Introduction to Pharmaceutical Dosage Forms PDF

Introduction to Pharmaceutical Dosage Forms Introduction to Pharmaceutical Dosage Forms Learning Objectives: At the end of the lesson, the student should be able to: 1. Know the reasons for formulating drugs into different dosage forms 2. Enumerate the different pharmaceutica...

Introduction to Pharmaceutical Dosage Forms Introduction to Pharmaceutical Dosage Forms Learning Objectives: At the end of the lesson, the student should be able to: 1. Know the reasons for formulating drugs into different dosage forms 2. Enumerate the different pharmaceutical dosage forms 3. Identify the functions of pharmaceutical dosage forms WHAT ARE DOSAGE FORMS? DOSAGE FORM a formulation containing specific quantity of pharmaceutical ingredients products designed for suitable administration of a drug to a patient for the diagnosis, treatment of a disease or relief of symptoms WHAT ARE DRUG PRODUCTS? DRUG PRODUCT represents a dosage form that contains the active ingredients and inactive ingredients. WHY DO WE NEED DOSAGE FORMS? The Need for Dosage Forms 1. To protect the drug subs. from the destructive influences of: a. atmospheric oxygen or humidity b. gastric acid after oral administration 2. To conceal the bitter, salty, offensive taste or odor of a drug subs. 3. To provide liq. preparations of subs. that are either insoluble or unstable in desired vehicle. 4. To provide clear liquid dosage forms of subs. 5. To provide rate-controlled drug action. The Need for Dosage Forms 6. To provide topical administration sites. 7. To provide for insertion of a drug into one of body’s orifices. 8. To provide for placement of drugs directly in the bloodstream or body tissues. 9. To provide for optimal drug action through inhalation therapy WHAT ARE THE CLASSIFICATION OF DOSAGE FORMS? Classifications of Dosage Form 1. According to the Method of Administration 2. According to the Physical Nature The dosages are divide in three forms: a. Solid dosage forms b. Liquid dosage forms c. Semi-solid dosage forms WHAT ARE THE CLASSIFICATION OF DOSAGE FORMS ACCORDING TO THEIR METHOD OR ROUTE OF ADMINISTRATION?  WHAT ARE ORALLY ADMINISTERED DRUGS? I. Method of Administration o Oral (mouth) Drug preparations intended to be taken by mouth Example: tablets, capsules, syrups, suspensions, oral drops, etc. I. Method of Administration oAbsorption through the oral mucosa Sublingual - under the tongue Buccal - buccal pouch WHAT ARE INHALATION DRUGS?  I. Method of Administration o Inhalation administered by the nasal or oral respiratory route for local or systemic effect Inhalants - consists of drugs or combinations of drugs that by virtue of high power pressure can be carried by air current into the nasal passage where they extend their effect. nebulizer, inhaler  WHAT ABOUT DRUGS ADMIISTERED PARENTERALLY? I. Method of Administration o Parenteral Drug preparations intended to be injected intravenously, intramascularly, subcutaneously Example: powder for injection  WHAT ABOUT DRUGS ADMINISTERED TOPICALLY? I. Method of Administration oTopical/Epicutaneous (skin surface) Drug preparations intended to be applied on the skin Examples: lotions, ointments, soap, creams, etc. WHAT ABOUT TRANSDERMAL DRUGS HOW DO THEY DIFFER WITH TOPICAL MEDICATIONS? I. Method of Administration o Transdermal drug delivery systems (skin surface) Drug preparations intended to be introduced through the surface of the skin and take effect systematically. Example: patch WHAT ABOUT DRUGS INTENDED FOR USE INTO THE RECTUM, VAGINA AND URETHRA? I. Method of Administration oRectal/vaginal/urethral (rectum,vagina,urethra) Drug preparations intended to take effect into body orifices Ex: suppositories WHAT ABOUT DRUGS USED FOR THE EYES, NOSE AND EAR? I. Method of Administration oIntraocular (eye) Conjuctival (conjuctiva) Ex: opthalmic drops/solutions I. Method of Administration oIntranasal (nose) Ex: nasal sprays/ inhalations / drops oAural (ear) Ex: otic drops /solutions  DRUG CLASSIFICATION ACCDG TO PHYSICAL NATURE A. Solutions a. Oral solutions b. Otic solutions c. Ophthalmic solutions d. Nasal solutions B. Aromatic water C.Enemas D. Gargles E. Mouthwashes F. Sprays G.Syrups H. Mucilages I. Elixirs J. Spirits A.Liniments B.Oleovitamins C.Toothache drops A.Emulsions B. Suspensions a.Gels b.Lotions c. Magmas and Milk d.Mixtures A.Tablets B. Capsules C.Powders a. Oral powders b. Dentrifices c. Douche powder d. Dusting powders ESC II. Physical Nature A.Liquid Dosage Form Solutions a homogeneous mixture that is prepared by dissolving a solid or liquid or gas in another liquid. Water – most commonly used solvents for drug solutions. WHAT ARE AROMATIC WATERS? I. Aqueous Solution o Aromatic water a.k.a “medicated vehicle” clear saturated