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Application of Biorelevant Dissolution Method for Intrauterine devices

zhang, zhongfang (2021) Application of Biorelevant Dissolution Method for Intrauterine devices. Master's Thesis, University of Pittsburgh. (Unpublished)

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There are currently a significant number of contraceptive options available for women. Despite this, there is a high unintended pregnancy rate throughout the world. Low- and Middle- Income countries have disproportionate unintended pregnancy rates. Adverse health, social and economic consequences are associated with unintended pregnancy. Only 5% of the unintended pregnancy is due to contraceptive product failure. The majority of unintended pregnancies are associated with a lack of incorrect and inconsistent product use. Thus, there is a desire and need for contraceptive products which limit the amount of ongoing effort required by the woman for efficient protection from unintended pregnancy. The uptake of long-acting reversible contraceptive (LARC) methods (intrauterine devices (IUDs), implants, and injectables) by women has significantly increased, especially in low-income countries. Among the contraceptive options, hormonal intrauterine devices, copper intra-uterine devices, and implants have the lowest failure rate (less than one percent). Compared with the oral contraceptives which need to be taken daily, LARCs offer women an option which can be effective without daily effort and decrease the burden of women’s daily life, the majority of women in the US who are using LARC contraception use IUDs1. Development of IUDs requires evaluation of their drug release characteristics during the product usage time. Although some in vitro studies for IUDs have been reported, none of them simulate the biological environment of the uterus. Specifically, these non-biologically relevant models, which have been previously applied, use organic solvents, higher temperatures, or surfactants, all of which do not simulate the uterine environment. The objective of this project
was to develop a biorelevant dissolution method for IUD products that can simulate the in the vivo release rate of the IUD.
Hence through this work, a biologically relevant in vitro dissolution method was developed and applied to study the in vitro dissolution profiles for levonorgestrel (LNG)containing IUDs: Mirena®, Skyla®, Lilleta®, Kyleena®. To support this work, a liquid chromatography-mass spectrometry(LC-MS)method for the quantitation of LNG was also developed and validated.


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Item Type: University of Pittsburgh ETD
Status: Unpublished
CreatorsEmailPitt UsernameORCID
ETD Committee:
TitleMemberEmail AddressPitt UsernameORCID
Date: 10 May 2021
Date Type: Publication
Defense Date: April 2021
Approval Date: 10 May 2021
Submission Date: 15 April 2021
Access Restriction: 2 year -- Restrict access to University of Pittsburgh for a period of 2 years.
Number of Pages: 87
Institution: University of Pittsburgh
Schools and Programs: School of Pharmacy > Pharmaceutical Sciences
Degree: MS - Master of Science
Thesis Type: Master's Thesis
Refereed: Yes
Uncontrolled Keywords: Contraception, Dissolution, IUDs, LNG
Date Deposited: 21 May 2021 16:04
Last Modified: 10 May 2023 05:15

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