Drug Delivery Systems - June 14-17, 2005 - Belgium
Drug Delivery Systems
June 14-17, 2005
Brussels, Belgium
Workshop A
8:30 AM ? 12:00 PM
Understanding and Achieving GMP and GLP Compliance in a Changing World
Barbara Immel, President, Immel Resources LLC, and Editor, Immel Report
I. FDA and International Requirements
- GMPs and GLPs requirements
- Comparing European and U.S. requirements, including EU Clinical Trial Directive requirements, OECD Principles of GLPs, and U.S. GMPs and GLPs
- Recent FDA inspectional observations and expectations
II. Common Problems
- Common problematic areas
- Smoothing the transition from R&D to clinical and then on to phase III and commercial product
- Inspection preparation tips, and how to become and remain inspection ready
III. Leading an Organization to Compliance
- Strategy, approach, and what you must have in order to succeed
- Training suggestions and ideas
- Internal auditing tips and suggestions
IV. Interactive Exercise
Participants will review and discuss recent FDA 483 observations from GMP inspections, in Europe and the U.S.; Common GLP violations, including identifying root cause(s) and corrective and preventive action; Working with a team, complete a class project and share key findings with overall class
Participants will receive the following bonus information:
- Pertinent regulations and guidance
- Copies of Immel Resources' GMP and GLP articles
- A recent issue of the Immel Report; 101 Great Training Tips
Workshop B
8:30 AM ? 12:00 PM
Design and Development of Self-Emulsifying Drug Delivery Systems (SEDDS) for Enhanced Oral Absorption of Poorly Soluble, Lipophilic Drugs
Ping Gao, Ph.D., Michigan Pharmaceutical Sciences, Pfizer
I. Design and Development of Conventional SEDDS
- Scientific rationale and technical considerations
- In vitro methods for evaluation of the formulation performance
- Key attributes of the SEDDS formulation and their impact on oral bioavailability
- Selection criteria for key excipients (solvent, surfactant, and lipid,) and their impact on oral bioavailability
- The evaluation of manufacturability
II. Design and Evaluation of Supersaturatable SEDDS and Their Utility
- Supersaturation phenomenon and precipitation inhibition
- In vitro test methods for evaluation of supersaturatable formulations
- Case studies of S-SEDDS (Paclitaxel, PNU-91325 and Drug X)
- The drug-polymer interaction
Participants will receive the following bonus information:
- Template examples
- Demos of emulsification and dispersion (multiple examples)
- References on each section
Workshop C
8:30 AM ? 12:00 PM
Strategies for Successful Development and Scale up of Oral Controlled-Release Products
Vishal K. Gupta, Ph.D., Research Manager, Tyco Healthcare
I. Fundamentals of Oral Controlled Release Drug Delivery Systems
- Do commercial landscape, therapeutic and other advantages warrant the need for value-added CR devices?
- Therapeutic and pharmacokinetic differences
- Formulation approaches and drug release mechanisms of controlled release
- Generic industry perspective ? how to circumvent existing patents and be "first to file"
II. Case Study I ? "A HPMC Based Matrix Tablet for 6-8 hrs CR Delivery"
- The formulation, pharmacokinetic, and IP objectives
- Design and development using roller compaction and direct compression
- FDA?s requirement for dissolution testing for CR products
- Understanding the value of pilot clinical study in refining formulation strategy
- The pitfalls when scaling up to manufacturing scale
- Stability and packaging
III. Thinking Out of the Box: A Novel Oral Multi-Particulate, Multi-Layer Bead System
- The unmet medical need for oral site-specific drug delivery systems
- Inherent physiological and formulation challenges and strategies
- Design, development, and optimization of a multi-particulate, multi-layer system
- Physiological relevance based in vitro dissolution method
IV. Use of Compression Coating to Achieve Controlled Release
- Merits and demerits of traditional compression coating
- The concept of "tablet-in-tablet"
- Animation of operating principle
- Demonstration of CR and other applications
V. Interactive Exercise: Practical Considerations in Developing CR Products
A multiple-choice quiz will be given on practical aspects on oral controlled release that would be useful to lab scientists and managers as they develop CR products.
