Solubility Enhancement

A number of methodologies can be adapted to improve solubilisation of poor water soluble drug and further to improve its bioavailability. Solubilisation of poorly soluble drugs is a frequently encountered challenge in screening studies of new chemical entities as well as in formulation design and development. Any drug to be absorbed must be present 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 qualitative terms, solubility may be defined as the spontaneous interaction of two or more substances to form a homogenous molecular dispersion. A saturated solution is one in which the solute is in equilibrium with the solvent. The solubility of a drug is represented through various concentration expressions such as parts, percentage, molarity, molality, volume fraction, mole fraction. Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.

  • Solid dispersion technique
  • Co-Solvency method
  • Supercritical fluid process
  • Salt forming

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