Spray foam corticosteroid product

• US 9,265,727 B1
• Filed: 01/14/2015
• Issued: 02/23/2016
• Est. Priority Date: 01/14/2015
• Status: Active Grant

• Current Assignee: Delcor Asset Corporation (Mylan N.V.)
• Original Assignee: Delcor Asset Corporation (Mylan N.V.)
• Inventors: Lowenborg, Michael V., Bhatia, Kuljit
• Primary Examiner(s): Schnizer, Richard
• Assistant Examiner(s): Peebles, Katherine
• Application Number:
  US14/596,867
• Time in Patent Office: 405 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A47K 5/14 Foam or lather making devices for shaving A45D27/02
• 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 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 47/06 Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• 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: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61K 9/124 characterised by the propellant
• CPC Class Codes: B65D 83/20 operated by manual action, e.g. button-type actuator or actuator caps actuators formed as a rigid elongate spout B65D83/306
• CPC Class Codes: B65D 83/207 Actuators comprising a manually operated valve and being attachable to the aerosol container, e.g. downstream a valve fitted to the container; Actuators associated to container valves with valve seats located outside the aerosol container portable spraying apparatus comprising pressurised supply containers B05B7/2402, B05B9/0805; manually actuated controlling means for spraying apparatus B05B12/002; actuators connected to the aerosol container by a flexible tube B65D83/756
• CPC Class Codes: B65D 83/752 characterised by the use of specific products or propellants

Abstract

A foamable pharmaceutical composition and a method of treating corticosteroid-responsive dermatoses of the skin are disclosed. The foamable pharmaceutical composition comprises a corticosteroid compound as an active ingredient; a quick-break foaming agent including an aliphatic alcohol, water, a fatty alcohol and a surface active agent; a buffering agent; and a propellant. The foamable composition is disposed within a pressurizable container that comprises an aerosol valve assembly including a dip tube communicating with a valve orifice through which the foamable composition is dispensed and an actuator to start and stop dispensation. The valve assembly dispenses a conically-shaped spray at a rate of about 2 to about 0.3 g/sec and provides a foam having a density of about 0.12 to about 0.25 when sprayed at a distance of about 5 to about 10 cm from the valve orifice onto a glass surface that is at ambient room temperature.

Claims

1. A foamable pharmaceutical composition comprising:

an effective amount of clobetasol propionate as an active ingredient;

a quick-break foaming agent that comprises a straight or branched chain C₁-C₄ aliphatic alcohol, water, a fatty alcohol and a surface active agent;

a buffering agent present in an amount sufficient to provide a pH value of about 3.0 to about 6.0; and

a propellant;

said foamable pharmaceutical composition being disposed in a pressurizable container at an internal pressure of about 40 to about 80 psi, said container comprising an aerosol valve assembly that includes a dip tube in communication with a valve orifice through which said foamable pharmaceutical composition can be dispensed and an actuator having a diameter of approximately 0.013 inches at the point of actuation to start and stop dispensation, said valve assembly on being actuated dispensing a substantially conically-shaped spray having an apex adjacent the valve orifice, said spray being dispensed at a rate of about 0.3 to about 2 g/sec, and wherein said foamable pharmaceutical composition provides an average foam bubble diameter of about 5 to about 40 μ

m, with at least 80 percent of the bubbles having a diameter of less than 40 μ

m, such that it forms a quick-breaking foam when applied to a skin surface.

2. The foamable pharmaceutical composition according to claim 1 wherein the foam has an initial density of about 0.12 to about 0.25 g/mL when sprayed at a distance of about 5 to about 10 cm from the valve orifice onto a glass surface at ambient room temperature.

3. The foamable pharmaceutical composition according to claim 1, wherein said average bubble diameter is about 10 to about 25 μ

m.

4. The foamable pharmaceutical composition of claim 1 further comprising a fragrance.

5. The foamable pharmaceutical composition of claim 4, wherein said fragrance is menthol.

6. The foamable pharmaceutical composition of claim 1 further comprising a humectant.

7. A pharmaceutical product comprising:

a) a pressurizable container;

b) a foamable pharmaceutical composition disposed within said pressurizable container that comprises i) an effective amount of clobetasol propionate as active ingredient, ii) a quick-break foaming agent that comprises a straight or branched chain C₁-C₄ aliphatic alcohol present at about 40 to about 90% w/w of the composition, iii) water, iv) a fatty alcohol, v) a surface active agent, vi) a propellant that provides an internal pressure of about 40 to about 80 psi to the container when the pressurizable-container is sealed, and vii) a buffering agent present in an amount sufficient to provide a pH value of about 3.0 to about 6.0;

said pressurizable container being sealed by an aerosol valve assembly that includes a dip tube that communicates with a valve orifice through which said foamable pharmaceutical composition can be dispensed and an actuator having a diameter of approximately 0.013 inches at the point of actuation to start and stop foam dispensation, said valve assembly on being actuated dispensing a substantially conically-shaped spray having an apex adjacent the valve orifice, said spray being dispensed at a rate of about 0.3 to about 2 g/sec and providing a foam having an initial density of about 0.12 to about 0.25 g/mL when sprayed at a distance of about 5 to about 10 cm, and wherein said foamable pharmaceutical composition provides an average foam bubble diameter of about 5 to about 40 μ

m, with at least $0 percent of the bubbles having a diameter of less than 40 μ

m.

8. The pharmaceutical product according to claim 7, wherein said average bubble diameter is about 10 to about 25 μ

m.

9. The pharmaceutical product according to claim 7, wherein said spray is dispensed at a rate of about 0.5 to about 1 g/sec and provides a foam having an initial density of about 0.12 to about 0.2 g/mL when sprayed at a distance of about 5 to about 10 cm from the valve orifice at ambient room temperature.

10. The pharmaceutical product according to claim 7 further comprising a fragrance.

11. The pharmaceutical product according to claim 10, wherein said fragrance is menthol.

12. The pharmaceutical product according to claim 7 further comprising a humectant.