Franc Aleš, Vetchý David, Fülöpová Nicole
Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, 612 42 Brno, Czech Republic.
Pharmaceuticals (Basel). 2022 Nov 13;15(11):1398. doi: 10.3390/ph15111398.
Currently, there is a growing need to prepare small batches of enteric capsules for individual therapy or clinical evaluation since many acidic-sensitive substances should be protected from the stomach's acidic environment, including probiotics or fecal material, in the fecal microbiota transplantation (FMT) process. A suitable method seems to be the encapsulation of drugs or lyophilized alternatively frozen biological suspensions in commercial hard enteric capsules prepared by so-called Enteric Capsule Drug Delivery Technology (ECDDT). Manufacturers supply these types of capsules, made from pH-soluble polymers, in products such as AR Caps, EnTRinsic, and Vcaps Enteric, or capsules made of gelling polymers that release their content as the gel erodes over time when passing through the digestive tract. These include DRcaps, EMBO CAPS AP, BioVXR, or ACGcaps™ HD. Although not all capsules in all formulations meet pharmaceutical requirements for delayed-release dosage forms in disintegration and dissolution tests, they usually find practical application. This literature review presents their composition and properties. Since ECDDT is a new technology, this article is based on a limited number of references.
目前，制备用于个体化治疗或临床评估的小批量肠溶胶囊的需求日益增长，因为在粪便微生物群移植（FMT）过程中，许多对酸敏感的物质，包括益生菌或粪便物质，需要保护其免受胃酸性环境的影响。一种合适的方法似乎是将药物或冻干或冷冻的生物悬浮液封装在通过所谓的肠溶胶囊药物递送技术（ECDDT）制备的商业硬肠溶胶囊中。制造商在诸如AR Caps、EnTRinsic和Vcaps Enteric等产品中提供这些由pH溶性聚合物制成的胶囊类型，或者提供由胶凝聚合物制成的胶囊，当它们在消化道中通过时，随着凝胶逐渐侵蚀，其内容物会释放出来。这些包括DRcaps、EMBO CAPS AP、BioVXR或ACGcaps™ HD。尽管并非所有制剂中的所有胶囊在崩解和溶出试验中都符合缓释剂型的药学要求，但它们通常都有实际应用。这篇文献综述介绍了它们的组成和性质。由于ECDDT是一项新技术，本文基于有限数量的参考文献。
