|
|
|
DCAT & ExcipientFest Partnership Information
 |
2008 Schedule & Presentations
|
 |
|
|
|
Pharma Expo (9AM - 6PM) 17-18 June
Visit the world’s top Excipient Manufacturers & Service Providers. Booths are conveniently arranged close and in route to all conferences and workshops. The Expo is an excellent environment to prearrange meetings between Key Purchasing Contacts and Suppliers to effectively maximize your visit to ExcipientFest. The Pharma Expo will continue on Wednesday the 20th. Booth List
Poster Presentation (10AM - 6PM) 17-18 June - Sponsored by FMC BioPolymer
The ExcipientFest- Europe Poster Presentation is an excellent opportunity to share your work and interact with colleagues from across the globe. A panel of judges from the European and international pharmaceutical industry will select the best two university posters and present awards. Participation of sub-graduate and graduate students is highly encouraged. Posters should focus on topics related to Excipient Technology or Drug Application. Click for additional details
|
|
ExcipientFest Educational Sessions
|
(9AM - 5PM)- Conference Halls: A & B iExpo Floor
ExcipientFest- Europe will feature seven- 45 minute presentationsper day on 17 & 18 June . These conferences will be held in the combined halls: A & B iExpo Floor . See schedules below for details.
|
|
|
WORKSHOP- Outline & Workshop Leaders
|
|
Workshop I (9AM - 5PM , Ditchley House, Conference Room A)
|
The Science of Tablet Technology
Mr. Aaron Barkley, Mr. Rob Tuohy - Emerson Resources |
|
Abstract: This is a very popular full-day workshop. The course will allow participants to develop a complete understanding of how a tablet formulation and process is rationalized. The seminar explores all areas of pharmaceutical formulation covering theory/design, raw materials, formulation/process development, production and coating. Participants will explore the development of tablet formulas within appropriate rationale. This workshop is limited to 35 participants.
Presented By: Emerson Resources: An organization servicing the pharmaceutical and biotech industries. The company has three areas of focus: 1) Scientific Affairs-providing delivery system development, analytical services and clinical supplies manufacturing; 2) Innovation Materials Technology (IMTech) provides value-added coating ingredients; 3) The Science Center offers innovative, experience-based training in: Formulation Development, Operator Training, Science-Based Tablet Development, Experimental Design, Solid Dosage Forms for Non-Technical Professionals, as well as customized courses.
Workshop Outline
1. Introductions
- Instructors & Emerson Inc.
- Goals
- Expectations
2. Statistics Review
- Variables
- Population
- Central tendency
- Dispersion
- Distribution
3. Raw Materials Characterization
- Physical
- Chemical
- Functional
- Classification
- Review common Excipients
4. Formulation Development
- Defining variables
- Variable relationships
- The hypothesis
- An initial theoretical formulation
- Experimental design
|
 |
5. Process Development
- Review conventional tabletting processes
- Pre-blending operations
- Granulation
- Blending
- Tabletting
- Mix time studies
- Formula & process optimization using compaction profiles
- Statistical process control
- In process specification rationalization
- Process capability
6. Tablet Coating Dynamics
- The suspension formulation
- Liquid delivery
- Process conditions
- Tablet dynamics during processing
7. Wrap up
- Specific questions
- Panel review
- Questions
|
Work Shop Leaders: Mr. Aaron Barkley and Mr. Rob Tuohy
 |
•Mr. Aaron Barkley (Emerson Resources Inc.) |
Mr. Aaron Barkley: Mr. Barkley holds a Bachelor of Science degree in Biology from Waynesburg College. Aaron has been actively involved in the pharmaceutical industry for 10 years and has played a critical role in the function and growth of two product development laboratories. His latest responsibilities included the design and execution of an 8000 ft2 contract manufacturing facility as well as the implementation of systems to establish ongoing contract manufacturing opportunities. Aaron has been with Emerson Resources, Inc. since its inception in 2000 and is now a member of the Business Development team. He has been involved in all phases of solid dose development and is experienced with a wide variety of equipment and manufacturing techniques for the production of instant and controlled release dosage forms.
