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首页> 外文期刊>Journal of Young Pharmacists >Performances of New Generation of Delayed Release Capsules
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Performances of New Generation of Delayed Release Capsules

机译：新一代缓释胶囊的性能

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Objective: The purpose of this study was to verify the claimed acid-resistant properties and other performance indicators for AR Caps (Capsule 5 from CapsCanada) and DRcaps (Capsule 6 from Capsugel) and compare them with the immediate release hydroxypropyl methylcellulose “HPMC” capsules (K-CAPS from CapsCanada). Methods: Shell weight variability, reaction to different relative humidity conditions, empty shells response to stress under the absence of moisture, powder leaking, disintegration and dissolution properties were assessed. Results: Shell weight variability was highest among Capsule 4. At 45% RH and 23oC different types of capsules had similar loss on drying (LOD range: 5.23% – 6.68%). In the absence of moisture and following the application of a stress, empty Capsule 4 shells performed the best with the highest percentage of intactness of capsules (80%) followed by Capsule 6 (50%) and then Capsule 5 (20%). Both disintegration and dissolution test results for Capsule 4 deemed satisfactory for conventional release purposes, but Capsule 5 and 6 do not comply with the USP requirement for delayed-release dosage form. None of the tested capsules have the ability to protect hygroscopic encapsulated material from humid conditions as generally claimed. Conclusion: While HPMC capsule made for conventional release properties may be fit for that purpose, the new generation of capsules designed to protect the ingredient from the acid environment of stomach have not performed in such a manner as to comply with the USP requirements for disintegration and dissolution of delayed-release dosage form.
机译：目的：本研究的目的是验证AR Caps（CapsCanada的Capsule 5）和DRcaps（Capsugel的Capsule 6）声称的耐酸性能和其他性能指标，并将其与速释羟丙基甲基纤维素“ HPMC”胶囊进行比较。 （来自CapsCanada的K-CAPS）。方法：评估了壳重量的变化性，对不同相对湿度条件的反应，空壳在没有水分的情况下对应力的响应，粉末泄漏，崩解和溶解特性。结果：胶囊4的壳重量差异最大。在45％RH和23oC下，不同类型的胶囊干燥失重相似（LOD范围：5.23％– 6.68％）。在没有水分和施加压力的情况下，空的Capsule 4壳表现最好，其中完整率最高的是胶囊（80％），其次是Capsule 6（50％），然后是Capsule 5（20％）。胶囊4的崩解和溶出度测试结果均被认为满足常规释放目的，但胶囊5和6不符合USP对延迟释放剂型的要求。如通常所要求的，没有一种测试的胶囊具有保护吸湿性封装材料不受潮湿条件影响的能力。结论：尽管为常规释放特性制造的HPMC胶囊可能适合该目的，但旨在保护成分免受胃酸环境侵害的新一代胶囊的性能却不符合USP崩解和分解的要求。延迟释放剂型的溶解。

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