aqueous solutions of volatile oils or other aromatic or volatile substances. used mainly as flavored or perfumed vehicles. WHAT ARE ENEMAS? I. Aqueous Solution o Enemas a.k.a “evacuation enemas” rectal solutions employed to evacuate the bowel  cleanse the bowel retention enemas (continuous drip) administered for local or for systemic effects WHAT ARE DOUCHES? I. Aqueous Solution oDouches (irrigations) applied into a cavity or part of the body used as cleansing or antiseptic agent WHAT ARE NASAL SOLUTIONS OR SPRAYS? I. Aqueous Solution oNasal solutions (sprays) administered to the nasal passage WHAT ARE OTIC SOLUTIONS? I. Aqueous Solution oOtic solutions dispensed in a container w/c permits the administration of drops into the ear WHAT ARE GARGLES AND MOUTHWASHES? I. Aqueous Solution oGargles/Mouthwashes used for deodorant, antiseptic and refreshing effect WHAT ARE TOPICAL SOLUTIONS? I. Aqueous Solution o Astringents Solutions w/c constrict the pores and precipitate proteins o Topical solutions Intended for topical application on the skin or mucous membranes Ex: local anti-infective solutions = kills microorganisms WHAT ARE ELIXIRS? II. Non-Aqueous Solutions oElixirs clear, pleasantly flavored sweetened hydro- alcoholic liquids intended for oral use used as flavors and vehicles main ingredient: ethanol and water WHAT ARE SPIRITS? II. Non-Aqueous Solutions oSpirits a.k.a. essences alcoholic or hydro-alcoholic solutions of volatile substances. commonly used as flavoring agent sometimes used medicinally by inhalation WHAT ARE LINIMENTS? II. Non-Aqueous Solutions o Liniment alcoholic or oleaginous solutions or emulsions of various medicinal subs. applied by being rubbed on the skin intended for external application Hydroalcoholic = rubafacient, counterirritant Oleaginous = massage WHAT ARE COLLODIONS?  II. Non-Aqueous Solutions o Collodions liquid preparations containing pyroxillin in a mixture of ethyl ether and ethanol applied to the skin by means of a soft brush or other suitable applicator when the ether and ethanol have evaporated, it leaves a film of pyroxylin on the surface Pyroxylin = soluble gun cotton WHAT ARE OLEOVITAMINS? II. Non-Aqueous Solutions o Oleovitamins fish liver oils diluted with edible vegetable oil or solutions of volatile substances of the indicated vitamins or vitamin concentrates (usually vit A & D) in fish liver oil WHAT ARE TOOTHACHE DROPS? II. Non-Aqueous Solutions oToothache drops used for temporary relief of toothache by application of cotton saturated with the product into tooth cavity. WHAT ARE SYRUPS AND MUCILAGES? II. Sweet or Viscid Aqueous Solutions o Syrups mixture of high concentration of sugar and water used as flavored or medicated syrup o Mucilages thick, viscid, adhesive liquids produced by  dispersing gum in water  extracting w/ water the mucilaginous principle from vegetable origin used as suspending agent WHAT ARE GELS AND JELLIES? III. Sweet or Viscid Aqueous Solutions o Gels Consists of dispersions of small or large molecules in an aq. liquid vehicle rendered jellylike (gelling agent) o Jellies (Gel) class of gels in w/c the structural coherent matrix contains high proportion of liquid (water) used as lubricants for surgical gloves, rectal thermometer WHAT ARE EXTRACTS?  II. Physical Nature B. Extracts solutions of active constituents of a crude drug (vegetable or animal) obtained by using suitable mestruum. Example: Methods of extraction maceration percolation Solvent is evaporated = residual mass/powder  adjusted to the prescribed standard ready for use as a medicinal agent or may be further processed to produce solid or semisolid extracts. B. Extracts o Tinctures alcoholic or hydro-alcoholic solutions prepared from:  vegetable materials  chemical substances o Fluidextracts liquid preparation of vegetable drugs containing alcohol as a solvent or as a preservative or both. Concentration = 1 g of drug/1 mL of solvent  II. Physical Nature C. Parenteral Preparations sterile preparations intended to be administered by injection under or through one or more layers of skin or mucous membranes. usually packed in ampoules or vials. Solutions ready for injections Dry, soluble products ready to be combined with a solvent just prior to the use Suspensions ready for injection Dry, insoluble products ready to be combined with a vehicle just prior to use Emulsions Parenteral Route Parenteral Routes Term Site 1. Intravenous Vein 2. Intraarterial Artery 3. Intracardiac Heart 4. Intraspinal/Intrathecal Spine 5. Intraosseous Bone 6. Intraarticular Joint 7. Intrasynovial Joint fluid area 8. Intracutaneous/ intradermal Skin 9. Subcutaneous Beneath the skin 10. Intramascular Muscle II. Physical Nature C. Intravenous Admixture a combination of one or more sterile