PPT-Kinetics & Drug Stability

Presented by Mrs Rama Shukla Asst Prof LNCP Bhopal FIRST ORDER KINETICS In First order kinetics Active enzymes are waiting to work Increase in Plasma drug concentration . 67 No 3 pp 21757585223 2010 ISSN 00016837 Polish Pharmaceutical Society Over the past few decades significant medical advances have been made in the area of drug deliv ery with the development of controlled release dosage forms There are large varie of . Documentation For Regulatory Submissions. Bob Seevers. Outcomes of Stability Studies. Retest date or shelf-life for APIs. Shelf-life for drug products. Stability-indicating analytical methods. Appropriately protective packaging for API and drug product. . . . SEMINAR BY. . C483 Spring 2013. Questions. 1. Enzymes . that join two substrates and require energy of a nucleoside triphosphate (such as ATP) to do so are called. A. ) . isomerases. .. B. ) . lyases. .. C. ) ligases.. Lecture 8: Tuesday, 9/15/15. Today’s Objective. Kinetics of rectilinear motion. . What is Kinetics?. Kinetics is the study of the relations between unbalanced forces and the resulting changes in . safety study . of . ticagrelor's. degradation combining . LC-MS and . in . silico. approach. H. SADOU YAYE*, B. DO, N. YAGOUBI. * . Pharmacist at . Pitié-Salpêtrière. Hospital (Paris) . P. hD student – University Paris . LEARNING OBJECTIVES. Awareness of ICH / . EMA . / other . Stability Guidelines. Understand . minimum requirements for . Routine Stability study . of . marketed products (for . API, . Drug Product . and . safety study . of . ticagrelor's. degradation combining . LC-MS and . in . silico. approach. H. SADOU YAYE*, B. DO, N. YAGOUBI. * . Pharmacist at . Pitié-Salpêtrière. Hospital (Paris) . P. hD student – University Paris . Biosimilar. product development. Dr.. Rashbehari Tunga. Head Biotech. Stelis . Biopharma. 1. Index. Introduction. Regulatory guideline related to stability. Summary . of stability requirement at various stage. . Day . 5: Begin Kinetics Lab. Warm Up. If you are given . 15 M . stock solution and you need to make . ONLY 20 mL . of a . 6 M solution. , how much of the stock solution should you use?. Agenda. Demonstration. Part 2. Solubility Analysis. Preformulation solubility . studies . focus . on:. Drug-solvent . systems that could occur . during the . delivery of a drug candidate. . E.g.: a drug . for oral . administration should . Lecturer Dr . Athmar. . Dhahir. . Habeeb. PhD in industrial pharmacy and pharmaceutical formulations. 2. 4. 6. 8. 10. 12. 14. 5. 4. 3. 2. 1. Indomethacin. (weak acid). Chlorpromazine. (weak base). Oxytetracycline. NOTE FOR GUIDANCE ON STABILITY TESTING: STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS (CPMP/ICH/2736/99) SION TO CPMP November 1999 RELEASE FOR CONSULTATION November 1999 DEADLINE FOR COM INTERNATIONAL COUNCIL FOR HARMONIZATION. Q1B- . Photostability. (PS) testing of NDSP. To collect the inform. about PS of new molecular entity and associated drug products. No information about the PS of drug after administration.