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O P H A R M A C O L O G Y INTRODUCTION T JDDE DEFINITION OF TERMS DRUG THE WORD DRUG COMES FROM DROGUE (“DROWGE”), MEANING ‘A DRY HERB.’ A DRUG CAN BE DEFINED AS: “A SUBSTANCE, MATERIAL OR PRODUCT USED FOR THE PURPOSE OF DIAGNOSIS, PREVENTI...

O P H A R M A C O L O G Y INTRODUCTION T JDDE DEFINITION OF TERMS DRUG THE WORD DRUG COMES FROM DROGUE (“DROWGE”), MEANING ‘A DRY HERB.’ A DRUG CAN BE DEFINED AS: “A SUBSTANCE, MATERIAL OR PRODUCT USED FOR THE PURPOSE OF DIAGNOSIS, PREVENTION, AND RELIEF OF SYMPTOMS OR CURE OF DISEASE.” WHO DEFINES A DRUG AS: “A SUBSTANCE, MATERIAL OR PRODUCT USED OR INTENDED TO BE USED TO MODIFY OR EXPLORE THE PHYSIOLOGICAL PROCESSES OR PATHOLOGICAL STATES FOR THE BENEFIT OF THE RECIPIENT.” MEDICINE CHEMICAL PREPARATION THAT IS ADMINISTERED TO PRODUCE A THERAPEUTIC EFFECT OTHER SUBSTANCES BESIDES THE ACTIVE DRUG EXCIPIENT LONG-TERM STABILIZATION BULKING UP SOLID FORMULATIONS, OFTEN REFERRED TO AS "BULKING AGENTS," "FILLERS," OR "DILUENTS.” THERAPEUTIC ENHANCEMENT OF THE ACTIVE INGREDIENT IN THE FINAL DOSAGE FORM, SUCH AS FACILITATING DRUG ABSORPTION, REDUCING VISCOSITY, OR ENHANCING SOLUBILITY CONSIDERED TO BE PHARMACOLOGICALLY INACTIVE AND SAFE ADVERSE EFFECTS ARE GENERALLY UNCOMMON, BUT THE POTENTIAL FOR TOXICITY IS INCREASED AT HIGH MG PER KG DOSES, ESPECIALLY IN NEONATES AND INFANTS. DOSE-RELATED TOXICITY AND HYPERSENSITIVITY REACTIONS ARE WELL- DOCUMENTED SOLVENT DISSOLVES A SOLUTE, RESULTING IN A SOLUTION COMMON EXCIPIENTS USED IN TABLETS EXCIPIENTS FUNCTION EXAMPLES Diluents Provide bulk and enable Sugar compounds e.g., lactose, accurate dosing of potent dextrin, glucose, sucrose, ingredients sorbitol Inorganic compounds e.g., silicates, calcium and magnesium salts, sodium or potassium chloride Binders, compression aids, Bind the tablet ingredients Mainly natural or synthetic granulating agents together giving form and polymers e.g., starches, sugars, mechanical strength sugar alcohols and cellulose derivatives Disintegrants Aid dispersion of the tablet in the Compounds which swell or gastrointestinal tract, releasing dissolve in water e.g., starch, the active ingredient and cellulose derivatives and increasing the surface area for alginates, crospovidone dissolution Glidants Improve the flow of powders Colloidal anhydrous silicon and during tablet manufacturing by other silica compounds reducing friction and adhesion between particles. Also used as anti-caking agents. Lubricants Similar action to glidants, Stearic acid and its salts (e.g., however, they may slow magnesium stearate) disintegration and dissolution. The properties of glidants and lubricants differ, although some compounds, such as starch and talc, have both actions. Tablet coatings and films Protect tablet from the Sugar (sucrose) has now been environment (air, light and replaced by film coating using moisture), increase the natural or synthetic polymers. mechanical strength, mask taste Polymers that are insoluble in and smell, aid swallowing, assist acid, e.g., cellulose acetate in product identification. Can be phthalate, are used for enteric used to modify release of the coatings to delay release of the active ingredient. May contain active ingredient. flavors and colorings. Coloring agents Improve acceptability to Mainly synthetic dyes and patients, aid identification and natural colors. Compounds that prevent counterfeiting. Increase are themselves natural stability of light-sensitive drugs. pigments of food may also be used. PHARMACOLOGY STUDY OF THE EFFECTS OF DRUGS ON THE FUNCTION OF LIVING SYSTEMS PHARMACOLOGY IS NOT SYNONYMOUS WITH PHARMACY PHARMACOLOGY - A BIOMEDICAL SCIENCE PHARMACY - A HEALTH SERVICES PROFESSION CONCERNED WITH THE APPLICATION OF THE PRINCIPLES LEARNED FROM PHARMACOLOGY CLINICAL PHARMACOLOGY CLINICAL PHARMACOLOGY IS THE SCIENTIFIC STUDY OF DRUGS IN MAN. MAIN OBJECTIVES ARE: MAXIMIZE THE EFFECT OF A DRUG MINIMIZE THE ADVERSE EFFECTS PROMOTE THE SAFETY OF PRESCRIPTION BRANCHES PHARMACODYNAMICS - WHAT DRUGS DO TO THE BODY AND HOW PHARMACOKINETICS - WHAT HAPPENS TO THE DRUG WHILE IN THE BODY PHASES OR STEPS LIBERATION - PROCESS BY WHICH MEDICATION ENTERS THE BODY AND LIBERATES THE ACTIVE INGREDIENT THAT HAS BEEN ADMINISTERED DISINTEGRATION, DISAGGREGATION AND DISSOLUTION DISSOCIATION GENERALLY REFERS TO BREAKING A COMPOUND INTO SMALLER PIECES TO FORM A SOLUTION. NOTE THAT THERE CAN BE DISSOCIATION WITHOUT THE FORMATION OF CHARGED SPECIES (I.E., IONIZATION) ABSORPTION– MOVEMENT OF DRUG INTO THE BLOODSTREAM DISTRIBUTION - TRANSMISSION OF THE DRUG FROM ONE LOCATION TO THE OTHER IN THE BODY METABOLISM - HOW THE DRUG IS PROCESSED IN THE BODY EXCRETION - HOW THE DRUG IS EXPELLED FROM THE BODY THERAPEUTICS THE BRANCH OF PHARMACOLOGY DEALS WITH THE ART AND SCIENCE OF TREATING DISEASE. IT IS THE APPLICATION OF PHARMACOLOGICAL INFORMATION, TOGETHER WITH KNOWLEDGE OF THE DISEASE, TO PREVENT AND CURE. CHEMOTHERAPY CHEMOTHERAPY REFERS TO TREATING DISEASES WITH CHEMICALS THAT KILL THE CELLS, ESPECIALLY THOSE OF MICROORGANISMS AND NEOPLASTIC CELLS. IT IS CLASSIFIED INTO TWO DIVISIONS. ANTIBIOTICS ANTI-NEOPLASTIC TOXICOLOGY TOXICOLOGY IS THE BRANCH OF PHARMACOLOGY THAT INCLUDES THE STUDY OF ADVERSE EFFECTS OF DRUGS ON THE BODY. DEALS WITH THE SYMPTOMS, MECHANISMS, TREATMENT, AND DETECTION OF POISONING CAUSED BY DIFFERENT CHEMICAL SUBSTANCES. THE MAIN CRITERION IS THE DOSE. ESSENTIAL MEDICINES ARE POISONS IN HIGH DOSES, AND SOME POISONS ARE ESSENTIAL MEDICINES IN LOW DOSES. DRUG INTERACTIONS STUDY OF HOW DRUGS AFFECT EACH OTHER RATIONAL PRESCRIBING ABOUT USING THE RIGHT MEDICINE DOSE