Abstract
Historically, pharmaceutical aerosols have been employed for the treatment of obstructive airway diseases, such as asthma and chronic obstructive pulmonary disease, but in the past decades their use has been expanded to treat lung infections associated with cystic fibrosis and other respiratory diseases. Tuberculosis (TB) is acquired after inhalation of aerosol droplets containing the bacilli from the cough of infected individuals. Even though TB affects other organs, the lungs are the primary site of infection, which makes the pulmonary route an ideal alternative route to administer vaccines or drug treatments. Optimization of formulations and delivery systems for anti-TB vaccines and drugs, as well as the proper selection of the animal model to evaluate those is of paramount importance if novel vaccines or drug treatments are to be successful. Pharmaceutical aerosols for patient use are generated from metered dose inhalers, nebulizers, and dry powder inhalers (DPIs). In addition to the advantages of providing more efficient delivery of the drug, low cost, and portability, pharmaceutical dry powder aerosols are more stable than inhalable liquid dosage forms and do not require refrigeration. Methods to manufacture dry powders in respirable sizes include micronization, spray drying, and other proprietary technologies. Inhalable dry powders are characterized in terms of their drug content, particle size, and dispersibility to ensure deposition in the appropriate lung region and effective aerosolization from the device. These methods will be illustrated as they were applied for the manufacture and characterization of powders containing anti-tubercular agents and vaccines for pulmonary administration. The influence of formulation, selection of animal model, method of aerosol generation, and administration on the efficacy demonstrated in a given study will be illustrated by the evaluation of pharmaceutical aerosols of anti-TB drugs and vaccines in guinea pigs by our group.
Highlights
Despite being treatable and, preventable, tuberculosis (TB) continues to be a major public health challenge in many parts of the world (Fair et al, 2007)
Perhaps the first documented use of inhaled therapy for TB treatment in humans is the work of Paraf et al in 1953 using liquid aerosols of antibiotics (Paraf et al, 1953), whereas the first use of an inhaled vaccine against TB was reported by Rosenthal et al (1968)
Poly(DL-lactide-co-glycolide) nanoparticles Solid lipid nanoparticles made of stearic acid Nanoparticles made of sodium alginate Poly(lactic acid) microparticles
Summary
Preventable, tuberculosis (TB) continues to be a major public health challenge in many parts of the world (Fair et al, 2007). The number of people infected with TB is growing as reflected by world-wide increases in new cases at an incidence rate of 1.8% per year between 1997 and 2000 (Corbett et al, 2003). The aim was to treat TB infected patients by directly observing them to take their medication (isoniazid, rifampicin, pyrazinamide, and streptomycin or ethambutol or both) for at least the first two months of treatment. This ensured that the medication was taken in the right combinations and appropriate dosage, which has reduced the incidence of multidrug resistant TB. The WHO estimates that the prevalence and death rates have been falling longer and faster than the incidence rate
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