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• 651 Downloads • Abstract The objective of this work was to suggest the biowaiver potential of biopharmaceutical classification system (BCS) Class II drugs in self-microemulsifying drug delivery systems (SMEDDS) which are known to increase the solubility, dissolution and oral absorption of water-insoluble drugs. Cyclosporine was selected as a representative BCS Class II drug. New generic candidate of cyclosporine SMEDDS (test) was applied for the study with brand SMEDDS (reference I) and cyclosporine self-emulsifying drug delivery systems (SEDDS, reference II). Solubility and dissolution of cyclosporine from SMEDDS were critically enhanced, which were the similar behaviors with BCS class I drug.

• Types Of Drug Formulation

Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Guidance for Industry. As for BCS class II drugs rate limiting step is drug release from the dosage form and solubility in the gastric fluid and not the absorption, so increasing the solubility in turn increases the bioavailability for BCS class II drugs [10, 13, 14]. Based on the BCS, drugs are classified into four categories according to their solubility and permeability properties as follows; high solubility–high permeability (class I); low solubility–high permeability (class II); high solubility–low permeability (class III); and low solubility–low permeability (class.

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The test showed the identical dissolution rate and the equivalent bioavailability (0.34, 0.42 and 0.68 of p values for AUC 0→24h, C max and T max, respectively) with the reference I. Based on the results, level A in vitro- in vivo correlation (IVIVC) was established from these two SMEDDS formulations.

Pharmaceutical development of drugs with poor water solubility requires the establishment of a suitable formulation layout among various techniques. Various approaches have been investigated extensively to improve the aqueous solubility and poor dissolution rate of BCS class II and IV drugs.

This study serves as a good example for speculating the biowaiver extension potential of BCS Class II drugs specifically in solubilizing formulation such as SMEDDS.

Types Of Drug Formulation

Contents • • • • • • BCS classes [ ] According to the Biopharmaceutical Classification System (BCS) drug substances are classified to four classes upon their solubility and permeability: • Class I - high, high • Example: • Those compounds are well absorbed and their absorption rate is usually higher than excretion. • Class II - high permeability, low solubility • Example:,,, paracetamol, • The of those products is limited by their solvation rate. A correlation between the bioavailability and the solvation can be found. • Class III - low permeability, high solubility • Example: • The absorption is limited by the permeation rate but the drug is solvated very fast. If the formulation does not change the permeability or gastro-intestinal duration time, then class I criteria can be applied.