CPC A61K 9/28 (2013.01) [A61J 3/005 (2013.01); A61J 3/06 (2013.01); A61J 3/10 (2013.01); A61K 9/0002 (2013.01); A61K 9/0053 (2013.01); A61K 9/1641 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2031 (2013.01); A61K 9/2054 (2013.01); A61K 9/2077 (2013.01); A61K 9/209 (2013.01); A61K 9/2095 (2013.01); A61K 9/284 (2013.01); A61K 9/2853 (2013.01); A61K 9/2866 (2013.01); A61K 9/2893 (2013.01); A61K 31/485 (2013.01); A61K 45/06 (2013.01); A61K 47/10 (2013.01); A61K 47/34 (2013.01); B29B 7/02 (2013.01); B29B 7/88 (2013.01); B29C 35/045 (2013.01); B29C 35/16 (2013.01); B29C 37/0025 (2013.01); B29C 43/003 (2013.01); B29C 43/02 (2013.01); B29C 43/52 (2013.01); B29C 71/00 (2013.01); B29C 71/009 (2013.01); A61K 9/2072 (2013.01); B29C 2035/046 (2013.01); B29C 2035/1658 (2013.01); B29K 2071/02 (2013.01); B29K 2105/0035 (2013.01); B29K 2105/251 (2013.01); B29K 2995/0088 (2013.01); B29L 2031/753 (2013.01)] | 3 Claims |
1. A method of treating pain comprising orally administering to a patient in need thereof a solid oral extended release dosage form comprising:
an extended release matrix comprising from about 10 mg to about 160 mg oxycodone hydrochloride;
a polyethylene oxide (PEO) having an approximate molecular weight of 2 million Da to 8 million Da based on rheological measurements; and
a PEO having an approximate molecular weight of 100,000 Da to 900,000 Da based on rheological measurements,
wherein the PEO comprises at least about 30% (by weight) of the total weight of the dosage form,
wherein the dosage form provides a dissolution rate, which when measured in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37° C., is between 12.5 and 55% (by wt) active agent released after 1 hour, between 25 and 65% (by wt) active agent released after 2 hours, between 45 and 85% (by wt) active agent released after 4 hours and between 55 and 95% (by wt) active agent released after 6 hours,
wherein the dosage form provides an in-vitro dissolution rate, when measured in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) comprising 40% ethanol at 37° C., characterized by the percent amount of active released at 0.5 hours, that deviates no more than about 20% points 0.5 hours from the corresponding in-vitro dissolution rate measured in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37° C. without ethanol,
wherein the dosage form is cured at a curing temperature ranging from about 68° C. to about 85° C.,
wherein the curing time is from about 30 minutes to about 4 hours,
wherein the dosage form is a tablet,
wherein the dosage form when subjected to a maximum force of about 196 N or about 439 N in a tablet hardness test, does not break,
wherein the tablet when subjected to an indentation test resists a work of at least about 0.06 J without cracking,
wherein the dosage form provides a mean tmax of oxycodone at about 2 to about 6 hours,
wherein the administration of the dosage form provides a mean maximum plasma concentration (Cmax) of oxycodone from about 6 ng/mL to about 240 ng/mL, and
wherein the oxycodone hydrochloride has a 14-hydroxycodeinone level of less than about 25 ppm.
|