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Low Variability Lung Delivery of Drugs: Novel Delivery Technology and Compliance Studies with Low Molecular Weight Heparin and Antibiotics

Scheuch G, Fischer A, Muellinger B, Zimlich WC.

Respiratory Drug Delivery 2008. Volume 1, 2008: 57-64.

Abstract:

When developing a drug for pulmonary delivery many variables need to be considered. Excessive inter-subject variability of the lung dose is just one of the variables that can “make or break” a development program. Variability in lung dose between patients arises from differences in breathing pattern, mouth/throat anatomy and lung morphology, and compliance / adherence with inhaled therapy. These three parameters are not factors of the device or of aerosol production, but are a function of or created by the individual patient utilizing the aerosol delivery system. Patient compliance is an especially important factor during clinical studies assessing the clinical effect of a treatment. Furthermore, patients who do not adhere to the administration regimen for a prescribed drug at home may add additional costs for the health care system when the lack of treatment leads to hospitalization. This paper discusses the use of the AKITA technology for controlled inhalation in two clinical trials. It was shown that AKITA minimizes variability in inhalation treatment as well as it provides an adherence measurement tool to assess patients’ behaviours towards self-administration of a therapeutic aerosol in the home-setting.