DOSAGE FORMS EXAM 3 - MCPHS FALL 2024 STUDY GUIDE WITH COMPLETE SOLUTIONS

DOSAGE FORMS EXAM 3 - MCPHS FALL 2024 STUDY GUIDE WITH COMPLETE SOLUTIONS Pharmaceutics - Answer️️ -General area of study concerned with the formulation, manufacture, stability and effectiveness of pharmaceutical dosage forms Drug - Answer️️ -any agent intended for use in the diagnosis, mitigation, treatment, cure or prevention of disease in humans or other animals Active Pharmaceutical Ingredient - Answer️️ -Any component that is intended to cause pharmacologic activity or other direct drug effects Broad steps of new drug development - Answer️️ -1) Drug Discovery 2) Animal Studies 3) Clinical Tests 4) Commercialization In silico screening - Answer️️ -Biological experimentation performed by a computer Drug discovery methods - Answer️️ -1) Screening natural compounds 2) Screening corporate compounds 3) In silico screening 4) Rational drug design 5) Combinatorial chemistry Combinatorial Chemistry - Answer️️ -Preparation of a large number of different compounds at the same time ©SOPHIABENNETT EXAM SOLUTIONS_2024/2025 Monday, September 2, 2024 12:59 PM Page | 2 ADMET - Answer️️ -Absorption Distribution Metabolism Excretion Toxicity Absorption (testing) - Answer️️ -To see that the drug passes GI track into blood stream Distribution (testing) - Answer️️ -To see that the the drug gets to target tissue Metabolism (testing) - Answer️️ -To see that the drug is not readily metabolized Excretion (testing) - Answer️️ -To see that the drug is not readily secreted Toxicity (testing) - Answer️️ -To see that the drug is not toxic to other cells or tissue Biologic Pre-clinical Tests - Answer️️ -Pharmacology, Drug metabolism and toxicology experiments Preformulation Studies - Answer️️ -1) Drug solubility 2) Partition coefficient 3) Dissolution rate 4) Physical form 5) Stability Clinical Phase I - Answer️️ -Study's absorption/metabolism, effects on organs and tissue and side effects on ~20-100 healthy volunteers IND - Answer️️ -Investigational New Drug Application Clinical Phase II - Answer️️ -Studies effectiveness in treatment, short-term side effects and dose range on a large number of patients (control and treatment groups) ©SOPHIABENNETT EXAM SOLUTIONS_2024/2025 Monday, September 2, 2024 12:59 PM Page | 3 Clinical Phase III - Answer️️ -Studies benefit/risk relationship of drug, less common/longer term side effects, and labeling information on a very large group of patients NDA - Answer️️ -New Drug Application Reasons for new drug failure - Answer️️ -Pharmacokinetics (39%) Lack of efficacy (30%) Animal toxicity (11%) Adverse effects in man (10%) Commercial reasons (5%) Other (5%) Solubility - Answer️️ -A measure of the maximum amount of substance that will dissolve in a liquid (at constant temperature) How to enhance aqueous solubility... - Answer️️ -1) create more soluble derivatives (i.e. salts or esters) 2) chemical complexation 3) reducing the drug's particle size What increases water solubility? - Answer️️ -Increased # of polar groups (-NH2, -OH, - SO3H, -COOH) and increased branching What decreases water solubility? - Answer️️ -Increasing # of C atoms in a molecule and increased molecular weight What properties are affected by particle size? - Answer️️ -dissolution r