Workshop D
1:30 PM ? 5:00 PM
Lipid Drug Delivery
Hemant N. Joshi, Ph.D., MBA, Associate Director, Barr Laboratories
I. Introduction
- Types of routes of administration
- Types of lipidic DDS
II. Lipid Digestion Process
- Digestion of lipids
- Absorption of drugs from the lipidic DDS
III. Conventional Lipidic DDS
- Types and compositions
- Methods of manufacture
- Analytical issues
- Scale-up issues
IV. Advanced Lipidic DDS
- Microemulsions
- Lipid-coated nanoparticles
- Liposomes
- Cochleate
- Lym-X-Sorb
V. In Vivo Performance of Lipidic DDS
- Food effect upon oral administration
- Role of plasma lipoproteins upon intravenous administration
VI. Interactive Exercise
This interactive exercise will consist of a group discussion, and followed by a presentation by each group.
Workshop E
1:30 PM ? 5:00 PM
Emerging Technologies in Oral Drug Delivery
Avinash Nangia, Ph.D., Vice President , Research and Development, Spherics
I. Newer Oral Drug Delivery Technologies
- Newer oral delivery systems being developed
- Recent development in oral drug delivery technologies
- Update on products based on these technologies
- Commercialization benefits
II. Associated Challenges
- Design challenges with each technology
- Which enabling technology is best suited for your drug
- Osmotic based systems
- Geometric based systems
- Gastro-retentive systems
III. Novel Bioadhesive Polymer Based Systems and Future Opportunities
- Bioadhesive polymers based oral dosage forms and their limited success
- Usage of novel hydrophobic bioadhesive polymers
- Challenging drugs with low and variable bioavailability in a consistent manner
- Understand the basic concept of bioadhesion
IV. Hydrophilic Bioadhesive Polymers
- Why hydrophilic bioadhesive polymers are not effective in the environment of the gastrointestinal tract
- Critical attributes that novel hydrophobic bioadhesive polymers offer
- Proof of concept studies conducted in different models
- Potential applications of novel bioadhesive polymers for systemic and target delivery of Biopharmaceutics Classification System class I to class IV drugs
V. Interactive Exercise
Workshop F
1:30 PM ? 5:00 PM
Successfully Managing the Development and Validation of Drug Delivery Combination Products
Maria E. Donawa, M.D., President, Donawa Consulting Srl
I. Increasing Range and Sophistication of New Drug Delivery Systems
- Unique characteristics of drug delivery systems which will influence development and validation requirements
- Information that should be gathered early in the development program
- What can be done to facilitate project managementII. Application of Design Controls to Manage Development and Validation
- Design controls and how they can be used
- Avoiding preapproval inspection problems
- Important device design verification and validation responsibilities including those of subcontractors
- Design control element that ensures critical device specifications are identified during design and development
II. Application of Design Controls to Manage Development and Validation
? Design controls and how they can be used
? Avoiding preapproval inspection problems
? Important device design verification and validation responsibilities including those of subcontractors
? Design control element that ensures critical device specifications are identified during design and development
III. Regulatory Requirements as a Key Design Input Parameter
- How drug delivery combination products are regulated in the U.S., including new initiatives of the Office of Combination Products
- How drug delivery combination products are regulated in Europe
- Understand that not only U.S. and European regulatory differences may exist, but also that requirements for product specifications may differ
IV. Other Key Design Input Parameters
- Understanding when device quality systems instead of pharmaceutical GMPs apply
- The importance of addressing manufacturing requirements of the drug delivery device during the earliest stages of the project
- Process validation requirements applicable to the drug delivery device
V. Interactive Exercise
Attendees will select a drug delivery combination product from a list of prepared case studies describing the product and its intended use, and list the types of design input requirements applicable to the system, identify the likely regulatory pathway for the product, determine whether quality systems or pharmaceutical GMPs will apply, and describe other required development and validation activities.
Wednesday
8:45 AM
Drug Delivery and Innovation
Lewis Bender, Sr. Vice President, Business Development, Emisphere Technologies, Inc.
While innovation may appear to have slowed in pharmaceuticals, the level of innovation has continued to accelerate in the drug delivery industry. Is this innovation due, in part, to the fact that there are no longer any large, independent leading drug delivery companies, but rather hundreds of small companies focusing on their own unique technologies? The cumbersome, "one-stop-shop" drug delivery business model has not worked well. Rather, it has been nimble, technology focused organizations that are producing unique and interesting innovative solutions for their partners. Can the pharmaceutical industry re-learn how to innovate from the drug delivery industry?
- The state of the levels of innovation in the pharmaceutical and drug delivery industries
- What the trends in drug delivery are with regard to new technologie
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