Advanced search
Publication Cover
Drug Development and Industrial Pharmacy Volume 35, 2009 - Issue 12
Submit an article Journal homepage
709
Views
32
CrossRef citations to date
0
Altmetric
Original Article

Formulation design and pharmaceutical development of a novel controlled release form of azithromycin for single-dose therapy

Julian B. Lo Pfizer Global R&D, Groton Laboratories, Groton, CT, USACorrespondence[email protected]
,
Leah E. Appel Bend Research Inc., Bend, OR, USA; Green Ridge Consulting, Bend, OR, USA
,
Scott M. Herbig Pfizer Global R&D, Groton Laboratories, Groton, CT, USA
,
Scott B. McCray Bend Research Inc., Bend, OR, USA
&
Avinash G. Thombre Pfizer Global R&D, Groton Laboratories, Groton, CT, USA
Pages 1522-1529 | Received 30 Jan 2009, Accepted 12 May 2009, Published online: 20 Nov 2009

References

  • Luke DR, Foulds G, Cohen SF, Levy B. (1996). Safety, toleration, and pharmacokinetics of intravenous azithromycin. Antimicrob Agents Chemother, 40(11):2577–81.
  • Blumer JL. (2005). Evolution of a new drug formulation: The rationale for high-dose, short-course therapy with azithromycin. Int J Antimicrob Agents, 26(Suppl. 3):S143–7.
  • Curatolo W, Luke D, Foulds G, Friedman H. (1996). Site-specific absorption and toleration of azithromycin. Proc Int Symp Control Rel Bioact Mater, 23:57–58.
  • Sutton SC, Evans LA, Fortner JH, McCarthy JM, Sweeney K. (2006). Dog colonoscopy model for predicting human colon absorption. Pharm Res, 23(7):1554–63.
  • Engelen L, de Wijk RA, van der Bilt A, Prinz JF, Janssen AM, Bosman F. (2005). Relating particles and texture perception. Physiol Behav, 86(1–2):111–7.
  • Thombre AG. (2005). Assessment of the feasibility of oral controlled release in an exploratory development setting. Drug Discov Today, 10(17):1159–66.
  • Trivedi NR, Rajan MG, Johnson JR, Shukla AJ. (2007). Pharmaceutical approaches to preparing pelletized dosage forms using the extrusion-spheronization process. Crit Rev Ther Drug Carrier Syst, 24(1):1–40.
  • Ghebre-Sellassie I, eds. (1994). Multiparticulate oral drug delivery. In: Drugs and the pharmaceutical sciences, vol. 65. New York: Marcel Dekker, Inc.
  • Hincal AA, Kas HS. (1994). Preparation of micropellets by spray congealing. Drugs Pharm Sci, 65:17–34.
  • Hagen TA, Lo JB, Thombre AG, Herbig SM, Appel LE, Crew MD, . (2006). Azithromycin dosage forms with reduced side effects. US Patent No. 6,984,403.
  • Amrol D. (2007). Single-dose azithromycin microsphere formulation: A novel delivery system for antibiotics. Int J Nanomedicine, 2(1):9–12.
  • Chandra R, Liu P, Breen JD, Fisher J, Xie C, LaBadie R, . (2007). Clinical pharmacokinetics and gastrointestinal tolerability of a novel extended-release microsphere formulation of azithromycin. Clin Pharmacokinet, 46(3):247–59.
  • Liu P, Allaudeen H, Chandra R, Phillips K, Jungnik A, Breen JD, . (2007). Comparative pharmacokinetics of azithromycin in serum and white blood cells of healthy subjects receiving a single-dose extended-release regimen versus a 3-day immediate-release regimen. Antimicrob Agents Chemother, 51(1):103–9.
  • Blasi F, Aliberti S, Tarsia P. (2007). Clinical applications of azithromycin microspheres in respiratory tract infections. Int J Nanomedicine, 2(4):551–9.
  • Niederman MS. (2005). Introduction. Int J Antimicrob Agents, 26(Suppl. 3):S141–2.
  • Tatum M, Amsden GW. (2006). Novel, single-dose microsphere formulation of azithromycin extended-release for the treatment of respiratory tract infections. Therapy, 3(3):357–63.
  • Blasi F, Tarsia P. (2005). Value of short-course antimicrobial therapy in community-acquired pneumonia. Int J Antimicrob Agents, 26(Suppl. 3):S148–55.
  • D’Ignazio J, Camere MA, Lewis DE, Jorgensen D, Breen JD. (2005). Novel, single-dose microsphere formulation of azithromycin versus 7-day levofloxacin therapy for treatment of mild to moderate community-acquired pneumonia in adults. Antimicrob Agents Chemother, 49(10):4035–41.
  • Drehobl MA, De Salvo MC, Lewis DE, Breen JD. (2005). Single-dose azithromycin microspheres vs. clarithromycin extended release for the treatment of mild-to-moderate community-acquired pneumonia in adults. Chest, 128(4):2230–7.
  • Swainston HT, Keam SJ. (2007). Azithromycin extended release: A review of its use in the treatment of acute bacterial sinusitis and community-acquired pneumonia in the US. Drugs, 67(5):773–92.
  • Hadley JA. (2005). Value of short-course antimicrobial therapy in acute bacterial rhinosinusitis. Int J Antimicrob Agents, 26(Suppl. 3):S164–9.
  • Murray JJ, Emparanza P, Lesinskas E, Tawadrous M, Breen JD. (2005). Efficacy and safety of a novel, single-dose azithromycin microsphere formulation versus 10 days of levofloxacin for the treatment of acute bacterial sinusitis in adults. Otolaryngol Head Neck Surg, 133(2):194–200.
  • Martinez FJ. (2005). Acute exacerbation of chronic bronchitis: Expanding short-course therapy. Int J Antimicrob Agents, 26(Suppl. 3):S156–63.
  • Baker R. (1987). Controlled release of biologically active Agents. New York: Wiley-Interscience.
  • Masters K. (1979). Spray drying handbook. 3rd ed. New York: Halsted Press.
  • Matsumoto S, Takashima Y. (1976). Drop size characteristics by spinning disk atomizer. Bull. Res. Lab. Nucl. React. (Tokyo Inst. Technol.), 1:85–91.
  • Curatolo WJ, Friedman HL, Korsmeyer RW, LeMott SR. (2000). Controlled release dosage forms of azithromycin. US patent no. 6,068,859.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.