Gastroresistant capsular device prepared by injection molding

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• 作者：Lucia Zema ; Giulia Loreti ; Alice Melocchi ; Alessandra Maroni ; Luca Palugan ; Andrea Gazzaniga ; ^{andrea.gazzaniga@unimi.it}
• 关键词：Injection molding (IM) ; Micromolding ; Capsular device ; Gastric resistance ; Enteric polymer ; Hydroxypropyl methyl cellulose acetate succinate (HPMCAS)
• 刊名：International Journal of Pharmaceutics
• 出版年：2013
• 出版时间：20 January, 2013
• 年：2013
• 卷：440
• 期：2
• 页码：264-272
• 全文大小：1488 K

文摘

In the present work, the possibility of manufacturing by injection molding (IM) a gastro-resistant capsular device based on hydroxypropyl methyl cellulose acetate succinate (HPMCAS) was investigated. By performing as an enteric soluble container, such a device may provide a basis for the development of advantageous alternatives to coated dosage forms. Preliminarily, the processability of the selected thermoplastic polymer was evaluated, and the need for a plasticizer (polyethylene glycol 1500) in order to counterbalance the glassy nature of the molded items was assessed. However, some critical issues related to the physical/mechanical stability (shrinkage and warpage) and opening time of the device after the pH change were highlighted. Accordingly, an in-depth formulation study was carried out taking into account differing release modifiers potentially useful for enhancing the dissolution/disintegration rate of the capsular device at intestinal pH values. Capsule prototypes with thickness of 600 and 900 ¦Ìm containing Kollicoat^? IR and/or Explotab^? CLV could be manufactured, and a promising performance was achieved with appropriate gastric resistance in pH 1.2 medium and break-up in pH 6.8 within 1 h. These results would support the design of a dedicated mold for the development of a scalable manufacturing process.