TRANSMUCOSAL HORMONE DELIVERY SYSTEM

摘要

The present invention provides a pharmaceutical composition for sublingual or buccal administration of actives with low to poor aqueous solubility, e.g. the hormone melatonin, 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.

主权项

1. A pharmaceutical composition containing melatonin in a solid dosage form for buccal or sublingual delivery comprising:
melatonin in an amount of about 0.05 mg to about 5 mg; a liquid 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.