How can we minimise time-to-market for inhalation drugs?
Asthma and chronic obstructive pulmonary disease (COPD) are some of the greatest challenges facing global health services, requiring a new generation of more effective treatments.
Pulmonary drug delivery is increasingly seen as an ideal way to tackle these respiratory diseases. This is largely because they are non-invasive, compared with other treatments, and easy to administer, increasing patient compliance and reducing pressure on healthcare professionals.
CDMOs can tailor their services to meet a project’s unique requirements and minimise time-to-market.
However, despite their advantages, these inhalation drugs pose challenges for drug developers that they need to overcome if they want to serve this market and deliver an effective treatment within a short timeframe.
Developing an inhalation drug is expensive, due to the need to design a delivery system for the treatment as well as the active pharmaceutical ingredient (API), meaning considerable funding is needed to deliver a new product successfully. This may not be an issue for larger companies, but it can be daunting for start-ups.
When formulating their drugs, manufacturers must ensure they choose the right dosage form for their target – such as a nebuliser, a dry powder inhaler (DPI) or a metered dose inhaler (MDI).
DPIs are often a popular choice for manufacturers as they are relatively straightforward for patients to use compared with the other options. When it comes to making them, the formulation can be produced as a solid-dose, then simply filled into a capsule. DPIs offer two medical device options, including the capsule design or a reservoir-filled approach. MDIs, on the other hand, tend to be more standardised in design and, therefore, more cost-effective to produce.
Whatever the chosen design, manufacturers must be able to demonstrate to regulators that their device doesn’t adversely affect the drug formulation. Many companies fall into the trap in early phase development of focusing on perfecting the formulation without considering the delivery device at the same time. This means that, on entering Phase III and introducing the device for the first time, they begin to run into obstacles that lead to costly delays.
Expert CDMO support
Taking this complexity into account, it is clear that drug developers may need expert support to help them deliver a successful new inhalation product. CDMOs can provide this specialist guidance, offering the expertise needed to bring a product to proof-of-concept, or to take it to market as quickly as possible.
CDMOs can tailor their services to meet a project’s unique requirements and minimise time-to-market. For instance, a generics company developing a generic MDI product may want a bio-equivalence study, tech transfer and manufacturing all within a short timeframe. A CDMO can provide the personnel and line capacity to deliver this. A company might have the in-house capacity to develop their product, but not to manufacture it, or it may be the case they have the space for production but don’t have the expertise to develop the drug. Working with a CDMO means pharmaceutical companies can select the right services for their needs.
When selecting a CDMO, the drug developer should request a complete overview of its inhalation experience including information relating to extractable and leachable (E&L) and analytical services. This is all vital for risk management and can help provide reassurance that the partner can manage any challenges in the development project. Inhalation products also require specific equipment, such as NGIs and Anderson testers, so it’s important to check that the CDMO has this equipment available.
Drug developers should also review their CDMO’s global regulatory expertise for inhalation drugs – having a partner that can support in navigating the compliance landscape can go a long way towards smoothing the path to approval and minimising time-to-market.
Support in streamlining inhalation drug development
Given the usability of inhalation drugs, combined with the enhanced effectiveness of pulmonary administration for many conditions, it is likely we will see many more such products reach the market in the coming years.
By working with a CDMO that has a pedigree in this space, inhalation drug developers can ensure they benefit from this boom.
To find out more about the effective development of inhalation drug products, read this European Pharmaceutical Manufacturer article, Inhalation drug development: techniques to reduce time to market.
You can also learn about Recipharm Inhalation Solutions™ here.
Alternatively, you can contact our expert team here.