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Background: Automation of pharmacotherapy is a recently emerging therapeutic approach that depends on advanced dosage form design engineered through carefully fabricated carriers from two or more excipients The study seeks to develop and characterised in a solid dosage form, a novel, highly functional composite polymer using a hydrophilic natural (Acacia gum) and synthetic Hydroxypropyl methyl cellulose (HPMC) polymer via cross-linking
Methods: HPMC and Acacia gum (AG) ratio 4:0; 3:1; 2:2; 1:3 and 0:4 were cross linked using citric acid. The batches were characterised by FTIR, welling index, viscosity and pH. Five batches of powder blends were prepared using the hybridized HPMC-AG composite polymer 'F1, F2, F3, F4, and F5 as binder in the valsartan (VAL) powder blends. The blends were evaluated for bulk density, angle of repose and compressibility index. Tablets were formulated by direct compression method using Cadmach rotary tableting machine, 12.5 mm die and compression pressure of 10 KN. The tablets parameters such as thickness, diameter, weight variation test, drug content, hardness, friability, and in vitro release studies in phosphate buffer solution (pH 6.8).
Results: The presence of the major functional groups of both polymers after cross-linking proved that there was no complex interaction after the reaction. The powder flow properties and tablets analysis for all batches F1 – F5, showed promising characteristics for an ideal tablet formulation, with average powder flow rate, tablet disintegration time, crushing strength and T90% as follow: F1 (0.10 gs-1, 16.00 min, 135 N, and 20.0 min.) respectively; F2 (0.254 gs-1, 8.48 min, 60 N, and 15.0 min.) respectively; F3 (0.269 gs-1, 10.30 mi, 85 N, and 12.0 min.) respectively; F4 (0.200 gs-1, 4.30 min, 65, and 8.0 min.) respectively; F5 ( 0.315 gs-1, 10.54 mi, 12 N, and 17.0 min.) respectively. The compact formulation 'F4'containing 80 mg VAL 50 mg HPMC, 150 mg AG and 120 mg cellactose have the best property for Self-Disintegrating Fast Dissolving VAL Tablet, better T90 % than the marked generic VALtablets.
Conclusion: A new 2-component composite polymer highly hydrophilic was formed from citric acid cross-linked HPMC and AG. When used with cellactose to formulate VAL tablets it compressed directly and is suitable for formulation of a new Self-Disintegrating Fast Dissolving Oral Solid Dosage Form with improved bioavailability.
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