Dissolution Tests

from 10/08/2008 to 10/09/2008

Damascus, Syria

Welcome

The Arab School for Science and Technology (ASST), the Scientific Council for Pharmaceutical Industries (SCPI), and ERWEKA have the pleasure to welcoming you to attend a workshop on “Dissolution Tests” held from the 8th to the 9th of October 2008 in Damascus, Syria.

Description and Objectives

It is known that Pharmaceutical industry is distinguished by being a science-based industry. Research and development is involved in all steps of this industry! from raw materials specifications to packaging materials. Since our industry, like most industries in the third World, is a generic industry, the main issue for efficacy remains the bioequivalence of the produced products. Hence bioequivalence is the most important factor in facilitating registration locally and abroad.

The Syrian Ministry of Health has always, through its regulatory directorates, initiating and encouraging the Syrian Pharmaceutical companies to adopt the very up-to-date technologies in production and quality control. Therefore, dissolution test is compulsory in all solid products and correlation between bioequivalence and dissolution test is very important in directing research in formulation and leading to effective dosage forms.

Bioequivalence testing is based on a comparison of the serum concentration profile of a medicinal product versus the serum profile obtained with the brand similar product. This study is a generally accepted surrogate for therapeutic equivalence. However, in some situations such a bioequivalence study may be replaced by in vitro dissolution testing. When such a substitution is allowed by registration authorities this is referred to as a "biowaiver". This workshop will provide such scientific knowledge, in addition to the standard methods for dissolution testing of immediate release and modified release of oral dosage forms.

Main Topics

  1. The standard methods for dissolution testing of oral dosage forms.
  2. In vitro/In-vivo Correlation (ivivc).
  3. The value of dissolution testing as a surrogate for bioequivalence testing.
  4.  Regulatory aspects of dissolution testing as a surrogate for in-vivo bioequivalence testing in Western Countries.
  5. Dissolution test methods for modified release products.

Lecturers


Professor Dr Hans E. Junginger

Prof. Junginger studied pharmacy at the University of Munich (1964 – 1967) and received his Ph. D. at the University of Saarland (Germany). He was appointed as Full Professor and Head of the Department of Pharmaceutical Technology Leiden University, The Netherlands, in 1980. 

Prof. Junginger retired from Leiden University in 2004 (early retirement) and is currently  a Visiting Professor at the Faculty of Pharmaceutical Sciences, Naresuan University in Phitsanulok, Thailand, at the Faculty of Pharmacy in Ljubljana in Slovenia and at the German University in Cairo, Egypt.

His current research areas are Mucosal Barrier Modulation and Drug Absorption Control including mucosal vaccine delivery, Skin Barrier Modulation and Drug Absorption Control.  Prof. Junginger co-authored more than 300 publications in peer reviewed journals, 50 book chapters, 3 books and 8 patents.

Until now 55 Ph.D. students of all over the world have graduated under his supervision and more than 30 postdocs visited his department at the Leiden/Amsterdam Center for Drug Research.

Prof. Junginger received many international awards. He additionally holds honorary doctorates form the University of Gent (Belgium), University of Potchefstroom (South Africa) and University of London (UK),  

Prof. Junginger is also a consultant to several international pharmaceutical companies.  In the last 5 years Prof. Junginger has accepted more than 200 invited (plenary) lectures around the world.

He loves travelling and got therefore the nickname “Flying Dutchman”. In his free time he loves swimming, to read criminal stories and to play piano.

 

Sandra Klein (Ph.D.)

Institute of Pharmaceutical Technology

University of Frankfurt, Germany


Sandra Klein is a pharmacist and got her Ph.D. from the Johann Wolfgang Goethe University of Frankfurt where she has worked in the group of Professor Jennifer B. Dressman since 2000. Presently she is a senior research associate at the Institute of Pharmaceutical Technology at the University of Frankfurt. Her main research interests are the development of MR formulations and the prediction of their in vivo performance, the use of cyclodextrins and cellulose esters for enhancing the bioavailability of poorly soluble drugs and the miniaturization of compendial dissolution test methods. Sandra Klein maintains membership in AAPS, APV and CRS and has been invited several times by the AAPS, APV, CRS, FIP and WHO to present lectures at international workshops and conferences.

