What Is Solubility And Intestinal Permeability?

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Solubility is defined as the greatest amount of a solid, liquid or gaseous chemical substance that will dissolve in equilibrium in a specified volume of solid, liquid or gaseous solvent at a particular temperature or pressure to form a homogenous solution. Meanwhile, dissolution is a process whereby the solid chemical substance is dissolved in the solvent to form a solution.

IUPAC Compendium of Chemical Terminology, 2009 defines solubility as the proportion of a specific solute in a specific solvent which can also be explained as the analytical composition of a saturated solution. Solubility can also be expressed as the concentration, molality, mole ratio and mole fraction.

Solubility is one of the important physicochemical properties affecting the bioavailability of a drug. Bioavailability is the rate and extent of drug absorption. Hence, the drug must first be in solution or solubilized so they can be absorbed to achieve the desired pharmacological response. Solubility is a critical factor if the
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Food and Drug Administration. This system restricts the prediction using the parameters solubility and intestinal permeability.

Solubility is based on the highest-dose strength of an immediate release product. A drug is considered highly soluble when the highest dose strength is soluble in 250 mL or less of aqueous media over the pH range of 1 to 7.5. The volume estimate of 250 mL is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting human volunteers with a glass of water. A drug substance is considered highly permeable when the extent of intestinal absorption is determined to be 90% or higher. Otherwise, the drug substance is considered to be poorly permeable. (Yu et al., 2002)

Table 1. Biopharmaceutics Classification System (BCS) with characteristics of drugs.
BCS class

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