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
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.
AAPS 2020 Poster - Improving the Stability of a Spray-Dried Peroxide-Susceptible Drug in Tablets
Compound X (Cmp-X) belongs to the class of PDE-5 inhibitors and is a BCS Class II candidate with equilibrium solubility <3 μg/mL, thus exhibiting a dissolution rate limited bioavailability. The purpose of this work is to develop an amorphous solid dispersion (ASD) by spray drying and monitor and improve the physical and chemical stability upon storage for developing a successful solid dosage formulation.