No | Module name | Drug Stability |
1 | Courses code | P20.02025 |
2 | Study loads | 2 credits |
3 | Semester | First Semester |
4 | Precondition | there is no |
5 | Competence |
Upon completion of this course, students are expected to be able to: 1. List and explain the physical and chemical properties of solvents and solutes that affect solubility and other properties of other bio-pharmaceuticals in the development of drug, bio- pharmaceutical, traditional medicine & supplement and cosmetics. 2. Explain the important factors required for the design, manufacture and evaluation of various dosage forms and other drug delivery systems. 3. Develop, validate and apply different instrumental methods to the analysis of medicinal substances in various dosage forms. 4. Identify and explain the principles that are involved in the absorption, distribution, metabolism and excretion of medicinal substances, and the factors that influence these processes. 5. Analyze and interpret data. 6. Design, manufacture and evaluate dosage forms and other drug delivery systems. 7. Characterize and evaluate physicochemical properties of pharmaceutical ingredients.Show contributions in individual or group projects. 8. Summarize information and communicate its development obtained from group experience. |
6 | Elements of competency | MKK |
7 | Type competency | supporting competence |
8 | Syllabus | 1. Introduction; 2. Introduction to the solid state; 3-4. Solid state stability; 5. Stability Analysis in Solid Dosage Forms; 6. Drug Stability Calculations; 7. Drug Stability from the Effect of Chemical Substances and Enzymes; 8. Mid-Term Exam; 9. Catalysis against Drug Stability; 10. Drug Kinetics; 11. Solid state; 12. Solid state Instability; 13. DSC PXRD SEM; 14. Factors Affecting the Reaction; 15. Quiseri parallel calculations; 16. Final Exam |
9 | Attribute to soft skills | ethics, awareness, discpline |
10 | Learning methods | Lecture and Discussion |
11 | Learning media | LCD |
12 | Appraisal | Written Test |
13 | Lecturer | Dr. rer. nat Apt. Anis Yohana Chaerunisa, M.Si. Prof. Apt. Muchtaridi, Ph.D. |
14 | References | Carstensen, Jens T., et al, Drug Stability : Principles and practices, Marcel Dekker, 2000 Yoshioka, Sumie and Stella, Valentino J., Stability of Drugs and Dosage forms, Kluwer academic, 2002 Tonnesen, Hanne H., Photostability of Drugs and Drug Formulations, CRC Press, 2004 Aulton, Michael E., Pharmaceutics : The Science of Dosage Form Design, W.B. Saunders Company, 2003 Piechocki, Joseph T., and Thoma, Karl, Pharmaceutical Photostability and Stabilization Technology, Informa Health, 2007. Kim Huynh-Ba, Handbook of Stability Testing in Pharmaceutical Development : Regulations, Methodologies and Best Practices, Springer Science, 2009 Brittain, Harry G., Polymorphism in Pharmaceutical Solids, Informa Health, 2009. Sinko, Patrick J., and Singh Yashveer, Martin’s Physical Pharmacy and Pharmaceutical Sciences : Physical Chemical and Biopharmaceutical Principles in the Pharmaceutical Sciences, Wolters Kluwer, 2011 Loftsson, Thorsteinn, Drug Stability for Pharmaceutical Scientists, Elsevier, 2014 |