ROUTE FREQUENCY OF ADMINISTRATION DURATION PHARMACOECONOMICS BRANCHOF HEALTH ECONOMICS THAT AIMS TO QUANTIFY IN ECONOMIC TERMS THE COST AND BENEFIT OF DRUGS USED THERAPEUTICALLY EXPERIMENTAL PHARMACOLOGY STUDY OF PHARMACOLOGY THROUGH BIOASSAY TO TEST THE EFFICACY AND POTENCY OF A DRUG POSOLOGY STUDY OF HOW MEDICINES ARE DOSED DEPENDS UPON VARIOUS FACTORS, INCLUDING AGE, WEIGHT, SEX, ELIMINATION RATE OF THE DRUG, GENETIC POLYMORPHISM, AND TIME OF ADMINISTRATION PHARMACOGENETICS THE BRANCH OF PHARMACOLOGY DEALS WITH THE GENETIC VARIATIONS THAT CAUSE DIFFERENCES IN DRUG RESPONSE AMONG INDIVIDUALS OR POPULATIONS. PHARMACOEPIDEMIOLOGY STUDY OF THE EFFECTS OF DRUGS ON LARGE NUMBERS OF PEOPLE WHAT IS AN EMERGENCY USE AUTHORIZATION? RISK-BASED PROCEDURE FOR ASSESSING UNLICENSED (UNDER DEVELOPMENT) VACCINES, THERAPEUTICS DURINGPUBLIC HEALTH EMERGENCIES OF INTERNATIONAL CONCERN AIM OF EXPEDITING AVAILABILITY TO PEOPLE AFFECTED BY A PUBLIC HEALTH EMERGENCY BASED ON AN ESSENTIAL SET OF AVAILABLE QUALITY, SAFETY, AND EFFICACY PERFORMANCE DATA ALL SAFETY DATA ACCUMULATED FROM PHASE 1 AND 2 STUDIES PORTION OF PHASE 3 DATA WILL INCLUDE A MEDIAN FOLLOW-UP OF AT LEAST 2- MONTHS WILL INCLUDE A PHASE 3 SAFETY DATABASE OF WELL OVER 3,000 RECIPIENTS E.G., COVID 19 VACCINES, IL-6 INHIBITORS (TOCILIZUMAB), ANTI- SARS-COV-2 MONOCLONAL ANTIBODIES (SOTROVIMAB), NUCLEOTIDE ANTIVIRAL DRUGS (REMDESIVIR) TO BE CONSIDERED, AN EUA MUST MEET THE FOLLOWING FOUR STATUTORY CRITERIA. THESE CRITERIA AIM TO ENSURE THAT THE PUBLIC RECEIVES THE BEST, SAFEST, MOST APPROPRIATE CARE POSSIBLE, EVEN IN AN EMERGENCY. THERE MUST BE A SERIOUS OR LIFE-THREATENING ILLNESS CAUSED BY A SPECIFIED CHEMICAL, BIOLOGICAL, RADIOLOGICAL, OR NUCLEAR AGENT. NO ADEQUATE APPROVED, ALTERNATIVE MEDICAL COUNTERMEASURES MUST BE AVAILABLE FOR THE SITUATION. THE KNOWN AND POTENTIAL BENEFITS NEED TO OUTWEIGH THE KNOWN AND POTENTIAL RISKS. IT MUST BE REASONABLE TO BELIEVE THAT THE PRODUCT COVERED BY THE EUA IS GOING TO BE EFFECTIVE FOR THE INTENDED USE— DIAGNOSING, TREATING, OR PREVENTING EITHER AN ILLNESS OR CONDITION CAUSED BY A SPECIFIC AGENT OR AN ILLNESS OR CONDITION CAUSED BY AN APPROVED OR AUTHORIZED MEDICAL COUNTERMEASURE DEPLOYED AGAINST THE AGENT. WHAT OTHER COUNTRIES HAVE A MECHANISM SIMILAR TO AN EUA? US FOOD AND DRUG ADMINISTRATION- EMERGENCY USE AUTHORIZATION CHINA NATIONAL MEDICINAL PRODUCTS ADMINISTRATION- EMERGENCY USE AUTHORIZATION EUROPEAN MEDICINES AGENCY – CONDITIONAL MARKETING AUTHORIZATION AUSTRALIA THERAPEUTIC GOODS ADMINISTRATION PROVISIONAL PATHWAY JAPAN PHARMACEUTICALS AND MEDICAL DEVICES AGENCY- CONDITIONAL EARLY APPROVAL SYSTEM THE EUA SHALL BE VALID UNTIL EXPRESSLY WITHDRAWN BY THE FDA DIRECTOR GENERAL OR UPON ISSUANCE OF FULL MARKET AUTHORIZATION/CERTIFICATE OF PRODUCT REGISTRATION IMMUNITY FROM LIABILITY IF