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Compatibility of arformoterol tartrate inhalation solution with three nebulized drugs
Phil Bonasia1, Carrie Cook, Yufei Cheng
1Sepracor Inc., Marlborough, MA 01752, USA.
Objective:
Arformoterol tartrate inhalation solution (15 microg/2 mL) is approved for the twice-daily, long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary diseases (COPD). This study assessed the chemical and physical compatibility of arformoterol (15 microg/2 mL) with ipratropium bromide (0.5 mg/2.5 mL), acetylcysteine (800 mg/4 mL), and budesonide (0.25 mg/2 mL and 0.5 mg/2 mL).
Methods:
Immediately (T(0)) and 30 min (T(30)) after preparation, the admixtures were tested by visual inspection, pH measurement, and HPLC assay of each active component.
Results:
For all admixtures, no visible signs of change were observed. The pH of all admixtures at T(0) ranged from 4.82 to 6.40, which was within the range of individual drugs. For all admixtures, no unacceptable changes (less than 1% or 0.1 pH unit) in the pH values were observed within 30 min compared with the initial pH values in the admixtures, which met acceptance criteria of not more than (NMT) 10.0%. At both T(0) and T(30), the assay of each active component in all admixtures ranged from 98.3% to 101.4% compared to the assay in control samples, which met acceptance criteria of NMT 10.0%. In addition, no changes (less than 8%) in the assay of each active component at T(30) were observed compared to the initial assay values, which met acceptance criteria of NMT 10.0%. This study did not evaluate the clinical efficacy or safety of mixing arformoterol in patients. Nor did the study assess the aerosol characteristics of these admixtures or any potential changes in drug output.
Conclusion:
The results demonstrated that arformoterol was chemically and physically compatible with commercially available nebulized formulations of ipratropium bromide, acetylcysteine, and budesonide.
Insights
Arformoterol tartrate is chemically and physically compatible with common nebulized COPD medications like ipratropium bromide, acetylcysteine, and budesonide. This finding supports potential combination therapies for chronic obstructive pulmonary disease (COPD) management.
Area of Science:
- Pharmaceutical Sciences
- Respiratory Medicine
- Drug Compatibility Studies
Background:
- Arformoterol tartrate is a long-acting beta-agonist used for chronic obstructive pulmonary disease (COPD).
- Nebulized combination therapies are increasingly explored for COPD management to improve patient adherence and treatment efficacy.
- Assessing the compatibility of arformoterol with other commonly prescribed nebulized medications is crucial for safe and effective co-administration.
Purpose of the Study:
- To evaluate the chemical and physical compatibility of arformoterol tartrate inhalation solution with ipratropium bromide, acetylcysteine, and budesonide.
- To determine if mixing arformoterol with these agents affects their stability or physical properties over a short timeframe.
Main Methods:
- Arformoterol admixtures with ipratropium bromide, acetylcysteine, and budesonide were prepared.
- Compatibility was assessed via visual inspection, pH measurement, and High-Performance Liquid Chromatography (HPLC) assay at immediately after preparation (T(0)) and 30 minutes (T(30)).
Main Results:
- No visible changes were observed in any of the admixtures.
- pH values remained within acceptable ranges and showed no significant changes within 30 minutes.
- HPLC assays confirmed that the concentration of each active component remained within 98.3% to 101.4% of control values, meeting acceptance criteria.
Conclusions:
- Arformoterol tartrate is chemically and physically compatible with nebulized ipratropium bromide, acetylcysteine, and budesonide.
- These findings suggest that arformoterol can be safely mixed with these common nebulized medications for short-term co-administration in COPD patients.
- Further studies are needed to assess clinical efficacy, safety, and aerosol characteristics of these admixtures.
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