 

Dr. Kerstin Pauli


Kerstin Pauli studied Food Chemistry and Pharmacy at the University of Bonn and received her PhD in Pharmaceutical Analytics. She joined Bayer HealthCare AG in 2000 and her career in Pharmaceutical Development – Quality Control Department spans over 7 years. In the first 2 years she was acting as Laboratory Manager followed by the position of a Group Leader for Dissolution Testing.

In her position she is responsible for all aspects regarding dissolution testing of development projects within Bayer Schering Pharma, including development and validation of dissolution methods, submission of development projects and handling of post approval changes, life cycle management and patent protection of market products.

She is also involved in early formulation development by applying dissolution kinetics within salt selection process.

Another main aspect of her work is automation. The dissolution group within Bayer Schering Pharma has a long experience in in-house development of dissolution robots.



Dr. Dirk Barends


Dirk Barends (1945) works at the RIVM, the National Institute of Public Health & Environment of The Netherlands, the scientific institute that carries out pre-clinical assessments and assessments of the technical quality for the Dutch Medicines Evaluation Board and the EMEA and also supports the Dutch Inspectorate with laboratory- and deskreseach. At the RIVM, he runs research programmes supporting these activities, its core being in vitro surrogate methods for efficacy and safety estimations. More recently he has also taken an interest in counterfeit medicines; risk analysis and Quality by Design.

His is (co)author of over 60 scientific publications and contributes regularly to conferences & workshops with invited lectures.

 

Mustafa Tatar (Erweka representative)


Area Sales Manager at Erweka since 2007, responsible for the market in South Germany, Austria and Switzerland.

Proceeding



Arab School for Science and Technology

ASST

Scientific Council

for Pharmaceutical Industry

            (SCPI)



Workshop on 

Dissolution Tests


Copyright ©2008 by the Arab School for Science and Technology

All rights reserved. No part of this publication may be reproduced in any form or by any means: graphic, electronic or mechanical, including photocopying, recording, taping, or information storage and retrieval systems without written permission from the Arab School.


Arab School for Science and Technology

ASST

The Arab School for Science and Technology (ASST) was founded in Damascus in 1978 through an initiative from the Kuwait Institute for Scientific Research (KISR), in Kuwait, and the Scientific Studies and Research Center (SSRC) and the Supreme Council of Sciences (SCOS), in Syria.

Other organizations also joined as co-sponsors of ASST. The sponsors are:


From Kuwait:

Kuwait Foundation for the Advancement of Sciences (KFAS)

Kuwait Institute for Scientific Research (KISR)

Kuwait University (KU)

Environmental Public Authority (EPA)

Council for Private Universities (CPU)


From Syria:

Scientific Studies and Research Center (SSRC)

Higher Institute of Applied Sciences and Technology (HIAST)

Atomic Energy Commission (AEC)


From Lebanon:

National Council for Scientific Research (CNRS)

Lebanese University (LU)


The School has three  Branches, the first in Syria, the second in Kuwait and the third in Lebanon.


ASST Objectives:

Supporting Arab World scientific and technological cooperation, particularly in the applied domain, and exploring specific specializations that would contribute to economic and social growth, with a view towards achieving progress in a foreseeable term within the manpower and financial resources available at the level of the Arab scientific and technical institutions.

Presenting state of the developments in science and technology to Arab professors, researches, engineers and active professionals in industry and other productive activity.

Providing a forum of interaction between Arab specialists and the world’s prominent scientific figures.

Creating an opportunity for Arab scientists in the Arab countries and abroad to closely review the scientific potential in their home countries, and to contribute towards its development.

Facilitating scientific cooperation among Arab states through the participation of researchers and specialists in the various meetings and activities organized by ASST.

Introducing Arab and international scientific circles to various aspects of Arab scientific activity and its progress by advertising ASST activities.


