DESIGN, FORMULATION AND EVALUATION OF METFORMIN HYDROCHLORIDE AND MIGLITOL BI-LAYER TABLET
Mangla Nand Singh*, Puneet Mishra, Dr. Indranil Yadav
Bi-layer tablets have been developed to achieve controlled delivery of different drugs with pre-defined release profiles. In the last decade, interest in developing a combination of two or more Active Pharmaceutical Ingredients (API) in a single dosage form (bi-layer tablet) has increased in the pharmaceutical industry, promoting patient convenience and compliance. Bi-layer tablets can be a primary option to avoid chemical incompatibilities between API by physical separation, and to enable the development of different drug release profiles (immediate release with sustained release). Despite their advantages, due to the use of different materials and complex geometric boundaries between the adjacent layers, the mechanical structures of this drug delivery system have become quite intricate, requiring complicated tablet architectures as well as patient-friendly. Bi-layer tablet by releasing the medicaments immediately for patient relief and also maintaining the therapeutic level to a extended period of time by controlling the release of drug in a sustained manner for better patient compliance and acceptability. In the formulation of bi-layer tablets we took different type of polymers such as HPMC K4M, HPMC K100M, Xanthum gum, binder , active pharmaceutical ingredients and diluents such as MCC, talc as glident. Then it has been done the preformulation study of drugs (Metformin Hydrochloride and Miglitol). In preformulation study it has been checked description of sample, melting point, solubility and then draw the calibration curve by using UV spectroscopy for obtaining percent release of drug. After that evaluated bi-layer tablet containing Metformin Hydrochloride and Miglitol and calculated its all the parameter. On the basis of calculated data, formulation F4 was the best formulation in all the formulated formulation. It has been concluded that bi-layer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one layer is immediate release as initial dose and second layer is maintenance dose.
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