USP Pharmaceutical Dosage Forms_Spring 2022.pdf

PHA 339 Alekha K. Dash, R.Ph., Ph.D. 1 Ø Understand and Differentiate between various dosage forms as specified in USP 1151 2 3 Ø Content Uniformity or Weight Variation?? Ø Content Uniformity: Assay of API content of Individual Units Ø Weight Variation: Weight of Individual Units 4 Ø Chemical Stabil...

PHA 339 Alekha K. Dash, R.Ph., Ph.D. 1 Ø Understand and Differentiate between various dosage forms as specified in USP 1151 2 3 Ø Content Uniformity or Weight Variation?? Ø Content Uniformity: Assay of API content of Individual Units Ø Weight Variation: Weight of Individual Units 4 Ø Chemical Stability: Expiration date of commercial products and Beyond use date of compounded products Ø Physical Stability: Reversible on shaking. Example: Dispersed products like emulsions Ø Performance over time: In vitro release, Disintegration, Dissolution 5 Ø Description: Size, Shape, Color etc. Ø Identification: API in drug products, Specific to API, should distinguish between similar molecules as API Ø Assay: Strength of API content in the formulation/ drug product Ø Impurities: Both API and Excipients, Synthetic byproducts, from processes, environments etc… 6 Uniformity of Dosage Forms Ø Water Content Ø Microbial limits Ø Anti Microbial preservative content Ø Anti-oxidant content Ø Sterility Ø Dissolution Ø Breaking Force, Friability Ø Leachable: Container closure systems (Rubber stopper, cap liner, plastic bottles etc.) Ø 7 Ø Other Tests: Alcohol contents, Redispersibility, Particle size distribution, rheological properties, reconstitution time, endotoxin/ pyrogens, particulate matter, functionality testing of delivery systems, delivered dose uniformity, viscosity, Osmolarity. 8 Ø Aerosols Ø Capsules Ø Inhalation Powders (DPIs) 9 Ø Emulsions (Creams and Lotions) 10 Ø Foams (Emulsions? Dispersions?) and Medical Gases 11 Ø Gels and Jellies; and Granules 12 Ø Medicated Gums and Implants 13 Ø Inserts, Liquids, Lozenges 14 Ø Ointments, Pastes 15 Ø Transdermal Systems, Pellets 16 Ø Pills, Plasters, Powders 17 Ø Medicated Soaps and Shampoos; Solutions 18 Ø Sprays, Suppositories, Suspensions 19 Ø Tablets, Tapes 20 21 22 23 24 25 26 Question: Classify the following Pharmaceutical Dosage Forms? A. B. C. D. E. F. Solid Dosage Forms Semi-Solid Dosage Forms Liquid Dosage Forms Oral Dosage Forms Biphasic Semi Solid Preparations Topical Dosage Forms Powders, Capsules, Tablets, Emulsions, Suspensions, Solutions, Creams, Ointments, Gels, Lotion, Irrigation, Troche, Pastes 27 Question: According to USP, which of the following statements is not true for different pharmaceutical dosage forms? A. Tape is a dosage form device composed of a woven fabric or synthetic material onto which an API is placed. B. Ointments are semisolid dosage forms containing more than 20% water and less than 50% hydrocarbons. C. Plaster is a dosage form containing a semisolid composition supplied on a support material for external application. D. Periodontal is a preparation that is applied around the tooth for localized action. E. Jelly is a semisolid dispersion of small inorganic particles containing a gelling agent for stiffness. B. Ointments are semisolid dosage forms containing more than 20% water less than 50% hydrocarbons. 28 ØUSP Chapter 1151: Pharmaceutical Dosage Forms 29