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 (Carr’s index), Hauser’s 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, Carr’s index 17.5%,
Hauser’s 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 350–2500 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.
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.
View Book :- http://bp.bookpi.org/index.php/bpi/catalog/book/190
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.
View Book :- http://bp.bookpi.org/index.php/bpi/catalog/book/190