Abstract

LISINOPRIL-EXCIPIENT COMPATIBILITY STUDIES FOR ADVANCED DRUG DELIVERY SYSTEMS DEVELOPMENT

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

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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 Lisinopril dihydrate for formulation development of Lisinopril ODTs. The drug-excipient compatibility studies were conducted to characterize the drug Lisinopril present in Orally Disintegrating Tablets Delivery System ODDS. Preformulation, formulation and evaluation of Lisinopril to avoid problems associated with conventional delivery system such as limited permeation, low dissolution and bioavailability and also to improve bioavailability and antihypertensive effect. 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 Lisinopril dihydrate and various excipients as mannitol, microcrystalline cellulose as diluents, and sodium starch glycolate, croscarmellose sodium, and crospovidone as superdisintegrants and sodium lauryl sulfate as wetting agent were evaluated for preformulation studies parameters. It was concluded that the drug Lisinopril dihydrate was found to be compatible with various excipients which were selected for the formulation development of the Lisinopril ODTs. 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: Lisinopril, Compatibility, Excipients, Development, Preformulation, Formulation.