Abstract

FAMOTIDINE-EXCIPIENT COMPATIBILITY STUDIES FOR ADVANCED DRUG DELIVERY SYSTEMS DEVELOPMENT

Abdalwali Ahmed Saif, Mahmoud Mahyoob Alburyhi*, Maged Alwan Noman,

Abstract

Various scientific and technological advancements have been made in the development of oral drug delivery systems. Orodispersible tablets dissolve rapidly and show higher bioavailability than conventional tablets. Stomach acidity symptoms are treated by many effective drugs; however, they are slow to produce the desirable effect. Therefore, to decrease the patient time in suffering of these symptoms, Orodispersible Drug-Delivery System significantly increased patient acceptance by virtue of rapid disintegration, self-administration without water and finally improved patient compliance. The main objective of the present study was to the preformulation studies were performed to know the physico-chemical and mechanical properties of Famotidine for formulation development of Famotidine ODTs. 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 drug-excipient compatibility studies were conducted to characterize the drug Famotidine present in Orodispersible Tablets Delivery System ODTDS. Preformulation, formulation and evaluation of Famotidine to avoid problems associated with conventional delivery system such as limited permeation, low dissolution and bioavailability and also to improve bioavailability and anti-peptic ulcer. 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 Famotidine and various excipients as mannitol, avicel PH 101and avicel PH 102 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 Famotidine was found to be compatible with various excipients which were selected for the formulation development of the Famotidine 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: Famotidine, Compatibility, Excipients, Development, Preformulation, Formulation.