Compact dosage unit for buccal administration of a pharmacologically active agent
OwnerVirgil A. Placeinventor
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Abstract
A simple and compact buccal dosage unit is provided for administering a pharmacologically active agent to a mammalian individual. The buccal dosage unit comprises the active agent to be administered, a polymeric carrier that bioerodes and provides for delivery of the androgenic agent over a predetermined time period, and, preferably, a lubricant such as magnesium stearate. The dosage units are ideal for administering drugs that have low oral bioavailability but are nevertheless potent and can thus be administered in small quantities, i.e., at low dosages, using the compact systems. Methods for administering active agents using the dosage units are provided as well.
Claims38
A compact buccal dosage unit for administering a pharmacologically active agent, comprising a compressed tablet of a substantially uniform mixture of a bioerodible polymeric carrier which upon sustained contact with the buccal mucosa completely erodes within a predetermined drug delivery period in the range of approximately 4 to 24 hours, and, incorporated therein, a therapeutically effective amount of a pharmacologically active agent, wherein the total weight of the unit is less than about 40 mg, the pharmacologically active agent represents at least about 40% of the total weight of the unit and the unit does not contain a disintegrant.
A compact buccal dosage unit for the administration of testosterone, the dosage unit comprising a compressed tablet of a substantially uniform mixture of a bioerodible polymeric carrier which upon sustained contact with the buccal mucosa completely erodes within a predetermined drug delivery period in the range of approximately 8 to 24 hours, and, incorporated therein, a therapeutically effective amount of testosterone, wherein the total weight of the unit is in the range of about 5 mg to 20 mg, the testosterone represents approximately 40 wt. % to 80 wt. % of the total weight of the unit, and the unit does not contain a disintegrant.
Dependencies are inferred from the claim text.