Initial Leuprolide Acetate Release from Poly(d,l-lactide-co-glycolide) in Situ Forming Implants as Studied by Ultraviolet–Visible Imaging

2020 ◽  
Vol 17 (12) ◽  
pp. 4522-4532
Author(s):  
Zhuoxuan Li ◽  
Huiling Mu ◽  
Susan Weng Larsen ◽  
Henrik Jensen ◽  
Jesper Østergaard
Keyword(s):  
Leuprolide Acetate ◽  
In Situ Forming ◽  
Visible Imaging ◽  
In Situ Forming Implants

First report on the efficacy of l-alanine-based in situ-forming implants for the long-term parenteral delivery of drugs

2005 ◽  
Vol 108 (2-3) ◽  
pp. 433-441 ◽  
Author(s):  
François Plourde ◽  
Aude Motulsky ◽  
Anne-Claude Couffin-Hoarau ◽  
Didier Hoarau ◽  
Huy Ong ◽  
...  
Keyword(s):  
First Report ◽  
Parenteral Delivery ◽  
In Situ Forming ◽  
In Situ Forming Implants

Isosorbide-based polysebacates as polymeric components for development of in situ forming implants

2019 ◽  
Vol 30 (4) ◽  
pp. 1072-1082
Author(s):  
Monika Śmiga-Matuszowicz ◽  
Anna Korytkowska-Wałach ◽  
Bożena Nowak
Keyword(s):  
In Situ Forming ◽  
In Situ Forming Implants

scholarly journals One-week in vivo sustained release of a peptide formulated into in situ forming implants

2017 ◽  
Vol 521 (1-2) ◽  
pp. 357-360 ◽  
Author(s):  
Marianne Parent ◽  
Igor Clarot ◽  
Sébastien Gibot ◽  
Marc Derive ◽  
Philippe Maincent ◽  
...  
Keyword(s):  
Sustained Release ◽  
In Situ Forming ◽  
In Situ Forming Implants

Sustained activity and release of leuprolide acetate from an in situ forming polymeric implant

2000 ◽  
Vol 1 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Harish B. Ravivarapu ◽  
Katie L. Moyer ◽  
Richard L. Dunn
Keyword(s):  
Leuprolide Acetate ◽  
Sustained Activity ◽  
In Situ Forming ◽  
Polymeric Implant

Nadir testosterone (T) following in-situ polymer delivered, subcutaneously administered leuprolide acetate in men with prostate cancer (PCa).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 204-204
Author(s):  
Przemyslaw Twardowski ◽  
John A. McLane ◽  
Stuart Atkinson ◽  
Debbie Boldt-Houle ◽  
Scott T. Tagawa
Keyword(s):  
Progression Free Survival ◽  
Pooled Analysis ◽  
Leuprolide Acetate ◽  
Fixed Dose ◽  
Open Label ◽  
Free Survival ◽  
In Situ Forming ◽  
Duration Of Response ◽  
Polymeric Delivery

204 Background: Achieving and maintaining T suppression to castration level is the cornerstone of androgen deprivation therapy (ADT) for advanced PCa. Modern assay methodology found median T level after surgical castration to be 15ng/dL; the 2016 European Association of Urology guidelines define castration as T < 20ng/dL. Additionally, reaching nadir T < 20ng/dL is correlated with improved duration of response to ADT, time to progression or disease-specific survival (Klotz 2015), and prognosis for overall survival (Kamada 2015). To examine the effectiveness of in-situ polymer-delivered, subcutaneously-administered leuprolide acetate (SC-LA) on T suppression, nadir T was evaluated in 4 pivotal trials. Methods: Eugonadal patients with advanced PCa were treated with either 7.5 (6 doses), 22.5, 30, or 45mg (2 doses each) SC-LA lasting 1, 3, 4, or 6 months, respectively in 4 open-label, fixed-dose, pivotal trials. Serum T levels were evaluated byradioimmunoassay. T was measured 2-4 times on day 0 and once on days 1, 3, 7, and every week until the next dose, and repeated until end of study. The 45mg group had an additional measurement on day 2. LA was measured on days 0, 4, 7, 14, 21, 28, 35, 42, 49, and 56 post-injection. Nadir T was the lowest value obtained in the entire trial. Results: Across the SC-LA formulations, median LA levels were consistently between 0.1-1ng/mL from week 2 until the end of study. When pooled, 90-96% of patients achieved T≤20ng/dL by week 6 and 90-97% maintained T≤20ng/dL from weeks 6-24. Pooled analysis (n = 437) showed 99%, 97%, 91%, and 80% of patients reached nadir T≤20ng/dL, ≤10ng/dL, ≤5ng/dL, and ≤3ng/dL respectively with a median nadir T≤3 ng/dL. When comparing across all doses, > 88% of patients reached nadir T≤5ng/dL. Conclusions: Across all doses, SC-LA achieves consistent and prolonged serum LA drug delivery above 0.1ng/mL and provides favorable T suppression < 20ng/dL, which may be attributed to the in-situ forming polymeric delivery system. Multiple T measurements throughout the study confirmed that 91% of PCa patients achieved low nadir T≤5ng/dL, which may have implications for extending progression-free survival and duration of response to ADT.

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