SYSTEMATIC REVIEW ON PREFORMULATION STUDIES AND RECENT TRENDS
Hatkar A. D, Taro S. S, Jaybhaye S.S, Phoke S. V
Department of Pharmaceutics, Institute of Pharmacy, Badnapur, Jalna- 431203 (MS), India
Abstract
Preformulation studies carried out by various research scientists are reviewed. Preformulation begins after literature search of similar type of compounds to provide and understand (i) the degradation process, (ii) any adverse conditions relevant to the drug, (iii) bioavailability, (iv) pharmacokinetics and formulation of similar compound and (v) toxicity. Preformulation influences (a) selection of the drug candidate itself, (b) selection of formulation components, (c) API & drug product manufacturing processes, (d) determination of the most appropriate container closure system, (e) development of analytical methods, (f) assignment of API retest periods (g) the synthetic route of the API, (h) toxicological strategy. Preformulation studies give directions for development of formulation in choice of drug form, excipients, composition, physical structure, helps in adjustment of pharmacokinetic and biopharmaceutical properties, support for process development of drug substance support for PAT (Process Analytical Technology) (critical process parameters),produce necessary and useful data for development of analytical methods.
Keywords: Preformulation, partition coefficient, dissolution rate, polymorphic
Journal Name :
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EPRA International Journal of Multidisciplinary Research (IJMR)
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Published on : 2024-11-27
Vol | : | 10 |
Issue | : | 11 |
Month | : | November |
Year | : | 2024 |