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The in vitro aerosol performance of two combination dry powder inhaler (DPI) products, Foster® NEXThaler® and Seretide® Diskus® were investigated with single particle aerosol mass spectrometry (SPAMS). The in-vitro pharmaceutical performance is markedly different for both inhalers. Foster® NEXThaler® generates a higher fine particle fraction (FPF <5 μm) and a much higher relative extra fine particle fraction (eFPF <2 μm). In terms of the composition of the aerodynamic particle size distribution (APSD), it could be verified with SPAMS that overall Foster® NEXThaler® emits a significantly higher number of fine and extra fine particles with a median aerodynamic diameter (MAD) of 2.1 μm while Seretide® Diskus® had a larger MAD of 3.1 μm. Additionally, the interactions between the two active pharmaceutical ingredients (APIs) in both products are different. While Seretide® emits a significant (37%) number of co-associated API particles, only a negligible number of co-associated API particles were found in Foster® NEXThaler® (<1%). A major difference with Foster® NEXThaler® is that it contains magnesium stearate (MgSt) as a second excipient besides lactose in a so-called 'dual excipient' platform. The data generated using SPAMS suggested that nearly all of the beclomethasone dipropionate particles in Foster® NEXThaler® also contain MgSt and must therefore be co-associated with this additional excipient. This may help explain why beclomethasone dipropionate in Foster® NEXThaler® forms less particle co-associations with the second API, formoterol fumarate, shows a lower cohesive strength in respect to beclomethasone itself and why both APIs exhibit superior detachment from the carrier as evidenced by the increased eFPF and smaller MAD.
This article was published in the following journal.
Name: International journal of pharmaceutics
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Relating to the size of solids.
A device that delivers medication to the lungs in the form of a dry powder.
Particles of any solid substance, generally under 30 microns in size, often noted as PM30. There is special concern with PM1 which can get down to PULMONARY ALVEOLI and induce MACROPHAGE ACTIVATION and PHAGOCYTOSIS leading to FOREIGN BODY REACTION and LUNG DISEASES.
An analytical technique for measuring particle size of molecules that are less than a micron in diameter dispersed or dissolved in a liquid.
The probability distribution associated with two mutually exclusive outcomes; used to model cumulative incidence rates and prevalence rates. The Bernoulli distribution is a special case of binomial distribution.
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