Novel Application of Mixed Solvency Concept to Develop and Formulate Dry Powder Injection for Reconstitution of a Poorly Water Soluble Drug, Amlodipine Besylate and their Evaluations

In the recent generation of pharmaceutical research, it has been observed that many newly designed and discovered drug products have less water solubility. Thus, leading to difficulties in several developmental, manufacturing and administrative processes. Furthermore, the clinical trials of these drugs have witnessed a great failure due to their poor pharmacokinetics. The lineup of our research work was promotion of mixed solvency concept by formulating the dry powder injection for reconstitution of poorly water-soluble drug amlodipine besylate by decreasing the solubilisers concentration in small proportion for expected synergistic enhancement of drug solubility in water. Solubilisers used are sodium benzoate, sodium caprylate, PVPK-25, sodium citrate, niacinamide, poloxamer 407, sodium acetate, L-arginine, benzoic acid, β-cyclodextrin and lysine hydrochloride to developed the dry powder injection for reconstitution of amlodipine besylate. The reconstitution time of amlodipine besylate injections were found 58 sec, 36 sec and 1 min 10 sec in selected blends. This drug is slightly soluble in water, and it comes in various forms, including tablets and other oral dosage forms. However, no amlodipine besylate dry powder injection or ready-made injections are currently available in the market. Dry powder injection for reconstitution of amlodipine besylate was formulated successfully and mixed solvency concept has been successfully employed. Keywords: Mixed solvency concept, Amlodipine besylate, Dry powder injection for reconstitution, Solubilisers, Solubility.