Abstract
Objective: The present work tackled the development and evaluation of inclusion complex of khellin (KH) and methyl-β-cyclodextrin (MβCD). In addition, it tested its possible hypoglycemic and hypolipidemic effects.Methods: Inclusion complexes of KH-MβCD in the presence of water-soluble polymer were prepared by freeze drying (FD), co-evaporation (EV) and kneading methods (KN). The selected ternary complex was characterized by Fourier transform infrared spectrophotometry (FTIR), x-ray diffractometry (XRD), differential scanning calorimetry (DSC) and scanning electron microscopy [1]. Assessment of the hypoglycemic effect of the selected ternary complex versus the standard drug metformin was studied. Two different doses of the ternary complex were administered orally to streptozotocin (STZ)-induced type 2diabetic rats. Their hypoglycemic and hypolipidemic effects were evaluated by measuring the fasting blood glucose level (BGL), total cholesterol (TC) and triglycerides levels (TG) along the study period.Results: The FD complex showed the highest drug dissolution rate. All the performed characterization analysis confirmed the formation of a KH-MβCD inclusion complex. The in vivo study declared that both doses showed a marked hypoglycemic and hypolipidemic effects compared to metformin.Conclusion: In conclusion, this study points for the first time that the complexation of KH with MβCD could notably improve the dissolution rate and hence the bioavailability of KH. Moreover, this study demonstrated that this compound has a hypoglycemic and hypolipidemic effect. Thus, it can be a promising natural supportive treatment in type 2 diabetes mellitus (T2DM).
Highlights
Diabetes mellitus is a serious health problem [2]
According to the definition set by Higuchi and Connors [38], the phase-solubility diagram could be classified as AL type having a slope
The present study has demonstrated the feasibility of enhancing the solubility and dissolution rate of KH by formulating inclusion complex with MβCD
Summary
Diabetes is considered as a disease symptomized by hyperglycaemia caused by a deficiency in insulin production, its activity or both [3,4,5]. It is a common and widespread disease in developed and developing countries [6]. About 382 million people across the globe are reported suffering from diabetes mellitus [7]. This number is estimated to reach 592 million by the year 2035 [8]. As predicted by the World Health Organization (WHO); this disease will become the 7th among the leading causes of deaths worldwide [6, 9]
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