1. PHARMACEUTICAL TECHNOLOGY CHEE 440

2. COURSE OBJECTIVES • introduce the fundamentals of preparing dosage forms • demonstrate the application of engineering fundamentals to large scale production of dosage forms • prepare student for an engineering position in the pharmaceutical industry CHEE 440

3. COURSE OUTLINE • Introduction • the need for delivery systems • Principles of Drug Absorption • Tablets, Capsules • unit operations • drug stability issues • Solutions, Suspensions, Emulsions • Principles of Sterilization • Good Manufacturing Practices CHEE 440

4. COURSE MATERIALS • recommended textbook • Pharmaceutics: The Science of Dosage Form Design, 3rd Ed., M.E. Aulton Editor, 2007. • other useful books • Remington: The Science and Practice of Pharmacy, 21st Ed., 2005 • Pharmaceutical Dosage Forms and Drug Delivery Systems, 6th Ed. 1995 • Perry’s Chemical Engineers’ Handbook • lecture notes • www.chemeng.queensu.ca/courses/CHEE440/lectures/index.php CHEE 440

5. GRADING • Midterm Exams (2) 50 % • Final Exam 50 % • Study problem sets • To aid in understanding material • solutions will be posted weekly CHEE 440

6. PHARMACEUTICAL INDUSTRY Drug Discovery - natural sources, synthesis/modification biological properties - pharmacology, pharmacokinetics Preclinical Studies preformulation - chem/phys properties - analytical assays • Formulation • development of dosage form • large-scale manufacturing Approval for Distribution Clinical Trials Post-Marketing Surveillance CHEE 440

7. Definitions drug - Any substance or mixture of substances manufactured, sold or represented for use in: a) the diagnosis, treatment, mitigation or prevention of a disease, a disorder, an abnormal physical state or the symptoms thereof in humans or animals b) restoring, correcting or modifying organic functions in humans or animals c) “disinfection” in premises in which food is manufactured, prepared or kept pharmaceutics - the area of study concerned with the formulation, manufacture, stability, and effectiveness of dosage forms pharmacology - the science of the properties of drugs and their effects on the body pharmacokinetics - the study of the kinetics of absorption, distribution, metabolism, and excretion of drugs and their corresponding pharmacologic response in animals/man clinic - a facility or area where ambulatory patients are seen for special study and treatment CHEE 440

8. Need for Dosage Forms • provide safe and accurate delivery of given dosage • protect drug from environmental degradation • protect drug from GI degradation • conceal bitter, salty taste, offensive odor • allow for administration of poorly soluble drug • provide rate-controlled action • allow for admin. by desired route CHEE 440

9. INTRODUCTION • drugs seldom administered alone • given as a formulation • contain additional ingredients called excipients • objective of dosage form design • achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality • must consider physical, chemical, biological properties of all components CHEE 440

10. Excipients CHEE 440

11. Routes of Administration CHEE 440