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Phases in drug developments I: Pre-clinical studies

Phases in drug developments I: Pre-clinical studies. Kausar Ahmad Department of Pharmaceutical Technology Kulliyyah of Pharmacy akausar@iium.edu.my http://staff.iium.edu.my/akausar. Phases in drug development. Preformulation. Physicochemical properties. Physicochemical properties.

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Phases in drug developments I: Pre-clinical studies

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  1. Phases in drug developments I: Pre-clinical studies Kausar Ahmad Department of Pharmaceutical Technology Kulliyyah of Pharmacy akausar@iium.edu.my http://staff.iium.edu.my/akausar RM-KAHS

  2. Phases in drug development RM-KAHS

  3. Preformulation RM-KAHS

  4. Physicochemical properties RM-KAHS

  5. Physicochemical properties RM-KAHS

  6. Spectroscopy RM-KAHS

  7. pKa • Determination of the dissociation constant for a drug - capable of ionization within a pH range of 1 to 10 • This is important since solubility, and consequently absorption, can be altered by changing pH (buffer). RM-KAHS

  8. Rate of dissolution • Determination of the rate is important when it is the rate limiting step in the drug absorption process. • If solubility of drug > 10 mg/ml, at pH7, there will be no problem of bioavailability or dissolution (Kaplan,1972) RM-KAHS

  9. Partition coefficient RM-KAHS

  10. Melting Point • Affected by purity • Affected by types of polymorphs RM-KAHS

  11. Crystal Properties & Polymorphism RM-KAHS

  12. Particle properties RM-KAHS

  13. Powder Flow & Compression Properties RM-KAHS

  14. Polyamide: Carrier for insoluble ingredients; Protector for sensitive ingredients; Slow delivery & long lasting effect 7 m, empty spheres 10 m, porous PHM4153 Dosage Design 2 2011/12

  15. Excipient: Particle size distribution PHM4153 Dosage Design 2 2011/12

  16. Excipient: Pore volume & pore diameter PHM4153 Dosage Design 2 2011/12

  17. Chemical Stability of Active Compounds RM-KAHS

  18. Excipients & Product Stability • Excipients are important for processing and efficacy • For tablets: binders, disintegrants, lubricants, and fillers. • For liquids: preservatives, thickener, colorants, flavours, sweeteners, buffer and water • Techniques to screen drug-excipient compatibility: • Thin-layer chromatography • Differential thermal analysis • Diffuse reflectance spectroscopy RM-KAHS

  19. Incompatibility PHM4153 Dosage Design 2 2011/12

  20. Detection of Incompatibility PHM4153 Dosage Design 2 2011/12

  21. Other factors to be considered in preformulation RM-KAHS

  22. Dosage form design RM-KAHS

  23. Dosage form RM-KAHS

  24. Formulation PHM4153 Dosage Design 2 2011/12

  25. Formulation requirement: efficacy, safety, and quality PHM4153 Dosage Design 2 2011/12

  26. Categories of excipients PHM4153 Dosage Design 2 2011/12

  27. Choosing excipients PHM4153 Dosage Design 2 2011/12

  28. Pharmaceutical evaluation RM-KAHS

  29. Example RM-KAHS

  30. Summary RM-KAHS

  31. References Aulton, M.E. (2002). Pharmaceutics – The Science of Dosage Form Design (2nd Ed.). Churchill Livingstone. Bugay, D. E. (1999). Pharmaceutical excipients : characterization by IR, Raman, and NMR spectroscopy. Kibbe, A. H. (2000). Handbook of pharmaceutical excipients. Rowe, R. C., Sheskey, P. J. & Owen, S. C. (2006). Handbook of pharmaceutical excipients Rowe, R. C. (2009). Handbook of pharmaceutical excipients. RM-KAHS

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