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US 2017/0304297 A1Published application
Immediate release abuse deterrent tablet
AssigneeAllergan Sales, Inc.
InventorsRahul Sareen, Shahin Fesharaki, Parag Shah
Life of this patent
Estimating the term…
Abstract
The invention relates to an abuse deterrent immediate release tablet.
Claims17
-23. (canceled)
A solid pharmaceutical tablet consisting essentially of:
- i) a compressed core;
- and
- ii) optionally an aesthetic or seal coating surrounding the compressed core, wherein the compressed core consists essentially of:
- a) a therapeutically effective amount of a drug that is subject to abuse, wherein the drug is selected from the group consisting of alfentanil, alimemazine, alprazolam, amphetamine, buprenorphine, butorphanol, clonazepam, codeine, cyclobenzaprine, diazepam, dihydrocodeine, dihydromorphine, dronabinol, estazolam, ezopiclone, fentanyl, flurazepam, hydrocodone, hydromorphone, lorazepam, methobarbital, methylphenidate, methadone, morphine, oxycodone, oxymorphone, phenobarbital, secobarbital, tempazepam, tramadol, triazolam, zaleplon, zopiclone, zolpidem and pharmaceutically acceptable salts thereof;
- b) about 1 to about 20 weight percent of a gelling agent selected from the group consisting of polyhydroalkylcellulose having a molecular weight greater than 50,000, a poly(hydroxyalkylmethacrylate) having a molecular weight of from 5,000 to 5,000,000;
- a poly(vinylpyrrolidone) having a molecular weight of from 100,000 to 3,000,000;
- a polysaccharide, a carboxyvinyl polymer, a polymer of acrylic acid cross-linked with a polyallyl ether of sucrose;
- polyacrylamides;
- polyethylene oxide polymers having a molecular weight of 100,000 to 7,000,000 and combinations thereof;
- c) about 1 to about 20 weight percent of an effervescent agent;
- d) optionally at least one conventional pharmaceutical processing excipient;
- and
- e) optionally a second aversive agent selected from the group consisting of a second nasal irritant, an antagonist agent, a bittering agents, a visual modifying agent, an emetic agent and combinations of the forgoing,
- wherein the tablet releases 40-90% of the drug in 30 minutes and 70-100% of the drug in 45 minutes when measured by a USP Apparatus Type 2 dissolution test at 50 rpms placed into 500 ml of purified water at 37° C.
11 more elements
The tablet as defined in claim 1 wherein a second aversive agent is present
A solid pharmaceutical tablet consisting essentially of:
- i) a compressed core;
- and
- ii) optionally an aesthetic or seal coating surrounding the compressed core, wherein the compressed core consists essentially of:
- a) a therapeutically effective amount of a drug selected from the group consisting of buprenorphine, codeine, dihydrocodeine, dihydromorphine, hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone and pharmaceutically acceptable salts there of;
- b) about 1 to about 20 weight percent of a polyethylene oxide polymer having a molecular weight of 100,000 to 7,000,000;
- c) about 1 to about 20 weight percent of an effervescent agent wherein the effervescent agent consists essentially of an alkaline source selected from the group consisting of a carbonate, bicarbonate and a mixture thereof and an acid source selected from the group consisting of an organic acid, a salt of an organic acid and a mixture thereof;
- d) at least one conventional pharmaceutical processing excipient selected from the group consisting of fillers, binders, lubricants, glidants, disintegrants, coloring agents, and mixtures thereof;
- e) optionally a second aversive agent selected from the group consisting of a second irritating agent, an antagonist agent, a bittering agent, a visual modifying agent, an emetic agent and combinations of the forgoing;
- and wherein the tablet releases 40-90% of the drug in 30 minutes and 70-100% of the drug in 45 minutes when measured by a USP Apparatus Type 2 dissolution test at 50 rpms placed into 500 ml of purified water at 37° C.
6 more elements
Dependencies are inferred from the claim text.