Dissolution
Testing in Pharmaceutical Analysis
Best Practices and Emerging Trends in Development,
Validation, & Automation
A Two-Day Comprehensive and Interactive Conference,
with Case Studies, Workshop and Exhibition addressing:
- Regulatory and Registration Requirements for
Dissolution Testing
- Update on Current Harmonization Process
- Role of Dissolution in regulatory submissions
and post approval stage
- Dissolution Testing from Pharmacopoeial Perspectives
- High Performance Dissolution Method Development
Strategies
- Validation of Dissolution Methods and Method
Transfer
- Impact of API property on dissolution method
development
- Control of Convective Diffusion Properties
- Hydrodynamic, Media and Flow Considerations
- Automation and Software
- Instrumental and Automation Design Considerations
- Performance Verification Test of Dissolution
Test Equipment
- Dissolution Profile Comparison
- Investigating OOS Results in Dissolution
Testing
- Setting Specifications
- Factors that Determine the Robustness of
Dissolution method
- Developing a Method Validation Protocol
- Applying a Design of Experiment (DOE) Approach
Distinguished Course Leaders
Mr. Samir Haddouchi
Project Manager, SPS Pharma
Services
Clermont Ferrand - France
Prior to joining SPS Pharma Services in 2005, Samir spent more than 10 years in the industry. As a chemist, he started working on the analytical development of agrochemical compounds at Sandoz Agro. During the Novartis merger reorganization, he moved to Orléans (France) in 1998 to join the analytical group in the technical development department where he became responsible for dissolution. Since he joined SPS Pharma Services, Samir manages SPS facilities in Clermont Ferrand (France) and is in charge of projects management.
 Dr.
Jianmei Kochling Scientific Associate Director,
Analytical R&D
Genzyme Corporation
Dr. Kochling is currently a Scientific Associate
Director of Analytical R&D, Drug and Biomaterial
R&D at Genzyme Corporation. She leads
her analytical teams in support of chemical
process and formulation development for multiple
drug programs. Her most recent research interest
involves infusing advanced technologies into
traditional analytical development activities.
For example, implementing statistical design
of experiments for HPLC and dissolution methods
development; exploring the use of the GastroPlus
program to simulate in vivo data for in vitro
dissolution method development in support
of formulation development, and IVIVR/IVIVC.
She also has a background in bioanalytical
analysis supporting pharmacology research,
as well as
experience in high throughput LC-MS analysis.
Jianmei Kochling received her PhD degree
in analytical chemistry from Northeastern
University. She began her drug development
career with Praecis Pharmaceuticals, Inc (currently
GSK), then Vertex, prior to joining Genzyme.
Dr. Margareth R. C.Marques
Senior Scientist
U.S. PHARMACOPEIA
Dr. Margareth Marques is senior scientist and Latin American Liaison at the Department of Standards Development at the United States Pharmacopeia. Scientific liaison for the USP Expert Committee on Biopharmaceutics being responsible for the development of dissolution testing for the monographs for dosage forms, and for the USP Expert Committee on Pharmaceutical dosage Forms. She is also responsible for developing specifications for reagents used in USP – NF monographs. She manages the USP database on chromatographic columns. She has a B.Sc. and an M. Sc. both in Pharmacy by the University of Sao Paulo, Brazil. She has a Ph. D. in Analytical Chemistry by the State University of Campinas, Brazil. She managed analytical laboratories at Ciba-Geigy, Sandoz, and Astra.
Mr. Larry Stevens, M.S.
Senior Scientist III
Alcon Research
Mr. Stevens is a Senior Scientist in the Drug Delivery group at Alcon Research Ltd. He received his MS degree in Chemistry from the University of North Texas. A member of AAPS and ACS, and with over 28 years of experience in the pharmaceutical industry, he has served as a bench chemist, supervisor, and as an instrumental system designer. His major field of interest is analytical methods development, with the last 20 years being directed toward developing unique tools and studies designed to advance drug delivery and controlled release research. Much of this has been devoted to experimental design, method, instrumental and software development to better understand and predict physicochemical and biological relationships related to drug delivery systems.
