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Abstract

The abstract discusses the significance of preformulation studies, which analyze the physicochemical characteristics of potential new drug candidates and their impact on drug performance and dosage form development. These studies provide essential information for designing formulations and may indicate the need for molecular modifications. Before creating pharmaceutical formulations, it's crucial to consider the inherent chemical and physical properties of each drug, which serve as the foundation for combining them with other ingredients in dosage form production. The primary objective of preformulation studies is to create elegant, stable, effective, and safe dosage forms. This is achieved by establishing kinetic rate profiles, assessing compatibility with other components, and determining the physicochemical parameters of the new drug substances. Several properties play vital roles in preformulation studies, including drug solubility, partition coefficient, dissolution rate, polymorphic forms, and stability. Polymorphism, which includes crystal and amorphous forms, can lead to variations in the chemical, physical, and therapeutic characteristics of the drug molecule. This article provides insights into these properties and techniques for evaluating preformulation parameters of drugs.

Keywords

Bulk characteristics, crystallization, flow properties, pKa, Hygroscopicity

Reference

  1. Allen, L. and Ansel, H.C., 2013. Ansel's pharmaceutical dosage forms and drug delivery systems. Lippincott Williams & Wilkins. 
  2. Vilegave, K., Vidyasagar, G. and Chandankar, P., 2013. Preformulation studies of pharmaceutical new drug molecule and products: An Overview. The American Journal of Pharmacy, 1(3), pp.1-20. 
  3. Chaurasia, G., 2016. A review on pharmaceutical preformulation studies in formulation and development of new drug molecules. Int J Pharm Sci Res, 7(6), pp.2313-2320. 
  4. Gopinath, R. and Naidu, R.A.S., 2011. Pharmaceutical preformulation studies– current review. International Journal of Pharmaceutical and Biological Archives, 2(5), pp.1391-1400. 
  5. Brahmankar, D.M. and Jaiswal, S.B., 2019. Biopharmaceutics and pharmacokinetics. Vallabh prakashan. 
  6. Lachman, L., Lieberman, H.A. and Kanig, J.L., 1976. The theory and practice of industrial pharmacy (pp. 210-212). Philadelphia: Lea & Febiger. 
  7. Gwen, M.J. and Joseph, R.R., 1996. In Banker GS and Rhodes CT, Eds., Modern Pharmaceutics, 3rd Edn, Vol. 72. 
  8. Robinson, J. and Lee, V.H., 1987. Controlled drug delivery: fundamentals and applications. CRC Press. 
  9. Jain, N.K. and Sharma, S.N., 1998. A textbook of professional pharmacy. New Delhi: Vallabh Prakashan, 4, pp.83-9. 
  10. Aulton, M.E. and Taylor, K. eds., 2013. Aulton's pharmaceutics: the design and manufacture of medicines. Elsevier Health Sciences. 
  11. Gaikwad, S.S., Avhad, R.D. and Kalkotwar, R.S., 2020. Formulation, development and in vitro characterization of modified release tablets of capecitabine. Drug Development and Industrial Pharmacy, 46(1), pp.20-30. 
  12. Garner, W.Y. and Barge, M.S., 1989. Good laboratory practice, an agrochemical perspective (ACS symposium series 369): American Chemical Society, Washington, DC, 1988 (ISBN 0-8412-1480-8). vii+ 165 pp. Price $39.95 (US and Canada), $47.95 (elsewhere). 
  13. Aulton, M.E. and Taylor, K. eds., 2013. Aulton's pharmaceutics: the design and manufacture of medicines. Elsevier Health Sciences. 
  14. Lachman, L., Lieberman, H.A. and Kanig, J.L., 1976. The theory and practice of industrial pharmacy (pp. 210-212). Philadelphia: Lea & Febiger. 
  15. Allen Jr, L.V., 1990. Pharmaceutical Dosage Forms and Drug Delivery Systems. 
  16. Vilegave, K., Vidyasagar, G. and Chandankar, P., 2013. Preformulation studies of pharmaceutical new drug molecule and products: An Overview. The American Journal of Pharmacy, 1(3), pp.1-20. 
  17. Sharma, S.N. and Jain, N.K., 1985. A text book of professional pharmacy. Vallabh Prakashan,, 201. 
  18. Robinson, J. and Lee, V.H., 1987. Controlled drug delivery: fundamentals and applications. CRC Press.

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Tushar B. Aher
Corresponding author

Department of bachelor’s in pharmacy, Shivajirao Pawar College of Pharmacy, Pachegaon, Ahmednagar-413725

Photo
Prof. Poonam P. Khade
Co-author

Department of bachelor’s in pharmacy, Shivajirao Pawar College of Pharmacy, Pachegaon, Ahmednagar-413725

Photo
Dr. Megha T. Salve
Co-author

Department of bachelor’s in pharmacy, Shivajirao Pawar College of Pharmacy, Pachegaon, Ahmednagar-413725

Tushar B. Aher, Prof. Poonam P. Khade, Dr. Megha T. Salve, Pharmaceutical Formulation and Development: A Comprehensive Review, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 11, 346-355. https://doi.org/10.5281/zenodo.10144551

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