US 11,833,244 B2
Bioerodible implant for long-term drug delivery and associated methods of manufacture and use
John H. Baillie, Glen Ellen, CA (US); Ruth Baillie, San Luis Obispo, CA (US); George Blouin, San Luis Obispo, CA (US); Newsha Farahani, Issaquah, WA (US); and Christopher Marx, Mukilteo, WA (US)
Assigned to Gesea Biosciences Inc., San Luis Obispo, CA (US)
Filed by Gesea Biosciences Inc., San Luis Obispo, CA (US)
Filed on Nov. 19, 2021, as Appl. No. 17/531,658.
Application 16/259,811 is a division of application No. 15/720,921, filed on Sep. 29, 2017, granted, now 10,188,602, issued on Jan. 29, 2019.
Application 17/531,658 is a continuation of application No. 16/259,811, filed on Jan. 28, 2019, granted, now 11,185,496.
Claims priority of provisional application 62/401,167, filed on Sep. 29, 2016.
Prior Publication US 2022/0249365 A1, Aug. 11, 2022
Int. Cl. A61K 9/00 (2006.01); A61K 31/567 (2006.01); A61K 47/36 (2006.01); A61K 9/50 (2006.01); A61F 6/08 (2006.01); A61F 6/22 (2006.01); A61K 31/167 (2006.01); A61K 31/325 (2006.01); A61K 31/57 (2006.01); A61K 31/593 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/24 (2006.01); A61K 47/28 (2006.01); A61K 31/192 (2006.01); A61F 2/30 (2006.01); A61L 27/54 (2006.01); A61L 27/58 (2006.01)
CPC A61K 9/0024 (2013.01) [A61F 6/08 (2013.01); A61F 6/22 (2013.01); A61K 9/0002 (2013.01); A61K 9/5021 (2013.01); A61K 31/167 (2013.01); A61K 31/192 (2013.01); A61K 31/325 (2013.01); A61K 31/567 (2013.01); A61K 31/57 (2013.01); A61K 31/593 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/24 (2013.01); A61K 47/28 (2013.01); A61K 47/36 (2013.01); A61F 2002/30677 (2013.01); A61L 27/54 (2013.01); A61L 27/58 (2013.01); A61L 2300/404 (2013.01)] 29 Claims
 
1. A method for administering an active agent to a subject in a controlled release manner, the method comprising:
(a) subdermally implanting into the subject a drug delivery system comprising a pellet that is bioerodible in situ and provides for controlled release of an active agent contained therein throughout an extended drug delivery time period; and
(b) allowing the pellet to remain in place throughout the extended drug delivery time period, the pellet comprising an elongated dosage form with
(i) a first region comprising a non-polymeric inner core having a length, a surface along the length, a first end, and an opposing second end, and
(ii) a second region comprising a non-polymeric outer shell enclosing the surface of the inner core along its length but not the first end or the second end, such that the inner core has exposed surface area at the first and second ends, wherein
(iii) the inner core and outer shell are comprised of a lipidic excipient composition including a first lipidic excipient and a second lipidic excipient having aqueous solubilities that differ by at least 10%, and further wherein
(iv) at least about 80 wt. % of the active agent is present in the core, at least about 80 wt. % of the active agent is present in the shell, or the core and the shell each contain at least about 20 wt. % of the active agent,
so that following subdermal implantation of the pellet gradually bioerodes and results in a serum level of the active agent sufficient to achieve therapeutic efficacy during the extended drug delivery time period.