Solid dosage formulations of narcotic drugs having improved buccal adsorption
AssigneeAlpex Pharma S.A.
InventorsFederico Stroppolo, Shahbaz Ardalan
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Abstract
Disclosed is a pharmaceutical composition in the form of a tablet suitable for dissolution in the buccal cavity, said composition comprising i) an effective amount of a narcotic active ingredient, and ii) a pharmaceutically acceptable amine having a pK of about 8 or greater, wherein the molar ratio of amine:active ingredient is at least about 5:1.
Claims2
A composition in the form of a tablet suitable for dissolution in the buccal cavity which comprises:
- about 0.1 weight % fentanyl citrate;
- about 4.3 weight % arginine;
- about 5.0 weight % PEG 6000;
- about 33.6 weight % sorbitol;
- about 51.7 weight % mannitol;
- about 2.7 weight % aspartame;
- about 1.0 weight % citric acid;
- and
- about 1.7 weight % magnesium stearate.
A method of administration of a narcotic to a mammal across the oral mucosa thereof, said method comprising orally administering to said mammal a pharmaceutical composition in the form of a tablet suitable for dissolution in the buccal cavity, said composition comprising:
- about 0.1 weight % fentanyl citrate;
- about 4.3 weight % arginine;
- about 5.0 weight % PEG 6000;
- about 33.6 weight % sorbitol;
- about 51.7 weight % mannitol;
- about 2.7 weight % aspartame;
- about 1.0 weight % citric acid;
- and
- about 1.7 weight % magnesium stearate.
Dependencies are inferred from the claim text.