Development of Products for Pulmonary Delivery
One of our core approaches is the use of in silico modeling to support formulation design and predict outcomes prior to any experimentation. We use the same technology and fundamental principles in early development as will be used in late stage, allowing us to establish a formulation process around scale-independent parameters and obtain safe, effective and quality products in a lean way.
Leveraging from a collaboration driven relationship with our suppliers, we are in continuous improvement on our formulation strategies. We acknowledge the relevance of choosing the right excipient and capsule from earlier stages. Additionally, we have a close partnership with Hovione Technology, which gives us access to broad range of DPI devices according to target use and dose: from single to multi-use inhalers.
Our state-of-the-art development methodology includes
- Spray drying of carrier free particles for high dosage and biopharmaceuticals
- Particle engineering by jet milling and wet polishing
- High and low shear mixing for standard and high dosage carrier-based formulations
- Precision capsule filling for formulation development and stability studies
- Seamless integration between formulation and device development
Our analytical technologies can support our customers in getting quickly into clinic stages while maximizing chances of success
- Cascade impaction (NGI, ACI, FSI) coupled with biorelevant tools for accurate performance characterization
- Biorelevant dissolution for inhalation products
- Particle surface analysis: raman imaging, specific surface area (by BET and iGC), atomic force microscopy
- Wet and dry particle size method development
- Amorphous content
- Powder rheology
Our commitment: less than 5 months from lab development to cGMP supply.
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