IP Library Patent Application 15683436
Patent Application
App. No. 15/683,436

TAMPER RESISTANT DOSAGE FORMS

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Patent No.
US None
App. No.
15/683,436
Abstract

The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Claims (50)

1 - 169 . (canceled)

170 . A cured shaped extended release tablet comprising:

(1) at least one high molecular weight polyethylene oxide having, based on theological measurements, an approximate molecular weight selected from 4,000,000 and 7,000,000; and

(2) oxycodone or a pharmaceutically acceptable salt;

wherein said tablet is prepared by a process comprising the steps of:

(a) forming a tablet-shaped pharmaceutical preparation comprising said oxycodone or pharmaceutically acceptable salt thereof and said high molecular weight polyethylene oxide;

(b) curing said tablet-shaped pharmaceutical preparation by subjecting said preparation to a temperature from about 60° C. to about 90° C. for a time of from about 15 minutes to about 10 hours; and

(c) optionally applying at least one coating to said tablet-shaped pharmaceutical preparation, before, during or after curing;

wherein said tablet comprises:

(i) 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt thereof, and at least 79% by weight of said high molecular weight polyethylene oxide;

(ii) 40 mg of said oxycodone or pharmaceutically acceptable salt thereof, and at least 72% by weight of said high molecular weight polyethylene oxide;

(iii) 60 mg of said oxycodone or pharmaceutically acceptable salt thereof, and at least 57% by weight of said high molecular weight polyethylene oxide; or

(iv) 80 mg of said oxycodone or pharmaceutically acceptable salt thereof, and at least 54% by weight of said high molecular weight polyethylene oxide; and

wherein percent by weight is based upon the total weight of said tablet-shaped pharmaceutical preparation, not including the combined weight of said applied coatings.

171 . A tablet as defined in claim 170 , wherein said oxycodone or pharmaceutically acceptable salt thereof is oxycodone hydrochloride.

172 . A tablet as defined in claim 170 , wherein said time in said curing step is 30 minutes to 90 minutes.

173 . A tablet as defined in claim 170 , wherein said temperature in said curing step is from 62° C. to 90° C.

174 . A tablet as defined in claim 170 , wherein at least one coating is applied to said tablet-shaped pharmaceutical preparation, before, during or after said curing step.

175 . A cured shaped extended release tablet comprising:

(1) at least one high molecular weight polyethylene oxide having, based on theological measurements, an approximate molecular weight selected from 4,000,000 and 7,000,000; and

(2) an opioid analgesic or a pharmaceutically acceptable salt thereof;

wherein said tablet is prepared by a process comprising the steps of:

(a) forming a tablet-shaped pharmaceutical preparation comprising said opioid or pharmaceutically acceptable salt thereof and said high molecular weight polyethylene oxide;

(b) curing said tablet-shaped pharmaceutical preparation by subjecting said preparation to a temperature from about 60° C. to about 90° C. for a time of from about 15 minutes to about 10 hours; and

(c) optionally applying at least one coating to said tablet-shaped pharmaceutical preparation, before, during or after curing;

wherein said high molecular weight polyethylene oxide is in an amount of at least 54%, by weight, based upon the total weight of said tablet-shaped pharmaceutical preparation, not including the combined weight of said applied coatings.

176 . A tablet as defined in claim 175 , wherein, said temperature in said curing step is from 62° C. to 90° C.

177 . A tablet as defined in claim 175 , wherein at least one coating is applied to said tablet-shaped pharmaceutical preparation, before, during or after said curing step.

178 . A tablet as defined in claim 175 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said opioid analgesic or pharmaceutically acceptable salt comprises hydrocodone or a pharmaceutically acceptable salt thereof.

179 . A tablet as defined in claim 175 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said opioid analgesic or pharmaceutically acceptable salt thereof comprises hydromorphone or a pharmaceutically acceptable salt thereof.

180 . A tablet as defined in claim 179 , wherein said hydromorphone or pharmaceutically acceptable salt thereof comprises hydromorphone hydrochloride.

181 . A tablet as defined in claim 175 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said opioid analgesic or pharmaceutically acceptable salt comprises oxymorphone or a pharmaceutically acceptable salt thereof.

182 . A tablet as defined in claim 181 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said oxymorphone or pharmaceutically acceptable salt thereof comprises oxymorphone hydrochloride.

183 . A tablet as defined in claim 175 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said opioid analgesic or pharmaceutically acceptable salt comprises morphine or a pharmaceutically acceptable salt thereof.

184 . A tablet as defined in claim 170 , wherein said tablet comprises 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 79%.

185 . A tablet as defined in claim 170 , wherein said tablet comprises 40 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 72%.

186 . A tablet as defined in claim 170 , wherein said tablet comprises 60 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 57%.

187 . A tablet as defined in claim 170 , wherein said tablet comprises 80 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 54%.

188 . A tablet as defined in claim 170 , wherein said tablet-shaped pharmaceutical preparation is formed by direct compression.

189 . A tablet as defined in claim 188 , wherein said tablet comprises 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 79%.

190 . A tablet as defined in claim 188 , wherein said tablet comprises 40 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 72%.

191 . A tablet as defined in claim 188 , wherein said tablet comprises 60 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 57%.

192 . A tablet as defined in claim 188 , wherein said tablet comprises 80 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 54%.

193 . A tablet as defined in claim 170 , wherein said curing comprises convection curing in a convection curing device.

194 . A tablet as defined in claim 175 , wherein said curing comprises convection curing in a convection curing device.

195 . A tablet as defined in claim 188 , wherein said curing comprises curing in a convection curing device.

196 . A tablet as defined in claim 170 , wherein said cured tablet-shaped pharmaceutical preparation has a density that is at least about 1% lower than the density of said preparation prior to curing.

197 . A tablet as defined in claim 175 , wherein said cured tablet-shaped pharmaceutical preparation has a density that is at least about 1% lower than the density of said preparation prior to curing.

198 . A tablet as defined in claim 188 , wherein said cured tablet-shaped pharmaceutical preparation has a density that is at least about 1% lower than the density of said preparation prior to curing.

199 . A tablet as defined in claim 188 , wherein said cured tablet-shaped pharmaceutical preparation has a density that is at least about 2% lower than the density of said preparation prior to curing.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 6, 2026
From: PURDUE PHARMA L.P.
To: KNOA PHARMA LLC
Reel/Frame 075516/0676 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 17, 2017
From: MCKENNA, WILLIAM H; MANNION, RICHARD O.; O'DONNELL, EDWARD P.; HUANG, HAIYONG H.
To: PURDUE PHARMA L.P.
Reel/Frame 043881/0325 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 17, 2017
From: PURDUE PHARMA L.P.
To: PURDUE PHARMA L.P.; PURDUE PHARMACEUTICALS L.P.
Reel/Frame 043881/0458 →