Tue, 21 Nov 2017

Co-Crystallization of Glipizide & Rosuvastatin Calcium and itís Characterization

Ashwini Deshpande*1, Tanvee  Patole1

1.SVKM’s NMIMS, School of Pharmacy & Technology Management, Babulde, Banks of Tapi River, Mumbai-Agra Road, Shirpur – 425 405, Dist.Dhulia, Maharashtra, India.


ABSTRACT

Co-crystals consists of API and a stoichiometric amount of a pharmaceutically acceptable co-crystal former. Pharmaceutical Co-crystals are nonionic supramolecular complexes and can be used to address physical property issues such as solubility, stability and bioavailability in pharmaceutical development without changing the chemical composition of the API. Maximum of the drugs belong to BCS class II, means these are drugs which have low solubility and high permeability. There are various methods of solubility enhancement such as salt formation, solvates, polymorphs, complexation, co-crystallization, etc. Co-crystallization mainly consists of two components the API and the coformer. Thse coformer is the one which acts as a main component for solubility enhancement. In case of ionization or salt formation there is a drawback as compared to co-crystallization. In case, of salt formation or ionization presence of an ionic center is required. This is not a requirement in case of co-crystallization.FDA has approved such combination called Juvisync1 (Sitagliptin and Simvastatin) in 2011.Glipizide belongs to the anti-diabetic class of drug and Rosuvastatin calcium is a cholesterol reducing agent. As both these drugs are class II drug, solubility issues has to be solved. As Glipizide was available not in its salt form, its co-crystallization was decided to do. Hence, co-crystallization method was selected as the method to enhance the solubility. The co-crystals were characterized and showed the conformance of the presence of both the APIs.

Keywords: Glipizide, Rosuvastatin calcium, co-crystals, coformer.


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