Preformulation Studies for Generic Omeprazole Magnesium Enteric Coated Tablets: Recent Study

C. O. Migoha; M. Ratansi; E. Kaale; G. Kagashe

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.
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.

Keywords: Preformulation studies, omeprazole magnesium enteric coated tablets, micromeritics properties

Abstract

Preformulation is an important step in the rational formulation of an active pharmaceutical ingredient (API). Micromeritics properties: bulk density (BD) and tapped density (TD), compressibility index (Carrs index), Hausers ratio (H), and sieve analysis were performed in order to determine the best excipients to be used in the formulation development of omeprazole magnesium enteric coated tablets. Results show that omeprazole magnesium has fair flow and compressibility properties (BD 0.4 g/mL, TD 0.485 g/mL, Carrs index 17.5%, Hausers ratio 1.2 and sieve analysis time 5 minutes). There were no significant drug excipient interactions except change in colour in all three conditions in the mixture of omeprazole and aerosil 200. Moisture content loss on drying in all three conditions was not constant and the changes were attributed to surrounding environment during the test time. Changes in the absorption spectra were noted in the mixture of omeprazole and water aerosil only in the visible region of 3502500 nm. Omeprazole magnesium alone and with all excipients showed no significant changes in omeprazole concentration for a 30-day period. Omeprazole magnesium formulation complies with USP standards with regards to the fineness, flowability, and compressibility of which other excipients can be used in the formulation.