BCS Class II Drug & Its Solubility Enhancement: A Review

Yogesh Kumar Bajpai; Sandeep Singh; Vijaylaxmi Bisht; Kanchan Butola; Abhishek Awasthi; Sahil Kumar

doi:10.55544/jrasb.1.5.5

Authors

Yogesh Kumar Bajpai Research Scholar, Department of Pharmacy, Guru Nanak College of Pharmaceutical Sciences, Dehradun-248007, Uttarakhand, INDIA.
Sandeep Singh Research Scholar, Department of Pharmacy, Guru Nanak College of Pharmaceutical Sciences, Dehradun-248007, Uttarakhand, INDIA.
Mrs. Vijaylaxmi Bisht Assistant Professor, Department of Pharmaceutics, Guru Nanak College of Pharmaceutical Sciences, Dehradun-248007, Uttarakhand, INDIA.
Kanchan Butola Assistant Professor, Department of Pharmaceutics, Guru Nanak College of Pharmaceutical Sciences, Dehradun-248007, Uttarakhand, INDIA.
Abhishek Awasthi Department of Pharmacy, Guru Nanak College of Pharmaceutical Sciences, Dehradun-248007, Uttarakhand, INDIA.
Sahil Kumar Department of Pharmacy, Guru Nanak College of Pharmaceutical Sciences, Dehradun-248007, Uttarakhand, INDIA.

DOI:

https://doi.org/10.55544/jrasb.1.5.5

Keywords:

API, Excipients, Bioavailability, BCS Class drug II

Abstract

The objective of this review article is to summarize literature data pertinent to potential excipient effects on intestinal drug permeability and transit. Despite the use of excipients in drug products for decades, considerable research efforts have been directed towards evaluating their potential effects on drug bioavailability. Potential excipient concerns stem from drug formulation changes (e.g., scale-up and post-approval changes, development of a new generic product). Regulatory agencies have established in vivo bioequivalence standards and, as a result, may waive the in vivo requirement, known as a biowaiver, for some oral products. Biowaiver acceptance criteria are based on the in vitro characterization of the drug substance and drug product using the Biopharmaceutics Classification System (BCS). Various regulatory guidance documents have been issued regarding BCS-based biowaivers, such that the current FDA guidance is more restrictive than prior guidance, specifically about excipient risk. In particular, sugar alcohols have been identified as potential absorption-modifying excipients. These biowaivers and excipient risks are discussed here.

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