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含胃复安的单层和双层口腔膜片的评估。

Evaluation of Monolayer and Bilayer Buccal Films Containing Metoclopramide.

作者信息

Grilc Blaž, Planinšek Odon

机构信息

Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, Slovenia.

出版信息

Pharmaceutics. 2024 Mar 2;16(3):354. doi: 10.3390/pharmaceutics16030354.

DOI:10.3390/pharmaceutics16030354
PMID:38543248
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10975540/
Abstract

The objective of this study was to develop buccal film formulations containing metoclopramide hydrochloride monohydrate (MCP) with and without a backing layer and to evaluate their release properties and physiochemical stability. The crystallization of MCP in the polymer matrix was monitored with image analysis techniques for rapid and scalable observation. The results showed that the addition of a protective layer and its thickness significantly affected the release rate and crystallization behavior of MCP in the formulations. The crystallization of MCP increased over time, and certain formulations showed higher susceptibility to crystallization. To understand the factors affecting the crystallization of MCP, the relationship between the viscosity and pH of the casting solution was examined, but no significant correlation was found. A significant correlation was observed between the plasticizer concentration and the physical state of MCP. Through a systematic Design of Experiment (DOE) approach, an optimal formulation was devised, successfully preventing crystallization of the active ingredient. However, enhancing the overall chemical stability of the formulated product remains a challenge.

摘要

本研究的目的是开发含和不含背衬层的盐酸甲氧氯普胺一水合物（MCP）口腔膜制剂，并评估其释放特性和物理化学稳定性。采用图像分析技术监测MCP在聚合物基质中的结晶情况，以便进行快速且可扩展的观察。结果表明，保护层的添加及其厚度显著影响了制剂中MCP的释放速率和结晶行为。MCP的结晶随时间增加，某些制剂表现出更高的结晶敏感性。为了解影响MCP结晶的因素，研究了浇铸溶液的粘度和pH值之间的关系，但未发现显著相关性。观察到增塑剂浓度与MCP的物理状态之间存在显著相关性。通过系统的实验设计（DOE）方法，设计出了一种最佳制剂，成功防止了活性成分的结晶。然而，提高制剂产品的整体化学稳定性仍然是一项挑战。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/f07941aa4f16/pharmaceutics-16-00354-g010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/a28a4bd131be/pharmaceutics-16-00354-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/21b77350ba41/pharmaceutics-16-00354-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/a64547621424/pharmaceutics-16-00354-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/98a432b6ec6b/pharmaceutics-16-00354-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/770fd41bdbef/pharmaceutics-16-00354-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/c69e154db3a3/pharmaceutics-16-00354-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/bbdbb705dec9/pharmaceutics-16-00354-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/ced0d55b0d7d/pharmaceutics-16-00354-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/f6a6ca71c8c7/pharmaceutics-16-00354-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/f07941aa4f16/pharmaceutics-16-00354-g010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/a28a4bd131be/pharmaceutics-16-00354-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/21b77350ba41/pharmaceutics-16-00354-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/a64547621424/pharmaceutics-16-00354-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/98a432b6ec6b/pharmaceutics-16-00354-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/770fd41bdbef/pharmaceutics-16-00354-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/c69e154db3a3/pharmaceutics-16-00354-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/bbdbb705dec9/pharmaceutics-16-00354-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/ced0d55b0d7d/pharmaceutics-16-00354-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/f6a6ca71c8c7/pharmaceutics-16-00354-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/716a/10975540/f07941aa4f16/pharmaceutics-16-00354-g010.jpg

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