Nanogram Level In Vitro Dose Proportionality And Stability Of Glycopyrrolate And Formoterol Fumarate In A Novel Cosuspension Metered Dose Inhaler Format

Co-suspension delivery technology in pressurized metered-dose inhalers for multi-drug dosing in the treatment of respiratory diseases

“…Co-suspension delivery technology has been used to combine two bronchodilators, glycopyrrolate and formoterol, in a commercially-approved single pMDI in the United States. Use of this format resulted in consistent, reproducible, dose-proportional drug delivery during various in vitro studies at a wide range of doses for each of these two drugs, achieving comparable doseresponse curves to their respective monotherapy formulations [44]. In vitro dose-ranging studies have also demonstrated the ability of this technology to formulate nanogram-level doses of medications without interfering with drug performance [44].…”

“…Co-suspension delivery technology may overcome many of the technical challenges associated with pMDI suspension formulations (Table 3) [21,24,25,41e46]. This technology combines multiple drugs into a single pMDI with reduced potential for drugedrug co-formulation interactions, while maintaining suspension uniformity, physicochemical stability, and consistent drug delivery at both delivered dose and aerosolization levels [44,45]. As more patients are being treated with drug combinations, co-suspension delivery technology provides a means to deliver multiple drugs from a single pMDI while maintaining drug delivery similar to the individual drug pMDIs.…”

“…Use of this format resulted in consistent, reproducible, dose-proportional drug delivery during various in vitro studies at a wide range of doses for each of these two drugs, achieving comparable doseresponse curves to their respective monotherapy formulations [44]. In vitro dose-ranging studies have also demonstrated the ability of this technology to formulate nanogram-level doses of medications without interfering with drug performance [44]. This allowed for a wide range of doses to be tested in clinical trials, providing full dose-response characterization, and eliminating confounding of clinical assessments by drug delivery differences.…”