Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|Title:||Solid nedocromil sodium, useful for the removal of obstructed air pathways|
|Abstract:||There are described new forms of nedocromil sodium, methods of producing these new forms and pharmaceutical formulations, especially pressurized inhalation aerosol formulations, containing finely divided nedocromil sodium. The formulations are indicated for the treatment of reversible obstructive conditions of the airways.|
|Inventor(s):||Brown; Kenneth (Loughborough, GB2), Clark; Andrew R. (Loughborough, GB2), Salliss; Richard (Holmes Chapel, GB2)|
|Assignee:||Fisons, plc (Ipswich, GB2)|
1. Solid nedocromil sodium which is cystalline and which contains bound water as determined by thermogravimetric analysis.
2. Solid nedocromil sodium according to claim 1 containing between 3.0 and 4.0% w/w bound water.
3. Solid nedocromil sodium according to claim 1 containing 3.5% bound water.
4. Nedocromil sodium according to claim 2 in powder form and having a Lovibond yellow reading of below 2.0 when containing 10% w/w water.
5. Nedocromil sodium according to claim 4 having a Lovibond yellow reading of between 0.8 and 1.8.
6. Nedocromil sodium according to claim 1, wherein the powder X-ray diffraction pattern shows that the material is crystalline.
7. Nedocromil sodium according to claim 1 whose infra-red spectrum shows a shoulder at 3500 cms.sup.-1 when its total water content is 10% w/w.
8. An inhalation formulation for treatment of a reversible obstructive condition of the airways comprising a pharmaceutically acceptable liquefied gas propellant containing nedocromil sodium according to claim 1 having a mass median diameter of less than 4 microns in a proportion which is effective for treatment of said condition.
9. A formulation according to claim 8, wherein not more than 5% by weight of the particles has a diameter of greater than 10 microns and not less than 90% by weight of the particles has a diameter of less than 6 microns.
10. A formulation according to claim 8, containing from 0.5 to 10% by weight of finely divided nedocromil sodium.
11. A formulation according to claim 8 comprising a mixture of propellants 12 and 114, the proportion of propellant 12 to 114 being in the range 2 to 1:1 by weight.
12. A formulation according to claim 11 containing sorbitan trioleate.
13. Nedocromil sodium in accordance with claim 1 the form of needles having a breadth of 1.5 to 3.5 microns and a length to breadth ratio of up to 10:1.
14. Nedocromil sodium according to claim 13 having a breadth of 1.5 to 2.5 microns.
15. A method of treatment of a reversible obstructive condition of the airways in a mammal which comprises administering by inhalation an effective amount of solid nedocromil sodium according to claim 1 to a mammal suffering from said condition.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.