Abstract

AMLODIPINE-EXCIPIENT COMPATIBILITY STUDIES FOR ADVANCED DRUG DELIVERY SYSTEMS DEVELOPMENT

Mahmoud Mahyoob Alburyhi*, Yahya Abduh Salim Mohamed, Abdalwali Ahmed
Saif and Maged Alwan Noman

ABSTRACT

Amlodipine besylate is indicated in the treatment of mild to moderateessential hypertension. Combination of amlodipine with a diuretic, anangiotensin converting enzyme inhibitor has been found to becompatible and showed additive antihypertensive effect. The mainobjective of the present study was to the preformulation studies wereperformed to know the development of formulation and evaluation ofAmlodipine Orodispersible Tablets to improve the bioavailability ofAmlodipine. In API development process, a detailed characterizationof the API and other formulation components is usually carried outduring the preformulation stage. The drug-excipient compatibilitystudies were conducted to characterize the drug Amlodipine present inOrodispersible Tablets Delivery System ODTs. Preformulation,formulation and evaluation of Amlodipine to avoid problemsassociated with conventional delivery system and one of the mostrecent antihypertensive agents. In the present study that thecompatibility was assessed by, FTIR spectroscopy, and melting pointapparatus, precompression parameters and powder flow properties.Results showed that physical mixtures of Amlodipine and various excipients such as MCC asdiluent, and sodium starch glycolate, crospovidone as superdisintegrants and sodium laurylsulfate as wetting agent were evaluated for preformulation studies parameters. It wasconcluded that the drug Amlodipine was found to be compatible with various excipients which were selected for the formulation development of the Amlodipine ODTs. Formulationscientist from his experience and knowledge have to significantly in the preformulation studystage and is an important factor in the ADDS (Advanced Drug Delivery Systems) productdevelopment process.

Keywords: Amlodipine Besylate, Compatibility, Excipients, Development, Preformulation, Formulation.