SOMETHING UNINTENTIONALLY GOES WRONG WITH THEIR PRODUCTS UNLESS THERE’S “WILLFUL MISCONDUCT” BY THE COMPANY INDIVIDUALSTO WHOM THE PRODUCT IS ADMINISTERED ARE INFORMED OF THE OPTION TO ACCEPT OR REFUSE ADMINISTRATION OF THE PRODUCT, OF THE CONSEQUENCES, IF ANY, OF REFUSING ADMINISTRATION OF THE PRODUCT, AND OF THE ALTERNATIVES TO THE AVAILABLE PRODUCT AND THEIR BENEFITS AND RISKS. CANNOT PURCHASE THE PRODUCTS FROM PRIVATE CLINICS OR PHARMACIES. ONLY THE GOVERNMENT IS DULY AUTHORIZED TO PROCURE AND ADMINISTER THE PRODUCTS. UNTIL SOURCES OF DRUGS PLANT SOURCES E.G., PLANT ALKALOIDS PLANT SOURCE IS THE OLDEST SOURCE OF DRUGS. MOST OF THE DRUGS IN ANCIENT TIMES WERE DERIVED FROM PLANTS. LEAVES: FLOWERS FRUITS SEEDS ROOTS BARK STEM ANIMAL SOURCES SHEEP THYROID IS A SOURCE OF THYROXIN, WHICH IS USED IN HYPERTENSION. COD LIVER IS USED AS A SOURCE OF VITAMINS A AND D. THE ANTERIOR PITUITARY IS A SOURCE OF PITUITARY GONADOTROPINS USED IN INFERTILITY TREATMENT. MINERAL/ EARTH SOURCES IRON IS USED IN THE TREATMENT OF IRON DEFICIENCY ANEMIA. ZINC IS USED AS A ZINC SUPPLEMENT. ZINC OXIDE PASTE IS USED IN WOUNDS AND IN ECZEMA. IODINE IS AN ANTISEPTIC. IODINE SUPPLEMENTS ARE ALSO USED. GOLD SALTS ARE USED IN THE TREATMENT OF RHEUMATOID ARTHRITIS SELENIUM AS SELENIUM SULFIDE IS USED IN ANTI-DANDRUFF SHAMPOOS. MICROBIOLOGICAL SOURCES PENICILLIUM NOTATUM IS A FUNGUS WHICH GIVES PENICILLIN. ACTINOBACTERIA GIVE STREPTOMYCIN. SEMI-SYNTHETIC SOURCES/ SYNTHETIC SOURCES SEMI-SYNTHETIC WHEN THE NUCLEUS OF A DRUG OBTAINEDFROM A NATURAL SOURCE IS RETAINED, BUT THE CHEMICAL STRUCTURE IS ALTERED SYNTHETIC WHEN THENUCLEUS OF THE DRUG FROM A NATURAL SOURCE, AS WELL AS ITS CHEMICAL STRUCTURE, IS ALTERED MOST OF THE DRUGS USED NOWADAYS ARE SYNTHETIC FORMS. RECOMBINANT DNA TECHNOLOGY INVOLVES CLEAVAGE OF DNA BY ENZYME RESTRICTION ENDONUCLEASES THE DESIRED GENE IS COUPLED TO RAPIDLY REPLICATING DNA (VIRAL, BACTERIAL PLASMID) THE NEW GENETIC COMBINATION IS INSERTED INTO THE BACTERIAL CULTURES, WHICH ALLOW THE PRODUCTION OF A VAST AMOUNT OF GENETIC MATERIAL E.G., MONOCLONAL ANTIBODIES PRODUCED EX VIVO USING TISSUE-CULTURE TECHNIQUES ADVANTAGES: HUGE AMOUNTS OF DRUGS CAN BE PRODUCED THE DRUG CAN BE OBTAINED IN PURE FORM IT IS LESS ANTIGENIC DISADVANTAGES: WELL- EQUIPPED LAB IS REQUIRED HIGHLY TRAINED STAFF IS REQUIRED IT IS A COMPLEX AND COMPLICATED TECHNIQUE DRUG DEVELOPMENT PROCESS REPRODUCTIVE TOXICITY TESTING INVOLVESTHE STUDY OF THE FERTILITY EFFECTS OF THE CANDIDATE DRUG AND ITS TERATOGENIC AND MUTAGENIC TOXICITY THEFDA HAS USED A 5-LEVEL DESCRIPTIVE SCALE TO SUMMARIZE INFORMATION REGARDING THE SAFETY OF DRUGS IN PREGNANCY. PREGNANCY- RISK CATEGORIES CATEGORY A: NO RISK IN HUMAN STUDIES (STUDIES IN PREGNANT WOMEN HAVE NOT DEMONSTRATED A RISK TO THE FETUS DURING THE FIRST TRIMESTER). CATEGORY B: NO RISK IN