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Science Snippets
Treatments for cystic fibrosis, increasing solubility and bioavailability, and influenza vaccination dosage
Patrick G. Clay
J Am Pharm Assoc (2003) 2013;53:448. doi:10.1331/JAPhA.2013.13528
Cystic fibrosis (CF) is among the deadliest and most treatment-challenging respiratory conditions facing patients and their physicians, so what are pharmaceutical scientists doing to make a difference? They are doing what they do best: using knowledge of medications and chemistry and blending it with physiology and anatomy to create a potential “solution.” Pilcer et al. +1 describe a novel, dried, aerosolized, nanoparticle coformulation of tobramycin and clarithromycin that, in vitro, seems to show great promise in improving pulmonary penetration. The approach of these scientists supports previously published information on the efficacy of combination tobramycin–macrolide efficacy against Pseudomonas pathogens. +2 In addition, a well-written review of the infectious agents found in CF patients bolsters the ingenuity of combination aminoglycoside–macrolide, even in today's CF population. +3 Further, this pathway follows the logic of a review of the state of the science for inhaled antibiotics in that although inhaled antibiotics represent a powerful tool to treat patients with CF, better formulations are needed. +4
Benmore et al. +5 tell a tale of how a novel approach to improve a drug's potential to attain increased solubility and bioavailability is being validated. Amorphous (not Morpheus from The Matrix—that was author Sophia Stewart) drugs offer enhanced solubility and bioavailability. A novel methodology described previously uses a combination of “wizardry” (i.e., use of acoustic levitation) combined with “a lightsaber” (i.e., use of laser heating to generate amorphous and nanocrystalline compounds). This article provides details on the analyses done to ensure that the “new” versions of the “older” medications chemical structure remained stable during the process. The long-term implications could be enhanced formulations of previously intravenous-only medications or substantively altered dosing formulations. In the immortal words of Captain Hikaru Sulu from the bridge of the Enterprise, we will all be “standing by, sir” to see what becomes of this technology.
As pharmacists further expand provision of influenza vaccinations, data continue to emerge on populations that warrant special dosing considerations, such as individuals with HIV. In a study comparing standard (15 μg antigen) and high (60 μg antigen) influenza vaccine doses, seroprotection (defined as >1:4 hemagglutination assay 3–4 weeks postinoculation) against H1N1 and influenza B occurred statistically more frequently in the high-dose arm. +6 These recent data reinforce previously published work +7 and contrast with previous studies that had given multiple doses 1 month apart. Currently, the Centers for Disease Control and Prevention (CDC) recommends a single inoculation of commercially available, inactivated, trivalent influenza vaccine. CDC does not comment on strength. Commercially available high-dose influenza vaccine is approved for adults 65 years or older. Whether the manufacturer is pursuing the additional indication or if CDC will modify its position next influenza season is unknown.
Pilcer G, Rosière R, Traina K, et al.  New co-spray-dried tobramycin nanoparticles-clarithromycin inhaled powder systems for lung infection therapy in cystic fibrosis patients.  J Pharm Sci.  2013; 102( 6): 1836– 46.
 
Tré-Hardy M, Nagant C, Manssouri N El, et al.  Efficacy of the combination of tobramycin and a macrolide in an in vitro Pseudomonas aeruginosa mature biofilm model .  Antimicrob Agents Chemother.  2010; 54( 10): 4409– 15.
 
Lipuma JJ.  The changing microbial epidemiology in cystic fibrosis.  Clin Microbiol Rev.  2010; 23( 2): 299– 323.
 
Ryan G, Jahnke N, Remmington T.  Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.  Cochrane Database Syst Rev.  2012; 12: CD008319.
 
Benmore CJ, Weber JK, Tailor AN, et al.  Structural characterization and aging of glassy pharmaceuticals made using acoustic levitation.  J Pharm Sci.  2013; 102( 4): 1290– 300.
 
McKittrick N, Frank I, Jacobson JM, et al.  Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial.  Ann Intern Med.  2013; 158( 1): 19– 26.
 
Cooper C, Klein M, Walmsley S, et al.  High-level immunogenicity is achieved vaccine with adjuvanted pandemic H1N1 (2009) and improved with booster dosing in a randomized trial of HIV-infected adults.  HIV Clin Trials.  2012; 13( 1): 23– 32.
 
The Science Snippets column highlights research articles published by APhA Academy of Pharmaceutical Research and Sciences (APhA–APRS) and APhA Academy of Pharmacy Practice and Management (APhA–APPM) members in journals other than JAPhA. Members of both Academies are encouraged to forward the PubMed citation or an electronic version of their article, as soon as they appear or ahead of print, to Contributing Editor Patrick G. Clay, PharmD, FCCP, CCTI, at pclay@aphanet.org.

References

Pilcer G, Rosière R, Traina K, et al.  New co-spray-dried tobramycin nanoparticles-clarithromycin inhaled powder systems for lung infection therapy in cystic fibrosis patients.  J Pharm Sci.  2013; 102( 6): 1836– 46.
 
Tré-Hardy M, Nagant C, Manssouri N El, et al.  Efficacy of the combination of tobramycin and a macrolide in an in vitro Pseudomonas aeruginosa mature biofilm model .  Antimicrob Agents Chemother.  2010; 54( 10): 4409– 15.
 
Lipuma JJ.  The changing microbial epidemiology in cystic fibrosis.  Clin Microbiol Rev.  2010; 23( 2): 299– 323.
 
Ryan G, Jahnke N, Remmington T.  Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.  Cochrane Database Syst Rev.  2012; 12: CD008319.
 
Benmore CJ, Weber JK, Tailor AN, et al.  Structural characterization and aging of glassy pharmaceuticals made using acoustic levitation.  J Pharm Sci.  2013; 102( 4): 1290– 300.
 
McKittrick N, Frank I, Jacobson JM, et al.  Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial.  Ann Intern Med.  2013; 158( 1): 19– 26.
 
Cooper C, Klein M, Walmsley S, et al.  High-level immunogenicity is achieved vaccine with adjuvanted pandemic H1N1 (2009) and improved with booster dosing in a randomized trial of HIV-infected adults.  HIV Clin Trials.  2012; 13( 1): 23– 32.
 
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