What's happening?

There are several emerging trends set to affect inhalation drug manufacturing. We are seeing increasing use of engineered particles, such as spray drying, rather than traditional micronisation in inhalation formulation development for pressurised metered dose inhalers (pMDIs) and dry powder inhalers (DPIs).

The most crucial factor when creating effective modified release formulations during drug product development is that they must be able to control the release rate of the active pharmaceutical ingredient (API). Excipients that can help facilitate this controlled release effectively are often those that can form thin films as well as tablet matrices.

The global injectable drug delivery devices market is expected to show significant growth in the coming years as manufacturers introduce technological advancements and product innovation meant to improve convenience, compli¬ance, and ease of administration of parenterals.

Controlled substances hold considerable potential as an alternative to opioids for use as painkillers and treatments for certain disorders. However, the regulatory requirements modulating controlled substance manufacturing, analysis, transport, import, and export are complex and challenging to navigate due to their tendency to be used for recreational use. 

Conventional dosage forms such as tablets and capsules remain the preferred dosage form for patients administering their medications at home. However, to overcome specific formulation challenges, including lower bioavailability, frequent application or common side effects, companies are now exploring other dosage forms, such as injectables.

As we have discussed in previous insights, there are several challenges hindering the widespread adoption of self-administration for highly viscous formulations, for example some biopharma treatments.

Thought and foresight into method development stages can ensure costly errors and delays are avoided later. Method development is a critical and continuous process that, if optimised, ensures successful progression of a drug product through its life cycle to commercialisation.

There is a need to adopt more environmentally friendly pMDI propellants, not only to reduce carbon footprint, but also to mitigate supply issues that may result from the decline in the use of existing propellants.

The growing burden of chronic diseases and elevated global awareness of vaccines is leading to a surge in outsourcing formulation development services.

Inhalation products are some of the most complicated and challenging drug dosage forms and are extremely complex to develop and manufacture. It is important to understand potential interactions between the formulation and the delivery device throughout the development stages, as well as when it reaches the end user.