ANIMAL STUDIES (THERE ARE NO ADEQUATE STUDIES IN HUMANS, BUT ANIMAL STUDIES DID NOT DEMONSTRATE A RISK TO THE FETUS). CATEGORY C: RISK CANNOT BE RULED OUT. THERE ARE NO SATISFACTORY STUDIES IN PREGNANT WOMEN, BUT ANIMAL STUDIES DEMONSTRATED A RISK TO THE FETUS; THE POTENTIAL BENEFITS OF THE DRUG MAY OUTWEIGH THE RISKS. CATEGORY D: EVIDENCE OF RISK (STUDIES IN PREGNANT WOMEN HAVE DEMONSTRATED A RISK TO THE FETUS; POTENTIAL BENEFITS OF THE DRUG MAY OUTWEIGH THE RISKS). CATEGORY X: CONTRAINDICATED (STUDIES IN PREGNANT WOMEN HAVE DEMONSTRATED A RISK TO THE FETUS, AND/OR HUMAN OR ANIMAL STUDIES HAVE SHOWN FETAL ABNORMALITIES; RISKS OF THE DRUG OUTWEIGH THE POTENTIAL BENEFITS). DOSAGE FORMS DOSAGE FORMS ARE GIVEN ORALLY LIQUID PREPARATIONS- MIXTURES, SUSPENSIONS, EMULSIONS, LINCTUSES, ELIXIRS, SYRUPS, TINCTURES, SPIRITS, AROMATIC WATER SOLID PREPARATIONS DOSAGE FORMS ARE GIVEN RECTALLY SUPPOSITORIES, ENEMAS DOSAGE FORMS ARE GIVEN PARENTALLY INJECTIONS (AMPOULES, VIALS, INFUSIONS) DOSAGE FORMS GIVEN THROUGH RESPIRATORY PASSAGES GASES, VAPORS, STEAM INHALATIONS, AEROSOLS, SPRAYS, NEBULIZERS TOPICALLY GIVEN (EXTERNAL APPLICATION, SKIN, MUCOUS MEMBRANES) CREAMS, OINTMENTS, LINIMENTS, LOTIONS, PASTES, POULTICES, DUSTING POWDERS, LOZENGES, EYE, EAR, AND NASAL DROPS, MOUTHWASHES, GLYCERIN, PAINTS, GARGLES, SOLUTIONS, VAGINAL DOUCHES, PESSARIES ORAL ROUTE MIXTURES: IT IS A LIQUID PREPARATION CONSISTING OF ONE OR MORE DRUGS DISSOLVED IN AQUEOUS VEHICLE, USUALLY FLAVORED, MEANT FOR INTERNAL ADMINISTRATION. E.G., CARMINATIVE MIXTURE SUSPENSION: MIXTURES OF INSOLUBLE OR SPARINGLY SOLUBLE DRUGS IN WATER OR OTHER VEHICLE, IN WHICH PARTICLES OF INSOLUBLE DRUGS ARE KEPT IN SUSPENDED STATE, WITH THE HELP OF A SUITABLE SUSPENDING AGENT. E.G., KAOLIN SUSPENSION EMULSIONS: MIXTURES CONTAINING TWO IMMISCIBLE LIQUIDS MADE MISCIBLE WITH THE HELP OF EMULSIFYING AGENTS. E.G., CASTOR OIL EMULSION. LINCTUSES: THICK VISCOUS LIQUID PREPARATIONS CONTAINING SUCROSE AND MEDICINES WITH DEMULCENT, EXPECTORANT AND SEDATIVE PROPERTIES. THEY ARE USED FOR COUGH. E.G., CODEINE LINCTUSES ELIXIRS: PLEASANTLY FLAVORED AND SWEETENED LIQUID PREPARATION CONTAINING HIGH PROPORTION OF ALCOHOL OR GLYCERIN OR PROPYLENE GLYCOL. E.G., PARACETAMOL ELIXIR SYRUPS: CONCENTRATED AQUEOUS SOLUTION OF SUCROSE OR OTHER SUGARS TO WHICH MEDICINES OR FLAVORING AGENTS MAY BE ADDED. E.G., CODEINE PHOSPHATE SYRUP TINCTURES: ALCOHOLIC OR HYDROCHLORIC SOLUTIONS CONTAINING COMPARATIVELY LOW CONCENTRATION OF ACTIVE PRINCIPLES OF CRUDE DRUGS. THEY ARE GENERALLY PREPARED BY PERCOLATION OR MACERATION. E.G., TINCTURE CARDAMOM COMPOUND. TABLETS: COMPACT PRODUCTS CONTAINING MEDICINES IN COMPRESSED FORM, DISCOID IN SHAPE BUT MAY BE ROUND OR LONG, CYLINDRICAL OR TRIANGULAR. E.G., ASPIRIN TABLET, CO TRIMOXAZOLE CAPSULES: CAPSULES CONSIST OF A MEDICINE