Having published work involving radiochemical, wet, spectroscopic and chromatographic methodologies, along with a series of dissolution and controlled release papers, more recent efforts have been focused on advancing dissolution science and instrumentation. This has resulted in optimizing hydrodynamic and kinetic models, improved predicting capabilities, in vitro to in vivo correlations, and the development of a fully automated multi-sample high-performance flow-through dissolution system. For some of this work, he was the recipient of an Alcon Research Technical Excellence Award. He has also served as an invited speaker at numerous conferences and workshops.
Dr. Erika Stippler
Director of Dosage Form
Performance Laboratory
U.S. PHARMACOPEIA
Erika Stippler, Ph.D., has more than sixteen
years experience in the pharmaceutical industry
and has worked at various Contract Research
Organizations in Germany and Switzerland. Currently,
she is the director of the Dosage Form Performance
Laboratory at the U.S. Pharmacopeia in Rockville,
MD.
Dr. Stippler studied chemistry in Romania
and received her M.S. in chemical engineering
in 1989 at the Babes-Bolyai University Cluj-Napoca.
Beginning in 1992, she worked as an analyst
in Zentrallaboratorium Deutscher Apotheker,
Eschborn and starting in 1996 as an external
Ph.D. student at the W. J. Goethe University
Frankfurt Institute of Pharmaceutical Technology.
Under the guidance of Prof. Dr. Jennifer B.
Dressman, she received her Ph.D. in 2004.
The title of her thesis is “Biorelevant Dissolution
Test Methods to Asses Bioequivalence of Drug
Products”. From 1998 to 2002, she was the
head of the Department Biopharmacy/Stability
Testing of Laboratory and Quality Services
in Eschborn, Germany. Following, she took
over the position of technical director of
PHAST laboratories.After 9 months project
management at Solvias, Switzerland she accepted
the director position at the U.S. Pharmacopeia.
Her scientific interest is focused on IVIVC-based
dissolution method development for various
dosage forms and on the characterization and
standardization of dissolution apparati and
dissolution methods for performance evaluation
of pharmaceutical products.
She is a member of American Association of
Pharmaceutical Scientists (AAPS) and International
Association for Pharmaceutical Technology
(APV).
Program Agenda
| Day 1 |
Monday, September 8th,
2008 |
| 8:00 AM - 8:30 AM |
Registration and
Continental Breakfast |
| 8:30 AM - 9:30 AM |
Regulatory and Registration
Requirements for
Dissolution Testing
- Relevant Guidelines (ICH, EU, FDA)
- Supportive dissolution data for variations
- Variation of dissolution methods
- Experience with authorities
- Biowaiver
- Examples
Role of Dissolution in regulatory submission
- Process
- Innovative
- Generic
- Post approval – SUPCA, filing variations
|
| 9:30 AM - 10:15 AM |
Dissolution Testing
– A Pharmacopeial Perspective
- European Pharmacopoeia : brief overview
- U. S. Pharmacopeia - review process
- USP and FDA interactions regarding
dissolution
- Harmonization process
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 11:15 AM |
USP Update: Performance
Verification Test of Dissolution Test Equipment
In order to assure that a potential high
variability in the dissolution results is
not due to malfunction of the dissolution
tester used, the dissolution equipment has
to be properly qualified. The USP Prednisone
Tablets RS are suitable for the performance
verification of apparatus1(basket) and 2
(paddle) dissolution equipments. Experiments
performed in the USP laboratory show that
the Prednisone Tablets RS are sensitive
to some of the dissolution equipment variables.
