Official USP Course - Sotax

Official USP Course:
Advanced Dissolution
11 & 12 November 2010
SOTAX AG in Allschwil - Basel, Switzerland
Course Description
► This two day course will enable Scientists to acquire a working knowledge and understanding of advanced
concepts related to dissolution and drug release testing, and understand how dissolution testing relates to drug
product quality and performance.
► The course provides an in-depth overview of USP dissolution and drug release testing. These tests are in vitro
performance tests that are applicable to many dosage forms including tablets, capsules, suspensions, transdermal
patches, suppositories, etc. They are important components of the specifications that establish the quality and
safety of drug products.
Who Should Participate
► Scientists, chemists and laboratory technicians who perform dissolution testing in the laboratory, QC and product
development professionals who review dissolution data.
Course Topics
► Theory and importance of dissolution testing
► Theory of dissolution
► Compendial dissolution testing
► IVIVC/IVIVR
► Development of dissolution and drug release testing methods
► Drug substance characteristics
► Selection of instruments and media
► Interpretation of results
► Data quality - analytical instrument qualification
► Qualification of instruments
► Sources of variability
► Performance verification test
► Validation of dissolution and drug release methods

Syllabus
Advanced Dissolution
Introduction—overview on history and theory
Compendial dissolution testing—what’s in the
book
► Relevant USP chapters
► Nomenclature of dosage forms
► Reason for multiple dissolution tests in
monographs
Goals of dissolution/drug release testing
► Importance of reliable results
► FDA product recall examples
► Determination of release rate
► Reasons for product stability testing
IVIVC / IVIVR
► FDA and WHO biopharmaceutics definitions
► Relevant USP chapters
► Which parameters are correlated
► IVIVC correlation levels A, B, C
► Using the BCS to categorize drugs
► Dissolution as part of quality control
► SUPAC guidance
Development of dissolution/drug release testing
methods
► Characteristics of quality dissolution methods
► Dissolution procedure requirements
► Categorization of API according to the BCS
Development—from API to dosage form
► Formulation type, excipients, release
characteristics
► Dissolution apparatus and medium, sampling,
and analysis
► Apparatus for conventional oral dosage forms
Development—selecting instruments and media
► Testing special dosage forms
► Examples of typical media
► Sampling schedule
► FDA guidance
Development—interpreting results
► Data treatment in Chapter
► Chapter acceptance tables
► Techniques for profile comparison
► f1 and f2 factors
► Practice exercises
Development—setting specifications
► Specifications for NDAs, ANDAs, IR drug
products, generic products, etc.
► Alteration and widening of dissolution
specifications
► Response to out-of-specification test results
Data quality—analytical instrument qualification
► Sources of variability
► Causes of artifacts
► Qualification of dissolution apparatus and
vessels according to Chapter
► FDA draft guidance
► Dissolution testkit
Validation—the dissolution test
► Validation of dissolution procedures
► Validation of operational conditions
Validation—API and dissolution media
► Validation of API-linked, excipient-linked, and
media-related parameters
► Deaeration techniques
► Perturbation studies
Validation—sampling, transfer, and processing
► Variability sources in the test procedure
► Manual vs. automatic sampling
► Appropriate sampling times
► Processing: filtration and dilution
► Sample transfer and storage
Validation—chemical analysis
► ICH guidance
► Placebo interference
► HPLC specificity
► System and method repeatability
► Solution stability
► Sample Analysis
SOTAX AG Phone +41 61 487 54 54 info@sotax.com
Binningerstrasse 106 Fax +41 61 482 13 31 www.sotax.com
CH-4123 Allschwil 1 2/4

Official USP Course
Advanced Dissolution
General Information
► Allschwil - Basel, Switzerland
Basel lies in the heart of Europe, along both banks of the Rhine. The city is at the centre of the idyllic border
triangle of France, Germany and Switzerland – Travellers can arrive by air at the EuroAirport, by car via the
motorway or by train at one of Basel’s three railway stations.
► Date/Time
Thursday 11 November, 08:30 – 17:30
Friday 12 November, 08:00 – 17:00
► Location
SOTAX AG
Binningerstrasse 106, CH-4123 Allschwil
Phone +41 61 487 54 54, http://www.sotax.com/SOTAX-AG-location.194.0.html
► Course language
English
► Course fee
Registration before 28 September: EUR 1’215
After 28 September: EUR 1’350
excluding taxes, including documents, coffee breaks and lunch
► Registration is required and seating is limited!
Send the filled in Registration form to:
Andrea Holzherr, Corporate Marketing & Communication
Fax +41 61 487 54 70, E-mail andrea.holzherr@sotax.com
► Accommodation information
Hotel Basel**** Phone +41 61 264 68 00, www.hotel-basel.ch
single room for CHF 205 per night excl. breakfast
Hotel Steinenschanze*** Phone +41 61 272 53 53, www.steinenschanze.ch
single room for CHF 165/175 per night incl. breakfast
Hotel Rochat** Phone +41 61 261 81 40, www.hotelrochat.ch
single room for CHF 125 per night incl. breakfast
Quote corporate booking reference USP SOTAX
We remind all delegates to book your own hotel room up to the 1 September, please reference SOTAX USP
when making your booking to receive a discounted rate.
We kindly ask that you note, we are only able to reserve a limited number of hotel rooms, hence these shall be
allocated on a first come, first served basis. Hotels that are located in Basel, are approx 30mins by tram or bus
to the SOTAX AG facility in Allschwil
More hotels: Tourism Basel, www.basel.com
► SOTAX and USP have the right to cancel the course if there are not enough seminar participants. The
registrants will be notified as soon as possible and will receive a full refund of fees paid.
SOTAX AG Phone +41 61 487 54 54 info@sotax.com
Binningerstrasse 106 Fax +41 61 482 13 31 www.sotax.com
CH-4123 Allschwil 1 3/4

Official USP Course
Advanced Dissolution
Registration Form
► Official USP Course : Advanced Dissolution
► Date : 11 & 12 November 2010 (Duration: 2 days)
► Location : SOTAX AG, Binningerstrasse 106, CH 4123 Allschwil
► Course fee : Until 27 September: EUR 1’215 excluding taxes
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After 28 September: EUR 1’350 excluding taxes
including documents, coffee breaks and lunch
SOTAX AG Phone +41 61 487 54 54 info@sotax.com
Binningerstrasse 106 Fax +41 61 482 13 31 www.sotax.com
CH-4123 Allschwil 1 4/4
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