Version 1
: Received: 26 December 2023 / Approved: 27 December 2023 / Online: 27 December 2023 (09:45:50 CET)
How to cite:
Chitnis, K.; Narala, N.; Narala, S.; Munnangi, S.R.; Vemula, S.K.; Repka, M.A. A New Frontier in Hypertension Management: Formulating and Characterizing Subcutaneous Implants using Hot Melt Extrusion. Preprints2023, 2023122064. https://doi.org/10.20944/preprints202312.2064.v1
Chitnis, K.; Narala, N.; Narala, S.; Munnangi, S.R.; Vemula, S.K.; Repka, M.A. A New Frontier in Hypertension Management: Formulating and Characterizing Subcutaneous Implants using Hot Melt Extrusion. Preprints 2023, 2023122064. https://doi.org/10.20944/preprints202312.2064.v1
Chitnis, K.; Narala, N.; Narala, S.; Munnangi, S.R.; Vemula, S.K.; Repka, M.A. A New Frontier in Hypertension Management: Formulating and Characterizing Subcutaneous Implants using Hot Melt Extrusion. Preprints2023, 2023122064. https://doi.org/10.20944/preprints202312.2064.v1
APA Style
Chitnis, K., Narala, N., Narala, S., Munnangi, S.R., Vemula, S.K., & Repka, M.A. (2023). A New Frontier in Hypertension Management: Formulating and Characterizing Subcutaneous Implants using Hot Melt Extrusion. Preprints. https://doi.org/10.20944/preprints202312.2064.v1
Chicago/Turabian Style
Chitnis, K., Sateesh Kumar Vemula and Michael A Repka. 2023 "A New Frontier in Hypertension Management: Formulating and Characterizing Subcutaneous Implants using Hot Melt Extrusion" Preprints. https://doi.org/10.20944/preprints202312.2064.v1
Abstract
Hypertension (HTN) is the foremost contributor to cardiovascular diseases (CVD), which remain a leading cause of death. However, adherence to the properly prescribed dosage form is critical and challenging for patients with chronic diseases such as HTN to prevent illness progression and death. The study’s objective was to develop AMB-loaded subcutaneous implants to reduce the frequency of administration, thus improving patient compliance during HTN management. AMB subcutaneous implants were prepared using continuous hot melt extrusion technology using PCL and PLGA with dimensions of 7.5 cm (length) by 2 mm (diameter). The implants were characterized for thermal characteristics, drug-excipient incompatibilities, surface morphology, fracturability, in vitro release, and stability studies. DSC showed that the drug was in the crystalline state in the fabricated implants. Scanning Electron Microscopy (SEM) revealed a smooth surface. The lead formulation presented good drug content, showed an extended drug release profile over 30 days, and followed zero-order release kinetics with a mean dissolution time of 15 days. The formulation was stable over 30 days in accelerated stability conditions (the last time point was tested, 40℃/75% RH), and the release profile was similar to the initial drug release profile. The lead formulation showed good fracturability during textural analysis. Therefore, the hot melt extruded implants could be an alternative management strategy for conventional amlodipine besylate (AMB) formulation.
Keywords
Hypertension, Subcutaneous Implants, Hot Melt Extrusion, Controlled Drug Delivery, Biodegradable, Implantable Drug Delivery
Subject
Medicine and Pharmacology, Pharmacy
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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