Melbourn Scientific provides a rapid formulation screening service for poorly soluble drugs and has been working with its clients to develop formulations that can be used in first-in-human trials.
As proteins and peptides become increasingly common as inhaled drugs, the biotech industry faces the challenge of how to deliver these fragile biomolecules without damaging them.
Trials by Melbourn Scientific have shown that controlled-dose nebulisers might reduce formulation costs and facilitate early-stage efficacy trials.
Nebulisers are often chosen as a delivery mechanism during biotech drug development.
They are less likely to denature proteins and other large molecules and they avoid the cost associated with formulation for dry-powder inhalers.
David Ward, formulation scientist at Melbourn Scientific, said: 'A drug that is only effective over a narrow dose range poses problems when used with a traditional jet nebuliser, because the dose is highly variable depending on the patient's breathing patterns.
'Additionally, the heat generated by the motor can affect the droplet size.
'In early-stage development the drug needs to be accurately delivered, so for some of the most fragile compounds we have been trialling the use a controlled-dose nebulisers to administer an exact dose.
'The nebulisers only deliver a drug during the first 80 per cent of the in-breath, the time over which the drug is deposited in the lungs.
'This can be valuable for accurate dose-range studies,' he added.
Although controlled-dose nebulisers are more expensive than jet nebulisers and may require the supervision of a clinician, they have the added advantage that the quantity of drug received by the patient can be accurately controlled and measured.
For small-scale trials they offer considerable advantages, according to Melbourn Scientific.
Nebulisers create a mist of medicine that can be inhaled passively, and the drug can be delivered as a solution or suspension, which increases the possibilities for formulation.
Nebulisers allow formulation in solution and so overcome some of the challenges of stabilising the drug.
However, fragile APIs can be denatured by traditional jet nebulisers.
The drug is delivered as an aerosol created by a compressor blowing air through the solution or suspension at high speed.
A controlled-dose nebuliser, in contrast, uses vibrating mesh technology, which is much gentler and so less likely to damage the drug.
Melbourn's fast formulation screening service will accelerate the development of nebuliser formulations, which are increasingly favoured for early-stage development.
