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.
Development of an X-ray Diffraction Method for the Quantification of API Recrystallized API
Typically, in the development of dry powder inhaler (DPI) formulations the use of a stable crystalline form of the active pharmaceutical ingredient (API) is desired. However, often in order to produce crystalline particles of suitable size for inhalation, micronization processes will be required, resulting in surface amorphous material which may affect the efficacy of the product. If required, additional conditioning/processing steps may then be applied to the API (or to ensure drug product stability under use) without requiring any additional solid state characterization of the API in the drug product.