Understanding biorelevant drug release from a novel thermoplastic capsule by considering microstructural formulation changes during hydration.

Abstract:

PURPOSE:To study the biorelevant drug release from novel starch-based polyvinyl alcohol capsules (S-PVA-C). The effect of the shell material is studied by considering microstructural formulation changes during hydration. METHODS:Two different self-emulsifying systems containing either fenofibrate or probucol were filled in S-PVA-C, as well as capsules of gelatin (SGC) and starch (VegaGels®). Release analysis employed a BioDis® apparatus, while disintegration was studied by texture analysis. For microstructural analysis we used small angle x-ray scattering (SAXS). RESULTS:S-PVA-C opened only partially in biorelevant media compared to completely opened SGC and VegaGels®. In case of the fenofibrate formulation, this opening mechanism caused only a short lag time, while the probucol formulation in S-PVA-C resulted in a sustained release. The latter formulation demonstrated much higher viscosity upon hydration compared to the fenofibrate system. Such a rheological effect on drug release was barely noted for SGC or VegaGels® and SAXS revealed differences in the hydrated microstructure. CONCLUSIONS:Even though S-PVA-C are highly attractive for encapsulation of rather hydrophilic formulations, some care is needed regarding an immediate release form. The type of formulation hydration must be considered for adequate selection of the capsule material.

journal_name

Pharm Res

journal_title

Pharmaceutical research

authors

Misic Z,Urbani R,Pfohl T,Muffler K,Sydow G,Kuentz M

doi

10.1007/s11095-013-1152-y

subject

Has Abstract

pub_date

2014-01-01 00:00:00

pages

194-203

issue

1

eissn

0724-8741

issn

1573-904X

journal_volume

31

pub_type

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