Dry Powder Formulation

Our advanced powder blends have the ability to optimize the delivery of your small molecule or biologic product candidate.

With options for off-the-shelf capsule devices and proprietary unit-dose and multidose platforms, our powder formulation technology has the ability to help at every stage of development.

Whether you’re developing a new chemical entity or looking to match formulations for a generic product, get in touch to see how our integrated approach could support your program.

Dry Powder Formulation: Particle Engineering

With micronization and spray-drying capabilities, particle size and aerosol performance could be optimized based on the needs of your program and the characteristics of the API, for both small molecules and macromolecules, including biologics.

Dry Powder Formulation: Spray Drying

We use spray drying to control particle size, shape, surface chemistry and morphology, particularly for high-dose inhaled products or biologics requiring low-energy processing.

With development and GMP spray-drying capabilities providing batches from 1 g to 10 kg, you can be confident in process scale-up from early development through all clinical phases to small-scale commercialization.

Dry Powder Formulation: Advanced Powder Blending

Enhance the powder flow and aerosolization characteristics of your inhaled formulation using force control agents and our advanced low- and high-shear blending technologies.

Our teams are experienced in handling a variety of molecules with a range of inhaled formulation challenges, including potent drug handling and combining two or more APIs into single-drug products.

Non-aqueous Liquid Formulation for pMDI

All components of a pressurized metered-dose inhaler (drug formulation, propellant, canister, metering valve and actuator) play important roles in the formation of the aerosol, and in determining its drug delivery characteristics to the lung.

With extensive experience in generic and new chemical entity formulation development, we have the ability to help optimize your formulation and device performance to bring your pMDI program to market.

We have particular expertise in:

• Non-aqueous pressurized solutions and suspensions using HFA propellants
• Full API characterization to establish critical parameters to optimize formulation and container closure system
• Seamless formulation scale-up between laboratory, pilot and commercially relevant scale
• Matched API, formulation and in vitro performance to reference listed drug (RLD) for generic programs
• Bridged performance for life-cycle management of existing marketed product

Liquid Formulation for Nebulization

Liquid formulations offer dose flexibility during pre-clinical and clinical development, and nebulized delivery technology may offer benefits to patients in respiratory and non-respiratory disease areas.

Our capability in solution and suspension approaches for small molecules and biologics could help you advance your development program to create new and improved therapies.

We have the ability to help with:

• Aqueous solutions and suspensions optimized for smart nebulizer delivery
• Freeze-dried powders for reconstitution
• Formulation optimization to maximize delivery to the lung, to minimize treatment time or reduce total delivered dose
• Early clinical and blow-fill-seal scale-up for late-phase clinical and commercial manufacturing managed via external partnerships