ISSN: 2161-0665
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Sudhir Kale*,S.K. Mody ,Chukewar atul,H.B. Patel ,C.M. Modi ,Biren Thakkar,Kalpesh Patni,Sudhir Patel,Hitesh Parmar,S. Rajesh Sundar,Mukul Jain
Background: The efforts are done to assess the properties of drug excipient to act as agent to bring about reduced teratogenic effects of drugs that can be used for treatment of metabolic disorders.
Objective: To evaluate anti-teratogenic effects of β cyclodextrin against tolbutamide induced teratogenecity in Wistar rats.
Methods: 3 groups comprising 10 mated female Wistar rats were exposed with β cyclodextrin (750 mg/kg), tolbutamide (400 mg/kg), β cyclodextrin + tolbutamide (750 + 400 mg/kg) during gestation day 6 to 18 and concurrent vehicle control group dosed with 0.5% CMC. β cyclodextrin was given 1 hr prior to tolbutamide treatment. The females were sacrificed on presumed gestation day 20 to assess the uterine parameters and fetal observations including visceral and skeletal examination.
Results: No deaths and clinical signs occurred in this study. No test substance related changes in body weight, food consumption and gross pathological findings noticed. The uterine parameters such as Mild increase in no. of early resorptions was noticed in females treated with tolbutamide at 400 mg/kg B. wt and dam receiving combination of β cyclodextrin and tolbutamide. The post implantation loss was slightly higher in groups treated with in combination of β cyclodextrin and tolbutamide (750 + 500 mg/kg) . In the present study, the mean body weights of fetuses (male and female) were significantly decreased in tolbutamide treated group. Fetus of dam treated with tolbutamide showed decrease in CRL than the control group.
Conclusion: The result of above study can be used to prevent teratogenic action of various useful drugs used in human and veterinary medicine. This experiment can be used as initial steps to study anti-teratogenic effect of various natural, artificial compound and their derivates to maintain therapeutic value of various popular drugs used in human and veterinary medicine (Table 1).