ORAL CONTRACEPTIVE DOSAGE FORMS AND METHODS OF MAKING SUCH DOSAGE FORMS
First Claim
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1. An oral dosage form comprising a progestogen dispersed in an enteric polymer and an estrogen.
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Accused Products
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.
100 Citations
174 Claims
- 1. An oral dosage form comprising a progestogen dispersed in an enteric polymer and an estrogen.
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2-3. -3. (canceled)
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8-9. -9. (canceled)
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12. (canceled)
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14-17. -17. (canceled)
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18. An oral dosage form comprising a tablet, wherein the tablet comprises:
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progestogen particles, wherein the progestogen particles comprise a progestogen dispersed in an enteric polymer; and an estrogen. - View Dependent Claims (21, 22, 23, 24, 29, 30, 32, 35, 39)
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19-20. -20. (canceled)
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25-28. -28. (canceled)
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31. (canceled)
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33-34. -34. (canceled)
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36-38. -38. (canceled)
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40-77. -77. (canceled)
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78. An oral dosage form comprising a tablet, wherein the tablet comprises:
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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.
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79. 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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80-172. -172. (canceled)
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173. A method of formulating an oral dosage form, comprising:
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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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174-277. -277. (canceled)
Specification