. Spherical pel- Soft Gel Capsule: a specific capsule type char- lets are sometimes referred to as beads. Pellets acterized by increased levels of plasticizers intended as implants must be sterile. (Also a producing a more pliable and thicker-walled solid granule or regular shape prepared by material than hard gelatin capsules. Soft gel compaction, molding, or granulation.) capsules are further distinguished because they Periodontal: descriptive term for a preparation that are single-piece sealed dosages. Frequently is applied around a tooth for localized action. used for delivering liquid compositions. Pill: a solid spherical dosage form usually pre- Solution: a liquid preparation that contains one pared by a wet massing technique. or more dissolved (molecularly dispersed) Plaster: a solid or semisolid mass supplied on a chemical substances in a suitable solvent or backing material and intended to provide pro- mixture of miscible solvents; it may be oral, longed contact with the skin. topical, otic, or ophthalmic. A clear, homog- Pledget: a small compress or tuft, usually of cot- enous liquid dosage form that contains one ton or cotton wool, used to apply disinfectant or more chemical substances dissolved in or medicament to the skin. a solvent or mixture of mutually miscible Poultice: a soft, moist mass of meal, herbs, seed, solvents. etc., usually applied hot on a cloth that consists Solution, Concentrate: a liquid preparation (i.e., a of gruel-like consistency. substance that flows readily in its natural state) Powder: an intimate mixture of dry, finely divid- that contains a drug dissolved in a suitable sol- ed drug and/or chemicals that may be intend- vent or mixture of mutually miscible solvents; ed for internal (oral) or external (topical) use. the drug has been strengthened by the evapo- Powder, Inhalation: a powder containing an API ration of its nonactive parts. for oral inhalation. The powder is used with a Spirit: an alcoholic or hydroalcoholic solution of device that aerosolizes and delivers an accu- volatile substances prepared usually by simple rately metered amount. solution or by admixture of the ingredients. 768 APPENDIX B Sponge: a porous, interlacing, absorbent material Tablet, Chewable: a tablet formulated so that it that contains a drug. It is typically used for may be chewed, producing a pleasant-tasting applying or introducing medication or for residue that is easily swallowed and does not cleansing. A sponge usually retains its shape. leave a bitter or unpleasant aftertaste. Spray: a liquid minutely divided as by a jet of air Tablet, Delayed-Release: a tablet with a coating or steam; used to facilitate application to the that is intended to postpone the release of the intended area medication until the tablet has passed through Stent, Drug-Eluting: a specialized form of implant the stomach. used for extended local delivery of the API to Tablet, Effervescent: a solid dosage form contain- the immediate location of stent placement. ing mixtures of acids and sodium bicarbonate, Sterile: completely lacking living (viable) micro- which release carbon dioxide when dissolved bial life. in water; it is intended to be dissolved or dis- Sterility: an acceptably high level of probability persed in water before administration. that a product processed in an aseptic system Tablet, Extended-Release: a tablet that is formu- does not contain viable microorganisms. lated so as to make the contained medication Stick: a slender, cylindrical dosage form of rigid available over an extended period following consistency. ingestion. Strip: see Tape, Medicated. Tablet, Orally Disintegrating: a solid dosage Sublingual: a route of administration (mucosal) form containing medicinal substances, which characterized by placement underneath the disintegrates rapidly, usually within a matter tongue and for release of the API for absorp- of seconds, when placed upon the tongue. tion in that region. Tape, Medicated: a dosage form or device com- Suppository: a solid dosage form in which one or posed of a woven fabric or synthetic material more APIs are dispersed in a suitable base and onto which an API is placed, usually with an molded or otherwise formed into a suitable adhesive on one or both sides to facilitate top- shape for insertion into the rectum to provide ical application. local or systemic effect. Targeted Release: release of the active ingredient Suspension: a liquid preparation that consists of from a dosage form modified to preferentially solid particles dispersed throughout a liquid deliver most of the drug to a specific region, phase in which the particles are not soluble; it organ, or tissue. may be oral, topical, otic, or ophthalmic. Terminal Sterilization: a process used to produce Swab: a small piece of relatively flat absorbent sterility in the final product contained in its material that contains a drug. A swab may also final packaging system. be attached to one end of a small stick. A swab Tincture: an alcoholic or hydroalcoholic solution is typically used for applying medication or prepared from vegetable materials or from for cleansing. chemical substances. Syrup: a solution containing a high concentration Topical: a route of administration characterized of sucrose or other sugars. See Solution. by application to the outer surface of the body. System, Intrauterine: a system that is intended Transdermal Delivery System, Electroporation: a for release of drug over a long period, such as transdermal delivery system enhanced by the a year. application of short, high-voltage electric puls- System: a dosage form developed to allow for uni- es to create aqueous pores in the lipid bilayer of form release or targeting of drugs to the body. the skin and thereby facilitate drug diffusion. System, Ocular: a dosage form intended for place- Transdermal Delivery System, High-Velocity ment in the lower conjunctival fornix, from Powder Particles: a transdermal drug deliv- which the drug diffuses through a membrane at ery system using supersonic shock waves of a constant rate. helium gas to enhance drug diffusion through System, Transdermal: a self-contained, discrete the skin. dosage form that is designed to deliver drug(s) Transdermal Delivery System, Iontophoresis: a through the intact skin to the systemic circu- transdermal drug delivery system enhanced lation. by the use of applied electric current to facili- tate drug diffusion through the skin. T Transdermal Delivery System, Phonophoresis: a Tablet: a solid dosage form containing medicinal transdermal drug delivery system enhanced by substance(s) with or without diluents. the application of low-frequency ultrasound to  APPENDIX B 769 facilitate drug diffusion through the skin (also Vaginal Tablet or Insert: a vaginal insert prepared ultrasound, sonophoresis, ultrasonophoresis, by compression of powdered materials into ultraphonophoresis). a suitable shape; it can also be prepared by Transdermal Matrix Patch: a transdermal matrix encapsulation in soft gelatin. system using a polymeric matrix containing Validation: scientific study to prove that a process drug intended for systemic delivery through is doing what it is supposed to do and is under the skin; generally, the skin is the rate- control. controlling membrane for drug diffusion. Vehicle: a term commonly encountered that refers Transdermal Membrane Patch: a transdermal to a component for internal or external use system containing a drug reservoir entrapped that is used as a carrier or diluent in which between backing and adhesive layers and liquids, semisolids, or solids are dissolved or a drug diffusion-controlling membrane; the suspended. Examples include water, syrups, reservoir is usually a semisolid dispersion or elixirs, oleaginous liquids, solid and semisolid solution of the drug. carriers, and proprietary products. Troche: see Lozenge. Veterinary: descriptive term for dosage forms intended for nonhuman use. U Urethral: a dosage form intended for insertion W into the urethra to provide a local effect of the Wafer: a thin slice of a material containing a active ingredient. medicinal agent. Water, Aromatic: a clear, saturated aqueous solu- V tion (unless otherwise specified) of one or Vaginal: a route of administration (mucosal) char- more volatile oils or other aromatic or volatile acterized by deposition into the vagina. substances.