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首页> 外文期刊>Pharmaceutical development and technology >Development of a novel bi-coated combination capsule containing mosapride and probiotics for irritable bowel syndrome
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Development of a novel bi-coated combination capsule containing mosapride and probiotics for irritable bowel syndrome

机译：含有莫沙必利和益生菌的新型双包衣胶囊开发用于肠易激综合征

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The objective of this study was to develop a novel combination product containing mosapride and probiotics for the treatment of irritable bowel syndrome. Enteric-coated hard gelatin capsules containing probiotics were prepared to protect acid-labile probiotics from the stomach by spray coating with hydroxypropylmethylcellulose phthalate, and then coated with various hydrophilic polymer solutions containing mosapride. The influence of different hydrophilic polymers on the aqueous solubility and dissolution of sparingly soluble mosapride from the capsule was investigated to select the one which imparted highest solubility to mosapride in an aqueous solution. The physicochemical properties of the hydrophilic polymer coating were assessed using SEM and DSC. In addition, the bioavailability of the mosapride-coated capsule in beagle dog was evaluated and compared to that of conventional mosapride tablet (CMT). Based on DSC studies, the mosapride in polymer coating underwent amorphization or molecular dispersion. The enteric-capsule coated with mosapride/HPMC exhibited improved solubility of mosapride at acidic pH and showed significantly improved AUC (1.5-fold) and Cmax (1.6-fold) compared to the CMT. In conclusion, drug/polymer coated enteric gelatin capsule can be an alternative technique for co-delivery of sparingly water-soluble drug and acid-labile drug for enhanced solubility and bioavailability as well as for protection from acid degradation.
机译：这项研究的目的是开发一种包含莫沙必利和益生菌的新型组合产品，用于治疗肠易激综合症。制备含有益生菌的肠溶硬明胶胶囊，通过用羟丙基甲基纤维素邻苯二甲酸酯喷涂包衣，然后用含有莫沙必利的各种亲水性聚合物溶液包衣，来保护酸不稳定的益生菌免受胃酸的侵害。研究了不同的亲水性聚合物对水溶性和难溶性莫沙必利从胶囊中溶出的影响，以选择对莫沙必利在水溶液中具有最高溶解度的一种。使用SEM和DSC评估亲水性聚合物涂层的物理化学性质。另外，评价了比格犬中包有莫沙必利的胶囊的生物利用度，并将其与常规莫沙必利片剂（CMT）的生物利用度进行了比较。根据DSC研究，聚合物涂层中的莫沙必利发生非晶化或分子分散。与CMT相比，涂有莫沙必利/ HPMC的肠溶胶囊在酸性pH值下显示出莫沙必利的改善的溶解度，并且显示出显着改善的AUC（1.5倍）和Cmax（1.6倍）。总而言之，药物/聚合物包衣的肠明胶胶囊可以作为共同递送少量水溶性药物和酸不稳定药物的替代技术，以提高溶解度和生物利用度并防止酸降解。

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