Development, Optimization and Comparative Evaluation of Diclofenac Sodium Sustained Release Matrix Tablets Using Polymers

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Auteur principal: Kunal Tanwar1*, Mukesh Gupta2, Chander Singh3
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Publié: Zenodo 2026
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author Kunal Tanwar1*, Mukesh Gupta2, Chander Singh3
author_facet Kunal Tanwar1*, Mukesh Gupta2, Chander Singh3
contents <p class="MsoNormal"><span>The present study was aimed at the formulation and evaluation of sustained release matrix tablets of Diclofenac Sodium using different hydrophilic and hydrophobic polymers to achieve prolonged drug release, improve therapeutic efficacy, and enhance patient compliance. Diclofenac Sodium, a widely used non-steroidal anti-inflammatory drug (NSAID), possesses a short biological half-life and requires frequent administration, which may lead to poor patient adherence and gastrointestinal side effects. To overcome these limitations, sustained release matrix tablets were prepared using various grades of Hydroxypropyl Methylcellulose (HPMC K4M, HPMC K15M, and HPMC K100M) along with Ethylcellulose as release-retarding polymers. The tablets were formulated by wet granulation technique and evaluated for pre-compression and post-compression parameters including angle of repose, bulk density, tapped density, hardness, friability, weight variation, thickness, and drug content uniformity. Drug-excipient compatibility studies were carried out using FTIR and DSC analyses, which confirmed the absence of significant interactions between the drug and excipients. In-vitro dissolution studies were performed using USP type II paddle apparatus in phosphate buffer pH 6.8 for 12 hours. Among all formulations, batch F4 containing HPMC K15M and Ethylcellulose exhibited the most desirable sustained release profile with 92% drug release over 12 hours, acceptable mechanical strength, and minimal burst release. Release kinetics studies indicated that the optimized formulation followed near zero-order kinetics, demonstrating controlled and concentration-independent drug release. Comparative dissolution studies with marketed formulation (Voveran SR) revealed similar release behavior. The study concluded that the developed sustained release matrix tablet of Diclofenac Sodium can serve as a promising alternative to conventional dosage forms for prolonged therapeutic action and improved patient compliance</span></p>
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publishDate 2026
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spellingShingle Development, Optimization and Comparative Evaluation of Diclofenac Sodium Sustained Release Matrix Tablets Using Polymers
Kunal Tanwar1*, Mukesh Gupta2, Chander Singh3
Diclofenac Sodium; Sustained Release Matrix Tablet; HPMC; Ethylcellulose; Wet Granulation; Controlled Drug Delivery; In-vitro Dissolution Study; Release Kinetics; FTIR; DSC
<p class="MsoNormal"><span>The present study was aimed at the formulation and evaluation of sustained release matrix tablets of Diclofenac Sodium using different hydrophilic and hydrophobic polymers to achieve prolonged drug release, improve therapeutic efficacy, and enhance patient compliance. Diclofenac Sodium, a widely used non-steroidal anti-inflammatory drug (NSAID), possesses a short biological half-life and requires frequent administration, which may lead to poor patient adherence and gastrointestinal side effects. To overcome these limitations, sustained release matrix tablets were prepared using various grades of Hydroxypropyl Methylcellulose (HPMC K4M, HPMC K15M, and HPMC K100M) along with Ethylcellulose as release-retarding polymers. The tablets were formulated by wet granulation technique and evaluated for pre-compression and post-compression parameters including angle of repose, bulk density, tapped density, hardness, friability, weight variation, thickness, and drug content uniformity. Drug-excipient compatibility studies were carried out using FTIR and DSC analyses, which confirmed the absence of significant interactions between the drug and excipients. In-vitro dissolution studies were performed using USP type II paddle apparatus in phosphate buffer pH 6.8 for 12 hours. Among all formulations, batch F4 containing HPMC K15M and Ethylcellulose exhibited the most desirable sustained release profile with 92% drug release over 12 hours, acceptable mechanical strength, and minimal burst release. Release kinetics studies indicated that the optimized formulation followed near zero-order kinetics, demonstrating controlled and concentration-independent drug release. Comparative dissolution studies with marketed formulation (Voveran SR) revealed similar release behavior. The study concluded that the developed sustained release matrix tablet of Diclofenac Sodium can serve as a promising alternative to conventional dosage forms for prolonged therapeutic action and improved patient compliance</span></p>
title Development, Optimization and Comparative Evaluation of Diclofenac Sodium Sustained Release Matrix Tablets Using Polymers
topic Diclofenac Sodium; Sustained Release Matrix Tablet; HPMC; Ethylcellulose; Wet Granulation; Controlled Drug Delivery; In-vitro Dissolution Study; Release Kinetics; FTIR; DSC
url https://doi.org/10.5281/zenodo.20395695