ENCLOSED IN A SHELL. SHELL IS MADE OF GELATIN. THIS IS CONVENIENT FOR MEDICINES HAVING UNPLEASANT TASTE. CAPSULES ARE USUALLY CYLINDRICAL. E.G., CAPSULE AMOXIL. PILLS: SPHERICAL OR OVOID MASSES CONTAINING ONE OR MORE MEDICAMENTS (MEDICINES). THEY ARE SMALLER IN SIZE AND CONTAIN SMALLER QUANTITY OF DRUG. POWDERS: MIXTURES OF TWO OR MORE MEDICINES IN FINELY DIVIDED FORMS. MINIMUM WEIGHT IS 120 MG. E.G., ATROPINE POWDER, ORS. GRANULES: PREPARATIONS OF MEDICINES USUALLY IN THE FORM OF SMALL IRREGULAR PARTICLES 2-4 MM IN DIAMETER. E.G., ENO GRANULES. RECTAL ROUTE SUPPOSITORIES SOLID PREPARATIONS MEANT FOR RECTAL ROUTE ADMINISTRATION. E.G., GLYCERIN SUPPOSITORY. ENEMAS: AQUEOUS, LIQUID, OILY SOLUTIONS OR SUSPENSIONS FOR RECTAL ROUTE. THEY ARE ANTI-INFLAMMATORY, HAVING ANTHELMINTIC, PURGATIVE AND SEDATIVE EFFECT. THEY ARE ALSO USED FOR X-RAY EXAMINATION OF THE LARGE GUT. E.G., PREDNISOLONE PARENTERAL ROUTE INJECTIONS: STERILE SOLUTIONS INTENDED FOR PARENTERAL ADMINISTRATION GIVEN FOR THOSE DRUGS THAT CANNOT BE GIVEN ORALLY OR ARE INACTIVATED IN THE BODY. THEY PRODUCE RAPID AND PROLONGED EFFECT. E.G., HYDROCORTISONE INJECTIONS. INHALATION ROUTE AEROSOL INHALATION: AEROSOL INHALATION CONSISTS OF SOLUTION OF MEDICINE IN A MIXTURE OF INERT PROPELLANTS HELD UNDER PRESSURE IN AEROSOL DISPENSER, CONSISTING OF METERING VALVE. E.G., SALBUTAMOL AEROSOL INHALATION INHALATIONS: LIQUID PREPARATIONS COMPOSED OF VOLATILE INGREDIENTS WHEN VAPORIZED ARE BROUGHT INTO CONTACT WITH THE LINING OF THE RESPIRATORY TRACT. E.G., BENZOIC INHALATION. SPRAYS: PREPARATIONS OF MEDICINES IN AQUEOUS, ALCOHOL OR GLYCEROL CONTAINING MEDIA APPLIED THROUGH NOSE OR THROAT BY ATOMIZER. E.G., LIGNOCAINE SPRAY. TOPICAL ROUTE LOTIONS: A LOTION IS A LOW- TO MEDIUM-VISCOSITY MEDICATED OR NONMEDICATED TOPICAL PREPARATION, INTENDED FOR APPLICATION TO UNBROKEN SKIN. CREAMS: OPAQUE, VISCOUS, RELATIVELY SOFT, CONSISTENTLY SPREADABLE, SEMISOLID DOSAGE FORM THAT OFTEN COMPRISE MORE THAN 20% WATER & VOLATILES AND NORMALLY LESS THAN 50% HYDROCARBONS, WAXES, OR POLYOLS AS THE VEHICLE FOR THE DRUG SUBSTANCE, INTENDED FOR EXTERNAL APPLICATION. OINTMENTS: SEMISOLID DOSAGE FORMS THAT COMPRISE LESS THAN 20% WATER & VOLATILES AND MORE THAN 50% HYDROCARBONS, WAXES, OR POLYOLS AS THE VEHICLE INTENDED FOR EXTERNAL APPLICATION. LINIMENTS: A LIQUID OR LOTION, ESPECIALLY ONE MADE WITH OIL, FOR RUBBING ON THE BODY TO RELIEVE PAIN PASTE: SEMISOLID DOSAGE FORMS CONTAIN A LARGE PROPORTION OF SOLID COMPONENTS. THEY DIFFER FROM OINTMENTS IN THEIR CONSISTENCY, AS THEY CONTAIN LARGER AMOUNTS OF SOLIDS AND CONSEQUENTLY ARE THICKER AND STIFFER. PASTES CAN BE MADE OF FATTY BASES, SUCH AS PETROLATUM AND HYDROPHILIC PETROLATUM, OR AQUEOUS GELS, SUCH AS CELLULOSES. PASTES MAY CONTAIN ONE OR MORE DRUG SUBSTANCES INTENDED FOR TOPICAL APPLICATION. POULTICES: THICK