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.
Highlights
Tablets are widely used as drug delivery system due to their convenience with respect to self-administration and ease of manufacture [1]
The preliminary results of the aforementioned experiments indicated that direct mixing and wet granulation (WG) were unsuitable, because the mixtures prepared by direct mixing displayed unacceptable physical properties
In the case of WG, the tablets suffered from capping and high disintegration times due to penetration of the dissolved mannitol into the chitin pores
Summary
Tablets are widely used as drug delivery system due to their convenience with respect to self-administration and ease of manufacture [1]. Pediatric, geriatric and mentally ill patients experience difficulties in swallowing conventional tablets, which leads to poor patient compliance. To overcome this deficiency, ODT formulations have been developed [3,4]. In Ph. Euro., an ODT is defined as a tablet to be placed in the mouth where it disperses rapidly before being swallowed in less than 3 minutes [5], while the FDA considers it as a solid oral preparation that disintegrates rapidly in the oral cavity with an in vivo disintegration time of approximately 30 s or less [4]. ODTs are advantageous due to their administration without water, rapid onset of action and improved bioavailability [6,7]
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