AMOXICILLIN-EXCIPIENT COMPATIBILITY STUDIES FOR ADVANCED DRUG DELIVERY SYSTEMS DEVELOPMENT

Abdalwali Ahmed Saif, Mahmoud Mahyoob Alburyhi*, Maged Alwan Noman and Abdulmalik Abudunia

ABSTRACT

The main objective of the present study was to the preformulation studies were performed to know the development of formulation and evaluation of Amoxicillin Trihydrate Fast Dissolving Tablets to improve the bioavailability of Amoxicillin Trihydrate which shows 60%, Amoxicillin Trihydrate is classified as a biopharmaceutics classification system (BCS) Class-I, Class-II and Class-IV Drug according to the dose. Amoxicillin is a hydrophilic drug, increase the solubility and permeability improve the bioavailability and onset of action of Amoxicillin Trihydrate has been done. 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 Amoxicillin Trihydrate present in Fast Dissolving Tablets Delivery System FDTs. Preformulation, formulation and evaluation of Amoxicillin Trihydrate to avoid problems associated with conventional delivery system such as limited permeation, low dissolution and bioavailability and also to improve bioavailability and one of the most used antibiotics. 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 Amoxicillin Trihydrate and various excipients as mannitol, and MCC as diluents, and sodium starch glycolate, croscarmellose sodium, and crospovidone as superdisintegrants were evaluated for preformulation studies parameters. It was concluded that the drug Amoxicillin Trihydrate was found to be compatible with various excipients which were selected for the formulation development of the Amoxicillin Trihydrate 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: Amoxicillin Trihydrate, Compatibility, Excipients, Development, Preformulation, Formulation, Antibiotics.