US 11,911,510 B2
Pharmaceutical dosage forms
Ozgur Akcan, Parlin, NJ (US); and Richard Mannion, Furlong, PA (US)
Assigned to Purdue Pharma L.P, Stamford, CT (US)
Appl. No. 16/642,742
Filed by Purdue Pharma L.P., Stamford, CT (US)
PCT Filed Aug. 30, 2018, PCT No. PCT/US2018/048904
§ 371(c)(1), (2) Date Feb. 27, 2020,
PCT Pub. No. WO2019/046611, PCT Pub. Date Mar. 7, 2019.
Claims priority of provisional application 62/552,521, filed on Aug. 31, 2017.
Prior Publication US 2021/0077409 A1, Mar. 18, 2021
Int. Cl. A61K 9/20 (2006.01); A61K 31/485 (2006.01)
CPC A61K 9/2031 (2013.01) [A61K 9/2013 (2013.01); A61K 31/485 (2013.01)] 12 Claims
OG exemplary drawing
 
1. A solid oral extended release pharmaceutical dosage form comprising an extended release matrix formulation, the extended release matrix formulation comprising:
(1) at least one active agent salt comprising a cationic active agent molecule and an anionic counterion, wherein the at least one active agent salt comprises oxycodone hydrochloride;
(2) about 15% by weight to about 25% by weight (based on the weight of the extended release matrix formulation) of at least one anionic surfactant comprising sodium lauryl sulfate, potassium lauryl sulfate, ammonium lauryl sulfate, ethanolammonium lauryl sulfate, diethanolammonium lauryl sulfate, and triethanolammonium lauryl sulfate or mixtures thereof, wherein the molar ratio of the at least one anionic surfactant to the at least one active agent salt is from about 1:2 to about 10:1; and
(3) at least about 40% by weight (based on the weight of the extended release matrix formulation) of at least one polyethylene oxide;
wherein the dosage form, when subjected to an in-vitro dissolution test in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37.0±0.5° C., provides a dissolution rate with an amount of the at least one active agent released at x hours, wherein x is an integer selected from a number between 2 and 12; and
an amount of the at least one active agent released at y hours, wherein y is an integer selected from a number between 6 and 24, and y≥x+4;
which complies at least for one combination of x and y with equations (I) and (II):
the amount released at y hours≤(y/x×amount released at x hours)×1.25 (I),
the amount released at y hours≥(y/x×amount released at x hours)×0.75 (II),
wherein the dosage form is free of core-shell particulates.