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US 2013/0171257 A1Published application
Extended release opioid abuse deterrent compositions and methods of making same
AssigneeAcura Pharmaceuticals, Inc.
InventorsVijai Kumar, David Dixon, Divya Tewari, Dilip B. Wadgaonkar
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Abstract
This invention relates to an abuse deterrent dosage form of opioid analgesics, wherein an analgesically effective amount of opioid analgesic is combined with a polymer to form a matrix.
Claims16
A method of making an extended release abuse deterrent dosage form comprising:
- a. mixing:
- (a) PEO having a molecular weight of from about 300,000 to about 5,000,000;
- (b) magnesium stearate;
- and
- (c) a drug susceptible to abuse selected from the group consisting of codeine, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone, pentazocine, tramadol and a pharmaceutically acceptable salt thereof;
- b. forming a matrix from the mixture of PEO, magnesium stearate and drug;
- c. heating the matrix to melt at least a portion of the PEO in the matrix;
- d. layering HPMC and PEG, either separately or in a mixture, onto the matrix that was heated to form a dosage form;
- wherein the dosage form provides extended release of the drug.
6 more elements
An extended release abuse deterrent dosage form comprising:
- a. a core matrix comprising a blended mixture of:
- (a) PEO having a molecular weight of from about 300,000 to about 5,000,000;
- (b) magnesium stearate;
- and
- (c) a drug susceptible to abuse selected from the group consisting of codeine, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone, pentazocine, tramadol and a pharmaceutically acceptable salt thereof;
- and
- wherein the matrix is heated to melt at least a portion of the PEO included in the matrix;
- and
- b. HPMC and PEG layered, either separately or as a mixture, onto the core matrix;
- and,
- wherein the dosage form provides extended release of the drug.
8 more elements
An extended release abuse deterrent dosage form comprising:
- a. a core matrix comprising a blended mixture of:
- (a) PEO having a molecular weight of from about 300,000 to about 5,000,000;
- (b) magnesium stearate;
- and
- (c) oxycodone or a pharmaceutically acceptable salt thereof;
- wherein the matrix is heated to melt at least a portion of the PEO included in the matrix;
- and
- b. HPMC and PEG layered, either separately or as a mixture, onto the core matrix;
- wherein the dosage form provides extended release of the drug.
6 more elements
An extended release abuse deterrent dosage form comprising:
- a. a core matrix comprising a blended mixture of:
- (a) PEO having a molecular weight of from about 300,000 to about 5,000,000;
- (b) magnesium stearate;
- and
- (c) hydrocodone, oxycodone or a pharmaceutically acceptable salt thereof;
- wherein the matrix is heated to melt at least a portion of the PEO included in the matrix;
- and
- b. PEG applied onto the core matrix;
- wherein the dosage form provides extended release of the drug.
6 more elements
A process of preparing a solid oral extended release pharmaceutical dosage form, comprising at least the steps of:
- a. combining at least
- i. at least one polyethylene oxide having a molecular weight of at least about 1,000,000, and
- ii. at least one active agent selected from the group consisting of alfentanil, buprenorphine, butorphanol, carfentanil, codeine, dezocine, diacetylmorphine, dihydrocodeine, dihydromorphine, diprenorphine, etorphine, fentanyl, hydrocodone, hydromorphone, -hydroxy-3-methylfentanyl, levo-β-acetylmethadol, levorphanol, lofentanil, meperidine, methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, pethidine, propoxyphene, remifentanil, sufentanil, tilidine, tramadol and a pharmaceutically acceptable salt thereof,
- to form a composition;
- b. shaping the composition to form an extended release matrix formulation;
- and
- c. heating the extended release matrix formulation to a temperature which is at least the softening temperature of said polyethylene oxide.
4 more elements
A process of preparing a solid oral extended release pharmaceutical dosage form, comprising at least the steps of:
- a. combining at least
- i. at least one polyethylene oxide having a molecular weight of at least about 1,000,000, and
- ii. at least one active agent selected from the group consisting of alfentanil, buprenorphine, butorphanol, carfentanil, codeine, dezocine, diacetylmorphine, dihydrocodeine, dihydromorphine, diprenorphine, etorphine, fentanyl, hydrocodone, hydromorphone, -hydroxy-3-methylfentanyl, levo-β-acetylmethadol, levorphanol, lofentanil, meperidine, methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, pethidine, propoxyphene, remifentanil, sufentanil, tilidine, tramadol and a pharmaceutically acceptable salt thereof,
- to form a composition;
- b. shaping the composition to form an extended release matrix formulation;
- and
- c. heating the extended release matrix formulation wherein the polyethylene oxide at least partially melts.
4 more elements
Dependencies are inferred from the claim text.