Naltrexone hydrochloride compositions
OwnerBenjamin Oshlack, Hua-Pin Huang +2inventors
InventorsBenjamin Oshlack, Hua-Pin Huang, Philip Goliber, Richard Mannion
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Abstract
The present invention relates to compositions and methods of stabilizing naltrexone hydrochloride.
Claims60
A pharmaceutical composition comprising naltrexone hydrochloride in an amount of 20 mg or less, and a stabilizer which inhibits the formation of at least one degradation product of the naltrexone hydrochloride.
A pharmaceutical composition comprising:
- naltrexone hydrochloride in an amount of 20 mg or less;
- and a stabilizer;
- said composition maintaining at least about 90% of said naltrexone hydrochloride in undegraded form after storage for 1 month at 40±2° C. and 75±5% relative humidity.
A pharmaceutical composition comprising naltrexone hydrochloride in an amount of 20 mg or less, and a stabilizer which inhibits the formation of a degradation product of the naltrexone hydrochloride, wherein the stabilizer is not BHT.
A pharmaceutical composition comprising naltrexone hydrochloride in an amount of 20 mg or less, and a stabilizer selected from the group consisting of organic acids, carboxylic acids, acid salts of amino acids, sodium metabisulphite, ascorbic acid and its derivatives, malic acid, isoascorbic acid, citric acid, tartaric acid, sodium sulphite, sodium bisulphate, tocopherol, water- and fat-soluble derivatives of tocopherol, sulphites, bisulphites and hydrogen sulphites, butylated hydroxyanisol (BHA), 2,6-di-t-butyl-alpha-dimethylamino-p-cresol, t-butylhydroquinone, di-t-amylhydroquinone, di-t-butylhydroquinone, butylhydroxytoluene, butylhydroxyanisole, pyrocatechol, pyrogallol, propyl/gallate, and nordihydroguaiaretic acid, phosphoric acids, sorbic and benzoic acids, esters, derivatives and isomeric compounds, ascorbyl palmitate, pharmaceutically acceptable salts thereof, and mixtures thereof.
A pharmaceutical composition comprising a combination of naltrexone hydrochloride in an amount of 20 mg or less, and a stabilizer which inhibits the formation of a degradation product from the naltrexone hydrochloride, wherein the combination is disposed about a pharmaceutically acceptable inert bead.
A pharmaceutical composition comprising naltrexone hydrochloride and a water soluble stabilizer which inhibits the formation of at least one degradation product of the naltrexone hydrochloride.
A pharmaceutical composition comprising:
- naltrexone hydrochloride in an amount of 20 mg or less;
- a stabilizer;
- and
- a chelating agent;
- wherein at least one of the stabilizer and chelating agent is capable of inhibiting the formation of at least one degradation product of the naltrexone hydrochloride.
A pharmaceutical composition comprising naltrexone hydrochloride in an amount of 20 mg or less, and a chelating agent which inhibits the formation of at least one degradation product of the naltrexone hydrochloride.
A method of preparing a pharmaceutical composition comprising incorporating naltrexone hydrochloride in an amount of 20 mg or less, and a stabilizer in a pharmaceutical composition, wherein said stabilizer inhibits the formation of at least one degradation product of the naltrexone hydrochloride.
A method of preparing a pharmaceutical composition comprising incorporating naltrexone hydrochloride in an amount of 20 mg or less, and a stabilizer in a pharmaceutical composition, wherein said composition maintains at least about 90% of said naltrexone hydrochloride in undegraded form after storage for 1 month at 40±2° C. and 75±5% relative humidity.
A method of preparing a pharmaceutical composition comprising incorporating naltrexone hydrochloride in an amount of 20 mg or less, and a stabilizer in a pharmaceutical composition, wherein said stabilizer inhibits the formation of at least one degradation product of the naltrexone hydrochloride, wherein the stabilizer is not BHT.
