Preformulation Studies for Generic Omeprazole Magnesium Enteric Coated Tablets: Advance Study | Chapter 2 | Issues and Development in Health Research Vol. 1

A critical step in the rational formulation of an active medicinal component is preformulation (API). In order to discover the appropriate excipients to use in the formulation development of omeprazole magnesium enteric coated tablets, micromeritics qualities such as bulk density (BD) and tapped density (TD), compressibility index (Carr’s index), Hauser’s ratio (H), and sieve analysis were used. The results demonstrate that omeprazole magnesium has reasonable flow and compressibility (BD 0.4 g/mL, TD 0.485 g/mL, Carr’s index 17.5 percent, Hauser’s ratio 1.2, and sieve analysis duration 5 minutes). In the combo of omeprazole and aerosil 200, there were no notable drug excipient interactions save for a change in colour in all three circumstances. Moisture content loss on drying was not constant in any of the three circumstances, and the variations were attributed to the surrounding environment during the test period. Only in the visible band of 350–2500 nm did the absorption spectra of the mixture of omeprazole and water aerosil change. For a 30-day period, omeprazole magnesium alone and with all excipients revealed no significant changes in omeprazole concentration. Magnesium omeprazole In terms of fineness, flowability, and compressibility, the formulation complies with USP criteria, and different excipients can be utilised in the formulation. When exposed to harsh conditions such as greater temperatures and relative humidity, the omeprazole magnesium powder did not change.

Author (s) Details

C. O. Migoha
Tanzania Medicines and Medical Devices Authority, P.O.Box 77150, Dar es Salaam, Tanzania and Pharm R&D Lab, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P.O.Box 65013, Dar es Salaam, Tanzania.

M. Ratansi
Pharm R&D Lab, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P.O.Box 65013, Dar es Salaam, Tanzania. G. O. Obajimi

E. Kaale
Pharm R&D Lab, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P.O.Box 65013, Dar es Salaam, Tanzania.

G. Kagashe
Department of Pharmaceutics, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P.O.Box 65013, Dar es Salaam, Tanzania.

View Book :- https://stm.bookpi.org/IDHR-V1/article/view/2153