Transmucosal hormone delivery system
AssigneePharmaceutical Productions Inc.
InventorJohn McCarty
Life of this patent
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Abstract
The present invention provides a pharmaceutical composition for sublingual or buccal administration of actives with low to poor aqueous solubility, e.g. the hormone estradiol, which contains a solution of the active in a pharmaceutically acceptable solvent adsorbed or absorbed onto particles of a pharmaceutically acceptable carrier and methods of preparing and using the pharmaceutical composition.
Claims17
A pharmaceutical composition containing estradiol in a solid dosage form for buccal or sublingual delivery comprising:
- estradiol in an amount of about 0.05 mg to about 2 mg;
- a liquid polyethylene glycol (PEG) in an amount of about 1 mg to about 50 mg;
- a solid adsorbent in an amount up to about 50 mg;
- a solid water-soluble excipient in an amount of about 25 mg to about 500 mg;
- a disintegrant in an amount of about 0.5 mg to about 50 mg;
- and
- a lubricant in an amount of about 0.1 mg to about 15 mg.
A method for increasing oral absorption and bioavailability while shortening onset of estradiol action in an oral solid dosage form comprising:
- providing estradiol in an amount of about 0.05 mg to about 2 mg;
- providing a liquid PEG in an amount of about 1 mg of to about 50 mg;
- providing a solid adsorbent in an amount up to about 50 mg;
- providing a co-solvent in an amount up to about 25 mg;
- providing a solid water-soluble excipient in an amount of about 25 mg to about 500 mg;
- providing a disintegrant in an amount of about 0.5 mg to about 50 mg;
- providing a lubricant in an amount of about 0.1 mg to about 15 mg;
- and
- forming a solid oral dosage for buccal or sublingual administration having increased oral absorption and bioavailability and shortened onset of action for estradiol.
Dependencies are inferred from the claim text.