Development and Characterization of Compression-Coated Tablet of Telmisartan Applying QbD Principles
Trivedi PJ*, Mehta DM, Suthar DD, Parejiya PB, Shelat PK
The objective of this study is to develop and evaluate compression coated drug delivery system, which involve rupturable coat around a rapidly disintegrated core tablet prepared by direct compression. Core tablet is containing an immediate dose of Telmisartan and mucoadhesive pellets for sustained release (SR) of Telmisartan. Sustained release pellets were prepared by extrusion-spheronization using quality by design (QbD) principle. Risk assessment was performed using fishbone diagram and failure mode and effect analysis (FMEA). A Plackett-Burman design (PBD) was used to screen seven potential high risk variables obtained from risk assessments study. Based on PBD out of seven potential high risk variables only two had significant effects on the quality of the pellets. This allowed to use 32 full factorial design for elucidation the relationship between the variable and critical quality attributes (CQAs). Optimized formulation of sustained release pellets was evaluated for different evaluation parameters. Core tablets and compression-coated tablets were subjected to various pre-compression and post-compression tests. Prepared compression-coated tablets were evaluated for lag time and in-vitro dissolution. DSC and FT-IR studies confirmed the compatibility between drug and excipients. Optimized formulation of SR pellets shows the satisfactory result. The core tablet shows the satisfactory disintegration time. Final batch of compression-coated tablet offered an immediate release (IR) of Telmisartan after predetermined lag time i.e., 4.5h, followed SR from mucoadhesive pellets. It can be concluded that bedtime dosing of chronomodulated compression coated tablets may offer a promising for controlling early morning surge in hypertension disease.
Telmisartan, Chronotherapy, Pellets, Quality by Design, Compression-Coating
Cite This Article
Trivedi, P. J., Mehta, D. M., Suthar, D. D., Parejiya, P. B., Shelat, P. K. (2018). Development and Characterization of Compression-Coated Tablet of Telmisartan Applying QbD Principles. International Journal for Pharmaceutical Research Scholars, 7(3); 58-76.