Pathway of Construction and Characterization of a Salbutamol Sulphate HFA152a pMDI Suspension
Giulia Carretta1, Caterina Antiga1, Alberto Colombo2, Giovanni Motta2, Massimo Carrara2, Francesca Buttini1
1 Food and Drug Department, University of Parma, Parco Area delle Scienze 27/A, 43124 Parma, Italy.
2 RxPack s.r.l, Via Mognago 47, 23848, Oggiono (LC), Italy.
Summary
The work illustrates the development of a suspension of Salbutamol Sulphate (SS) in HFA152a using an open chamber design valve manufactured by RxPack, commercially known as KHFA. Ethanol was used as a co-solvent and the product target dose was 122 µg of SS (corresponding to 100 µg/shot of salbutamol base). The object of this work was not to make a product copy of the Ventolin® but to develop a good performing product and to be aware of how each factor investigated affects the performance of the system.
Preliminary studies were conducted with a full factorial DoE evaluating the impact of Critical Material Attributes (CMAs), such as ethanol content, valve metering volume, and actuator orifice diameter (AOD), on the critical quality attributes of the products in terms of Emitted Dose (ED) and Fine Particle Fraction (FPF). These initial studies led to identify the lead product consisting of: 50 µL valve, 0.3 mm AOD and 6% ethanol content. The lead product proves to have good respirability thus obtaining FPF values of 45.5% and MMAD of 2.55 µm. So, in conclusion, always paying attention to respecting both the environment (e.g. by making more sustainable choices that lead to less use of propellant and ethanol), and the characteristics that make an inhalation product effective, it is possible to obtain a pMDI with good inhalation characteristics using this new eco-friendly propellant HFA152a.