Dornase alpha

Shire, S. J. (1996), Stability, characterization and formulation of recombinant human deoxyribonuclease (Pulmozyme , Dornase Alpha), in Pearlman, R., and Wang, Y. J. Eds., Formulation, Characterization and Stability of Protein Drugs, Plenum Press, New York, pp. 393 126. 

Dornase alpha Recombinant enzyme Pulmozyme (rhDNAse)... 

Duma.se alpha is indicated for the treatment of cystic fibrosis in conjunction with other available therapies, such as antibiotics, brunchodilators, and corticosteroids. Adult dosage is 2.S mg inhaled once daily, administered via a recommended nebulizer. Dornase alpha. should not be mixed or diluted with other agents in the nebulizer becau.se of the possibility of adverse physicochemical changes that may affect activity. Common adverse effects include sure throat. hoarsene.s.s. and facial edema. 

Dornase alpha, rhDNase, a glycoprotein that contains 260 amino acids with an approximate MW of 37,000 Da. 

The aqueous solution contains 1.0 mg/mL of dornase alpha, 0.15 mg/mL of calcium chloride dihydrate, and 8.77 mg/mL of sodium chloride. The solution contains no preservative. The nominal pH of the solution is 6.3 and is used as nebulizer. 

The only U.S. FDA-approved DNase product, Dornase alpha (inhalation solution), has been developed as a therapeutic agent for the management of CF. The product is supplied in single-use ampules delivering 2.5 ml of a sterile, clear, colorless solution containing 1.0 mg/ml of dornase alpha with no preservative. Administration is by nebulizer aerosol delivery systems. 

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