Patent Application
20070286817
In one embodiment of the present invention, there is provided a method of delivering an aerosol medium composition containing an antibiotic via the SWIRLER drug delivery system. The aerosol medium composition may comprise diluents such as sterile water for injection, 0.9% sodium chloride for injection, 5% dextrose for injection, 5% dextrose and 0.9% sodium chloride for injection, 5% dextrose in lactated Ringers for injection, 5% dextrose-0.45% sodium chloride-0.15% potassium chloride for injection or lactated Ringers injection.
In one embodiment, the antibiotic is suspended in the aerosol medium at a particle size range that will meet the subvisible particulate testing acceptance criteria as per USP 788 viz. not more than 600 particles ≧25 microns and not more than 6000 particles ≧10 microns.
In one embodiment, the invention comprises a method of treating respiratory disorders using the SWIRLER drug delivery system to deliver an aerosol containing an antibiotic compound and to reduce the particle size of at least about 95% of the antibiotic droplets in the aerosol to about 1-3 microns or less, thereby allowing the antibiotic aerosol to reach the alveoli of the lung. In another embodiment, at least about 95% of the antibiotic particles is delivered at a particle size of less than 1.1 microns.
This method is useful for treating a respiratory disorder such as, but not limited to, cystic fibrosis.
When used herein, the term “about” shall generally mean within 20 percent.
It will be understood by those with skill in the art that the invention may be performed within a wide and equivalent range of conditions, parameters and the like, without affecting the spirit or scope of the invention or any embodiment thereof.
A drug such as Piperacillin (2 g-4 g lyophilized powder per vial), Tazobactam (0.25 g-0.50 g lyophilized powder per vial), Tygacil (50 mg lyophilized powder per 5 mL vial), or ZOSYN® (2-4 g piperacillin plus 250-500 mg tazobactam), and at least one intravenous diluent, for example but not limited to sterile water for injection, 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, 5% dextrose in Lactated Ringers injection, 5% dextrose-0.45% sodium chloride-0.15% potassium chloride injection or lactated Ringers injection may be administered using a SWIRLER drug delivery system, or an equivalent aerosol delivery system, at a particle size of 95% particles ranging from about 1 to about 3 microns and preferably less than about 1.1 microns to ensure deep lung delivery to the alveolar region of the lungs. Those skilled in the art will readily be capable of determining whether a delivery system is able to provide the aerosol particle sizes of the present invention.
The following examples are presented to illustrate certain embodiments of the present invention, but should not be construed as limiting the scope of this invention.
The commercial Tygacil® 2nd Generation product was used to conduct the study. Sterile Water for injection and 0.9% Normal Saline were used at diluents. Tygacil® is a sterile, lyophilized powder for intravenous infusion, containing 53 mg of the Tigecycline active ingredient. Tygacil® additionally contains lactose monohydrate as a diluent/stabilizer and hydrochloric acid and/or sodium hydroxide (as needed) for pH adjustment. The product is supplied in a single dose; Type I, clear, glass vial, sealed under a blanket of nitrogen with a gray butyl rubber stopper and a snap-off aluminum crimp seal.
aA 6% overage is included to compensate for the non-withdrawable amount of solution after constitution, i.e. solution adhering to the inside wall of the vial.
bAn in-house specification for bacterial endotoxins test is also applied.
cRemoved during lyophilization.
dUsed for sparging and blanketing the bulk solution and as inert cover in the filled vials.
Prior to reconstitution, Tigecycline for Injection is an orange powder or cake. One (1) vial of Tygacil® was reconstituted using 100 ml of 0.9% Sodium Chloride (Normal Saline) or Sterile Water for Injection USP. The Tigecycline powder was allowed to dissolve in the diluents. A clear yellow to orange solution was obtained. The solution was then transferred into the SWIRLER® device. Oxygen was supplied to the SWIRLER® via an NG tube to aerosolize the solution. An oxygen air pressure regulator was used to set the air pressure to 15 CFM. A Malvern MXS, S/N 6196 was used to measure the particle size of the droplets. Results show a high percentage (90%) of the particles are less than 1.1 micron which is the desired size for deep lung delivery. Data are reported in Table 2 below:
Many variations of the present invention not illustrated herein will occur to those skilled in the art. The present invention is not limited to the embodiments illustrated and described herein, but encompasses all the subject matter within the scope of the appended claims.
This application claims priority from co-pending U.S. provisional application No. 60/811,671 filed on Jun. 7, 2006.
| Number | Date | Country | |
|---|---|---|---|
| 60811671 | Jun 2006 | US |
