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Review Papers | Pharmaceutical Science | India | Volume 14 Issue 3, March 2025 | Popularity: 4.9 / 10
A Review on Biopharmaceutical Classification of Drug from Orally Administered Drug Product
Smriti Mathur
Abstract: Through the biopharmaceutics classification system (BCS), a mechanistic framework for understanding the concept of drug absorption in terms of permeability and solubility has been made available. This article reviews the BCS categorisation standards and challenges. The current BCS guidelines from the world health organisation state that biowaiver extensions for medications or active pharmaceutical components from different BCS classes that have scientific support are taken into consideration. The US food and drug administration and the european medicines agency both allow biowaivers under very specific conditions. The study explains possible new criteria and class boundaries proposed for additional biowaivers based on the underlying physiology of the gastrointestinal system under required conditions. The potential applications of BCS in drug delivery, drug discovery, and drug research are discussed, along with BCS extension. The biopharmaceutical classification system (BCS) is an advanced technique for classifying drugs based on intestinal permeability, water solubility, and dissolution all of which affect the absorption of active pharmaceutical ingredients (API) from immediate - release solid oral forms. It is more advantageous for formulation researchers to use modernistic techniques rather than experimental ones when developing new dosage forms.
Keywords: drug absorption, biopharmaceutics classification system, permeability and solubility, biowaiver guidelines, drug formulation
Edition: Volume 14 Issue 3, March 2025
Pages: 315 - 319
DOI: https://www.doi.org/10.21275/SR25305122136
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