Thus the results support the suitability
of the Prednisone Tablets RS for performance
verification test of apparatus 1 and apparatus
2 dissolution equipment.
a. What are the dissolution equipment parameters
which may contribute to the high variability
in dissolution results?
b. How USP Prednisone Tablets RS indicate
a not "well controlled" dissolution
equipment?
c.What are the USP standards for performance
verification test?
|
| 11:15 AM - 12:00 PM |
High-Performance
Dissolution: Improving Dissolution Measurements
through Enhanced Understanding and Control
of Hydrodynamics
The control of convective diffusion properties
through hydrodynamics is emerging as a critical,
and perhaps the key factor in obtaining
appropriately responsive, relevant and reliable
dissolution measurements. Applying to all
types of dissolution measurements, this
is especially relevant to flow-through techniques,
producing a vast improvement in dissolution
measurements. This session will focus on
better understanding and controlling these
factors along with the resulting advantages.
The utility of a fully automated high-performance
system will also be discussed relating to
improved physicochemical properties, formulation
sensitivity and in vivo correlation. The
following will be discussed.
- Understanding the role of convective
diffusion and hydrodynamics
- Comparisons between radial and linear
flow systems
- Optimization opportunities, a high-performance
approach
- Improved physicochemical properties
- Improved in vivo / in vitro relationships
and correlations
|
| 12:00 PM - 1:15 PM |
Luncheon |
1:15 PM - 2:00 PM
|
High-Performance
Dissolution: Method Development Strategies
The successful development of a discriminating
dissolution method is often the critical
factor in moving product development forward,
releasing manufactured product, avoiding
an unnecessary product recall, establishing
an in vivo relationship, and even substituting
in vitro data in place of in vivo for future
product upgrades. Dissolution still represents
a synergistic formulation effect that can
be seldom represented by determining a single
compositional property. As such, the development
of an appropriately responsive, relevant
and reliable method is vital. Taking advantage
of convective diffusion and controlling
hydrodynamics, method development strategies
will be examined spanning a range of sample
types, geometries and solubilities. The
following will be discussed.
- General method design considerations:
purpose, QbD, IVIVR/C and design space
- Sample and cell geometry
- Hydrodynamic, media and flow considerations
- Detection strategies: chromatographic
or spectroscopic
- Sample types: tablet, device, gel,
film, suspension and liquid
- Case types: fast, moderate and long
release
- Kinetics, end point and modeling
- IVIVR/C
|
| 2:00 PM - 4:15 PM
2:45 PM - 3:00 PM (Mid-Afternoon Coffee
Break) |
Dissolution Method
Validation Workshop
- Introduction
- Sampling
- Selection of filters, sinkers, etc
- Deaeration
- Specificity
- Linearity
- Accuracy
- Precision
- Robusteness
- Solution stability
- Pharmacopeial methods
- Method transfer
Group exercise:
Developing a method validation protocol
|
| 4:15 PM - 4:30 PM |
Questions & Answers |
| 4:30 PM |
Conclusion of Day
One |
|
|
| Day 2 |
Tuesday, September 9th,
2008 |
| 8:00 AM - 8:30 AM |
Continental Breakfast |
| 8:30 AM - 10:15 AM |
Flow Through Dissolution
Testing for Low Dose Products
- History
- Introduction
- Applications to low dose products
- Challenges & issues
- Powders and granulates
- Parenteral forms
- Method development parameters
• Case studies
- Microcapsules and nanocapsules
- Ocular Device
- Drug eluding stents
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 11:15 AM |
Using Bio-Relevant
Media for In Vitro Testing to Assess Dosage
Form Performance In Vivo as a Risk Management
Tool
In the early formulation dosage form development
phase, understanding dissolution mechanism
through understanding the intrinsic property
of the API is an important effort for formulation
dosage form and dissolution method development.
Without establishing a dissolution method,
biological relevant media can be chosen
for various testing for API and dissolution.
Information obtained in conjunction with
animal data provides insight for decision
making and risk management.
