How do I develop an inhaled drug product?
Quotient is your answer.
Integrated capabilities and expertise for nasal and pulmonary delivery
Our extensive expertise and capabilities for nasal and pulmonary delivery include:
- Pre-formulation and API characterisation
- Formulation and process development
- Inhaled device evaluation and selection
- Clinical manufacturing and supply (Phase I-III)
- Clinical pharmacology assessments
We have a wide range of processing and analytical equipment to support the development and manufacture of inhaled drug products:
- Spray drying
- Blending and encapsulation
- Aerosol characterization
Phase 1/1b study of inhaled formulation in healthy volunteers & asthmatics
PUR1900 is an iSPERSE™ formulation incorporating a large, complex anti-fungal compound that can be administered at high therapeutic dose to the lung while minimizing systemic side effects. Patients with severe asthma and CF are afflicted with ABPA, a complex hypersensitivity reaction that occurs in response to colonization of the airways with Aspergillus fumigatus. This Phase I study was designed to evaluate the safety, tolerability and PK of single and multiple ascending doses of PUR1900 capsules administered as dry powder for inhalation in Part 1 (single ascending dose; SAD) and Part 2 (multiple ascending dose; MAD) respectively, in healthy volunteers.
Inhaled Product Development
With more than 30 years’ experience, Quotient is a leader in the development, manufacture and assessment of inhalation products, helping clients to accelerate molecules from first-in-human through to proof-of-concept.
Application of Translational Pharmaceutics® to reduce time, cost and risk in the early development of inhaled drug products - RDD 2015
The efficiency and effectiveness of new drug development has remained problematic over the last decade. Translational Pharmaceutics has emerged as a new paradigm to improve R&D productivity.
Assessing the Financial Impact of Translational Pharmaceutics®
Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.