Nasal spray formulation and method
AssigneeBalance Pharmaceuticals, Inc.
InventorsJohn R. Daniels, Malcolm C. Pike, Darcy V. Spicer, AnnaMarie Daniels
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Abstract
A nasal spray formulation for use in female contraception or in the treatment of benign gynecological disorders is described. The nasal preparation is comprised of a GnRH compound and an estrogenic compound in the form of a water-soluble complex with a water-soluble cyclodextrin. The preparation effectively suppresses ovarian estrogen and progesterone production, and prevents signs and symptoms of estrogen deficiency, without a significant increase in the risk of endometrial hyperplasia.
Claims18
A nasal spray formulation, consisting essentially of an aqueous medium having dissolved therein
- (i) a GnRH compound, and
- (ii) an estrogenic compound, and optionally an androgenic compound, present in the form of a water-soluble complex with a water-soluble cyclodextrin
- where the concentration of GnRH compound and estrogenic compound in the formulation are effective, when administered intranasally, to suppress ovarian estrogen and progesterone production and to prevent signs and symptoms of estrogen deficiency, without a significant increase in the risk of endometrial hyperplasia.
A nasal spray formulation, consisting essentially of an aqueous medium having dissolved therein
- (i) a GnRH compound, and
- (ii) an estrogenic compound, and optionally an androgenic compound, present in the form of a water-soluble complex with a water-soluble cyclodextrin
- wherein said formulation when intranasally administered as a daily bolus (i) is effective to achieve an average serum concentration over 24 hours of the estrogenic compound that is within 10% of the average serum concentration over 24 hours of the estrogenic compound when delivered transdermally and (ii) is as effective in preventing bone mineral density loss as transdermal administration of the estrogenic compound.
Dependencies are inferred from the claim text.