Inhalation Drug Development Services

Inhalation drug development demands a strategic approach to formulation, analytical testing and device selection to meet requirements for pharmaceutical CMC development and regulatory compliance and optimize inhaled drug delivery efficacy, quality, safety and performance. An inhalation route of drug administration presents new and evolving opportunities for the treatment of respiratory diseases including asthma, respiratory infections, chronic obstructive pulmonary disease (COPD) and lung cancer. Furthermore, the field of systemic drug targeting through pulmonary drug delivery is experiencing increased industry focus. However, formulations and devices need to be rationally designed to achieve appropriate aerodynamic properties for effective lung deposition and effective inhalation products.

With 30 years of experience in supporting development of inhaled therapeutics for our global clients, our experts provide formulation development, repurposing or reformulation, product characterisation studies, method development and validation, inhalation product analysis, inhaler testing, device verification testing, in vitro bioequivalence testing, CMC support for NDAs/ANDAs and clinical manufacturing services.

Our expert formulation development scientists have extensive experience in product development across all categories of inhaled products including dry powder formulations and devices, nebulised solutions/suspensions and metered dose inhalation (pMDI) product types, as well as a range of other novel respiratory delivery systems and drug delivery technologies. Our unique project management approach enables you to interact directly with our expert scientists as the development process advances.

With the largest GMP ICH stability storage facility in Europe, we manage all aspects of stability including storage, long-term and accelerated stability across product's development from early preclinical to commercial batch stability. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory expectations.

New Service: Fast to Clinic Formulation Platform for Dry Powder Inhaler (DPI) Products

We offer a “fast to clinic” platform for inhaled medicines, particularly dry powder inhaler (DPI) products, incorporating unique proprietary ‘mSAS®’ (modified Supercritical Anti-Solvent) drug formulation technology from CrystecPharma. The technique enables new forms of molecules to be crystallised and novel particles to be manufactured in ways that greatly enhance their therapeutic performance.
LEARN MORE: Fast to Clinic Formulation Platform for Dry Powder Inhaler (DPI) Products >

In Vitro Test Methods for Nasal Drug Products - Part1 - AINI

Inhalation Drug Product Analysis

• OINDP Product Performance Analysis
• IVBE Studies
• Clinical & Finished Product Release Testing
• Extractables/Leachables
• MDRS Particle Studies

Formulation Development

• Nasal Drug Development
• Formulation Development
• Drug Repurposing for OINDP Administration
• Clinical Materials Manufacturing

Product Development & Characterisation

• Device Compatibility Studies
• Device Verification Testing
• Patient In-use / Misuse Studies

GMP Stability Studies

• ICH & Bespoke Conditions
• Outsourcing Stability
• Temperature Cycling
• Photostability Studies
• Contingency Storage

In Vitro Performance Testing

In Vitro Performance Testing 

• In Vitro Bioequivalence (IVBE) Studies
• Comparator Studies
• Dissolution Testing
• Realistic Flow Profiles

Device Experience

Device Experience

• Pressurized Metered Dose Inhalers (pMDI) 
• Nasal Sprays 
• Dry Powder Inhalers (DPI) 
• Nebulizers, Soft Mist OINDPs

Powder and Particle Morphology Studies

• MDRS Particle Size Studies
• Powder and Particle Characterisation
• Laser Particle and Droplet Sizing
• Sub-visible Particle Determination

Inhaled and Nasal Biologic Drug Development

Strengths in both biologic characterisation (ICH Q6B) and assessment of the delivered dose uniformity from device and particle size of the emitted drug