ASST Sessions:

Through the organization of high level technical sessions and seminars featuring lecturers presented by prominent international experts, ASST aims at providing high level educational programmes to Arab specialists in fields considered important for the progress of the Arab countries.

 

Cooperation with National, Regional, and International Organizations and Foundations:

Various national and international organizations have had several cooperation programmes with ASST. These include: Academy of Scientific Research and Technology (Egypt), National Research Center (Egypt), Qatar University, AGFUND,  ALECSO, ESCWA, OPEC, UNESCO, UNEP, UNIDO, IFSTAD, ROSTAS, AFESD, Federation of Arab Scientific Research Councils (FASRC), World Intellectual Property Organization (WIPO), in addition to other organizations.

 

Arab School for Science and Technology (ASST)

P.O. Box 7028

Damascus – Syria

Telephone: 963 11 5118904

 Fax:          963 11 5111083

Email: asst@net.sy

www.arabschool.org.sy

 

The Scientific Council for Pharmaceutical Industry in Syria

SCPI

 

The Scientific Council for Pharmaceutical Industry (SCPI) in Syria, founded in 1993 by a decree of the minister of health, is the professional organization representing all parties involved in Pharmaceutical industry, including Pharmaceutical companies, legislation, registration section within the ministry of health, plus academia. The main objective of the council is to represent Pharmaceutical industry before Ministry of Health and other ministries in technical, legislation and regulation affairs.

During the past few years, the Syrian Pharmaceutical industry had proved to be the best example of industrial investment in the country. In only 18 years, the Syrian Pharmaceutical industry managed to increase its share in the local market from 6% to more than 90%. Reaching the 90% coverage of local market was not achieved by only increasing production capability but by continuous follow-up of Good manufacturing Practice Guidelines adopted by WHO and other international organizations.

However, up-grading technical knowledge and continuous education of staff involved in this industry could be considered the most influential factor. Such follow-up and continuous development enabled our industry to be the fastest growing industry in the third world. The Syrian Pharmaceutical industry is distinguished by its highly qualified personnel. University graduates represent 30% of all employees in this industry. Therefore, the council, bearing in mind that Pharmaceutical industry is distinguished by being a research-based industry, concentrates its main activities on scientific and technical affairs. Therefore, SCPI, since its foundation in 1993, had organized or collaborated in organizing many scientific conferences, workshops and symposia in all Pharmaceutical fields with local and international organizations. However, the new international economic changes make competition very hard, particularly, for an industry from the third world. Therefore, bearing in mind that our industry's survival is a vital issue for our country, modernization and continuous development of the industry should be manifested at all levels: production, quality control and R&D.

Therefore, the council considers that collaboration with such well-reputed organization such as ASST in this workshop will significantly participate in improving and accelerating the local industry development, which will be manifested in an improved health system, and flourished local Pharmaceutical industry.   

Dissolution Testing, Bioavailability & Bioequivalence are the most important issues for people working in the Pharmaceutical industry field. Therefore, Dissolution Workshop will give a chance for these people to get up to date with regulatory guidelines and technical as well as methodological developments in the field. Attendees to this workshop will be able to learn from experts and share their experience with biowaiver applications. Topics that will be covered will illustrate how to effectively use dissolution testing in Bioequivalence studies. 

SCPI

Damascus –Syria

Telephone: 963 11 2758120

 Fax: 963 11 3312561

Contents

 

Dissolution Testing: from the Past to Future

Prof. Hans E. Junginger

1


Practical Aspects of Dissolution Testing A) Selection of an Adequate Test Equipment and B) Overcoming Typical Problems in Dissolution Testing

Dr. Sandra Klein

29


Standard methods for Dissolution Testing of oral Drug Products A) for highly soluble drugs in IR dosage forms and B) for poorly soluble drugs in IR dosage forms

Dr. Sandra Klein

63


in vitro- in vivo Correlation (ivivc)

Prof. Hans E. Junginger

87


Regulatory Aspects of Dissolution as a Surrogate for inVivo Bioequivalence Testing in Western Countries

Dr. Dirk. M. Barends

131


Biorelevant Dissolution Test Methods for Modified Release Products

Dr. Sandra Klein

153


Application of Dissolution Testing in Industrial Product Development (Quality by Design)

Dr. Kerstin Pauli

179


Practicality of  Dissolution as a surrogate for in vivo Bioequivalence Testing: the Biopharmaceutics Classification System (BCS) and the Biowaiver monograph series.

