The Science Journal of the American Association for Respiratory Care

1999 OPEN FORUM Abstracts

LEVALBUTEROL HCL (LEV) IS COMPATIBLE WITH IPRATROPIUM BROMIDE (IB) AND CROMOLYN SODIUM (CS): RESULTS OF A MIXING STUDY.

MaryAnn Murphy, RPh, Walter Piskorski, (Charles Eck, PhD. Sepracor, Inc., Marlborough, MA; (Primedica Corp, Cambridge, MA.

Background: Frequently, asthma patients or caregivers administer several medications by co-mixing the products in the nebulizer, despite labeling indicating that there is no data to support this practice. This study was conducted to determine if LEV is compatible when mixed with IP (Atrovent Inhalation Solution) or CS (Intal Inhalation Solution) and if mixing alters the chemical composition of the products. Method: Control samples were prepared, and the concentration of each analyte was determined by diluting and analyzing each individually. Analytes were quantified against standard calibration curves using duplicate injections. Recoveries for the three analytes were 112.9% for LEV, 103% for IP, and 116.2% for CS. Afterwards, one 0.63 mg/3 mL vial of LEV was mixed with one 0.02%/2.5 mL vial of IP or one 20 mg/2 mL ampule of CS. For each combination, six samples of solutions were prepared and stored separately. The first mixture was diluted for analysis immediately after mixing; the other samples were analyzed after being stored at room temperature for 1, 2, 3, 4, and 7 hours (8 hour time point for LEV/CS).

Results: Recoveries for the LEV/IP mixture ranged from 100-102.1% of the LEV control amount and 99.5-104.9% of the IP control amount (Table). Similar findings were noted for the LEV/CS mixture, with LEV recoveries ranging from 97.7-102.8% of control, and CS recoveries of 103-104.9% of control. For both mixtures, no changes in physical appearance were noted, neither chemical mixture was adversely affected by the process of mixing, and the assay content did not change over time. Conclusion: Levalbuterol HCl is compatible with ipratropium bromide or cromolyn sodium inhalation solution formulations when mixed, and the chemical products are not adversely affected by mixing at the time of mixing or for 78 hours after mixing.

Sample time Lev % control* IP % control CS % control
Controlg 112.9 103 116.2
Immediate 102.1; 102.8 102.9 103.1
1 hr 101.3; 99.7 103.9 104.9
2 hr 101; 100.8 100 104.5
3 hr 100; 102 104.9 103
4 hr 101.5; 97.7 99.5 104.2
7/8 hr 100.6; 101.1 102.4 104.2
*Lev recovered in IP mixture; Lev recovered in CS mixture
gPercent control is % label claim

OF-99-103

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