生物学的同等性とバイオアベイラビリティのジャーナル

概要

Designing, Development and Formulation of Mouth Disintegrating Telmisartan Tablet with Extended Release Profile Using Response Surface Methodology

Muhammad Abdullah Akram, Taha Nazir, Nida Taha, Adeel Adil, Muhammad Sarfraz and Saeedur Rasheed Nazir

The Mouth Disintegrating Tablets (MDT’s) is continuously growing in clinical practice. The pharmaceuticals researchers are exploring the formulations for extended release dosage form with optimal therapeutic benefits. Hence, we aimed this study to develop the mouth disintegrating telmisartan tablet with extended release profile using response surface methodology. Mouth Disintegrating Extended Release Tablets (MDERT’s) was prepared with the intention of obtaining immediate as well as sustain therapeutic effect. The MDERT’s characterized with different determinants. The results were tabulated to illustrate the drug release curves of all 6 formulations upto 12 hrs, DSC spectra of Telmisartan, Kyron T134134, Primogel, Telmisartan + Kyron T134134 + Primogel, Chitosan, CMC and different excepients. The response surface models were developed for disintegration time, wetting time, water absorption ratio and cumulative % drug release (10 min) to determine the significant variance. The cumulative release %age of Telmisartan formulation F2 was comparatively important because of having ≥80% cumulative release. Moreover, a least volume of media 17ml was used by F2 formulation. Whereas, Fourier Transform Infrared Spectroscopy (FT-IR) and DSC studies were executed for any possible chemical interaction or incompatibility in drugs, polymers and excipients used in intended formulations. Additionally, the wetting and dispersion time for F2 were also in targeted rang of 52 and 44 seconds respectively, indicating the rapid disintegration of Telmisartan to produce desired therapeutic effects. Hence, in conclusion, the determinants of MDERTS are adjustable within acceptable range to enhance the efficiency. An extended release profile using response surface methodology may also be designed to formulate the MDT’s to render the dose, regimen, protocol and frequency of hypertensive patient in clinical practice.