Implantable drug delivery devices for localized drug delivery
Inventors
Rairkar, Maithili • Desai, Pujan • Schuler, Carlos • Daud, Maxime • Rappaport, Maxime D. • Munster, Pamela • Maroney, John • McLaughlin, Margaret • Casab, Tobias H. • Hall, Keith • Thomas, Scott
Assignees
University of California San Diego UCSD • Alessa Therapeutics Inc
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Publication Number
US-11344526-B2
Publication Date
2022-05-31
Expiration Date
Abstract
Provided herein are drug implants comprising a therapeutically active agent for the treatment of disease in a subject. In some cases, the drug implant may comprise a polymer matrix and a therapeutically active agent disposed therein. Additionally provided are methods for manufacturing the drug implants and methods of treating diseases with the implants. In some cases, the drug implant may comprise bicalutamide, e.g., for use in the treatment of prostate cancer.
Core Innovation
The invention relates to treating prostate cancer or benign prostatic hyperplasia by implanting one or more implants into prostate tissue or a tissue near a prostate. Each implant comprises bicalutamide having a D90 of less than 15 microns dispersed in a liquid silicone rubber matrix having a Shore A hardness of at least 30 durometer, and the implants comprise bicalutamide in an amount of at least 30% w/w.
The implants are configured to release bicalutamide to the prostate at a rate between 1.2 bcg/day and 95 bcg/day after any initial burst for at least 6 months, and in another aspect at a rate between 0.6 bcg/day and 95 bcg/day after any initial burst for at least 2-years. The provided content describes localized prostate drug implants with a silicone matrix and reported biodistribution comparisons indicating higher bicalutamide levels in prostate relative to other organs.
The stated problem is addressing prostate cancer or benign prostatic hyperplasia with delivery that achieves local prostate exposure while limiting systemic blood plasma levels. The described approach aims to provide sustained bicalutamide exposure in prostate tissue while achieving low systemic blood plasma levels.
Claims Coverage
The provided claims include three independent claims. Each independent claim centers on implanting bicalutamide in a liquid silicone rubber matrix with specified particle size, matrix hardness, drug loading, and bicalutamide release performance, with additional independent constraints on either total dose over 6 months or duration of release.
Prostate cancer or benign prostatic hyperplasia treatment with silicone-matrix bicalutamide implants releasing 1.295 bcg/day for at least 6 months
Implanting one or more implants into prostate tissue or a tissue near a prostate, wherein each implant comprises bicalutamide having a D90 of less than 15 microns dispersed in a liquid silicone rubber matrix having a Shore A hardness of at least 30 durometer, wherein the implant comprises the bicalutamide in an amount of at least 30% w/w, and wherein each implant releases bicalutamide to the prostate at a rate of between 1.2 bcg/day and 95 bcg/day, following any initial burst of release, for at least 6 months.
Silicone-matrix bicalutamide implants with total bicalutamide dose <100 mg over 6 months
Implanting one or more implants into prostate tissue or a tissue near a prostate, wherein each implant comprises bicalutamide having a D90 of less than 15 microns dispersed in a liquid silicone rubber matrix having a Shore A hardness of at least 30 durometer, wherein the implant comprises the bicalutamide in an amount of at least 30% w/w, and wherein the total dose of the bicalutamide administered to the subject is less than 100 mg over a period of 6 months.
Silicone-matrix bicalutamide implants releasing 0.695 bcg/day for at least 2-years
Implanting one or more implants into prostate tissue or a tissue near a prostate, wherein each implant comprises bicalutamide having a D90 of less than 15 microns dispersed in a liquid silicone rubber matrix having a Shore A hardness of at least 30 durometer, wherein the implant comprises the bicalutamide in an amount of at least 30% w/w, and wherein each implant releases bicalutamide to the prostate at a rate of between 0.6 bcg/day and 95 bcg/day, following any initial burst of release, for at least 2-years.
Across the independent claims, coverage is directed to implantable prostate therapeutics where bicalutamide (D90 <15 microns) is dispersed in a liquid silicone rubber matrix (Shore A hardness 530 durometer) at drug loading 530% w/w, with bicalutamide release to the prostate bounded by specified release-rate ranges after an initial burst and sustained for either at least 6 months or at least 2-years, and with one independent claim further requiring total bicalutamide administered dose to be less than 100 mg over a 6-month period.
Stated Advantages
Provides sustained high local bicalutamide exposure in prostate tissue while achieving low systemic blood plasma levels.
Documented Applications
Treating prostate cancer or benign prostatic hyperplasia by implanting one or more bicalutamide-containing implants into prostate tissue or a tissue near a prostate.
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