with special emphasis on:
- Basic Concepts
- Crystallography
- Advanced Analytical Issues -- Mixtures
- Chemical and Physical Stability
- Regulatory Issues
Dr. Stephen R. Byrn
Scientists from SSCI, a Division of Aptuit
FDA & USPTO representatives (based on availability)
This two-day course is aimed at professionals in the field of pharmaceutical solids who would like to expand their knowledge base. The course provides information which enables faster drug development and quality by design. Presenters will discuss strategic approaches to understanding and predicting the properties and pharmaceutical behavior of solids, as well as the important area of regulatory aspects of pharmaceutical solids including Process Analytical Technologies and risk-based GMPs. Participants will each receive Solid-State Chemistry of Drugs (Byrn, Pfeiffer & Stowell, 2nd Edition) and Crystal Structure Analysis, A Primer (Glusker and Trueblood), as well as a course notebook. The two day course may conclude with a presentation by a senior official from the United States Patent and Trademark Office or European Patent Office and a panel discussion including high-profile patent attorneys in pharmaceutical solids.
The course will consist of two all-day presentations and will meet from 8 am to 5 pm.
The course will address the following questions:
- When are polymorphs important?
- What types of studies are required to characterize polymorphs?
- What information can be gained from single crystal X-ray structure determination?
- What should be done to characterize amorphous solids?
- How can stability and rates of transformation be analyzed and predicted?
- How is the polymorph or hydrate present related to stability?
- What specifications should be set and how can analytical procedures for mixtures of solids be developed and validated?
- What is required in a regulatory submission (Q6A) and how should it be approached?
- How can Process Analytical Technology (PAT) be integrated into a solid-state program?
This fundamental course on pharmaceutical solids provides a fast-paced, cutting-edge overview of the ideas, issues, language, and methodologies of pharmaceutical solid-state research. Professionals from many diverse backgrounds are being recruited into the pharmaceutical industry, including process chemists, engineers, materials scientists, pharmaceutical scientists, and many others. The course will help these professionals integrate more quickly into the pharmaceutical industry and work more effectively as colleagues and managers.
Pharmaceutical Solids: Introduction
Basic Definitions and Introduction
Polymorphs and Hydrates
Amorphous Forms and Water
Role of Solid-State Studies in the Drug Industry
Crystallography
Essential Knowledge: Basic principles, structures, space groups, unit cells, symmetry, crystal packing, computer programs, prediction and calculation of powder patterns
Chirality and Amorphous Structures: Space groups, structures, spontaneous resolution
Emerging Capabilities in Crystal Engineering
Crystallization and Control of Crystallization
Hydrates and Clathrates
Characterization of Hydrates/Solvates
Disorder of Solvent Molecules
Prediction of Hydrate Behavior Based on Structure
Amorphous Forms
Structure, Thermodynamics, and Dynamics
Water Sorption
Assessment of Disorder in Solids
Advanced Analytical Issues and Process Analytical Technology (PAT)
Microscopy
X-ray Powder Diffraction
Calorimetry
Water Analysis
Dissolution Testing and Stability
Thermal Methods
Advanced NMR, IR, and Raman Spectroscopy
Advanced Topics and Regulatory Aspects of Mixture Analysis
Water Sorption Isotherms
Process Analytical Technology and Its Applications in Solids Analysis
Regulatory Issues
Strategic Approaches to Regulatory Considerations
Overviews of Q6A and BACPAC
Setting Specifications
Quality by Design - Risk-Based GMPs
Reducing Time to Market
Chemical and Physical Transformations
Mobility and Physical Transformations of Amorphous Forms
Rates of Water Uptake and Loss from Hydrates
Motion, Chemical Transformations, and Solid-Solid Reactions
Summary and Stability Prediction
To register, please use our registration form. You may also mail or fax in your registration form. Since registration at each session is limited to forty participants, please register early! A course outline and directions to your hotel will be mailed with confirmation of your registration.
The fee includes taxes, luncheons on all days, beverage breaks, books, and course notes. You may pay for the course using a credit card, check, purchase order. Government employees may contact SSCI to ask about discounted fees. Please note that the cost of your hotel room is not included in the course fee. You are responsible for making your own hotel reservations.
For further information, please contact SSCI, a Division of Aptuit:
Telephone: 765-463-0112 / 800-375-2179
Fax: 765-463-4722
SSCI, a Division of Aptuit provides a wide range of research and analytical services focused on pharmaceutical and biopharmaceutical solids. We are experts in the characterization, chemistry, and properties of solid materials. SSCI operates at the forefront of technology in these areas:
- Polymorphism and salt selection studies
- Solid-state analytical research
- Characterization of small molecule and biological solids
- Analysis of drug substance and dosage form
- Verification of sameness for drug substance production and clinical trials
- Production control
- Development of analytical methods and strategies (traditional and on-line)
- Expert services and litigation assistance
All work at SSCI is carried out in strict compliance with cGMP. Rush services are available for analytical and contract research work. For detailed information on SSCI's research, analytical, and consulting capabilities, and for upcoming conference presentations and short courses, visit the SSCI web site: www.ssci-inc.com
Dr. Stephen R. Byrn is Charles B. Jordan Professor at the School of Pharmacy, Purdue University. His research focuses on the solid-state chemistry of drugs and has emphasized the application of new instrumental techniques to pharmaceutical problems. He is a member of the USP Council of Experts and past chair of the FDA pharmaceutical sciences advisory committee. He is also extensively involved in stability studies of solids. Dr. Byrn has broad experience as a consultant in the pharmaceutical industry and is one of the founders of SSCI.