Technology and Quality of Inhalation Drug Products

Programme

Regulatory Requirements for Respiratory Drugs
Pharmacopoeia requirements
USP <601> Aerosols, Nasal Sprays, Metered Dose Inhalers, and Dry Powder Inhalers
Ph.Eur., Preparation of Inhalation (Inhalanda), 2.9.18 Preparation for Inhalations
Guidance documents
EM(E)A: Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products
FDA: Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products
Specifications for raw materials (APIs and excipients) and components for container closure system (valves, canisters, actuators)
Analytical test methods and specifications for the drug product, U.S. vs. EU
Product characterization studies
Finished product stability

Regulatory Strategy for the Global Respiratory Market
The respiratory market – A global view
Development of OINDPs for the global market in a fragmented regulatory environment
Aspects for a common world-wide regulatory strategy

Good Development Practices for Inhalation Drug Products
Guidelines and evolution of regulatory framework
Quality by Design in inhalation drug product development
Container closure systems
Device development and medical device aspects
Device functionality and patient usability

Extractables / Leachables Assessment for MDI and DPI Devices
The relevance of extractables and leachables testing for MDI and DPI
The strategy for E & L testing for MDI and DPI
Illustrative examples from E & L investigations on MDI and DPI
The evaluation and assessment of E & L data

Requirements for Starting Materials and Device Components
Drug substance requirements and characteristics
Engineered drug particles
Functional excipients for inhalation drug products
Devices and device components

Dose Content Uniformity Test - a Key Method to
Characterize Inhalation Drugs
Basics of the method according to USP <601> and
Ph.Eur. Inhalanda
Challenges in sample preparation
MDIs
DPIs
Testing design and specifications: U.S. vs. EU
Additional requirements of EM(E)A and FDA
guidelines
What is the future for DCU method: Zero tolerance vs. parametric tolerance interval test

Particle Size Distribution and Determination
Current test requirements (USP <601> and Ph. Eur. Inhalanda)
Key aspects of testing (concentrating on ACI and NGI)
Proposed future developments

Nasal and Nebulizer Testing
Requirements for product and performance quality tests
Discussion of the types of testing required from
USP <5> and <601>
Specific requirements for nebulisers (EP 2.9.44)

Product Characterisation Studies
Requirements for Drug Product Characterisation
Studies:
FDA Draft Guidance for Industry for MDIs and DPIs
EMA Guidelines for OINDPs
Specific differences for MDIs and DPIs


WORKSHOP I
Transfer of Inhalation Specific Methods – Dose
Content Uniformity (DCU) and Aerodynamic Particle Size Distribution (APSD)

Transfer of these key methods for the characterization and control of respiratory drugs based on the new USP General Chapter <1224> Transfer of Analytical Procedures
Overcome issues in method transfer considering the human factor in the predominantly manual based sample preparation of both procedures.

WORKSHOP II
Product Characterisation
Discussion of the requirements for drug product characterisation studies, the differences depending on territory and product type.
Examples of how the guidance documents can be interpreted for particular products, and why these studies are important.