products added to an IV fluid for administration mixed in a suitable environment using aseptic technique (Laminar flow hood) Intavenous Admixtures o Intravenous fluids sterile, large volume solutions intended to be administered by intravenous infusions contain sugar, amino acids or electrolytes  Intavenous Admixtures o Total Parenteral Nutrition preparation containing calories, nitrogen and other nutrients in sufficient quantities preferred source of: calories = dextrose  nitrogen = protein hydrolysate  electrolyte and vitamins = nutrients Pharmaceutical Dosage Forms Opthalmic Preparations Ophthalmic Preparations- sterile preparations to be used on the eyes. Solutions Suspensions Ointments Lens care products-sterile preparations intended to protect the lens Wetting solutions-preparations designed to furnish hydrophilic coating over the characteristically hydrophilic surface of hard contact lens surfaces Cleaning solutions-used to remove surface contaminants, lipids, protein and the like  Disinfection solutions-isotonic Soaking solutions- used to store and hydrate hard lenses and to disinfect such lenses Artificial tears-solution intended to rewet hard lenses in situ ads referred to as rewetting solutions or artificial tears. Medicated Applications Medicated Applications-applied to the skin or inserted into body orifices in liquid, semi solid, or solid forms Ointments Cataplasm (poultice)-a soft moist mass of meals, herb, seed ect. Usually applied hot in clothes. They are intended to localize infectious materials in the body or to act as counter irritants. Pastes-concentrates of absorptive powders dispersed in petrolatum or hydrophilic petrolatum. CONT. MEDICATED APPLICATIONS Powders Dressings Creams-viscous liquid or semi- solid emulsions of either the oil or water in oil type. Cream of the oil in water type includes shaving creams, hand creams, foundation creams,etc.: water in oil creams include cold creams and emollient creams  Plasters-substances intended for external application; they are made of such materials and of such consistency as to adhere to the skin and attach to a dressing. Suppositories Solid Dosage Forms  Powders Oral powders-generally supplied as finely divided powder or as effervescent granules Dentifrices-maybe prepared in the form of a bulk powder generally containing soap or detergent, mild abrasive and an anticariogenic agent.  Douches powders-soluble powders intended to be dissolved in water prior to use as antiseptic or cleaning agents for a body cavity. They are most commonly intented for vaginal use although they may be formulated for nasal, otic or ophthalmic use Dusting powders-locally applied non-toxic preparations that are intended to have no systemic action..  Insufflations-finely divided powders introduced into the body cavities such as the ears, nose, throat, tooth sockets and vagina with the use of an insufflators(powder blower) Triturators-dilutions of potent powdered drugs prepared by intimately mixing them with a suitable diluents in 1:10 DILUTIONS  Oral Solid Dosage Forms Tablets - solid dosage form containing drug substances with or without suitable diluents and prepared either by compression or molding methods. Compressed tablets Sugar coated tablets Film coated tablets Enteric coated tablets Multiple compressed tablet Controlled release tablet Effervescent tablet Compressed suppositories or inserts Buccal or sublingual tablets EC Controlled release tablet  Multiple compressed tablet Sugar coated Film coated  Molded tablets or tablet triturates Hypodermic tablets Capsules-solid dosage forms in which the drug substance is enclosed in either a hard or soft soluble container or of a suitable form of gelatin  Pills-small, round, solid dosage forms containing medicinal agents and intended for oral administration Troches-also known as lozenges or pastilles; they are discoid shaped solid containing the medicinal agent in a suitably flavored base. They are placed in the mouth where they slowly dissolve, liberating the active ingredient  Cachets-related to capsules in as much as they provide an edible container for the oral administration of solid drugs. They vary in sizes, ¾ to 1/8 inches in diameter and they consist of 2 concave pieces of wafer made of flour and water Pellets-small, sterile cylinders about 3.2mm in diameter by 8mm in length, formed by compression from medicated masses. Storage Temperature of Pharmaceuticals (USP) Freezer – between -25⁰C and -10 ⁰C (-13⁰F and 14⁰F ) Cold – not exceeding 8⁰C (46⁰F) Refrigerator – between 2⁰C and 8⁰C (36⁰F and 46⁰F) Cool – between 8⁰C and 15⁰C (46⁰F and 59⁰F) Warm – between 30⁰C and 40⁰C(86⁰F and 104⁰F ) Excessive Heat – above 40⁰C(104⁰F ) Controlled Room Temperature – between 20⁰C and 25⁰C (68⁰F and 77 ⁰F )