PASTY PREPARATION IS USED EXTERNALLY TO REDUCE INFLAMMATION AND PAIN. DUSTING POWDER: A MIXTURE OF TWO OR MORE SUBSTANCES IN FINELY POWDERED FORM. IT IS APPLIED EXTERNALLY BUT NOT ON OPEN WOUNDS. EYE DROPS: STERILE SOLUTIONS OR SUSPENSIONS FOR INSTILLATION INTO EYES. THEY CONTAIN SUBSTANCES WITH ANTISEPTIC, ANESTHETIC, ANTI- INFLAMMATORY, ANTI-MICROBIAL, MYDRIATIC OR MYCOTIC PROPERTIES. E.G., CHLORAMPHENICOL EYE DROPS, PILOCARPINE. EYE LOTIONS: SOLUTIONS FOR WASHING OR BATHING EYE. E.G., SODIUM BICARBONATE EYE LOTION. EYE OINTMENT: SEMISOLID SOFT PREPARATION FOR APPLICATION TO CONJUNCTIVAL SAC OR LID MARGIN. EAR DROPS: LIQUID PREPARATIONS INSTILLED INTO THE EAR. E.G., CHLORAMPHENICOL. LOZENGES: SOLID DOSAGE FORMS OF MEDICINES FOR SLOW DISSOLUTION IN MOUTH. THEY CONSIST OF MEDICINES MOSTLY IN FLAVORED BASES. E.G., STREPSILS. PAINTS: LIQUID PREPARATIONS MEANT FOR SKIN, MUCOUS MEMBRANES CONTAINING VOLATILE SOLVENT WHICH EVAPORATES QUICKLY TO LEAVE A DRY FILM OF MEDICINE. THEY CONTAIN GLYCERIN WHICH PROLONGS THEIR EFFECT. E.G., GUM PAINT, THROAT PAINT. GARGLES: AQUEOUS SOLUTIONS USUALLY IN CONCENTRATED FORM, USED AFTER DILUTED FOR PREVENTION OR TREATMENT OF THROAT INFECTIONS. THEY ARE USUALLY THROWN OUT OF MOUTH MOUTH WASHES: AQUEOUS SOLUTIONS ARE CONCENTRATED WITH DEODORANT, ANTISEPTIC, LOCAL ANALGESIC, ASTRINGENT PROPERTIES. THEY ARE THROWN OUT OF MOUTH AFTER RINSING.. PESSARIES: SOLID BODIES FOR VAGINAL ADMINISTRATION CONTAINING DRUGS FOR LOCAL ACTIONS. E.G., NYSTATIN PESSARIES. CONTROVERSIAL ISSUES SURROUNDING DRUG INVENTION AND DEVELOPMENT MISTRUST OF SCIENTISTS AND THE PHARMACEUTICAL INDUSTRY GREED OF COMPANIES AND SCIENTISTS GRAFT, FRAUD, AND MISCONDUCT BY SCIENTISTS AND INDUSTRY EXECUTIVES, AND UNETHICAL BEHAVIOR IN UNIVERSITY LABORATORIES AND COMMUNITY PHYSICIANS’ OFFICES PROFIT MOTIVE AND AN OBLIGATION TO SHAREHOLDERS OF INVESTOR-OWNED PHARMACEUTICAL COMPANIES PRICING AND PROFITABILITY MANY HEALTH INSURERS SEEK TO CONTROL COSTS BY CHOOSING NOT TO COVER CERTAIN “BRAND NAME” PRODUCTS FEW DRUGS (ESPECIALLY FOR TREATMENT OF CANCER) HAVE BEEN INTRODUCED TO THE MARKET IN RECENT YEARS AT PRICES THAT GREATLY EXCEEDED THE COSTS OF DEVELOPMENT, MANUFACTURE, AND MARKETING OF THE PRODUCT INTELLECTUAL PROPERTY AND PATENTS THE U.S. PATENT PROTECTION SYSTEM MANDATES THAT WHEN A NEW DRUG IS INVENTED, THE PATENT COVERING THE PROPERTY LASTS ONLY 20 YEARS FROM WHEN THE PATENT IS FILED. THE PATENT OWNER MAY BRING SUIT TO PREVENT OTHERS FROM MARKETING THE PRODUCT, GIVING THE MANUFACTURER OF THE BRAND-NAME VERSION EXCLUSIVE RIGHTS TO MARKET AND SELL THE DRUG DRUG PROMOTION THE AMOUNT SPENT ON THE PROMOTION OF DRUGS APPROXIMATES OR PERHAPS EVEN EXCEEDS THAT SPENT ON RESEARCH AND DEVELOPMENT. THE MAJOR CRITICISM OF DRUG MARKETING INVOLVES SOME UNSAVORY APPROACHES TO INFLUENCE PHYSICIAN