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Preclinical formulations: insight, strategies, and practical considerations.

Authors
  • Shah, Sanket M
  • Jain, Ankitkumar S
  • Kaushik, Ritu
  • Nagarsenker, Mangal S
  • Nerurkar, Maneesh J
Type
Published Article
Journal
AAPS PharmSciTech
Publisher
American Association of Pharmaceutical Scientists
Publication Date
Oct 01, 2014
Volume
15
Issue
5
Pages
1307–1323
Identifiers
DOI: 10.1208/s12249-014-0156-1
PMID: 24920522
Source
Medline
License
Unknown

Abstract

A lot of resources and efforts have been directed to synthesizing potentially useful new chemical entities (NCEs) by pharmaceutical scientists globally. Detailed physicochemical characterization of NCEs in an industrial setup begins almost simultaneously with preclinical testing. Most NCEs possess poor water solubility posing bioavailability issues during initial preclinical screening, sometimes resulting in dropping out of an NCE with promising therapeutic activity. Selection of right formulation approach for an NCE, based on its physicochemical properties, can aid in improving its solubility-related absorption and bioavailability issues. The review focuses on preclinical formulations stressing upon different preclinical formulation strategies and deciphers the understanding of formulation approaches that could be employed. It also provides detailed information related to a vast pool of excipients available today, which is of immense help in designing preclinical formulations. Few examples mentioned, throw light on key aspects of preclinical formulation development. The review will serve as an important guide for selecting the right strategy to improve bioavailability of NCEs for academic as well as industrial formulation scientists.

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