- Understand dissolution mechanism by
understanding API intrinsic properties
- Decision for choosing critical drug
substance physical properties for dosage
form development. e.g., particle size,
morphology, and polymorphs
- Impact of API property on dissolution
method development
How to use biological relevant media as
a tool for risk management for formulation
development |
| 11:15 AM - 12:00 PM |
Automation and Software:
High-Performance Flow-Through Dissolution:
Instrumental Design, Automation & Software
In addition to increased efficiency and
decreased operational cost, automation of
appropriate dissolution methods can substantially
improve precision, reproducibility and sensitivity
to formulation differences. Utilizing improved
control of hydrodynamics and convective
diffusion, a fully automated high-performance
multi-sample system has been developed.
This has been shown useful for a wide array
of dissolution applications, producing a
higher rate of data acquisition, precision
and ultimately improved correlation in vivo.
This session will discuss critical automation
and design aspects of this instrumental
system focusing on the sample manifold,
sampling interface, detection, data collection
and processing. Also discussed will be method
design considerations for product, and ultimately
in vivo relevance. The following will be
discussed.
- A fully automated high-performance system
approach
- Instrumental / automation design considerations
- Calibration
- Multiple sample components
- Methodology design considerations
- Software: control, data processing,
modeling
|
| 12:00 PM - 1:15 PM |
Luncheon |
| 1:15 PM - 2:45 PM |
Lab Automation
Improving productivity is essential in
all industrial fields. Within pharma, Quality
control labs implemented automation to increase
the speed of releasing batches.
R&D departments have also to shorten
development time and costs. Therefore, automation
can be of importance for QC and R&D
departments.
The purpose of this presentation is to
present the benefits of implementing automation
in the laboratory.
CASE STUDY:
Investigating of Parameters that Influence
the Robustness of a Dissolution Method for
a Tablet Drug Product Using a Design of
Experiment (DOE) Approach
A dissolution method was tested according
to statistical design of experiments to
assess its robustness. Specirfically, the
cone formation during dissolution testing
was examined as a response to several critical
method parameters change.
Conclusions: DOE approach is an effective
way to probe the primary factors that determine
the robustness of dissolution method. Understanding
the key parameters will significantly improve
the robustness of the dissolution method
|
| 2:45 PM - 3:00 PM |
Questions and Answers |
| 3:00 PM |
Conclusion of Program |
|
|
Who should attend?
This 2-day conference, with discussions, case
studies and workshops is directed toward Directors,
Managers, Supervisors, Analysts, and Associates
in the Pharmaceutical, Biopharmaceutical, Devices,
and allied industries with daily responsibilities
in the following areas:
- Dissolution
- Quality Control
- Stability
- Analytical Method Development and Validation
- Formulation
- Product Development
- Chemistry, Manufacturing and Controls (CMC)
- Quality Assurance
- GMP/GLP Compliance
- Pre-Clinical Research
- Regulatory Affairs
- Pharmacokinetics/Pharmacodynamics
- Validation
- Calibration/Metrology
- Product Submission
- Training
- Documentation and Technical Writing
- Contract Laboratories
- Consultants
- Contract manufacturing
- and other Compliance professionals
Registration Information:
Registration Fee: $950.00 +
GST
Online Registration
Payment Information
Hotel Accommodations
Course Location:
Academy of Applied Pharmaceutical Sciences (AAPS)
200 Consumers Road, Suite 200
North York, Ontario
M2J 4R4 Canada
Map
Registration Fee Includes:
Presentation Materials,
Luncheon, and Refreshments
Cancellation/Substitutions Policy:
CANCELLATION POLICY: Cancellation is accepted in writing (by mail, or fax) up to 4 weeks before the program start date, after which cancellations are not accepted and do not qualify for refund or credit. All Cancellations are subject to a $212.00 CAD (incl. GST)/person processing fee. Substitution of delegate/s with the member/s of the same organization is permitted at any time. IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.
Certificate of Attendance:
All participants will receive a certificate of attendance upon completion of the course
For registration or any further information, please contact us at:
Tel: (416) 410-7402
Fax: (416) 491-5810
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