ABSTRACT
Introduction: The potential limitations of drug delivery based on the administration of conventional single per-oral dosage forms, particularly those containing active pharmaceutical ingredients with short biological half-lives has led to the development of sustained release dosage forms.
Objective: The objective of this study was to develop an oral sustained release diclofenac sodium tablets using a blend of hydrophobic (Eudragit RS PO) polymer in combination with hydrophilic polymers (Abelmoschusesculentus and polyethylene glycol) as release rate controlling factor.
Method: Nine (9) batches of diclofenac sodium tablets were prepared with a combination of Eudragit, Abelmoschus esculentus and polyethylene glycol (PEG) at various ratios using direct compression technique. The powder blends of the different batches were evaluated for flow properties (flow rate, angle of repose, Hausner’s ratio and Carr’s index) before compression into tablets. The tablets were analyzed for their hardness, weight uniformity, tablet dimensions, friability, crushing strength and an in-vitro dissolution study in simulated gastric and intestinal fluid for 8 hours using USP-22 dissolution apparatus.
Result: The powder blend of the tablet Batches had bulk densities ranging between 0.41-0.57, tapped densities between 0.50 - 0.72, compressibility indices between 11.9 - 20.8%, Hausner’s ratio within 1.14 - 1.26 as well as angles of repose less than 30°. All formulated tablets of the various batches had uniform weight, crushing strength ranging from 3.13-7.89 kgf and friability values less than 1.0%. All formulated tablet batches exhibited sustained release properties with Batch 7 having the highest release of over 80% of its drug content in 8 h.
Conclusion: Sustained release tablets of diclofenac sodium were successfully prepared using different ratio combinations of Eudragit, Abelmoschus esculentus, and polyethylene glycol (PEG) as release retarding polymers.
