Research Article | Open Access
Formulation and Evaluation of Metformin and Glimepiride Fast Dissolving Tablet
Rahulkumar Damodhar Rahane, Dr. Punit R.Rachh
Pages: 3461-3471
Abstract
Metformin hydrochloride and Glimepiride are orally active hypoglycaemic substance these are used in non-insulin
dependent (type 2) diabetes mellitus.Metformin is slowly and incompletely absorbed from the GI tract, mainly
absorbed from upper GI tract.Glimepiride is less soluble and is BCS class II drug. Hence to improve absorption and
solubility Fast Dissolving Tabletof Metformin hydrochloride and Glimepiride combination is developed which may
have better patient palatability, especially in case of geriatric and paediatric patients.
Fast dissolving tablets of Metformin hydrochloride and Glimepiride were developed using simple wet mixing
approach. Drug excipients compatibility was performedforall selected excipients as per Carstensen approach as dry
and with 5 % moisture at 550C to observe any incompatibility within drug and excipients.Glimepiride is less soluble
and is BCS class II drug; hence initially solubility enhancement study was carried outusingsimple physical mixture
withPolyvinylpyrrolidone K30with various ratios to get better dissolution ofGlimepiride. Further
Polyvinylpyrrolidone K30 was used in formulation of fast dissolving tablets.
Fast dissolving tablets were prepared using wet mixing approach using microcrystalline cellulose, crospovidone,
polyvinyl pyrrolidone K30, shellac, croscarmellose, aspartame and magnesium stearate. Furtherfast dissolving
tablets are evaluated for description, average weight, friability, hardness, disintegration time, wetting time and
dissolution.Optimizedformulation was subjected to stability study at accelerated condition of 400C/75 % RH and
long term condition of 300C/75 % Rh (Zone IVb) as per ICH recommendation. Parameters evaluated for stability
were description, hardness, disintegration time, dissolution, assay and related substances. UV spectrophotometric
method was used for dissolution study and high performance liquid chromatographic method was used for related
substance test. Stability study indicates that all parameters observed were well within proposed limit.
Based on this study it can be concluded that fast dissolving tablets of metformin hydrochloride and Glimepiride can
be used alternatively instead of conventional tablets for better patient palatability.
Keywords
:Metformin Hydrochloride, Glimepiride,fastdissolving tablets, solubility enhancement, wet granulation,simultaneous estimation, UV spectrophotometer, high performance liquid chromatography.