Oral contraceptive dosage forms and methods of making such dosage forms
OwnerZe'ev Shaked, Justin R. Hugheyinventors
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Abstract
Disclosed herein are oral dosage forms and methods of their use, in particular oral dosage systems for the delivery of drugs for use as a female oral contraceptive. In an embodiment, an oral dosage form includes a progestogen dispersed in an enteric polymer and an estrogen.
Claims33
An oral dosage form comprising a progestogen dispersed in an enteric polymer and an estrogen.
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An oral dosage form comprising a tablet, wherein the tablet comprises:
- progestogen particles, wherein the progestogen particles comprise a progestogen dispersed in an enteric polymer;
- and
- an estrogen.
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An oral dosage form comprising a tablet, wherein the tablet comprises:
- drospirenone particles, wherein the drospirenone particles comprise drospirenone dispersed in an enteric polymer, wherein the enteric polymer comprises hydroxypropyl methyl cellulose acetate succinate;
- and
- ethinylestradiol;
- wherein the tablet is at least partially coated with an enteric polymer.
A method of producing a contraceptive state in a subject comprising administering to a subject an oral dosage form comprising an effective amount of a progestogen dispersed in an enteric polymer and an effective amount of an estrogen.
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A method of formulating an oral dosage form, comprising:
- forming a mixture of an enteric polymer and a progestogen;
- heating at least a portion of the enteric polymer to a temperature at or above the glass transition temperature of the enteric polymer to form a heated mixture of enteric polymer and the progestogen;
- permitting the heated mixture to solidify as a solid mass comprising the progestogen dispersed in the enteric polymer;
- and
- combining the progestogen dispersed in an enteric polymer with an estrogen to form the oral dosage form.
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Dependencies are inferred from the claim text.