Inhaled formulation and device selection: bridging the gap between preclinical species and first-in-human studies.

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery
• Respiratory Medicine

Background:

• Factors influencing inhaled first-in-human (FIH) device and formulation selection differ from preclinical stages.
• Delivery issues can negatively impact respiratory pipeline programs.
• A holistic approach is needed to align preclinical and FIH delivery systems.

Purpose of the Study:

• To provide a scientific strategy for bridging the gap between preclinical and human inhaled drug delivery.
• To discuss considerations for FIH device selection (MDI, DPI, nebulizer) and formulation optimization.
• To highlight examples of successful preclinical to human delivery transitions.

Main Methods:

• Review of factors influencing inhaled device and formulation selection.
• Analysis of preclinical versus FIH delivery system considerations.
• Case studies illustrating scientific strategy for preclinical to human delivery.

Main Results:

• Preclinical and FIH delivery considerations are often misaligned.
• A holistic strategy is crucial for successful inhaled product development.
• Appropriate scientific strategy can mitigate risks associated with delivery challenges.

Conclusions:

• Integrating preclinical and FIH delivery strategies minimizes risks in respiratory drug development.
• Careful selection of inhaled devices (MDI, DPI, nebulizer) and formulation optimization are key.
• Holistic planning ensures a smoother transition from preclinical studies to human trials.