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Evaluation of Manufacturing Robustness for a Biodegradable Subcutaneous Implant Containing Bictegravir for HIV Prevention

Chen, Yu-Chieh (2023) Evaluation of Manufacturing Robustness for a Biodegradable Subcutaneous Implant Containing Bictegravir for HIV Prevention. Master's Thesis, University of Pittsburgh. (Unpublished)

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According to World Health Organization (WHO), the global impact of human immunodeficiency virus (HIV) infection remains a significant concern, necessitating the development of effective prevention strategies. Oral pre-exposure prophylaxis (PrEP) is one method available for HIV reducing the risk of HIV transmission. However, several barriers such as patient adherence and persistence to product use have limited its widespread uptake. To address this challenge, a long-acting injectable PrEP product was recently approved by the FDA, as long-acting products are associated with improved adherence and compliance.
Toward this end, Research Triangle Institute (RTI) International is currently developing a long-acting HIV PrEP product in the form of a biodegradable implant made from polycaprolactone (PCL), which incorporates the antiretroviral drug Bictegravir (BIC). This thesis focuses on the characterization of the BIC-loaded PCL implants and the validation of manufacturing processes to support technology transfer activities.
Two high-performance liquid chromatography (HPLC) analytical procedures for both assay and dissolution study were qualified to be accurate and reliable. Formulation paste containing Bictegravir and castor oil was prepared and loaded into PCL tubes to fabricate the implants at Magee-Womens Research Institute (MWRI). Then, these implants were characterized and compared with those from RTI to validate the impact of different processing parameters.
The implants consistently achieved the target drug loading of 120 mg of Bictegravir per implant, with uniform distribution within individual implants as well as between implants. Notably, significant differences in the in-vitro release profiles were observed between the two sets of implants after 2 weeks during the dissolution study, which indicated the importance of sealing integrity in ensuring reproducibility and quality of implants. Consequently, further investigations into testing the sealing integrity should be developed.
In conclusion, this thesis employed qualified HPLC methods for the characterization of BIC-loaded PCL implants. The cross-lab evaluation of implants underscored the significance of implant sealing integrity as a crucial processing aspect, emphasizing the need for ongoing research to investigate the testing and validation of sealing integrity.


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Item Type: University of Pittsburgh ETD
Status: Unpublished
CreatorsEmailPitt UsernameORCID
Chen, Yu-Chieharielchen@pitt.eduyuc184
ETD Committee:
TitleMemberEmail AddressPitt UsernameORCID
Committee ChairRohan, Lisarohanlc@upmc.edurohanl
Sravan, Patelpatels10@mwri.magee.edusrp75
Jan, Beumerbeumerjh@upmc.edujhb11
Date: 3 August 2023
Date Type: Publication
Defense Date: 28 June 2023
Approval Date: 3 August 2023
Submission Date: 26 July 2023
Access Restriction: 2 year -- Restrict access to University of Pittsburgh for a period of 2 years.
Number of Pages: 121
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: biodegradable subcutaneous implant, Bictegravir, HIV prevention
Date Deposited: 03 Aug 2023 12:08
Last Modified: 03 Aug 2023 12:08


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