Respisolv – pressurised metered dose inhaler (pMDI) formulation for respiratory drug delivery.

Pharmaterials are pleased to announce the launch of Respisolv, which is a technology for stabilisation of pressurised metered dose inhaler (pMDI) formulations of both low molecular weight and macromolecular APIs.

pMDIs are the most widely prescribed devices for pulmonary drug delivery. In these devices, propellants provide the energy for aerosolization of the drug formulation into respirable particles. Non-ozone depleting hydroflourocarbon (HFAs) propellants, i.e. HFA-134a and HFA-227ea, have now replaced ozone depleting chlorofluorocarbon (CFC) propellants. Due to different physical properties between CFCs and HFAs, e.g. higher polarity of the HFA-propellants, a direct substitution into existing pMDIs has proved to be difficult leading to the uses of less favourable co-solvent systems. The most widely used co-solvent for such formulations is ethanol.

Pharmaterials’ Respisolv technology uses a range of naturally occurring additives which have been shown to be soluble in HFAs. Traditionally, they are used as flavouring substances in the food industry and they are generally recognised as safe (“GRAS”). They are rapidly absorbed, detoxified, and excreted in man. No adverse effects have been reported and they lack a significant carcinogenicity, genotoxic and mutagenic potential.

The Respisolv additives can be used instead of ethanol and/or surfactants in suspension pMDI formulations. In our formulations, it has been demonstrated that drug particles do not exhibit growth in particle size during storage, are easily re-dispersed and do not flocculate so quickly as to prevent reproducible dosing of the drug. The additives can also act as lubricants to metering valves and this can significantly reduce blocking of the valves during operation.

Pharmaterials’ broad knowledge of inhalation product design and development means that it is best placed to offer comprehensive inhalation product development service to customers.

Pharmaterials are ready to assist you with your pMDI formulation and to discuss the benefits of the Respisolv technology.

Please contact us for more details.