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Claims for Patent: 8,574,622

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Claims for Patent: 8,574,622

Title:Controlled release delivery system for nasal applications
Abstract: This invention relates to a pernasally administrable preparation for the controlled release of sexual hormones to the systemic circulation, in particular to a formulation which enables its active ingredient to be absorbed in a sustained manner providing a better bioavailability at very low doses and longer duration of action.
Inventor(s): Mattern; Claudia (Stans, CH)
Assignee: M & P Patent Aktiengesellschaft (Vaduz, LI)
Application Number:13/194,928
Patent Claims: 1. A testosterone gel formulation for nasal administration to a patient for controlled release of testosterone into systemic circulation of the patient following the nasal administration for treating the patient with testosterone therapy, the testosterone gel formulation comprising: (a) testosterone, wherein said testosterone is present within the testosterone gel formulation in an amount of from about 0.5% to about 10% by weight of the testosterone gel formulation: (b) at least one lipophilic or partly lipophilic carrier present in an amount of from about 60% to about 98% by weight of the testosterone gel formulation; (c) a compound or a mixture of compounds having surface tension decreasing activity present in an amount of from about 1% to about 20% by weight of the testosterone gel formulation; and (d) a viscosity regulating agent present in an amount of from about 0.5% to about 10% by weight of the testosterone gel formulation.

2. The testosterone gel formulation according to claim 1, wherein said lipophilic carrier comprises an oil.

3. The testosterone gel formulation according to claim 2, wherein said oil is a vegetable oil.

4. The testosterone gel formulation according to claim 3, wherein said vegetable oil is castor oil.

5. The testosterone gel formulation according to claim 1, wherein said compound or said mixture of compounds having surface tension decreasing activity comprise an oleoyl macrogolglyceride or a mixture of oleoyl macrogolglycerides.

6. The testosterone gel formulation according to claim 1, wherein said viscosity regulating agent is colloidal silicon dioxide.

7. A testosterone gel formulation for nasal administration for controlled release of testosterone into systemic circulation of a patient following nasal administration to the patient, the testosterone gel formulation comprising: (a) testosterone, wherein said testosterone is present within the testosterone gel formulation in an amount of from about 0.5% to about 6% by weight of the testosterone gel formulation; (b) castor oil in an amount of from about 75% to about 95% by weight of the testosterone gel formulation; (c) oleoyl macrogolglycerides in an amount of from about 1% to about 5% by weight of the testosterone gel formulation; and (d) colloidal silicon dioxide in an amount of from about 0.5% to about 5% by weight of the testosterone gel formulation; wherein the testosterone serum level achieved following the nasal administration of the testosterone gel formulation to the patient is sustained above the patient's testosterone baseline for at least 6 hours.
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