BCS and Solubility Enhancement

BCS and Solubility Enhancement Photo

The Biopharmaceutical Classification System (BCS) is an experimental model that calculates portability and solubility under endorsed guidelines. The main purpose of the system was to aid in the governance of post-approval modifications and generics, providing approvals based solely on in vitro data when applicable. Waivers, dispensation to skip in vivo bioequivalence studies, are reserved for drug products that expedient certain concerns around solubility and permeability and that are also rapidly dissolving. The objective of this work was to advise the biowaivers potential of biopharmaceutical classification system which is known to increase the solubility, dissolution, oral absorption of water insoluble drugs.

A number of techniques can be adapted to develop solubilisation of poor water soluble drug and further to improve its bioavailability. Solubilisation of meagrely soluble drugs is a periodically encountered objection in screening studies of advanced chemical entities as well as in formulation architecture and advancement. Any drug to be absorbed necessary to be existent in the form of an aqueous solution at the site of absorption. ‘Solubility’ is defined as maximum amount of solute that can be dissolved in a given amount of solvent. Quantitatively it is defined as the concentration of the solute in a saturated solution at a certain temperature. In terms of quality, solubility defined as the instinctive communication of two or more substances to produce a homogenous molecular diffusion. A saturated solution is one in which the solute is in stability with the solvent. The solubility of a drug is characterized through several concentration expressions such as parts, percentage, molarity, and molality.

  • BCS biowaivers
  • Dissolution testing in drug formulation
  • In vitro diffusion cells for dissolution testing in formulation development
  • In vitro preclinical ADME/BCS testing

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