Objective: The aim of the present work was to formulate and evaluate oral disintegrating tablets of Ketorolac tromethamine HCl by statistical experimental design. The Ketorolac is an NSAIDs drug, which has high solubility and high permeability (BCS class I). Methods: Tablets were prepared by direct compression technique using dehydrated Banana powder (Musa acuminata) and Plantago ovata powder (Ispaghula) as independent variables. In vitro disintegration time and % drug release were selected as dependent variables. The model was found to be linear and the curvature effect was significant. Therefore, study resorted to composite design for optimization. Results: DSC studies indicated that the drug and excipients were compatible. Pre-compression parameters had shown fairly good flow properties. The directly compressed tablets were evaluated for pharmaco technical properties and were found to be within specified limits. Kinetic studies revealed that drug release from all formulations followed first order release. Based on simulation given by the software most economical batch which was in desired range was selected. Conclusion: The statistical model is mathematically valid as the experimental values and predicted values suggested by the model were relatively close to each other. The results demonstrated the effectiveness of the proposed design for development of Ketorolac tromethamine HCl fast disintegrating tablets with optimized properties.
Objective: The purpose of the present work was to enhance antimicrobial activity of Suppress release Amoxicillin Camphor complexed Mucoadhesive tablets by Statistical Experimental Design using Sigma tech software version 3.1. Amoxicillin has short half-life (1 h) which requires frequent administration of the conventional amoxicillin tablets and is mainly used in the eradication of Helicobacter pylori that resides in the stomach. Methods: Amoxicillin-Sodium cholate (ASC) and camphor complexes (ACC) were prepared to enhance antimicrobial activity. Results: TLC and FT-IR studies confirmed the formation of drug complex. Zone of inhibition by agar well diffusion method of ACC showed greater inhibition than ASC, solubility of ACC was enhanced by re-crystallization technique. Hence ACC needle shaped re-crystallized was used to sustained release tablets using mucoadhesive polymers. Chitosan, HPMC K-15 and Ethyl cellulose (EC) were selected as independent variables and ex vivo mucoadhesion time, % drug release at 24 h and t 50 % (time to release 50 % drug) were selected as dependent variables. DSC studies indicated drug and excipients were compatible. Swelling studies and scanning electron microscopic analysis confirmed the drug release mechanism from sustained release tablets. In-vitro release studies and ex vivo studies of amoxicillin confirmed the sustained drug release profile with first order release kinetics better mucoadhesion and enhanced antimicrobial activity. The optimized formulation was found to be stable at accelerated storage conditions for 3 months. Conclusion: The results demonstrated the effectiveness of the proposed statistical design for optimization of ACC sustained release tablets.
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