Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review

Donald R VanDevanter1, David E Geller21Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, 2Nemours Children’s Clinic, Orlando, FL, USAAbstract: From its introduction, the antibiotic tobramycin has been an important tool in the management of per...

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Autores principales: VanDevanter DR, Geller DE
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Publicado: Dove Medical Press 2011
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spelling oai:doaj.org-article:81eeaeda0656423b9a410505cf45e0302021-12-02T01:18:48ZTobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review1179-1470https://doaj.org/article/81eeaeda0656423b9a410505cf45e0302011-09-01T00:00:00Zhttp://www.dovepress.com/tobramycin-administered-by-the-tobireg-podhalerreg-for-persons-with-cy-a8320https://doaj.org/toc/1179-1470Donald R VanDevanter1, David E Geller21Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, 2Nemours Children’s Clinic, Orlando, FL, USAAbstract: From its introduction, the antibiotic tobramycin has been an important tool in the management of persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infections. Initially an intravenous rescue treatment for pulmonary exacerbations, tobramycin delivered by inhalation has become a mainstay of chronic suppressive CF infection management. Platforms for tobramycin aerosol delivery have steadily improved, with increased lung deposition complimented by decreased device complexities, loaded tobramycin doses, delivery times, and treatment burdens. Most recently, a unique tobramycin inhalation powder (TIP) formulation with a portable delivery system, the TOBI® Podhaler® (Novartis AG, Basel, Switzerland) has been developed and approved in Europe, Canada, and Chile. Four capsules, each containing 28 mg of TIP are successively pierced and inhaled via the T-326 Dry Powder Inhaler Device (Novartis AG, Basel, Switzerland). No external power source is required to deliver an efficacious tobramycin dose in minutes. By comparison, tobramycin inhalation solution (TIS) (TOBI®; Novartis), is delivered by LC® Plus (PARI Respiratory Equipment Inc, Midlothian, VA) jet nebulizer powered by an air compressor over 15–20 minutes. Comparative pharmacokinetics, safety, and efficacy studies of TIS and TIP in CF subjects with P. aeruginosa ≥ 6 years old demonstrate that: tobramycin lung deposition with 112 mg TIP is comparable to that attained with 300 mg TIS, TIP is more effective than placebo and not inferior to TIS with respect to pulmonary function benefit, and TIP has significantly faster treatment times and achieves higher patient satisfaction than TIS. TIP is associated with an increased frequency of mild to moderate local adverse events (cough, dysphonia, and dysgeusia) compared with TIS, however, these become less frequent as subjects gain TIP experience. These results suggest that the TOBI Podhaler may better meet the needs of many CF patients and families by reducing treatment time and complexity and improving patient satisfaction compared with TIS.Keywords: dry powder inhaler, tobramycin, cystic fibrosisVanDevanter DRGeller DEDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2011, Iss default, Pp 179-188 (2011)
institution DOAJ
collection DOAJ
language EN
topic Medical technology
R855-855.5
spellingShingle Medical technology
R855-855.5
VanDevanter DR
Geller DE
Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review
description Donald R VanDevanter1, David E Geller21Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, 2Nemours Children’s Clinic, Orlando, FL, USAAbstract: From its introduction, the antibiotic tobramycin has been an important tool in the management of persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infections. Initially an intravenous rescue treatment for pulmonary exacerbations, tobramycin delivered by inhalation has become a mainstay of chronic suppressive CF infection management. Platforms for tobramycin aerosol delivery have steadily improved, with increased lung deposition complimented by decreased device complexities, loaded tobramycin doses, delivery times, and treatment burdens. Most recently, a unique tobramycin inhalation powder (TIP) formulation with a portable delivery system, the TOBI® Podhaler® (Novartis AG, Basel, Switzerland) has been developed and approved in Europe, Canada, and Chile. Four capsules, each containing 28 mg of TIP are successively pierced and inhaled via the T-326 Dry Powder Inhaler Device (Novartis AG, Basel, Switzerland). No external power source is required to deliver an efficacious tobramycin dose in minutes. By comparison, tobramycin inhalation solution (TIS) (TOBI®; Novartis), is delivered by LC® Plus (PARI Respiratory Equipment Inc, Midlothian, VA) jet nebulizer powered by an air compressor over 15–20 minutes. Comparative pharmacokinetics, safety, and efficacy studies of TIS and TIP in CF subjects with P. aeruginosa ≥ 6 years old demonstrate that: tobramycin lung deposition with 112 mg TIP is comparable to that attained with 300 mg TIS, TIP is more effective than placebo and not inferior to TIS with respect to pulmonary function benefit, and TIP has significantly faster treatment times and achieves higher patient satisfaction than TIS. TIP is associated with an increased frequency of mild to moderate local adverse events (cough, dysphonia, and dysgeusia) compared with TIS, however, these become less frequent as subjects gain TIP experience. These results suggest that the TOBI Podhaler may better meet the needs of many CF patients and families by reducing treatment time and complexity and improving patient satisfaction compared with TIS.Keywords: dry powder inhaler, tobramycin, cystic fibrosis
format article
author VanDevanter DR
Geller DE
author_facet VanDevanter DR
Geller DE
author_sort VanDevanter DR
title Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review
title_short Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review
title_full Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review
title_fullStr Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review
title_full_unstemmed Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review
title_sort tobramycin administered by the tobi® podhaler® for persons with cystic fibrosis: a review
publisher Dove Medical Press
publishDate 2011
url https://doaj.org/article/81eeaeda0656423b9a410505cf45e030
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