The soft gelatin capsule dosage form is often employed for poorly water soluble active ingredients (BCS class II or IV) which utilize lipid-based formulations in order to enhance oral bioavailability.  However, this dosage form can present significant issues for finished product analyses.  With predominantly water soluble gelatin in the capsule shell and water insoluble API in the capsule fill, sample preparation schemes can be very challenging.  The effects of dissolved gelatin on chromatographic performance and possible matrix effects on sensitivity for other analytical techniques can often lead to multiple and unique preparation schemes.   This talk will present a case study for a soft gelatin capsule formulation which requires 5 different methods (assay, degradation methods, excipient analysis) each with different sample preparation schemes unique to the specific method.  Special attention will be given to analytical issues relating to gelatin cross-linking effects.

Analytical challenges in testing soft gelatin capsule dosage forms used for poorly soluble drugs

248th National Meeting (2014)

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