A method of preparing a pharmaceutical composition comprising combining naltrexone hydrochloride in an amount of 20 mg or less, and a stabilizer selected from the group consisting of organic acids, carboxylic acids, acid salts of amino acids, sodium metabisulphite, ascorbic acid and its derivatives, malic acid, isoascorbic acid, citric acid, tartaric acid, sodium sulphite, sodium bisulphate, tocopherol, water- and fat-soluble derivatives of tocopherol, sulphites, bisulphites and hydrogen sulphites, butylated hydroxyanisol (BHA), 2,6-di-t-butyl-alpha-dimethylamino-p-cresol, t-butylhydroquinone, di-t-amylhydroquinone, di-t-butylhydroquinone, butylhydroxytoluene, butylhydroxyanisole, pyrocatechol, pyrogallol, propyl/gallate, and nordihydroguaiaretic acid, phosphoric acids, sorbic and benzoic acids, esters, derivatives and isomeric compounds, ascorbyl palmitate, pharmaceutically acceptable salts thereof, and mixtures thereof.
A method of preparing a pharmaceutical composition comprising combining naltrexone hydrochloride in an amount of 20 mg or less and a stabilizer to form a naltrexone hydrochloride combination, wherein said stabilizer inhibits the formation of at least one degradation product of the naltrexone hydrochloride, wherein the naltrexone hydrochloride combination is disposed about a pharmaceutically acceptable inert bead.
A method of preparing a pharmaceutical composition comprising incorporating naltrexone hydrochloride in an amount of 20 mg or less, and a water soluble stabilizer in a pharmaceutical composition, wherein said stabilizer inhibits the formation of at least one degradation product of the naltrexone hydrochloride.
A method of preparing a pharmaceutical composition comprising incorporating naltrexone hydrochloride in an amount of 20 mg or less, a stabilizer and a chelating agent in a pharmaceutical composition, wherein the formation of at least one degradation product of the naltrexone hydrochloride is inhibited.
A method of preparing a pharmaceutical composition comprising incorporating naltrexone hydrochloride in an amount of 20 mg or less, and a chelating agent in a pharmaceutical composition, wherein said chelating agent inhibits the formation of at least one degradation product of the naltrexone hydrochloride.
A pharmaceutical composition comprising naltrexone hydrochloride in an amount of 20 mg or less, and a means of stabilizing the composition to inhibit the formation of at least one degradation product of the naltrexone hydrochloride.
A pharmaceutical composition comprising:
- naltrexone hydrochloride in an amount of 20 mg or less;
- and
- a means of stabilizing the composition such that said composition maintains at least about 90% of said naltrexone hydrochloride in undegraded form after storage for 1 month at 40±2° C. and 75±5% relative humidity.
A pharmaceutical composition comprising an inert core, a first layer and a second layer, the first layer being between the core and the second layer, the first layer comprising naltrexone hydrochloride and a stabilizer and the second layer comprising a hydrophobic material, wherein one or more inert cores are included in a dosage form to provide a total of 20 mg or less naltrexone hydrochloride.
A pharmaceutical composition comprising an inert core, a first layer, a second layer and a third layer, the first layer being between the core and the second layer, the second layer being between the first layer and the third layer, the first layer comprising naltrexone hydrochloride and a stabilizer, the second layer comprising a first hydrophobic material and the third layer comprising a second hydrophobic material wherein one or more inert cores are included in a dosage form to provide a total of 20 mg or less naltrexone hydrochloride.
A pharmaceutical composition comprising about 10 mg oxycodone hydrochloride, less than about 5.0 mg naltrexone hydrochloride, and a stabilizer.
A pharmaceutical composition comprising a first component comprising about 10 mg oxycodone hydrochloride, and a second component comprising less than about 5.0 mg naltrexone hydrochloride, and a stabilizer.
A pharmaceutical composition comprising about 20 mg oxycodone hydrochloride, less than about 5.0 mg naltrexone hydrochloride, and a stabilizer.
A pharmaceutical composition comprising a first component comprising about 20 mg oxycodone hydrochloride, and a second component comprising less than about 5.0 mg naltrexone hydrochloride, and a stabilizer.
A pharmaceutical composition comprising about 40 mg oxycodone hydrochloride, less than about 5.0 mg naltrexone hydrochloride, and a stabilizer.
A pharmaceutical composition comprising a first component comprising about 40 mg oxycodone hydrochloride, and a second component comprising less than about 5.0 mg naltrexone hydrochloride, and a stabilizer.
A pharmaceutical composition comprising about 5-20 mg hydrocodone bitartrate, less than about 5.0 mg naltrexone hydrochloride and a stabilizer.
A pharmaceutical composition comprising a first component comprising about 5-20 mg hydrocodone bitartrate, and a second component comprising less than about 5.0 mg naltrexone hydrochloride and a stabilizer.
Dependencies are inferred from the claim text.