Abstract

A novel modified biomaterial of periwinkle shell powder, MBPSP was developed from Tympanotonus fuscata. It was assessed as a bulking agent in the formulation of pyrimethamine and pyridoxine hydrochloride tablets adopting dicalcium phosphate dihydrate (DCP) as a standard. A 100 g of the ground periwinkle shell was broken down in 166.0 ml of 2 M hydrochloric acid, clarified and treated with 5 M sodium hydroxide. The thick white precipitate obtained was washed severally and to it, ortho-phosphoric acid was dropped in bits until a thick, dehydrated bulk was attained which was dried at 60 o C and classified with 250 μm sieve. The product was coded MBPSP. Two batches of granules containing pyrimethamine (25 mg) and pyridoxine hydrochloride (50 mg) were generated by the wet granulation employing MBPSP alongside DCP. The granules were lubricated with magnesium stearate and talc and compacted into tablets at 7.55kN using a 10.50 mm diameter die and flat-faced punch fixed in a hydraulic hand press. The tablet produced were evaluated using the British Pharmacopoeia specifications. The weight variation for the pyrimethamine or pyridoxine hydrochloride tablets containing MBPSP or DCP were 0.06, 0.1, 0.097 and 0.143 % respectively. The total drug content for the individual lots of tablets for either pyrimethamine or pyridoxine hydrochloride was within 85.00-115.00 % of their label claim. Higher mechanical strength were noted for the batch of tablets manufactured with DCP and containing pyrimethamine and pyridoxine hydrochloride than MBPSP. Though the entire batches of tablets for the two drugs manufactured with either MBPSP or DCP disintegrated in less than 5.00 min with no significant difference in their individual disintegrating time (p>0.05), pyridoxine hydrochloride tablets prepared with DCP disintegrated in lesser time when compared to MBPSP (p<0.05). Only the pyrimethamine tablets prepared with MBPSP attained 75.00 % drug release in 45.00 min in line with the United States Pharmacopoeia (USP) criteria. Therefore, MBPSP could be another very useful bulking agent in the formulation of pyrimethamine immediate-release tablets by the wet granulation technique. Keywords: Modified biomaterial, Tympanotonus fuscata, periwinkle, shell, pyrimethamine, pyridoxine hydrochloride, tablet.

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