Study of the design and characterization of new bisoprolol fumarate tablet formulations
The purpose of the study was to develop sustained release tablets containing bisoprolol fumarate and an innovative combination of Precirol ATO5 and hydroxypropyl methylcellulose, in order to conclude upon: properties of pharmaceutical tablet formulations, drug-excipients interactions, evaluate their in vitro release behavior.
Methods
The tablet formulations with rate controlling polymers were prepared by melt granulation technique. The physical-chemical characterization of new tablet formulation was performed by FT-IR spectroscopy, differential scanning calorimetry, thermogravimetric analysis and X-ray diffraction. The formulations were also evaluated for in vitro dissolution test to select the optimized formulation.
Results
Structural evaluation indicated the presence of interactions between tablet components which did not affect drug release. The tablets displayed good mechanical properties, with friability values close to zero and drug content was found to be uniform in all formulas. Release profile showed a tendency to follow Korsmeyer-Peppas and Higuchi kinetics.
Conclusions
In the present study we investigated the effect of concentration of matrix former compounds (hydroxypropyl methylcellulose and glyceril palmitostearate) on the release rate of bisoprolol fumarate. The study evidenced the assembling through physical bonds between the excipients and the drug, which do not affect the release of the bioactive compound. Continue reading here