Abstract
The aim of this study was to prove the principle of local delivery of metformin hydrochloride, METHCl, to the abdomen area in order to reduce the intra-badominal visceral fat compared to the METHCL oral tablets. Intraabdominal visceral and subcutaneous fat were highly correlated with body weight of obese people. So, this will be beneficial to assist wight loss in those individuals. Furthermore, oral METHCl tablets (600 mg) might show reduction in weight in diabetic pateints. However, the reqiured high doses is still an issue which put the patients under stress of METHCl side effects. In this preliminary trial, METHCl was formulated in the form of local hydrogel using the carbopol 934 within very small drug dose (6 mg/g). The prepared hydrogel was pharmaceutically evaluated for its pH, viscosity, spreadability, and in vitro release. Furthermore, the abdominal fat lowering activity of METHCl gel was compared to the oral METHCl tablets and control (placebo) groups in human volunteers. The study showed that the prepared METHCl gel significantly (p<0.05, ANOVA/Tukey) decrease the diameter of the abdomen compared to the placebo group and to 50% of participant taking oral METHCl tablets after three weeks treatment. In addition, the group taking METHCl oral tablets failed to decrease the inta-abdominal fat in approximately 50% of participants. In conclusion, METHCl hydrogel could be considered a promising novel formulation which can decrease the accumulated fats in the abdomen reigon with small dose comapred to oral METHCl tablets.
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