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共处理的几丁质-甘露醇作为口腔崩解片的新型辅料。

Co-processed chitin-mannitol as a new excipient for Oro-dispersible tablets.

作者信息

Daraghmeh Nidal, Chowdhry Babur Z, Leharne Stephen A, Al Omari Mahmoud M H, Badwan Adnan A

机构信息

The Jordanian Pharmaceutical Manufacturing Co., PO Box 94, Naor 11710, Jordan.

Faculty of Engineering & Science, University of Greenwich, Medway Campus, Chatham Maritime Kent ME44TB, UK.

出版信息

Mar Drugs. 2015 Mar 30;13(4):1739-64. doi: 10.3390/md13041739.

DOI:10.3390/md13041739
PMID:25830680
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4413185/
Abstract

This study describes the preparation, characterization and performance of a novel excipient for use in oro-dispersible tablets (ODT). The excipient (Cop-CM) consists of chitin and mannitol. The excipient with optimal physicochemical properties was obtained at a chitin: mannitol ratio of 2:8 (w/w) and produced by roll compaction (RC). Differential scanning calorimetry (DSC), Fourier transform-Infrared (FT-IR), X-ray powder diffraction (XRPD) and scanning electron microscope (SEM) techniques were used to characterize Cop-CM, in addition to characterization of its powder and ODT dosage form. The effect of particle size distribution of Cop-CM was investigated and found to have no significant influence on the overall tablet physical properties. The compressibility parameter (a) for Cop-CM was calculated from a Kawakita plot and found to be higher (0.661) than that of mannitol (0.576) due to the presence of the highly compressible chitin (0.818). Montelukast sodium and domperidone ODTs produced, using Cop-CM, displayed excellent physicochemical properties. The exceptional binding, fast wetting and superdisintegration properties of Cop-CM, in comparison with commercially available co-processed ODT excipients, results in a unique multifunctional base which can successfully be used in the formulation of oro-dispersible and fast immediate release tablets.

摘要

本研究描述了一种用于口腔崩解片（ODT）的新型辅料的制备、表征及性能。该辅料（Cop-CM）由几丁质和甘露醇组成。几丁质与甘露醇比例为2:8（w/w）时通过滚压法制得的辅料具有最佳物理化学性质。除了对Cop-CM的粉末及其ODT剂型进行表征外，还采用差示扫描量热法（DSC）、傅里叶变换红外光谱法（FT-IR）、X射线粉末衍射法（XRPD）和扫描电子显微镜（SEM）技术对Cop-CM进行表征。研究了Cop-CM粒度分布的影响，发现其对片剂整体物理性质无显著影响。根据河合图解计算出Cop-CM的压缩性参数（a），发现由于存在高压缩性的几丁质（0.818），Cop-CM的压缩性参数（0.661）高于甘露醇（0.576）。使用Cop-CM制备的孟鲁司特钠和多潘立酮ODT显示出优异物理化学性质。与市售的共处理ODT辅料相比，Cop-CM具有出色的黏合性、快速润湿性和超崩解性，形成了一种独特的多功能基质，可成功用于口腔崩解和速释片剂的配方。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/53fcb1ffd999/marinedrugs-13-01739-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/e89e5a5d4cc4/marinedrugs-13-01739-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/ed24fde1ac54/marinedrugs-13-01739-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/c4322978191c/marinedrugs-13-01739-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/22dea5342f59/marinedrugs-13-01739-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/4060eb9edb7c/marinedrugs-13-01739-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/1a5b7a54820c/marinedrugs-13-01739-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/e6733e1f1522/marinedrugs-13-01739-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/68d165e51ad5/marinedrugs-13-01739-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/53fcb1ffd999/marinedrugs-13-01739-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/e89e5a5d4cc4/marinedrugs-13-01739-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/ed24fde1ac54/marinedrugs-13-01739-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/c4322978191c/marinedrugs-13-01739-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/22dea5342f59/marinedrugs-13-01739-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/4060eb9edb7c/marinedrugs-13-01739-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/1a5b7a54820c/marinedrugs-13-01739-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/e6733e1f1522/marinedrugs-13-01739-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/68d165e51ad5/marinedrugs-13-01739-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab2f/4413185/53fcb1ffd999/marinedrugs-13-01739-g009.jpg

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