Inhalers are the dominant method of drug delivery to address respiratory conditions. Traditionally, three primary delivery platforms were used to treat respiratory disease: nebulisers, Metered Dose Inhalers (MDIs), and Dry Powder Inhalers (DPIs).
Softhale’s new generation Soft Mist Inhalers provide clear benefits:
- They help the medication pass the natural curve of the throat
- They give users time to naturally breathe in the medication
- They help users get the medication deep into their lungs
Applications across pharmaceutical and non-pharmaceuticals
Our new generation SMI transfers an approved 20th century concept into 21st century concept with its own independent patent position. Softhale’s platform is of value for pharmaceuticals and generic pharmaceuticals considering 505(b) NDA and 505(j) ANDA regulatory pathways; companies with life-cycle management interest, and innovative drug companies who are looking for drug applications via the lung.
The SOFTHALER © has been designed with improvements to existing SMI products but also designed to ensure that the FDA will allow ANDA approvals using the device.
Our product pipeline
Softhale’s SMI devices are technically flexible, allowing the introduction of other active ingredients. The associated increase in spray volume means that a wider drug portfolio as well as increasingly complex formulations are possible. This in turn offers the opportunity to work with a broader range of API candidates with limited solubility and a range of branded product developments. It also makes the SMI devices suitable for other indications which can be treated via the lungs.