Abstract

ROSUVASTATIN CALCIUM-EXCIPIENT COMPATIBILITY STUDIES FOR ADVANCED DRUG DELIVERY SYSTEMS DEVELOPMENT

Mahmoud Mahyoob Alburyhi*, Maged Alwan Noman, Abdalwali Ahmed Saif, Mohammed Abbas Hamidaddin, Tawfeek A. A. Yahya and Mokhtar Abd-hafiz Al-Ghorafi

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Abstract

The safety, efficacy, quality and stability of a formulation are major concepts of any API development process. In API development process, a detailed characterization of the API and other formulation components is usually carried out during the preformulation stage. The main objective of the present study was to the preformulation studies were performed to know the physico-chemical and mechanical properties of Rosuvastatin calcium for formulation development of FDTs. The drug-excipient compatibility studies were conducted to characterize the drug Rosuvastatin present in Fast Dissolving Drug Delivery System FDDs. Preformulation, formulation and evaluation of Rosuvastatin to avoid problems associated with conventional delivery system such as limited permeation, low dissolution and bioavailability and also to improve bioavailability and hypocholesteremic effect in blood vessels. In the present study that the compatibility was assessed by, FTIR spectroscopy, and melting point apparatus, precompression parameters and powder flow properties. Results showed that physical mixtures of Rosuvastatin calcium and various excipients as mannitol, microcrystalline cellulose as diluents, and sodium starch glycolate, croscarmellose sodium, and crospovidone as superdisintegrants and PEG6000, tween80 and sodium lauryl sulfate as wetting agents were evaluated for preformulation studies parameters. It was concluded that the drug Rosuvastatin calcium was found to be compatible with various excipients which were selected for the formulation development of the Rosuvastatin calcium FDTs. Formulation scientist from his experience and knowledge have to significantly in the preformulation study stage and is an important factor in the ADDS (Advanced Drug Delivery Systems) product development process.

Keywords: Rosuvastatin calcium, Compatibility, Excipients, Development, Superdisintegrants, Preformulation, Formulation.