2005 OPEN FORUM Abstracts
FINE PARTICLE DELIVERY OF LEVALBUTEROL IS SUBSTANTIALLY COMPARABLE FROM VALVED HOLDING CHAMBERS (VHCs), ONE OF WHICH IS MANUFACTURED FROM A TRANSPARENT, BUT ELECTROSTATIC CHARGE DISSIPATIVE POLYMER
Jolyon P. Mitchell Ph.D, Kimberly J. Wiersema B.A., Cathy C. Doyle B.Sc, Mark W. Nagel HB.Sc, Trudell Medical Aerosol Laboratory, London, Canada, and Dominic P Coppolo RRT, Monaghan Medical Corp., Syracuse, NY, USA
Xopenex HFAT (45 µg/actuation levalbuterol tartrate ex actuator) inhalation aerosol (Sepracor Inc., Marlborough, MA, USA), is a recently approved hydrofluoroalkane (HFA) formulation for delivery by pressurized metered-dose inhaler (pMDI) for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease. VHCs are prescribed for patients that have difficulty coordinating pressurized metered-dose pMDI use, but those made from conventional polymers are susceptible to accumulation of electrostatic charge during manufacture. Whereas such charge can be minimized by pre-washing with ionic detergent, it may be desirable to be able to use the product straight from the packaging without pre-treatment, especially in the case of an acute exacerbation. We report a study in which two VHCs (AeroChamber Plus® and AeroChamber Max® with mouthpiece, Monaghan Medical Corp., Plattsburgh, NY (n=10 devices/group)) were evaluated with Xopenex HFA. Both VHCs were pre-washed, rinsed and drip-dried before testing in accordance with the manufacturer's instructions. The AeroChamber Max VHC is manufactured from charge dissipative materials, and was therefore also evaluated without pre-washing. Measurements were made at 28.3 L/min ± 5% by Andersen 8-stage cascade impactor equipped with USP induction port in accordance with the procedure in < 601> of the US Pharmacopeia. 10-actuations of medication were delivered via the VHC on test, and the mass of levalbuterol collecting in the induction port and on each stage of the impactor was subsequently assayed by HPLC-UV spectrophotometry. Fine particle mass (particles < 4.7 µm aerodynamic diameter), considered most likely to penetrate to the airways of the lungs, was 28.8 ± 2.4 µg, 33.5 ± 1.5 and 36.5 ± 1.0 µg for the AeroChamber Plus (pre-washed), AeroChamber Max (pre-washed) and AeroChamber Max (no pretreatment) VHCs respectively. Although small differences existed between these results, they are unlikely to be of clinical significance given the inter-patient variability seen with inhaled drug delivery (1). The performance of the AeroChamber Max VHC was substantially comparable whether or not the devices were pre-washed.
(1) Cripps,A.; Riebe,M.; Schulze,M. et al., Respir Med. 2000; 94Suppl.B:3-9.
Name and Credentials: Mr. Dominic P. Coppolo RRT
Mailing Address: Monaghan Medical Corp., 102 West Division St., Suite 300, Syracuse, NY 13204, USA
Voice Phone & Fax: Voice: -472-2136, Fax: -472-1924
(if different from presenter): Dr. Jolyon P. Mitchell Ph.D
Mailing Address: Trudell Medical International, 725 Third St., London, Ontario, Canada, N5V 5G4
Voice Phone & Fax: Voice: -455-7060 ext. 2206, Fax: -455-9053