Preparation and Characterization of a Novel Co-processed Excipient of Chitin and Crystalline Mannitol |
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Authors: | Nidal Daraghmeh Iyad Rashid Mahmoud M H Al Omari Stephen A Leharne Babur Z Chowdhry Adnan Badwan |
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Institution: | (1) The Jordanian Pharmaceutical Manufacturing Co., PO Box 94, Naor, 11710, Jordan;(2) School of Science, University of Greenwich at Medway, Chatham Maritime, Kent, ME4 4 TB, UK; |
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Abstract: | A co-processed excipient was prepared from commercially available crystalline mannitol and α-chitin using direct compression
as well as spray, wet, and dry granulation. The effect of the ratio of the two components, percentage of lubricant and particle
size, on the properties of the prepared co-processed excipient has been investigated. α-Chitin forms non-hygroscopic, highly
compactable, disintegrable compacts when co-processed with crystalline mannitol. The compaction properties of the co-processed
mannitol–chitin mixture were found to be dependent upon the quantity of mannitol added to chitin, in addition to the granulation
procedure used. Optimal physicochemical properties of the excipient, from a manufacturing perspective, were obtained using
a co-processed mannitol–chitin (2:8, w/w) mixture prepared by wet granulation (Cop-MC). Disintegration time, crushing strength, and friability of tablets, produced
from Cop-MC using magnesium stearate as a lubricant, were found to be independent of the particle size of the prepared granules.
The inherent binding and disintegration properties of the compressed Cop-MC are useful for the formulation of poorly compressible,
high-strength, and low-strength active pharmaceutical ingredients. The ability to co-process α-chitin with crystalline mannitol
allows chitin to be used as a valuable industrial pharmaceutical excipient. |
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