Design, Optimisation, and Evaluation of Triple-Layer SustainedRelease Matrix Tablets for Co-Delivery of Diclofenac Sodium and Chondroitin Sulphate in Osteoarthritis Management
Abstract
Background: Osteoarthritis (OA) requires long-term co-administration of chondroitin sulphate (CTN) and diclofenac sodium (DFC). Conventional immediate-release forms cause high dosing frequency, plasma fluctuations, and significant GI side effects. Objective: To design and optimize a once-daily triple-layer sustained-release matrix tablet for CTN (300 mg) and DFC (150 mg) using HPMC K4M and guar gum as rate-controlling polymers. Methods: Nine formulations (F1–F9) were prepared via central composite design (RSM). HPMC K4M and guar gum were optimized against cumulative drug release (%CDR) and swelling index. Dissolution (USP II, pH 6.8, 12 h), release kinetics, and accelerated stability (40°C/75% RH, 90 days, ICH guidelines) were evaluated. Results: All formulations met pharmacopeial standards. Optimized F7 (HPMC K4M 450 mg, guar gum 387.84 mg) achieved 12-hour dual sustained release via nonFickian anomalous transport (n = 0.6968). The RSM quadratic model for %CDR showed excellent fit (Adj. R² = 0.9997, p < 0.0001), with HPMC K4M as the dominant rate-controlling polymer. Drug content: DFC 98.02%, CTN 98.95%. F7 remained stable over 90 days. Conclusion: The optimized triple-layer matrix F7 enables once-daily co-sustained release of CTN and DFC for OA, offering improved patient adherence, reduced GI toxicity, and a scalable platform combining disease-modifying and anti-inflammatory therapy.
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