SPREADING IMPLEMENT

• US 20120220959A1
• Filed: 05/04/2012
• Published: 08/30/2012
• Est. Priority Date: 01/11/2007
• Status: Active Grant

• Current Assignee: Acrux DDS Pty Ltd (Acrux Limited)
• Original Assignee: Acrux DDS Pty Ltd (Acrux Limited)
• Inventors: Bayly, Peter, Bayly, Mark Simon, Ahlstrom, Magnus, Watkinson, Adam Charles
• Granted Patent: US 8,419,307 B2
• Time in Patent Office: Days
• US Class Current: 604/290
• CPC Class Codes: A45D 34/04 Appliances specially adapted for applying liquid, e.g. using roller or ball
• CPC Class Codes: A45D 40/26 Appliances specially adapted for applying pasty paint, e.g. using roller, using a ball
• CPC Class Codes: A61K 2800/48 Thickener, Thickening system
• CPC Class Codes: A61K 2800/592 Mixtures of compounds complementing their respective functions
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 8/26 Aluminium; Compounds thereof
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61M 35/003 Portable hand-held applicators having means for dispensing or spreading integral media hand-held massage devices with liquid delivery A61H7/003
• CPC Class Codes: A61Q 15/00 Anti-perspirants or body deodorants deodorisation of air A61L9/00

Abstract

This invention relates to an implement 1 for applying a volume of liquid to a treatment surface. The implement includes a support means 3 onto which is mounted a receptacle 2, the receptacle defining a reservoir space 4 which receives the liquid. The receptacle includes a wall 6 having a working surface that is used to spread the liquid over the treatment surface. The wall 6 is resiliently deformable so in use the working surface maintains contact with the treatment surface when spreading the liquid. The implement has a specific application in applying a transdermal lotion to the axilla area of the user. The invention also relates to a system for transdermal administration of a physiological active agent from a liquid composition and a method of conducting the same.

Claims

1-39. -39. (canceled)

40. 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.

41. A method according to claim 40, 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.

42. A method according to claim 41, 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.

43. A method according to claim 41, 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.

44. A method according to claim 40 wherein the liquid is in the form of a lotion or gel.

45. A method according to claim 40 wherein the liquid has a viscosity greater than water and less than 300 centipoise.

46. A method according to claim 40 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.

47. A method according to claim 40 wherein the liquid pharmaceutical composition comprises the penetration enhancer in an amount of from 0.01% to 15% w/v of the liquid.

48. A method according to claim 40 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.

49. A method according to claim 48 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.

50. A method according to claim 40 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.

51. A method according to claim 40 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.

52. 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 0.1% 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;

53. A method according to claim 52 wherein the person is male.

54. A method according to claim 53 wherein the male is suffering hypogonadism.

55. A method according to claim 54 wherein the liquid is applied to provide a serum testosterone level in the range of from 300 to 1000 ng/dl.

56. A method according to claim 52 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.

57. A method according to claim 52 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.

58. A method according to claim 52 wherein the viscosity modulating agent is polyvinyl pyrrolidone.

59. A method according to claim 58 wherein the polyvinyl pyrrolidone is present in the liquid in an amount in the range of from 1% to 3% w/v.

60. A composition according to claim 52 wherein the testosterone is present in the liquid in an amount of at least 1% w/v.

61. A composition according to claim 52 wherein the volatile solvent is present in the liquid in an amount of at least 80% v/v.

62. A method according to claim 52 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.