Novel Starch‐Based PVA Thermoplastic Capsules for Hydrophilic Lipid‐Based Formulations
| Autor: | Zdravka Misic, Martin Kuentz, Georg Sydow, Katharina Muffler |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
food.ingredient
Thermoplastic Starch Pharmaceutical Science Capsules Gelatin Polyvinyl alcohol law.invention chemistry.chemical_compound food Fenofibrate law Organic chemistry Solubility Crystallization Hypolipidemic Agents chemistry.chemical_classification Lipids Chemical engineering chemistry Polyvinyl Alcohol Pharmaceutics Extrusion Hydrophobic and Hydrophilic Interactions |
| Zdroj: | Journal of Pharmaceutical Sciences. 101:4516-4528 |
| ISSN: | 0022-3549 |
| DOI: | 10.1002/jps.23315 |
| Popis: | For decades, gelatin has been used in the rotary die process as a shell‐forming material of soft capsules because of its unique physicochemical properties. However, with respect to the encapsulation of comparatively hydrophilic lipid‐based formulations, gelatin has one considerable drawback: Immediately after production, the capsule shell contains a large amount of water (up to 35%). There is the potential for water to migrate from the capsule shell into the formulation, which will lead to a decrease in drug solubility and, in turn, the potential for drug crystallization. The present study introduces a novel capsule material that was obtained from extrusion. The starch‐based polyvinyl alcohol thermoplastic capsules (S‐PVA‐C) mainly comprised a blend of starch and PVA. Gelatin and the novel material were used to encapsulate a hydrophilic lipid‐based system of fenofibrate. Considerable water migration was observed from the soft gelatin shell to the hydrophilic formulation during drying and drug crystallization resulted in soft gelatin capsules. In contrast, S‐PVA‐C displayed no substantial water exchange or drug crystallization upon storage. The thermoplastic capsule material further exhibited more surface roughness and higher resistance to mechanical deformation compared with gelatin. In conclusion, S‐PVA‐C provided a robust drug product following encapsulation of a rather hydrophilic lipid‐based formulation. |
| Databáze: | OpenAIRE |
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