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US 2013/0171256 A1Published application
Alcohol-resistant extended release dosage forms comprising venlafaxine
AssigneeCima Labs Inc.
InventorEhab Hamed
Life of this patent
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Abstract
This disclosure relates to an extended release oral dosage form comprising a matrix containing a viscosity modifier (but no lipid) and coated granules containing venlafaxine or a pharmaceutically acceptable salt or solvate thereof. The dosage form has alcohol resistance and may also have crush resistance.
Claims39
An extended release oral dosage form comprising:
- a matrix, wherein the matrix comprises a viscosity modifier in an amount from about 1 to about 60 percent by weight of the dosage form;
- and
- coated granules comprising venlafaxine or a pharmaceutically acceptable salt or solvate thereof;
- wherein the matrix does not contain a lipid.
1 more element
An extended release oral dosage form comprising:
- a matrix, wherein the matrix comprises a viscosity modifier in an amount from about 1 to about 60 percent by weight of the dosage form;
- and
- coated granules comprising venlafaxine or a pharmaceutically acceptable salt or solvate thereof;
- wherein the matrix does not contain a lipid;
- in which the percent of venlafaxine released after 2 hours in a solution of 0.1N hydrochloric acid and 40% alcohol is no more than 10 percentage points greater than the percent of said venlafaxine released in a solution of 0.1N hydrochloric acid in the absence of alcohol.
2 more elements
An extended release oral dosage form comprising:
- a matrix, wherein the matrix comprises a viscosity modifier in an amount from about 1 to about 60 percent by weight of the dosage form;
- and
- coated granules comprising venlafaxine or a pharmaceutically acceptable salt or solvate thereof;
- wherein the matrix does not contain a lipid;
- in which the release of venlafaxine from the dosage form 6 hours after testing is less than about 80 percent when tested in 500 ml of 0.1N hydrochloric acid solution using USP dissolution apparatus.
2 more elements
An alcohol-resistant extended release oral dosage form comprising:
- a matrix, wherein the matrix comprises a first viscosity modifier in an amount from about 5 to about 45 percent by weight of the dosage form;
- and coated granules, wherein the coated granules comprise:
- a granule comprising venlafaxine or a pharmaceutically acceptable salt or solvate thereof in an amount from about 10 to about 90 percent by weight of the granule, a first strong film former in an amount from about 1 to about 90 percent by weight of the granule, a second viscosity modifier in an amount from about 1 to about 90 percent by weight of the granule, and a fat/wax in an amount from about 0 to about 40 percent by weight of the granule;
- and a coating on the granule, wherein the coating is present in an amount from about 5 to about 70 percent by weight of the coated granule, and wherein the coating comprises a second strong film former in an amount from about 1 to about 50 percent by weight of the coated granule, and an anti-adherent in an amount from about 10 to about 25 percent by weight of the coated granule;
- and wherein the matrix does not comprise a lipid.
2 more elements
An alcohol-resistant extended release oral dosage form comprising a matrix, wherein the matrix comprises a first viscosity modifier in an amount from about 25 to about 45 percent by weight of the dosage form;
- and coated granules, wherein the coated granules comprise:
- a granule consisting essentially of venlafaxine or a pharmaceutically acceptable salt or solvate thereof in an amount from about 30 to about 90 percent by weight of the granule, a first strong film former in an amount from about 5 to about 40 percent by weight of the granule, a second viscosity modifier in an amount from about 1 to about 60 percent by weight of the granule, and a coating on the granule, wherein the coating is present in an amount from about 30 to about 70 percent by weight of the coated granule, and wherein the coating comprises a second strong film former in an amount from about 10 to about 50 percent by weight of the coated granule, and an anti-adherent in an amount from about 10 to about 25 percent by weight of the coated granule;
- and wherein the matrix does not comprise a lipid.
An alcohol-resistant extended release oral dosage form comprising a matrix, wherein the matrix comprises hydroxypropylmethylcellulose in an amount from about 25 to about 45 percent by weight of the dosage form;
- and coated granules, wherein the coated granules comprise:
- a granule consisting essentially of venlafaxine or a pharmaceutically acceptable salt or solvate thereof in an amount from about 40 to about 75 percent by weight of the granule, ethylcellulose in an amount from about 10 to about 30 percent by weight of the granule, hydroxypropylmethylcellulose in an amount from about 20 to about 40 percent by weight of the granule;
- and a coating on the granule, wherein the coating is present in an amount from about 30 to about 55 percent by weight of the coated granule, and wherein the coating comprises ethylcellulose in an amount from about 10 to about 50 percent by weight of the coated granule, and magnesium stearate in an amount from about 10 to about 25 percent by weight of the coated granule;
- and wherein the matrix does not comprise a lipid.
1 more element
An alcohol-resistant extended release oral dosage form comprising a matrix, wherein the matrix comprises hydroxypropylmethylcellulose in an amount of about 30 percent by weight of the dosage form;
- and coated granules, wherein the coated granules comprise:
- a granule consisting essentially of venlafaxine hydrochloride in an amount of about 40 to about 50 percent by weight of the granule, ethylcellulose in an amount from about 10 to about 20 percent by weight of the granule, and hydroxypropylmethylcellulose in an amount from about 30 to about 40 percent by weight of the granule;
- and a coating on the granule, wherein the coating is present in an amount from about 30 to about 55 percent by weight of the coated granule, and wherein the coating consists essentially of ethylcellulose in an amount from about 10 to about 50 percent by weight of the coated granule, and magnesium stearate in an amount from about 10 to about 25 percent by weight of the coated granule;
- and wherein the matrix does not comprise a lipid.
1 more element
A sustained-release oral dosage form for twice-a-day administration comprising:
- a matrix, wherein the matrix comprises a viscosity modifier in an amount from about 20 to about 60 percent by weight of the dosage form and wherein the Cmax changes less than about 50% when food is ingested with the dosage form compared to when food is not ingested with the dosage form;
- and
- coated granules comprising venlafaxine or a salt form thereof.
Dependencies are inferred from the claim text.