Suppr超能文献

基于羟丙甲纤维素邻苯二甲酸酯/明胶的新型制剂工业化生产肠溶硬胶囊及泮托拉唑释放研究

Industrial Manufacture of Enteric Hard Capsules Using Novel Formulations Based on Hypromellose Phthalate/Gelatin and Investigation of Pantoprazole Release.

作者信息

Kalmer Ramin Ramezani, Haddadan Mohsen Mohammadi, Azizi Maryam, Ghanbari Mojgan, Samandarian Dariush, Sadjadinia Atefeh, Ramezanalizadeh Hamed, Karimi Afzal, Golizadeh Mortaza

机构信息

Iran Gelatin Capsule Mfg Co., Tehran 3351773415, Iran.

Institute of Nano Science and Nano Technology, University of Kashan, Kashan, P.O. Box. 87317-51167, I. R. Iran.

出版信息

ACS Omega. 2023 Mar 17;8(12):11293-11303. doi: 10.1021/acsomega.2c08290. eCollection 2023 Mar 28.

Abstract

Capsules are popular oral dosage forms because of their ease of production. They are widespread pharmaceutical products. Hard capsules are preferred dosage forms for new medicines undergoing clinical tests because they do not require expansive formulation development. Functional capsules with built-in gastroresistance, aside from the traditional hard-gelatin or cellulose-based vegetarian capsules, would be beneficial. In this research, the effect of polyethylene glycol-4000 (PEG-4000) was investigated on the formulation of uncoated enteric hard capsules based on hypromellose phthalate (HPMCPh) and gelatin. Three different formulations based on HPMCPh, gelatin, and PEG-4000 were tested to achieve the optimal formulation for the industrial production of hard enteric capsules with desired physicochemical and enteric properties. The results reveal that the capsules containing HPMCPh, gelatin, and PEG-4000 (F1) are stable in the stomach environment (pH = 1.2) for 120 min, and during this time, no release happens. The outcomes also demonstrate that PEG-4000 blocks the pores and improves enteric hard capsule formulation. In this research, we present a specific procedure for manufacturing uncoated enteric hard capsules on an industrial scale that does not require an extra coating step for the first time. The industrial-scale validated process can considerably reduce the cost of manufacturing standard enteric-coated dosage forms.

摘要

胶囊剂因其易于生产而成为受欢迎的口服剂型。它们是广泛使用的药品。硬胶囊是正在进行临床试验的新药的首选剂型,因为它们不需要进行广泛的制剂开发。除了传统的硬明胶或纤维素基植物胶囊外,具有内置抗胃酸作用的功能性胶囊将是有益的。在本研究中,研究了聚乙二醇-4000(PEG-4000)对基于邻苯二甲酸羟丙甲纤维素(HPMCPh)和明胶的未包衣肠溶硬胶囊制剂的影响。测试了三种基于HPMCPh、明胶和PEG-4000的不同制剂,以获得具有所需物理化学和肠溶特性的硬肠溶胶囊工业生产的最佳制剂。结果表明,含有HPMCPh、明胶和PEG-4000的胶囊(F1)在胃环境(pH = 1.2)中稳定120分钟,在此期间没有释放发生。结果还表明,PEG-4000堵塞了孔隙并改善了肠溶硬胶囊制剂。在本研究中,我们首次提出了一种在工业规模上制造未包衣肠溶硬胶囊的具体方法,该方法不需要额外的包衣步骤。经过工业规模验证的工艺可以显著降低标准肠溶制剂的制造成本。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef30/10061655/3b1b2171756e/ao2c08290_0002.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验