Assessment of disintergrant properties of <i>Pleurotus tuberregium</i>, corn starch and <i>Hydroxypropyl methylcellulose</i> in <i>Cloxacillin trihydrate<i> capsule formulations

Background and aim: This research is aimed at evaluating Pleurotus tuber-regium (PTR) as a local pharmaceutical excipient and compare its disintegrant properties with standard disintegrants, corn starch BP and hydroxylpropyl methylcellulose (HPMC) BP in Cloxacillin trihydrate capsule formulation. Methods: Micronised powder and powder prepared from the giant mushroom, P. tuber-regium (Fr) Sing, corn starch BP and HPMC powders were subjected to physicochemical tests (pH, hydration capacity, swelling capacity) and micromeritic tests. Wet granulation method with 7.5 %w/v microcrystalline cellulose as binder was used to produce Cloxacillin trihydrate granules using concentrations of 5.0, 7.5, 10.0 and 12.5 %w/w of the disintegrants. After drying the wet mass and sieving, granule bulk was lubricated, mixed and hand-filled into gelatin capsules to give Cloxacillin trihydrate 500 mg capsules. Physicochemical properties - weight uniformity, disintegration time and moisture absorption tests were evaluated. Results: Micromeritic and powder properties of the disintegrants were comparable. At similar disintegrant concentrations, disintegration time of Cloxacillin trihydrate capsules formulated with PTR powder was less than those formulated with corn starch and HPMC. At 7.5 %w/w, disintegration time (minute) were: PTR 6.30 ± 0.23, corn starch 6.40 ± 0.15 and HPMC 8.50 ± 0.02. Disintegration time decreased with increase in disintegrant concentration. Weight variation for all formulations were within Pharmacopoeial standards of not more than ± 5% for solid dosage forms ≥ 324 mg. Conclusion: P. tuber-regium powder as a disintegrant in Cloxacillin trihydrate capsule formulation, showed greater disintegrant ability than formulations with the standard disintegrants. Therefore, the mushroom, P. tuberregium powder could be used as a suitable substitute for corn starch BP and HPMC in Cloxacillin trihydrate capsule formulation.