Speakers
Dr Carol Barbour, UK
Dr Manfred Fischer, Skyepharma (member of Vectura group), Switzerland
Dr Armin Hauk, Sartorius Stedim Biotech GmbH, Germany
Dr Rudi Müller-Walz, Skyepharma (member of Vectura group), Switzerland
Mark Parry, Intertek Melbourn, UK
Objectives
This GMP Education Course on Nasal and Inhalation Drug Products aims at providing delegates with a sound understanding and best practices in the development and analytical quality control of Metered Dose Inhaler (MDI), Dry Powder Inhaler (DPI) and Nasal Drug Products. The course provides a comprehensive overview of the regulatory requirements in Europe and U.S. (Ph.Eur., USP, FDA, and EM(E)A) and shows how all these requirements can be put into practice.
Background
The market for Oral Inhalation and Nasal Drug Products (OINDPs) has become increasingly important and at the same time the number of requirements from regulatory authorities have increased.
Key guidance documents and relevant pharmacopoeial General Chapters are:
FDA Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI), EM(E)A: Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products,
Ph.Eur. 2.9.18, Preparations for Inhalation (Inhalanda), USP <601> Inhalation and Nasal Drug Products: Aerosols, Sprays and Powders-Performance Quality Tests.
Pharmaceutical development based on Quality by Design (QbD) principles is key to achieve inhalation drug products of high reproducible performance. Extensive characterisation of the drug substance and drug product batches is necessary to qualify an inhalation drug product for its intended use - the delivery of the drug substance into the lungs.
Challenging issues in the development and control of inhalation drug products are:
- Physical characterisation of starting materials
- Control of extractables and leachables
- Reproducibility of the delivered dose
- Constant particle size distribution throughout shelf-life
- Patient friendly performance characteristics of the drug produc
The objective of this course is to cover all aspects of development and analytical testing of Inhalation and Nasal Drug Products with a focus on practical examples.
Workshops are an essential part of the course in order to encourage the exchange of experience and to allow interactive and in depth discussion of the subject.
Target Group
This course is dedicated to scientists and managers in the pharmaceutical industry working in
Quality control
Quality assurance
Analytical development
Formulation and process development
Regulatory Affairs
The course is also intended for participants from contract laboratories, regulatory authorities, and inspectorates.
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
- Evolution of regulatory framework
- Guidelines on combination drug products
- Quality by Design in inhalation drug product development
- Container closure systems for MDIs
- Formulation and technologies
- Regulatory considerations
- Differences to inhalation products
- 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
- Current test requirements (USP <601> and Ph. Eur. Inhalanda)
- Key aspects of testing (concentrating on ACI and NGI)
- Proposed future developments
- 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)
- Drug substance requirements and characteristics
- Engineered drug particles
- Functional excipients for inhalation drug products
- Excipients for nebulized and nasal formulations
- Types of spacer device
- Potential challenges with spacers
- Testing required to characterise performance
- Inhaler devices and device components
- Nebuliser technologies
- Device development and medical device aspects
- Device functionality and patient usability
- Basics on Human Factor Engineering
- Formulation of Biologics for Inhaled and Nasal Drug Products
- 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
- 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
- General requirements for generic OIPs
- In-vitro equivalence of the original and generic products
- Development approaches
- Requirements for Drug Product Characterisation Studies: FDA Draft Guidance for Industry for MDIs and DPIs, EMEA 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.
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