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ASSESSMENT OF THE PROGESTIN POLYMERIC VAGINAL FILMS BY AN OPTIMIZED SOLVENT-CAST PLATFORM

TONG, XIN (2018) ASSESSMENT OF THE PROGESTIN POLYMERIC VAGINAL FILMS BY AN OPTIMIZED SOLVENT-CAST PLATFORM. Master's Thesis, University of Pittsburgh. (Unpublished)

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Abstract

Background: Although many birth control options are provided for women nowadays, the rate of
unintended pregnancies remains high internationally and nationally. Novel contraceptive methods,
such as contraceptive vaginal films, are needed to meet the users’ biological, social and economic
needs. An established solvent-cast platform can potentially be an option for vaginal administration
of progestins for contraception. The goal of this work is to the feasibility and versatility of film
platform for incorporating progestins. Methods: A panel of progestins, desogestrel (DES),
etonogestrel (ENG), dienogest (DNG) and ulipristal acetate (UPA) were chosen based on their
different physiochemical properties and availability. The progestins were incorporated into a fastdissolved film formulation and the films were evaluated for appearance; weight; thickness;
puncture strength; water content; disintegration time and drug content. Stability for each of these
parameters was monitored for 3 months under two storage conditions (25°C/65%RH;
40°C/75%RH). Additionally, in vitro dissolution was investigated using a USP 1 method. Results:
All four progestins could be successfully incorporated into the film formulation, despite their
different lipophilicities. When comparing across progestin films for two dosing levels, differences
were observed with respect to the physical characteristics ofthe progestin film. A decrease in drug
content was observed for desogestrel (DES) films over 3 months. However, other progestin films
remained stable throughout 3 months. Film physical properties were consistent throughout this
time frame. The in vitro dissolution study showed that all four progestins released 80% of the drug
within 15 minutes. Conclusion: Results demonstrated that the progestins could be formulated as polymeric vaginal films, despite their different physiochemical properties. For ENG, DNG and
UPA films, the physical characterizations of the progestin films remained stable for at least 3
months. However, the amount of progestin located into the film impacted the puncture strength
and water content of the films. This project demonstrated the capacity of the film to be applied for
vaginal delivery of progestins.


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Details

Item Type: University of Pittsburgh ETD
Status: Unpublished
Creators/Authors:
CreatorsEmailPitt UsernameORCID
TONG, XINx.o.tong@pitt.eduxit250000-0003-2200-0899
ETD Committee:
TitleMemberEmail AddressPitt UsernameORCID
Committee ChairRohan, Lisalrohan@mwri.magee.edu
Committee MemberGibbs, Robertgibbsr@pitt.edu
Committee MemberSant, Vinayakvis45@pitt.edu
Date: 13 April 2018
Date Type: Publication
Defense Date: 29 March 2018
Approval Date: 13 April 2018
Submission Date: 12 April 2018
Access Restriction: 2 year -- Restrict access to University of Pittsburgh for a period of 2 years.
Number of Pages: 73
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: progestin; polymeric vaginal films; formulation modification; physical characterizations
Date Deposited: 13 Apr 2018 14:39
Last Modified: 13 Apr 2018 14:39
URI: http://d-scholarship.pitt.edu/id/eprint/34286

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