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Question

Posted on: March 6 2013

The aim is to treat a patient with an aerosol solution similar to PULMICORT slurry for atomization 2 ml, but with the active ingredient beclomethasone Dipropionate

250 micrograms per 1 à 2 ml. < br/>

Answer

A formula for a solution for inhalation of Beclomethasone Dipropionate (1.25 mg/ml) is described in the American literature. However, it contains 70 ml of ethanol as solvent at a total of 120 ml. The remaining 50 ml consists of physiological serum. Now, you guys are asking a solution that is 10x times weaker. I suspect that the amount of alcohol can be greatly reduced but how strong I don't know. This should be tried out. Maybe 10 ml of alcohol is sufficient. I suppose this small amount of alcohol is not harmful and is tolerated when nebulisation?

An alternative preparation is possible by solubilisation. R/(1) Beclomethasondiprop 12.5 mg; (2) Polysorbate 80 1ml; (3) Ethanol 13ml; (4) Dextrose 5.4 g; (5) NaCl 0.9 g and (6) water (freshly boiled and cooled) up to 100ml. We first prepare a solution of 1 and 2 in 3; and from 4 OR 5 in 50ml of 6. The latter is added under good mixing to the first after which the whole is brought to volume.

I also note that both solutions should be sterile filtered and packaged divided into smaller volumes in pre-sterilized receptacles (see Galenic formularium Pag 133).