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The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery

The Port Delivery System with ranibizumab (PDS) is an innovative intraocular drug delivery system designed for the continuous delivery of ranibizumab into the vitreous for 6 months and beyond. The PDS includes an ocular implant, a customized formulation of ranibizumab, and four dedicated ancillary d...

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Autores principales: Ranade, Shrirang V., Wieland, Mark R., Tam, Tammy, Rea, Jennifer C., Horvath, Judit, Hieb, Aaron R., Jia, Weitao, Grace, Lori, Barteselli, Giulio, Stewart, Jay M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9067954/
https://www.ncbi.nlm.nih.gov/pubmed/35499315
http://dx.doi.org/10.1080/10717544.2022.2069301
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author Ranade, Shrirang V.
Wieland, Mark R.
Tam, Tammy
Rea, Jennifer C.
Horvath, Judit
Hieb, Aaron R.
Jia, Weitao
Grace, Lori
Barteselli, Giulio
Stewart, Jay M.
author_facet Ranade, Shrirang V.
Wieland, Mark R.
Tam, Tammy
Rea, Jennifer C.
Horvath, Judit
Hieb, Aaron R.
Jia, Weitao
Grace, Lori
Barteselli, Giulio
Stewart, Jay M.
author_sort Ranade, Shrirang V.
collection PubMed
description The Port Delivery System with ranibizumab (PDS) is an innovative intraocular drug delivery system designed for the continuous delivery of ranibizumab into the vitreous for 6 months and beyond. The PDS includes an ocular implant, a customized formulation of ranibizumab, and four dedicated ancillary devices for initial fill, surgical implantation, refill-exchange, and explantation, if clinically indicated. Ranibizumab is an ideal candidate for the PDS on account of its unique physicochemical stability and high solubility. Controlled release is achieved via passive diffusion through the porous release control element, which is tuned to specific drug characteristics to accomplish a therapeutic level of ranibizumab in the vitreous. To characterize drug release from the implant, release rate was measured in vitro with starting concentrations of ranibizumab 10, 40, and 100 mg/mL, with release of ranibizumab 40 and 100 mg/mL found to remain quantifiable after 6 months. Using a starting concentration of 100 mg/mL, active release rate at approximately 6 months was consistent after the initial fill and first, second, and third refills, demonstrating reproducibility between implants and between multiple refill-exchanges of the same implant. A refill-exchange performed with a single 100-µL stroke using the refill needle was shown to replace over 95% of the implant contents with fresh drug. In vitro data support the use of the PDS with fixed refill-exchange intervals of at least 6 months in clinical trials.
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spelling pubmed-90679542022-05-05 The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery Ranade, Shrirang V. Wieland, Mark R. Tam, Tammy Rea, Jennifer C. Horvath, Judit Hieb, Aaron R. Jia, Weitao Grace, Lori Barteselli, Giulio Stewart, Jay M. Drug Deliv Research Article The Port Delivery System with ranibizumab (PDS) is an innovative intraocular drug delivery system designed for the continuous delivery of ranibizumab into the vitreous for 6 months and beyond. The PDS includes an ocular implant, a customized formulation of ranibizumab, and four dedicated ancillary devices for initial fill, surgical implantation, refill-exchange, and explantation, if clinically indicated. Ranibizumab is an ideal candidate for the PDS on account of its unique physicochemical stability and high solubility. Controlled release is achieved via passive diffusion through the porous release control element, which is tuned to specific drug characteristics to accomplish a therapeutic level of ranibizumab in the vitreous. To characterize drug release from the implant, release rate was measured in vitro with starting concentrations of ranibizumab 10, 40, and 100 mg/mL, with release of ranibizumab 40 and 100 mg/mL found to remain quantifiable after 6 months. Using a starting concentration of 100 mg/mL, active release rate at approximately 6 months was consistent after the initial fill and first, second, and third refills, demonstrating reproducibility between implants and between multiple refill-exchanges of the same implant. A refill-exchange performed with a single 100-µL stroke using the refill needle was shown to replace over 95% of the implant contents with fresh drug. In vitro data support the use of the PDS with fixed refill-exchange intervals of at least 6 months in clinical trials. Taylor & Francis 2022-05-02 /pmc/articles/PMC9067954/ /pubmed/35499315 http://dx.doi.org/10.1080/10717544.2022.2069301 Text en © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Ranade, Shrirang V.
Wieland, Mark R.
Tam, Tammy
Rea, Jennifer C.
Horvath, Judit
Hieb, Aaron R.
Jia, Weitao
Grace, Lori
Barteselli, Giulio
Stewart, Jay M.
The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery
title The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery
title_full The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery
title_fullStr The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery
title_full_unstemmed The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery
title_short The Port Delivery System with ranibizumab: a new paradigm for long-acting retinal drug delivery
title_sort port delivery system with ranibizumab: a new paradigm for long-acting retinal drug delivery
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9067954/
https://www.ncbi.nlm.nih.gov/pubmed/35499315
http://dx.doi.org/10.1080/10717544.2022.2069301
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