Abstract
The flow, tableting and in vitro release properties of directly compressed chlorpheniramine maleate (CPM) tablets containing fluid bed dried and lyophilized microcrystalline cellulose (MCC) obtained from Gossypium herbaceum (GH) were investigated. Delignification of dried GH linters was done through the soda process to obtain alpha cellulose which was hydrolyzed with 2.0 N hydrochloric acid to get MCC. The MCC was washed with water until neutral. Drying was done by either fluid bed method or lyophilization to obtain MCC-GossF and MCC-GossL respectively. Chlorpheniramine tablets containing 20, 30 and 40% of the MCCs were prepared by direct compression method. Avicel PH102 (AVH-102) served as comparing standard. Using standard methods, evaluation of the powders and the tablets was done. The evaluated parameters of the powders and tablets conformed to the British Pharmacopoeia specifications. The CPM tablets containing MCC-GossF (coded CGF) had better flow but were not mechanically as strong as those containing MCC-GossL (coded CGL). The hardness and disintegration times of the tablets were in the order of CGF < CGL and the friability was in the order of CGF > CGL. Similar parameters of DCL compared well with CPM tablets containing AVH-102 (coded DAV). The MCC obtained from GH had dilution potential up to 40% except in CGF-4 tablets. The in vitro dissolution showed > 80% CPM release from all the batches within 30 min. The release kinetics were of mixed order while the mechanism of drug release was Fickian. The MCCs served as good directly compressible binder for chlorpheniramine maleate.
Highlights
Direct compression technology is a process that involves the direct compression of the powder or granule blends of the Active Pharmaceutical Ingredient (API) and suitable excipients into a firm compact
It was observed that the bulk and tapped densities of the different batches of chlorpheniramine maleate increased as the quantity of chlorpheniramine maleate content of the powder bed was increased and microcrystalline cellulose (MCC) content decreased
The angle of repose of the different powders containing fluid bed dried MCC (CGF-2 to CGF-4) and CAV-2 to CAV-4 ranged from 27.16 ± 0.55 to 28.45 ± 0.36° and falls under the category of excellent flowing powders [25,3033] while CGL-2 to CGL-4 batches showed good flow (Table 2)
Summary
Direct compression technology is a process that involves the direct compression of the powder or granule blends of the API and suitable excipients into a firm compact. Since the formation of larger particle agglomerates from small drug particles through a binding process is not applicable in direct compression, tablets prepared by this method would disintegrate faster than when wet or dry granulation methods are used [3]. This is a result of the fast penetration of water into the hydrophilic tablet matrix by Corresponding author: Nkemakolam Nwachukwu Department of Pharmaceutics and Pharmaceutical Technology, University of Port Harcourt, Nigeria
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