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| Comparative study on the preclinical pharmacokinetics of progesterone sustained release vaginal ring |
| 1.National Research Institute for Family Planning, Beijing 100081；2.Graduate School of Peking Union Medical College |
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Abstract Adapting female ovariectomized Bama mini pigs as experimental animals, it is to compare commercially available progesterone vaginal gel with self-made progesterone sustained release vaginal ring in the pharmacokinetic characteristics, and to optimize the prescription process and provide a scientific basis for the determination of the release of self-made vaginal ring in vitro. Methods: On the basis of the preliminary experiment, gel and self-made vaginal ring of progesterone were administered to the Bama mini pigs, and then blood samples were collected at different time points, and the validated LC MS/MS method was used for detection. Then it had been conducting a comparative study on the pharmacokinetic characteristics. Results: The correlation between in vivo and in vitro of self-made vaginal ring of progesterone was good. The highest blood drug concentration of self-made vaginal ring and commercial gel were 7.054 ng/ml and 10.818 ng/ml, respectively. The blood drug concentration of self-made vaginal ring of progesterone in vivo was more stable. Conclusion: Compared with commercial progesterone gel, self-made vaginal ring of progesterone has more stable blood concentration in vivo and can reduce the times of administration. Based on the reference reports and preliminary research results, it is estimated that the release amount of progesterone vaginal ring for assisted reproduction in vitro should be in the range of 20-25 mg/d.
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