Decisions made during the preclinical and early clinical phases of a drug development project can determine the regulatory acceptability of the application to market a new or generic drug. This one-day course provides attendees with an overview of the important steps in the development of a solid oral drug, from the point at which the chemical and polymorphic properties of the active ingredient have been decided to the manufacture of material for early-stage clinical evaluation.
The course focuses on tablet and capsule dosage forms and covers the important steps in formulation, process and analytical development. It also covers options for primary packaging and suggestions for improving product stability in blister and bottle packs. The role of stability evaluation under real-time, accelerated and stress conditions will also be discussed.
Learning Objectives:
- Understand the expectations of regulatory reviewers in relation to solid oral dosage forms
- Be able to judge the acceptability of dissolution methods based on drug release type and API solubility
- Understand the relative benefits and disadvantages of tablet and capsule dosage forms
- Appreciate the significance of important material properties (powder flow, behaviour during compression etc.)
- Understand the role of each component in a formulation and how to evaluate chemical compatibility
- Appreciate the importance of suitable analytical methods during early-stage development
- Know how to choose between direct compression and wet/dry granulation processes for tablet development
- Understand how to evaluate the tabletability of a formulation
- Be able to develop strategies to achieve target release profiles
- Appreciate the reasons and options for film and functional coating
- Be able to design appropriate development stability studies
- Understand the factors affecting the choice of primary packaging
Who will Benefit:
- QA managers and personnel
- Formulation development personnel
- Laboratory managers and analysts
- Production managers and operators
- Project managers
- Regulatory affairs professionals
- Consultants
- 8:30 – 9:00 AM: Registration
- 9:00 AM: Session Start Time
- Module 1 – Regulatory Requirements
- Overview of US and EU requirements for solid oral dosage forms
- Product development and the common technical document
- Types of release
- Biopharmaceutics/developability classification systems
- Module 2 – Formulation and Analytical Development
- Analytical methods required to support product development
- Dissolution method requirements
- Excipient types and roles
- Evaluating excipient compatibility
- Powders and powder flow
- Granules and wet/dry granulation
- Drying
- Tablets and capsules – overview and comparison
- Modified release formulations
- Coating
- Module 3 – Tableting
- Deformation mechanisms of solid materials
- The tableting process
- Direct compression or granulation?
- Tooling options
- Common problems – capping, lamination, sticking and friability
- Hardness and tensile strength
- Scale-up and strain rate sensitivity
- Compaction simulation
- Module 4 – Packaging and Stability Evaluation
- Packaging options for tablets and capsules
- Oxygen and moisture vapour transmission rates of typical materials
- Options for improving stability
- Designing development stability studies
- Stability evaluation – interpreting stress, accelerated and real-time data
Mark Powell
Director, Mark Powell Scientific Limited
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.
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