Hypoglycemic potential of tablet Metformin 500 mg (Glucophage & Metphage): a pharmacological end point evaluation.
Quantitative determination of pharmacological response or clinical end point study is essential for successful evaluation of clinical pharmacology and Bioavailability/ Bioequivalence issues. Stride has been made for proper selection of a quality drug product from the various available therapeutic, which is the prime responsibility of Health care provider and specially pharmacist. Study was conducted in respect to investigate the Pharmacodynamics response, differences and individual variation of oral, Metphage (Metformin 500 mg tablet) as a test formulation manufactured by Efroze Chemical Industries (Pvt.) Ltd. and Glucophage (Metformin 500 mg tablet) as a reference formulation manufactured by Merck Marker. Blood glucose levels/hypoglycemic effect produced by both formulation were studied under cross over trial with respect to placebo/control treatment and result were discussed accordingly. There were no hypoglycemic episodes requiring medical intervention and/or pharmacologic therapy so the patients can easily manage it. Results of the study clearly suggest that formulation manufactured by Efroze Chemical Industries (Pvt.) Ltd. is near to the standard formulation and produced comparable results. No significant differences in pharmacodynamics was observed, however, minor differences might relate with inter individual variation in human volunteers and in different formulation as well as different pharmaceutical unit. Although this data assure the ultimate quality of Metformin 500 mg tablet manufactured by Efroze Chemical Industries (Pvt.) Ltd. but every Generic equivalent should be studied for assurance of safety and efficacy because life of patient is a matter of concern. Such type of study would provide better evaluation of the performance of a drug from a dosage form.
Ali
Obaid
O
Central Drugs Laboratory, Ministry of Health, Karachi, Govt. of Pakistan. mobaidali@yahoo.com
Obaid
Roohi
R
Ahmed
Syed Waseemuddin
SW