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Claims for Patent: 8,419,307

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Claims for Patent: 8,419,307

Title:Spreading implement
Abstract: Described are methods comprising applying a liquid pharmaceutical testosterone composition with an implement comprising a support and a receptacle mounted on the support and defining a reservoir space with an open top to receive the liquid, wherein the receptacle includes a flexible membrane integrally forming a base and a wall, the wall being substantially transverse to the base and having a working surface to spread the liquid over the treatment surface, wherein the base has a continuous surface such that liquid cannot pass through the base, wherein the wall includes an inner portion which extends from the base to an upper end and an outer skirt portion, wherein the inner portion and skirt portion form a double-wall structure, and wherein at least the wall is resiliently deformable so the working surface maintains contact with the treatment surface when spreading the liquid.
Inventor(s): Bayly; Peter (Victoria, AU), Bayly; Mark Simon (Victoria, AU), Ahlstrom; Magnus (Victoria, AU), Watkinson; Adam Charles (Victoria, AU)
Assignee: Acrux DDS Pty Ltd. (West Melbourne, Victoria, AU)
Application Number:13/464,556
Patent Claims: 1. A method of increasing the testosterone blood level of a person in need thereof comprising applying to at least one axilla of the person a liquid pharmaceutical composition comprising testosterone and a carrier wherein said composition is applied with an implement comprising: a support; and a receptacle mounted on the support and defining a reservoir space with an open top and being configured to receive the liquid in the reservoir space through the open top, wherein the receptacle includes a flexible membrane integrally forming a base and a wall, the wall being substantially transverse to the base and having a working surface configured to spread the liquid over the treatment surface, wherein the base has a continuous surface such that liquid cannot pass through the base, wherein the wall includes an inner portion which extends from the base to an upper end and an outer skirt portion, wherein the inner portion and skirt portion form a double-wall structure, and wherein at least the wall is resiliently deformable so in use the working surface maintains contact with the treatment surface when spreading the liquid.

2. A method according to claim 1, wherein the liquid pharmaceutical composition comprises: (a) a pharmaceutically effective amount of testosterone; (b) one or more of lower alkyl alcohols; wherein the combined amount of lower alkyl alcohols is at least 60% v/v of the composition; (c) one or more penetration enhancers; and (d) a viscosity modulating agent for increasing the viscosity of the composition.

3. A method according to clam 2, wherein the one or more penetration enhancers is selected from the group consisting of fatty acids, fatty acid esters, fatty alcohols, glycols and glycol esters, 1,3-dioxolanes and 1,3-dioxanes, macrocyclic ketones containing at least 12 carbon atoms, oxazolidinones and oxazolidinone derivatives, alkyl-2-(N,N-disubstituted amino)-alkanoate esters, (N,N-disubstituted amino)-alkanol alkanoates, sunscreen esters and mixtures thereof.

4. A method according to claim 2, wherein the one or more penetration enhancers is selected from the group consisting of glycols, oleic acid, isopropyl myristate, cyclopentadecanone, sorbitan monooleate, octisalate, octyldimethyl-para-aminobenzoate, octyl para-methoxycinnamate, and combinations thereof.

5. A method according to claim 1 wherein the liquid is in the form of a lotion or gel.

6. A method according to claim 1 wherein the liquid has a viscosity greater than water and less than 300 centipoise.

7. A method according to claim 1 wherein the person is a male suffering hypogonadism and the liquid is applied to provide a serum testosterone level in the range of from 300 to 1000 ng/dl.

8. A method according to claim 1 wherein the liquid pharmaceutical composition comprises the penetration enhancer in an amount of from 0.01% to 15% w/v of the liquid.

9. A method according to claim 1 wherein the support of the implement is detachably connectable to a container containing the liquid and which is provided with a pump dispenser for delivering the liquid from the container and the method comprises delivering the volume of liquid from the container to the receptacle for application to the treatment surface.

10. A method according to claim 9 wherein the support is detachably connected to the container and surrounds the pump so as to reduce the likelihood of inadvertent discharge from the pump.

11. A method according to claim 1 wherein the support is relatively rigid in comparison to at least the wall of the receptacle so that at least the wall is movable relative to the support when applying the liquid.

12. A method according to claim 1 wherein the method further comprises applying a volume of the liquid to the reservoir space; and deforming the wall of the receptacle containing the volume of liquid against the treatment surface of the subject and spreading the liquid over the treatment surface comprising at least one axilla of the subject using the working surface.

13. A method of increasing the testosterone blood level of a person in need thereof comprising applying to at least one axilla of the person a liquid pharmaceutical composition comprising testosterone and a carrier wherein said composition is applied with an implement comprising: a support; and a receptacle mounted on the support and defining a reservoir space with an open top and being configures to receive liquid in the reservoir space through the open top, wherein the receptacle includes a flexible membrane integrally forming a base and a wall, the wall being substantially transverse to the base and having a working surface configured to spread the liquid over the treatment surface, wherein the base has a continuous surface such that liquid cannot pass through the base, wherein the wall includes an inner portion which extends from the base to an upper end and an outer skirt portion; wherein the inner portion and skirt portion form a double walled structure, and wherein at least the wall is resiliently deformable so in use the working surface maintains contact with the treatment surface when spreading the liquid; and wherein the liquid pharmaceutical composition comprises: (i) a pharmaceutically effective amount of testosterone; (ii) octyl salicylate penetration enhancer in an amount of from 0.01% to 15% w/v of the liquid; (iii) volatile solvent selected from the group consisting of ethanol, isopropanol and mixtures thereof in a total amount of from 70% to 99% v/v of the liquid; and (iv) a viscosity modulating agent in an amount to provide the liquid with a viscosity greater than water and less than 300 centipoise.

14. A method according to claim 13 wherein the person is male.

15. A method according to claim 14 wherein the male is suffering hypogonadism.

16. A method according to claim 15 wherein the liquid is applied to provide a serum testosterone level in the range of from 300 to 1000 ng/dl.

17. A method according to claim 13 wherein the support of the implement is detachably connectable to a container containing the liquid and which is provided with a pump dispenser for delivering the liquid from the container and the method comprises delivering the volume of liquid from the container to the receptacle for application to the treatment surface.

18. A method according to claim 13 wherein the support is detachably connected to the container and surrounds the pump so as to reduce the likelihood of inadvertent discharge of the liquid from the pump.

19. A method according to claim 13 wherein the viscosity modulating agent is polyvinyl pyrrolidone.

20. A method according to claim 19 wherein the polyvinyl pyrrolidone is present in the liquid in an amount in the range of from 1% to 3% w/v.

21. A composition according to claim 13 wherein the testosterone is present in the liquid in an amount of at least 1% w/v.

22. A composition according to claim 13 wherein the volatile solvent is present in the liquid in an amount of at least 80% v/v.

23. A method according to claim 13 wherein the method further comprises applying a volume of the liquid to the reservoir space; and deforming the wall of the receptacle containing the volume of liquid against the treatment surface of the subject and spreading the liquid over the treatment surface comprising at least one axilla of the subject using the working surface.
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