Tobramycin inhalation powder: a review of its use in the treatment of chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis.

PMID 24194436


Inhaled tobramycin, an aminoglycoside antibacterial, has been in widespread use in the form of a nebulized solution against Pseudomonas aeruginosa for many years. More recently, tobramycin inhalation powder (TIP; TOBI(®) Podhaler(™)) was formulated using PulmoSphere(™) technology for administration as a dry powder via the T-326 Inhaler. This technology enables the administration of an intrapulmonary drug dose that is similar to that achieved with nebulized tobramycin inhalation solution (TIS), but reduces the administration time for TIP to one-third of that for TIS. TIP is approved in several countries, including the EU and US, for use in cystic fibrosis (CF) patients aged ≥6 years with P. aeruginosa infection. In well designed clinical trials in CF patients, the antipseudomonal efficacy of intermittent twice-daily TIP 112 mg was greater than that of placebo in one trial (a second trial was unable to recruit sufficient patient numbers for meaningful analyses), and non-inferior to that of intermittent twice-daily nebulized TIS 300 mg/5 mL with regard to lung function and sputum density of P. aeruginosa. In addition, patients using TIP were more satisfied with their treatment than those using nebulized TIS, largely as a result of improved overall convenience. TIP is generally well tolerated, with a similar safety profile to that of TIS, except for a higher incidence of cough. In conclusion, TIP administered via the T-326 Inhaler is an effective antipseudomonal agent with non-inferior efficacy and generally similar tolerability to that of nebulized TIS in CF patients with chronic P. aeruginosa infection. Compared with nebulized TIS, TIP has a faster delivery and is more portable and convenient.

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Tobramycin for identification, European Pharmacopoeia (EP) Reference Standard