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Co-processed chitin-mannitol as a new excipient for Oro-dispersible tablets
Nidal Daraghmeh1,2, Babur Z Chowdhry3, Stephen A Leharne4
1The Jordanian Pharmaceutical Manufacturing Co., PO Box 94, Naor 11710, Jordan. nidalda@hotmail.com.
Marine Drugs
|April 2, 2015
Summary
A novel oro-dispersible tablet (ODT) excipient, Cop-CM, combining chitin and mannitol, demonstrates superior binding and disintegration properties. This multifunctional base offers enhanced performance for fast-release oral dosage forms.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Drug Delivery Systems
Background:
- Oro-dispersible tablets (ODTs) require specialized excipients for rapid disintegration and dissolution.
- Current ODT excipients face limitations in achieving optimal physicochemical and performance characteristics.
Purpose of the Study:
- To develop and characterize a novel co-processed excipient (Cop-CM) for ODTs.
- To evaluate the performance of Cop-CM in ODT formulations.
Main Methods:
- Cop-CM was prepared by roll compaction (RC) at an optimal chitin:mannitol ratio (2:8 w/w).
- Characterization involved DSC, FT-IR, XRPD, and SEM.
- Compressibility was assessed using Kawakita plots.
- ODTs containing Montelukast sodium and domperidone were formulated and evaluated.
Main Results:
- The optimal Cop-CM formulation exhibited superior compressibility (a=0.661) compared to mannitol (a=0.576).
- Particle size distribution did not significantly impact tablet properties.
- ODTs formulated with Cop-CM showed excellent physicochemical properties, including fast wetting and superdisintegration.
- Cop-CM demonstrated superior binding, wetting, and disintegration compared to commercial excipients.
Conclusions:
- Cop-CM is a multifunctional excipient with exceptional properties for ODT formulation.
- This novel excipient facilitates the development of effective oro-dispersible and fast immediate-release tablets.
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