Formulation and Evaluation of Bilayer Tablets Containing Diclofenac Sodium and Pantoprazole Sodium

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Auteur principal: Ganesh Parihar*, Gaurav Devkhane, Gayatri Shingane, Dr. Pavan Narkhede, Dr. Prafulla Tathe
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Publié: Zenodo 2026
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author Ganesh Parihar*, Gaurav Devkhane, Gayatri Shingane, Dr. Pavan Narkhede, Dr. Prafulla Tathe
author_facet Ganesh Parihar*, Gaurav Devkhane, Gayatri Shingane, Dr. Pavan Narkhede, Dr. Prafulla Tathe
contents <p class="MsoNormal"><span>Non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac sodium are widely used for the management of pain and inflammation; however, their chronic use is associated with gastrointestinal (GI) complications, including ulceration and bleeding. Pantoprazole sodium, a proton pump inhibitor (PPI), is commonly co-administered to mitigate NSAID-induced gastric damage. The present study aims to develop and evaluate a bilayer tablet system comprising an immediate release (IR) layer of pantoprazole sodium and a sustained release (SR) layer of diclofenac sodium to enhance therapeutic efficacy while minimizing adverse effects. Bilayer tablet technology offers a promising approach for the sequential delivery of drugs with different release profiles. In this investigation, the IR layer was formulated using superdisintegrants such as crospovidone to achieve rapid drug release, whereas the SR layer was developed using hydrophilic polymers like hydroxypropyl methylcellulose (HPMC) to control drug release over an extended period. Preformulation studies including compatibility analysis (FTIR), flow properties, and compressibility were performed to ensure suitability of excipients. The tablets were prepared using a direct compression technique. The developed formulations will be evaluated for physicochemical parameters, including hardness, friability, weight variation, drug content, and in vitro dissolution behavior. The anticipated outcome is a bilayer tablet that provides immediate gastric protection followed by prolonged anti-inflammatory action, thereby improving patient compliance and therapeutic outcomes.</span></p>
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publishDate 2026
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spellingShingle Formulation and Evaluation of Bilayer Tablets Containing Diclofenac Sodium and Pantoprazole Sodium
Ganesh Parihar*, Gaurav Devkhane, Gayatri Shingane, Dr. Pavan Narkhede, Dr. Prafulla Tathe
Bilayer tablet; Diclofenac sodium; Pantoprazole sodium; Sustained release; Immediate release; NSAIDs; Gastroprotection
<p class="MsoNormal"><span>Non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac sodium are widely used for the management of pain and inflammation; however, their chronic use is associated with gastrointestinal (GI) complications, including ulceration and bleeding. Pantoprazole sodium, a proton pump inhibitor (PPI), is commonly co-administered to mitigate NSAID-induced gastric damage. The present study aims to develop and evaluate a bilayer tablet system comprising an immediate release (IR) layer of pantoprazole sodium and a sustained release (SR) layer of diclofenac sodium to enhance therapeutic efficacy while minimizing adverse effects. Bilayer tablet technology offers a promising approach for the sequential delivery of drugs with different release profiles. In this investigation, the IR layer was formulated using superdisintegrants such as crospovidone to achieve rapid drug release, whereas the SR layer was developed using hydrophilic polymers like hydroxypropyl methylcellulose (HPMC) to control drug release over an extended period. Preformulation studies including compatibility analysis (FTIR), flow properties, and compressibility were performed to ensure suitability of excipients. The tablets were prepared using a direct compression technique. The developed formulations will be evaluated for physicochemical parameters, including hardness, friability, weight variation, drug content, and in vitro dissolution behavior. The anticipated outcome is a bilayer tablet that provides immediate gastric protection followed by prolonged anti-inflammatory action, thereby improving patient compliance and therapeutic outcomes.</span></p>
title Formulation and Evaluation of Bilayer Tablets Containing Diclofenac Sodium and Pantoprazole Sodium
topic Bilayer tablet; Diclofenac sodium; Pantoprazole sodium; Sustained release; Immediate release; NSAIDs; Gastroprotection
url https://doi.org/10.5281/zenodo.19684292