Development and evaluation of co-processed <i>Phoenix dactylifera</i> l. Sugar and <i>Manihot Esculenta</i> starch as delivery diluent in the formulation of ketoconazole-dry-suspension-for-reconstitution

Abstract

The aim of this work is to compare the effect of co-processed Phoenix dactylifera L. fruit sugar extract and Manihot esculenta starch diluent, and of conventional artificial sweetener (sugar) and corn starch diluent, in the formulation of ketoconazole dry suspension. Physico-mechanical means were used to co-process 5, 25, 50 and 75 % (w/w) Phoenix dactylifera L. sugar syrup with Manihot esculenta starch to create test diluents a, b, c, and d respectively. Same procedure was used to prepare test diluents e, f, g, and h of co-processed Phoenix dactylifera L. sugar with corn starch, while test diluent i is corn starch-industrial sugar diluent used as control. The compatibility of ketoconazole with 1:1 ratio of Manihot esculenta starch - Phoenix dactylifera L. sugar was determined using Fourier transform infrared (FT-IR) spectroscopy. To formulate ketoconazole dry-suspension-for-reconstitution, solvent evaporation process was first used to incorporate ketoconazole powder into the test diluent. Dry starch binder, suspending agents and other components were then mixed together and optimized with isopropyl alcohol, and blended with ketoconazole-diluent mixture to form ketoconazole dry suspension. Suspensions formulated with test diluents a, b, c, d, e, f, g and i were labelled as A, B, C, D, E, F, G, H, and I respectively. The dry suspensions were transferred to different 100 ml bottles, and each reconstituted with freshly boiled and cooled water to produce 20 mg/ml ketoconazole for evaluation studies. The reconstituted suspensions were evaluated for taste, sedimentation volume, degree of flocculation, drug content, and in-vitro dissolution time in gastric pH 1.2. Considering all the parameters, the ketoconazole dry suspension with the co-processed 50 and 75 % Phoenix dactylifera L. sugar in Manihot esculenta starch diluents had satisfying taste masking ability, release characteristics and other acceptable suspension properties with respect to co-processed Phoenix dactylifera L. sugar in corn starch, and are comparable to conventional industrial sugar- corn starch diluents.

Keywords: Co-processed, physico-chemical, solvent evaporation, sedimentation volume, taste evaluation

Journal of Pharmaceutical and Allied Sciences, Vol. 16 No.4 (2019)