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Innovative Suppository Base for NSAIDs: Design, Formulation and In-Vitro Bioequivalence Assessment
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| Author:
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AYESHA SYED, PREETI VIJAYKUMAR KARWA, SHOAIB AKTHAR MALLIK, RAKSHITHA V SANKA, ABDUL KALAM M, SOHAL MALLICK, SHASHANK R
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| Abstract:
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Rectal drug delivery serves as an effective alternative to oral administration by bypassing hepatic first-pass metabolism and reducing gastrointestinal irritation associated with non-steroidal anti-inflammatory drugs (NSAIDs). Suppositories are widely used rectal dosage forms for achieving both local and systemic therapeutic effects; however, conventional bases such as cocoa butter and polyethylene glycol exhibit limitations including polymorphism, poor thermal stability, and mucosal irritation. The present study was undertaken to develop and evaluate a natural suppository base using mango seed kernel fat (MKF) as a substitute for conventional bases in diclofenac sodium suppositories. Suppositories were prepared by the fusion method and evaluated for physical appearance, weight variation, hardness, melting point, liquefaction time, displacement value, and in-vitro drug release. Differential scanning calorimetry (DSC) studies revealed the disappearance of the characteristic melting peak of diclofenac sodium in the optimized formulation, indicating molecular dispersion of the drug within the lipid matrix and enhanced thermal stability of the system. Among the formulations developed, formulation F2 showed satisfactory physicochemical and release characteristics. It exhibited a torpedo shape with a smooth surface and uniform appearance. The mean weight was 0.978 ± 0.04 g, hardness was 1.5 ± 0.07 kg, melting point was 33 °C, and liquefaction time was 3.39 ± 0.01 minutes. The displacement value was found to be 0.652. In-vitro drug release studies revealed 95.18 ± 2.84% drug release within 60 minutes. The results indicate that mango seed kernel fat can be effectively utilized as a natural suppository base, offering improved thermal stability, adequate mechanical strength, and enhanced drug release. MKF-based suppositories may therefore provide a suitable and patient-acceptable alternative for rectal delivery of diclofenac sodium.
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| Keyword:
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Diclofenac sodium, mango seed kernel fat, suppository base, rectal drug delivery, NSAIDs, in-vitro drug release.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2026.18.01.002
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| Download:
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