Back to results
US 10,500,215 B2Granted
Formulations and methods for providing progestin-only contraception while minimizing adverse side effects associated therewith
AssigneeAllergan Sales, Inc.
InventorsCharles Ebert, Gary Hoel, Angela Anigbogu, Samir Roy
Life of this patent
Estimating the term…
Abstract
Formulations and methods for providing progestin-only contraception to a woman while minimizing various side effects, such as breakthrough bleeding, that are normally associated with progestin-only contraception are disclosed and described. In one aspect, the method can include transdermally administering a formulation having a contraceptively effective amount of a single progestin as the sole active hormonal agent to the woman as part of a contraceptive regimen.
Claims21
A transdermal patch comprising:
- a) norethindrone as the sole hormonal active agent or a combination of norethindrone and norethindrone acetate as the sole hormonal active agents in an amount of from 1% to 15% w/w;
- and
- b) a permeation enhancer comprising (i) isopropyl myristate and (ii) lauryl alcohol,
- wherein the transdermal patch is formulated to minimize adverse side effects associated with progestin-only contraception by providing:
- a) a minimum norethindrone serum level of at least 300 pg/ml from 24 hours to 168 hours following application of the patch to an outer skin surface;
- and
- b) a maximum norethindrone serum level of less than 2400 pg/ml from about 24 to 96 hours following application of the patch to the outer skin surface,
- wherein the side effects are selected from the group consisting of strokes, myocardial infarctions, embolisms, breakthrough bleeding and combinations thereof.
5 more elements
Dependencies are inferred from the claim text.