Abstract
Objective: This present study was aimed to evaluate the potential of chitosan succinate as a coating polymer.Methods: In this study, chemical modification of chitosan was performed by substituting a succinate group into chitosan’s amine group. This reactionused a water-solvent method to obtain chitosan succinate. Chitosan succinate was characterized and used as a coating agent in enteric-coated tabletdosage forms containing sodium diclofenac as the drug model at concentrations of 3% and 4% and combined it with hydroxypropyl methylcellulosephthalate (HPMCP) in ratios of 3:1 and 2:1 (3%). The obtained tablets were evaluated based on their physical appearance, uniformity of weight andsize, thickness film, disintegration time for an hour in acid, and dissolution profile.Results: Although the enteric-coated tablets with 3% and 4% chitosan succinate dissolved after 1 h in acid, they could not hold drug release in theacid medium under 10%. The enteric-coated tablet combined with chitosan succinate and HPMCP (3:1 and 2:1) at 3% did not dissolve after 1 h in theacid medium and could hold drug release up to 8.53% in acid.Conclusion: A combination of chitosan succinate and HPMCP (3:1 and 2:1) at 3% has a better ability to hold drug release in acid medium and met therequirement as a coating in enteric-coated tablet dosage forms.
Highlights
Application of coatings to the surface of pharmaceutical solid dosage forms, tablets, has been practised for over 150 years [1]
Hydroxypropyl methylcellulose phthalate (HPMCP) and cellulose acetate succinate are common excipients used in enteric-coated tablets [3]
We concluded that the endothermic peak of chitosan succinate (79°C) differed from its origin polymer (82.4°C), and they had different melting traces, wherein chitosan succinate was 131.1°C and chitosan 122.7°C
Summary
Application of coatings to the surface of pharmaceutical solid dosage forms, tablets, has been practised for over 150 years [1]. Entericcoated tablets are used to prevent stomach irritation and a drug’s release into the stomach for the delivery of drugs to the intestine for absorption into the bloodstream [2]. Enteric-coated tablets supported by polymers have good stability in stomach fluids and dissolve well in the intestine [1]. Hydroxypropyl methylcellulose phthalate (HPMCP) and cellulose acetate succinate are common excipients used in enteric-coated tablets [3]. These are prepared from modified cellulose with dicarboxylic acid, such as phthalic or succinic acid. Group of carboxyl was substituted by hydroxyl group to increase its solubility because this group can ionize to become carboxylate ion with high solubility in alkaline [4]
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