Science & Research

Pharmacokinetic Comparison of Locally Acting Orally Inhaled Drug Products

Principal Investigator: Jurgen B. Bulitta, Ph.D.

Performer: University of Florida College of Pharmacy

Project Duration: 09/22/2016 – 03/20/2018

Regulatory Science Challenge:

Asthma and other diseases of the respiratory tract are common chronic diseases which significantly affect the quality of patients’ life and have a substantial economic impact. As the prevalence of these chronic diseases is continuously rising, there is an urgent need for cost-effective generic inhalation drug products to reduce the financial burden of effective and safe asthma medications. Consequently, there is a need to develop and incorporate new scientific approaches into regulatory guidance documents for Orally Inhaled Drug Products (OIDPs), and such development will in turn support the FDA in assessing and revaluating these products.

The FDA seeks to assess whether pharmacokinetic (PK) studies can answer three important questions pertaining to local bioequivalence of inhalation drug products:

  1. Is the dose available to the lung equivalent?
  2. Is the pulmonary residence time equivalent?
  3. Is the central to peripheral drug deposition ratio equivalent?

It is generally accepted that the first two questions can be answered by PK studies (especially for drugs whose oral absorption is negligible or blocked). In the present project, the third question will be the primary focus—namely, whether PK studies can differentiate between formulations (generic vs innovator product) that differ in the central to peripheral drug deposition ratio in the lung.

Project Description & Goals:

This work will address an important scientific gap by testing whether 1) PK studies can detect differences in the regional deposition (i.e. c/p drug deposition ratio) and 2) evaluate whether the PK parameters affected by differences in regional deposition are due to the physicochemical drug properties.

There are three major aims for this study:

  • Develop dry powder drug/lactose blends that differ in the central to peripheral deposition ratio. Fully characterize the blends through relevant in vitro tests. Ensure that the drug characteristics of both blends are similar so that the PK is only affected by differences in the deposition ratio
  • Produce dry powder inhaler devices under GMP conditions and obtain an investigator-initiated IND
  • Perform pharmacokinetic studies in healthy volunteers to evaluate the impact of the c/p deposition ratio on the drug exposure




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