Film Coating of Phosphorylated Mandua Starch on Matrix Tablets for pH-Sensitive Release of Mesalamine
Mayank Kumar Malik,
Vipin Kumar,
Vinoth Kumarasamy,
Om Prakash Singh,
Mukesh Kumar,
Raghav Dixit,
Vetriselvan Subramaniyan,
Jaspal Singh
Affiliations
Mayank Kumar Malik
Department of Chemistry, Gurukula Kangri (Deemed to be University), Haridwar 249407, India
Vipin Kumar
Department of Pharmaceutical Sciences, Gurukula Kangri (Deemed to be University), Haridwar 249407, India
Vinoth Kumarasamy
Department of Parasitology and Medical Entomology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Cheras, Kuala Lumpur 56000, Malaysia
Om Prakash Singh
Department of Kaya Chikitsa, Rishikul Campus, Haridwar, Uttarakhand Ayurved University, Dehradun 248001, India
Mukesh Kumar
Department of Botany and Microbiology, Gurukula Kangri (Deemed to be University), Haridwar 249407, India
Raghav Dixit
Department of Pharmaceutical Sciences, Gurukula Kangri (Deemed to be University), Haridwar 249407, India
Vetriselvan Subramaniyan
Pharmacology Unit, Jeffrey Cheah School of Medicine and Health Sciences, Monash University, Jalan Lagoon Selatan, Bandar Sunway, Selangor Darul Ehsan 47500, Malaysia
Jaspal Singh
Department of Chemistry, Gurukula Kangri (Deemed to be University), Haridwar 249407, India
Chemically modified mandua starch was successfully synthesized and applied to coat mesalamine-loaded matrix tablets. The coating material was an aqueous dispersion of mandua starch modified by sodium trimetaphosphate and sodium tripolyphosphate. To investigate the colon-targeting release competence, chemically modified mandua starch film-coated mesalamine tablets were produced using the wet granulation method followed by dip coating. The effect of the coating on the colon-targeted release of the resultant delivery system was inspected in healthy human volunteers and rabbits using roentgenography. The results show that drug release was controlled when the coating level was 10% w/w. The release percentage in the upper gastric phase (pH 1.2, simulated gastric fluid) was less than 6% and reached up to 59.51% w/w after 14 h in simulated colonic fluid. In addition to in vivo roentgenographic studies in healthy rabbits, human volunteer studies proved the colon targeting efficiency of the formulation. These results clearly demonstrated that chemically modified mandua starch has high effectiveness as a novel aqueous coating material for controlled release or colon targeting.
