METHODS TO ADMINISTER ETHINYL ESTRADIOL AND PRODRUGS THEREOF WITH IMPROVED BIOAVAILABILITY
First Claim
1. A method of administering ethinyl estradiol or a prodrug thereof to a patient with improved bioavailability comprising the step of orally administering a solid dosage form containing ethinyl estradiol or the prodrug thereof that releases an effective amount of the ethinyl estradiol or the prodrug thereof in the oral cavity for absorption through the oral mucosa to treat the patient for a predetermined indication and wherein the patient is instructed to orally administer the solid dosage form with about 2 ounces of water or less.
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Accused Products
Abstract
Methods of improving the bioavailability of ethinyl estradiol by orally administering to a patient a solid dosage form containing ethinyl estradiol or prodrug thereof where that dosage form releases at least some of the ethinyl estradiol or prodrug thereof in the oral cavity for absorption through the oral mucosa to treat the patient for a predetermined indication such as, for example, hormone replacement therapy or contraception. The solid dosage forms may be selected from, among others, chewable tablets, fast melt tablets, films, dissolving films, mucoadhesive tablets, lozenges, and chewing gum.
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Citations
26 Claims
- 1. A method of administering ethinyl estradiol or a prodrug thereof to a patient with improved bioavailability comprising the step of orally administering a solid dosage form containing ethinyl estradiol or the prodrug thereof that releases an effective amount of the ethinyl estradiol or the prodrug thereof in the oral cavity for absorption through the oral mucosa to treat the patient for a predetermined indication and wherein the patient is instructed to orally administer the solid dosage form with about 2 ounces of water or less.
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24. An orally administered solid dosage form capable of delivering ethinyl estradiol with improved bioavailability to a patient in need thereof, said solid dosage form comprising:
- (i) about 0.5 μ
g to about 50 μ
g of ethinyl estradiol and (ii) an oral dissolution enhancing carrier that provides for at least 15% absorption of the ethinyl estradiol through the oral mucosa when said solid dosage form is orally administered to the patient with 2 ounces of water or less. - View Dependent Claims (25, 26)
- (i) about 0.5 μ
Specification