Der Pharmacia Lettre
Abstract
Author(s): Sachin Patil, Shilpa Chaudhari and M. P. Ratnaparkhi
The basic goal of the present investigation is to achieve the drug delivery system that is therapeutically effective
and nontoxic for an extended period of time considering the design of proper dosage regimen as an important
element in accomplishing this goal. The present investigation is to reduce the frequency of dose administration and
to prevent nocturnal heart attack and also to improve the patient compliance. Developing a stable and optimized
bilayer tablet having extended release (ER) layer of Metoprolol Succinate which is a Beta blocker and immediate
release(IR) layer of Ramipril which is an ACE inhibitor and successfully relieve hypertention. Eight batches of
bilayer tablets of Metoprolol Succinate(ER) and Ramipril(IR) were developed by Direct Compression technique.
Preformulation studies and analytical studies of Metoprolol Succinate and Ramipril like compatibility studies with
polymers, using FTIR and DSC were carried out. The APIs and Excipients were found to be very compatible with
each other. It was found that the in vitro drug release of Metoprolol Succinate ER was best explain by Higuchi
model. Formulation 7 complied with all the USP specifications and thus was taken as stability batch successfully.
Ultimately Direct compression by using this formula is the best process for preparing this formulation
