Bisoprol-Excipient Compatibility Studies For Advanced Drug Delivery Systems Development

Fast dissolving drug delivery systems offers a solution for pediatric, geriatric, mentally ill people and those patients having difficulty in swallowing tablets or capsules. In the present study, an attempt had been made to prepare fast dissolving tablets of Bisoprolol Fumarate, an antihypertensive agent. The main objective of the present study was to the preformulation studies were performed to know the physio-chemical and mechanical properties of Bisoprolol Fumarate for formulation development of Bisoprolol Fumarate FDTs. 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 Bisoprolol Fumarate present in FDTs. Preformulation, formulation and evaluation of Bisoprolol Fumarate to avoid problems associated with conventional delivery system such as limited permeation, low dissolution and bioavailability and also to improve bioavailability and antihypertensive agent. 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 Bisoprolol Fumarate and various excipients as mannitol, and avicel PH 101as diluents, and croscarmellose sodium, crospovidone as superdisintegrants were evaluated for preformulation studies parameters.

It was concluded that the drug Bisoprolol Fumarate was found to be compatible with various excipients which were selected for the formulation development of the Bisoprolol Fumarate 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.

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Materials

Bisoprolol Fumarate as a gift from (Modern Pharmaceutical Industry Company-Yemen). While Talc, Crospovidone, Croscarmellose Sodium, Aspartame, Aerosil, Magnesium Stearate, Avicel PH 101, Mannitol and other materials were obtained as a gift from (Shaphaco Pharmaceutical Industry Company-Yemen).

Alburyhi, Mahmoud & Saif, Abdalwali & Noman, Maged & A. Alkhawlani, Mohammed. (2024). BISOPROLOL-EXCIPIENT COMPATIBILITY STUDIES FOR ADVANCED DRUG DELIVERY SYSTEMS DEVELOPMENT. 10. 304-324.

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