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Preparation and Characterization of a Novel Co-processed Excipient of Chitin and Crystalline Mannitol

  • Research Article
  • Theme: Advances in Pharmaceutical Excipients Research and Use: Novel Materials, Functionalities and Testing
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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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Authors and Affiliations

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

    Nidal Daraghmeh, Iyad Rashid, Mahmoud M. H. Al Omari & Adnan Badwan

  2. School of Science, University of Greenwich at Medway, Chatham Maritime, Kent, ME4 4 TB, UK

    Nidal Daraghmeh, Stephen A. Leharne & Babur Z. Chowdhry

Authors
  1. Nidal Daraghmeh
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  2. Iyad Rashid
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  3. Mahmoud M. H. Al Omari
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  4. Stephen A. Leharne
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  5. Babur Z. Chowdhry
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  6. Adnan Badwan
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Correspondence to Adnan Badwan.

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Guest Editors: Otilia Koo, Thomas Farrell, Allison Radwick, and Sameer Late

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Daraghmeh, N., Rashid, I., Al Omari, M.M.H. et al. Preparation and Characterization of a Novel Co-processed Excipient of Chitin and Crystalline Mannitol. AAPS PharmSciTech 11, 1558–1571 (2010). https://doi.org/10.1208/s12249-010-9523-8

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  • DOI: https://doi.org/10.1208/s12249-010-9523-8

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