Therapeutic microfoam

• US 20040101480A1
• Filed: 01/15/2003
• Published: 05/27/2004
• Est. Priority Date: 05/26/1999
• Status: Abandoned Application

• Current Assignee: BTG International Limited (Boston Scientific Corporation)
• Original Assignee: BTG International Limited (Boston Scientific Corporation)
• Inventors: Shilton-Brown, Sheila B., Wright, David D. I., Osman, Tariq, Harman, Anthony D.
• Application Number:
  US10/342,329
• Publication Number:
  US 20040101480A1
• Time in Patent Office: Days
• US Class Current: 424/9.52
• CPC Class Codes: A61K 31/08 acyclic, e.g. paraformaldehyde
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
• CPC Class Codes: B05B 11/02 Membranes or pistons acting on the contents inside the container, e.g. follower pistons
• CPC Class Codes: B05B 7/0037 including sieves, porous members or the like
• CPC Class Codes: B05B 7/0483 with gas and liquid jets intersecting in the mixing chamber
• CPC Class Codes: B65D 83/14 for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a 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 83/48 Lift valves, e.g. operated by push action B65D83/50 takes precedence
• CPC Class Codes: B65D 83/60 Contents and propellant separated
• CPC Class Codes: B65D 83/62 by membrane, bag, or the like containers in which the content is delivered by the contracting forces inherent in the bag B65D83/0061

Abstract

Improved therapeutic sclerosing microfoams are provided that have advantage in producing a consistent profile injectable foam with minimal input by the physician yet using high volume percentages of blood dispersible gases, thus avoiding use of potentially hazardous amounts of nitrogen.

Claims

1. A microfoam comprising a physiologically acceptable gas that is dispersible in blood and an aqueous sclerosant liquid characterized in that the microfoam has a density of from 0.07 to 0.19 g/cm³ and is capable of being passed down a 21 gauge needle without reverting back to gas and liquid by more than 10%, based on liquid content reverting back to unfoamed liquid phase.

3. A microfoam as claimed in claim 1 or claim 2 characterized in that it has a half-life as measured by drainage through a funnel of 1 cm neck diameter of at least 2 minutes, more preferably 2.5 minutes and most preferably 3 minutes:

4. A microfoam as claimed in any preceding claim characterized in that the gas includes less than 40% v/v nitrogen.

5. A microfoam as claimed in any preceding claim characterized in that the density is from 0.09 to 0.16 g/mL.

6. A microfoam as claimed in any preceding claim characterized in that 50% or more by number of the gas bubbles of at least 25 μ

m diameter are of no more than 120 μ

m diameter and at least 95% of these gas bubbles are of no more than 250 μ

m.

7. A microfoam as claimed in any preceding claim characterized in that it is of density of from 0.11 to 0.14 g/cm³.

8. A microfoam as claimed in any preceding claim characterized in that the gas comprises at least 50% oxygen or carbon dioxide.

9. A microfoam as claimed in any preceding claim characterized in that the sclerosant liquid is aqueous polidocanol or sodium tetradecyl sulfate.

10. A microfoam as claimed in claim 9 characterized in that the sclerosant is aqueous polidocanol, the concentration of polidocanol being is from 0.5 to 4% vol/vol in the liquid.

11. A microfoam as claimed in claim 9 or claim 10 characterized in that sclerosant is made up in water or saline solution.

12. A microfoam as claimed in claim 11 characterized in that the saline is phosphate buffered saline pH 6.0 to pH 8.0.

13. A microfoam as claimed in claim 10, 11 or 12 characterized in that the aqueous solution contains a minor amount of alcohol.

14. A microfoam as claimed in any preceding claim characterized in that it contains 1 to 10% vouvol glycerol.

15. A method of treating a patient in need of sclerotherapy of a blood vessel comprising administering a microfoam as claimed in any preceding claim to that blood vessel.

2. A microfoam comprising a physiologically acceptable gas that is dispersible in blood and an aqueous sclerosant liquid characterized in that the microfoam has a density of from 0.07 to 0.19 g/cm³ and is capable of being passed down a 21 gauge needle such that 50% or more by number of its gas bubbles of at least 25 μ

m remain at 150 μ

m diameter or less and at least 95% of these bubbles at 280 μ

m diameter or less.