Dr. Dirk M. Barends

213


Identification of the Optimal Drug Form for further Development by applying Dissolution Kinetics – Analytical Perspective

Dr. Kerstin Pauli

 

233


Guidance for industry

259

Participants

A number of about 120 professors, researchers scientists and professionals involved in pharmaceutical industry from different countries attend the workshop.

Official Language

The language of the workshop is English which will be used in all presentations and discussions.

Organizing Committee

  • Dr. Maher Agi

ASST Secretary General

  • Souraya Kanawati

ASST Session Coordinator

  • Alia Kouatly

Internal Relations Officer    

  • Ramzi Rifai

Public Relations Officer

  • Violet Kalemkerian

Secretariat

  • Sahar Shalati

Secretariat

Programe

First Day: Wednesday 8 October 2008


08.30 - 09.00 Registration

 

09.00 Opening Ceremony

 

09.15 -10.00 Prof. Hans E. Junginger, Marburg, Germany

Dissolution Testing: from the Past to Future -  Applications in Bioequivalence Testing


10.00 -10.45 Dr. Sandra Klein, University of Frankfurt, Germany

Practical Aspects of Dissolution Testing A) Selection of an Adequate Test Equipment and B) Overcoming Typical Problems in Dissolution Testing

 

10.45 - 11.15 Coffee Break

 

11.15 -12.00 Dr. Sandra Klein, University of Frankfurt, Germany

Standard methods for Dissolution Testing of oral Drug Products A) for highly soluble drugs in IR dosage forms and B) for poorly soluble drugs in IR dosage forms

 

12.00 -12.45 Prof. Hans E. Junginger, Marburg, Germany

in vitro- in vivo Correlation (ivivc)

 

12.45 -14.15 Lunch Break

 

14.15 -16.00 Representative from ERWEKA, Heusenstamm, Germany and Dr.Sandra Klein, University of Frankfurt

Hands-on-Dissolution Experiments / Demonstration: Mechanical Calibration, Testing and Practical Aspects (Group1)

 

14.00 -16.00  Talk with the Experts (Group2)

 

16.00 -16.15 Coffee Break

 

16.00 – 18-00 Representative from ERWEKA, Heusenstamm,  

                      Germany and Dr. Sandra Klein, University of Frankfurt

Hands-on-Dissolution Experiments / Demonstration: Mechanical Calibration, Testing and Practical Aspects (Group 2)

 

16.00 -18.00         Talk with the Experts (Group1)

 

 

 

Second Day: Thursday 9 October 2008

 

09.00 - 9.45 Dr. Dirk. M. Barends, Bilthoven, The Netherlands

Regulatory Aspects of Dissolution as a Surrogate for inVivo Bioequivalence Testing in Western Countries,

 

09.45 - 10.30 Dr. Sandra Klein, University of Frankfurt, Germany

Biorelevant Dissolution Test Methods for Modified Release Products

 

10.30 -11.00 Coffee Break

 

11.00 -11.45 Dr. Kerstin Pauli, Leverkusen, Germany

Application of Dissolution Testing in Industrial Product Development (Quality by Design)


11.45 -12.30 Dr. Dirk M. Barends, Bilthoven, The Netherlands

Practicality of  Dissolution as a surrogate for in vivo Bioequivalence Testing: the Biopharmaceutics Classification System (BCS) and the Biowaiver monograph series.

 

12.30-14.00 Lunch Break

 

14.00 – 14.45 Dr. Kerstin Pauli, Leverkusen, Germany

 Identification of the Optimal Drug Form for further Development by applying Dissolution Kinetics – Analytical Perspective

 

14.45 – 16.00 Discussion of all topics of the Workshop

 

 16.00Closing of the Workshop:  Panel Discussion

Media gallery

Documents

Description