Patent ID: 11911510
Assignee: PURDUE PHARMA L.P.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 10:
11. A process of preparing a solid oral extended release pharmaceutical dosage form, comprising the steps of
(a) combining at least
(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;

to form a composition;
(b) shaping the composition to form an extended release matrix formulation; and
(c) optionally curing said extended release matrix formulation comprising at least a curing step of subjecting the extended release matrix formulation to a temperature which is at least the softening temperature of said polyethylene oxide for a time period of at least about 1 minute;
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).