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Novel Application of Hot Melt Extrusion for Pharmaceutical Vaginal Film Products

Regev, Galit (2017) Novel Application of Hot Melt Extrusion for Pharmaceutical Vaginal Film Products. Doctoral Dissertation, University of Pittsburgh. (Unpublished)

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The vaginal film dosage form is a highly applicable and versatile delivery platform for a variety of active pharmaceutical agents. Several behavioral studies have reported its desirability by women as a vaginal dosing platform. Traditionally, pharmaceutical films have been manufactured using solvent casting (SC) techniques. Hot melt extrusion (HME) is an advantageous manufacturing method since it is a continuous process requiring fewer steps for efficient large-scale manufacturing and batch uniformity. HME could potentially lead to lower manufacturing costs due to its simplicity, minimal processing steps, and its availability worldwide. The goal of this project was to evaluate the feasibility of HME for the manufacture of pharmaceutical vaginal films. To achieve this, drug candidates with varied chemical properties (hydrophobic or hydrophilic small molecule, protein or bacteria) were studied. The specific compounds selected were metronidazole (hydrophilic small molecule), dapivirine (hydrophobic small molecule), levonorgestrel (hormone), griffithsin (protein) and Lactobacillus (probiotic bacteria). Single layer films were successfully manufactured using HME. The films were fully characterized and the obtained attributes were within target specifications. Batch to batch reproducibility and within batch consistency for film manufacture using HME was studied for the dapivirine HME vaginal film product. A design of experiments was applied to evaluate the impact of HME processing parameters on final film product attributes. In addition, the application of HME to produce multilayer vaginal films was explored. These studies demonstrated that the novel application of HME for vaginal film product manufacture is versatile, reproducible, and robust. Further this method can be applied to generate both single and multilayer vaginal film products which can be used to address a multitude of women’s reproductive health needs.


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Item Type: University of Pittsburgh ETD
Status: Unpublished
CreatorsEmailPitt UsernameORCID
Regev, Galit
ETD Committee:
TitleMemberEmail AddressPitt UsernameORCID
Committee ChairRohan,
Committee MemberLi,
Committee MemberSant,
Committee MemberSant,
Committee MemberTwist,
Date: 25 April 2017
Date Type: Publication
Defense Date: 11 October 2016
Approval Date: 25 April 2017
Submission Date: 6 April 2017
Access Restriction: 5 year -- Restrict access to University of Pittsburgh for a period of 5 years.
Number of Pages: 179
Institution: University of Pittsburgh
Schools and Programs: School of Pharmacy > Pharmaceutical Sciences
Degree: PhD - Doctor of Philosophy
Thesis Type: Doctoral Dissertation
Refereed: Yes
Uncontrolled Keywords: Hot melt extrusion, vaginal film, microbicide, solvent cast, quality by design (QbD), HIV prevention, bacterial vaginosis,continuous manufacturing process, design of experiments (DOE), multi purpose technology (MPT)
Date Deposited: 25 Apr 2017 17:32
Last Modified: 25 Apr 2022 05:15


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