BEHAVIOR. EXPLOITATION OR “MEDICAL IMPERIALISM” PRIVATE-SECTOR INVESTMENT IN PHARMACEUTICAL INNOVATION HAS FOCUSED ON PRODUCTS THAT WILL HAVE LUCRATIVE MARKETS IN WEALTHY COUNTRIES INEQUITABLEACCESS TO NEW PHARMACEUTICALS IN THE VERY COUNTRIES WHERE THEY HAVE BEEN TESTED TO LOWER COSTS, COMPANIES INCREASINGLY TEST THEIR EXPERIMENTAL DRUGS OUTSIDE THE U.S. AND THE E.U., IN COUNTRIES WITH LESS REGULATION AND EASIER ACCESS TO LARGE NUMBERS OF PATIENTS. IF THE DRUG IS SUCCESSFUL IN OBTAINING MARKETING APPROVAL, CONSUMERS IN THESE COUNTRIES OFTEN CANNOT AFFORD THE DRUGS THEY HELPED TO DEVELOP. PRODUCT LIABILITY FEAR OF LIABILITY CAUSES PHARMACEUTICAL COMPANIES TO BE OVERLY CAUTIOUS ABOUT TESTING > DELAYS ACCESS TO THE DRUG DRUG COSTS INCREASE FOR CONSUMERS WHEN PHARMACEUTICAL COMPANIES INCREASE THE LENGTH AND NUMBER OF TRIALS THEY PERFORM TO IDENTIFY EVEN THE SMALLEST RISKS AND WHEN REGULATORY AGENCIES INCREASE THE NUMBER OR INTENSITY OF REGULATORY REVIEWS. EXCESSIVE LIABILITY COSTS CREATE DISINCENTIVES FOR THE DEVELOPMENT OF SO-CALLED “ORPHAN DRUGS,” PHARMACEUTICALS THAT WOULD BENEFIT ONLY A SMALL NUMBER OF PATIENTS. “ME TOO” VERSUS TRUE INNOVATION: THE PACE OF NEW DRUG DEVELOPMENT “ME-TOODRUG” IS A TERM USED TO DESCRIBE A PHARMACEUTICAL THAT IS USUALLY STRUCTURALLY SIMILAR TO ONE OR MORE DRUGS THAT ALREADY ARE ON THE MARKET. OTHER NAMES FOR THIS PHENOMENON ARE “DERIVATIVE MEDICATIONS, " “MOLECULAR MODIFICATIONS,” AND “FOLLOW-UP DRUGS.” SOMETIMES, A ME-TOO DRUG IS A DIFFERENT MOLECULE DEVELOPED DELIBERATELY BY A COMPETITOR COMPANY TO TAKE MARKET SHARE FROM THE COMPANY WITH EXISTING DRUGS. VALID CRITICISMS OF ME-TOO DRUGS: EXCESSIVE EMPHASIS ON PROFIT WILL STIFLE TRUE INNOVATION. SOME ME-TOO DRUGS ARE MORE EXPENSIVE THAN THE OLDER VERSIONS THEY SEEK TO REPLACE, THE COSTS OF HEALTHCARE ARE INCREASED WITHOUT CORRESPONDING BENEFIT TO PATIENTS NEVERTHELESS, FOR SOME PATIENTS, ME-TOO DRUGS MAY HAVE BETTER EFFICACY OR FEWER SIDE EFFECTS OR PROMOTE COMPLIANCE WITH THE TREATMENT REGIMEN DRUG NOMENCLATURE SYSTEMATIC NAMING OF DRUGS 3 TYPES OF NAMES CHEMICAL (SCIENTIFIC) NAME BASED ON THE MOLECULAR STRUCTURE OF THE DRUG; DESCRIBES THE ATOMIC OR MOLECULAR STRUCTURE OF THE DRUG INTERNATIONAL UNION OF PURE AND APPLIED CHEMISTRY (IUPAC) USUALLY TOO COMPLEX AND CUMBERSOME FOR GENERAL USE E.G. 2-ACETOXYBENZOIC ACID N-ACETYL-P-AMINOPHENOL 1-(ISOPROPYLAMINO)-3-(1-NAPHTHYLOXY) PROPAN-2- OL GENERIC (NONPROPRIETARY) NAME ASSIGNED/ DESIGNATED NAME FOR A NEWLY APPROVED DRUG INTERNATIONAL NONPROPRIETARY NAME (INN) E.G. ACETYLSALICYLIC ACID ACETAMINOPHEN (US), PARACETAMOL (WORLDWIDE) PROPRANOLOL BRAND (TRADE OR PROPRIETARY) NAME EXCLUSIVE NAME OF A DRUG SUBSTANCEOR DRUG PRODUCT OWNED BY A COMPANY UNDER TRADEMARK LAW E.G. ASPIRIN BIOGESIC INDERAL END

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