EVALUATION OF PRELIMINARY TRIAL BATCHES OF FORMULATIONS CONTAINING ORAL HYPOGLYCEMIC DRUGS METFORMIN HYDROCHLORIDE AND CANAGLIFLOZIN

The in-vitro drug release profile from a hydrophilic matrix tablet is influenced by the viscosity of the gel layer formed due to its polymer hydration, and it depends on various other physical properties like a drug: polymer ratio water-solubility and particle size of the drug, particle size and type of the polymer, type of diluents used, and temperature of media. The drug release profile of different formulations i.e., C1to C6 formulated by utilizing Hypromellose K4M, Hypromellose K15M and Hypromellose K100M Respectively. K4M, which is low viscosity polymer, shows a faster release at initial time points. Hypromellose polymer (K100M) is hydrophilic in nature, showing fast hydration and controlling the dissolution profile. The dissolution profile of batch C1 to C2 having drug (Metformin HCl): polymer ratio 1:0.25 and 1:0.5 gives little controlled release profiles of the drug in C1, C2. Hence, 1:0.5 drug (Metformin HCl) to HPMC K100M was used for further study. It had been observed that HPMC K15M and K4M could not retard the release rate sufficiently to get the active content release from the dosage form at a regulated rate but HPMC K100M could. Thus, high viscosity grade HPMC K100M was selected for the study. The active content released from the tablet is dependent on the viscosity. Polymer with higher viscosity prevents rapid release in the beginning but have no effect on the later stages of the release rate of active content.