|
|
|
 |
Mr. Robert Tuohy (Emerson Resources Inc.) |
Mr. Robert Tuohy (Emerson Resources Inc.): Mr. Tuohy offers extensive knowledge relative to the design and development of various oral solid dosage forms including immediate/control release coatings, extrusion/spheronization technology, tablet compaction optimization, unique granulation approaches, formulation rationalization through experimental design, encapsulation and more. Rob has vast experience in performing all pertinent analytical techniques required to successfully develop a viable commercial dosage form. Rob has actively served as an onsite process validation consultant and has extensive knowledge of regulatory requirements coupled with an understanding of the technical aspects of operations. Mr. Tuohy holds a Bachelor of Science in Chemical Engineering from Virginia Polytechnic Institute & State University. He as work with DuPont Pharmaceuticals and is member of the AAPS, NJPHAST and American institute of Chemical Engineers. This is Rob’s 1st year speaking at ExcipientFest Europe.
|
|
|
| Workshop II (9AM - 5PM, Ditchley House, Conference Room B) |
Formulation and Coating Technology for Pharmaceutical Applications
Kevin Hughes, Paul Smith, PhD, Marcel Cimpan, James Gilmour - Colorcon |
Abstract: This full-day seminar will give the participants an overview of the key manufacturing processes used in single and multi-unit solid oral dose formulation, from core formulation through to coating, for both tablets and capsules. The seminar will look at Excipient selection and how they can provide multi-functional benefits to tablets and capsules formulations through binding capability, improved disintegrant/dissolution properties and enhanced flow and lubricity. The discussion will extend to selection for extended and delayed release technologies for both tablets and multi-particulates and how these formulations can provide consistent release over time or targeted delivery, while simplifying both the development and production process. It will also explore the influence of tablet design and formulation of film-coating quality. This includes film-coating equipment/processes, formulation of film-coating systems, coating process optimization, printing technologies, and troubleshooting coated tablet defects.
Presented By Colorcon: A global manufacturer and leader in Film Coating products and Excipients for the Pharma Industry.
Workshop Leaders: Kevin Hughes, Paul Smith, PhD, Marcel Cimpan, James Gilmour
 |
• Kevin Hughes (Colorcon) |
Kevin Hughes (Global Technical Manager – Excipients. Colorcon Limited. Mr Hughes graduated with a BSc (Hons) Food Science from Nottingham University in 1994. He has been involved in the pharmaceutical industry for 12 years. Focussing on research and development he has held a number of positions with Nutraceuticals Ltd, Boots Plc and Colorcon Ltd. Over this time he has built up a good level of expertise in oral solid dosage forms.
|
|
|
 |
Paul Smith, PhD (Colorcon) |
| Dr Paul Smith - Global Technical Manager (Modified Release) at Colorcon Ltd. Paul graduated with a BSc in Biochemistry from the University of Liverpool in 1995, and subsquently gained a PhD in Molecular Biology from the University of Edinburgh. He worked as a research scientist within the biotechnology sector, both in academia and industry. Paul has been involved with the pharmaceutical industry for a number of years and joined Colorcon in 2005, as a specialist in modified release formulation. |
|
| |
|
|
 |
Marcel Cimpan (Colorcon) |
Since March 2003, Marcel Cimpan has been the Technical Manager at Colorcon. In this position Marcel is responsible for the technical support of Colorcon in the EMEA region. Marcel has worked for Colorcon since 1998 holding various positions within technical and sales. Previously Marcel worked for Terapia SA, Romania (currently Ranbaxi) a major generic manufacturer where he held positions in API synthesis, Technological Development, leaving for Colorcon from the position of Head of Marketing Department. Marcel holds degrees in Chemical Engineering from the Faculty of Chemistry and Chemical Technology, “Babes-Bolyai” University, Cluj-Napoca, Romania.
|
|
|
 |
James Gilmour (Colorcon) |
Mr. Gilmour has vast experience working in film coating application to pharmaceutical substrates of non-functional and functional coatings, formulation of non-functional and functional (modified release) products. Mr. Gilmour previously worked for the Wellcome Foundation in Pharmaceutical Development – formulation and scale up, followed by providing Technical Support to the tablet manufacturing department specializing in dispensing, granulation, compression, encapsulation and film coating. Mr. Gilmour has been involved with the pharmaceutical industry for over 35 years and this is his first year speaking at ExcipientFest Europe.
|
|
|
| Workshop III (9AM - 5PM, Ditchley House, Conference Room A) |
Design of Experiments as a Tool for Pharmaceutical Manufacturing, Tech Transfer
& Trouble Shooting
Mr. Aaron Barkley, Mr. Rob Tuohy - Emerson Resources |
| |
Abstract: During the development of a pharmaceutical product, a large amount of resources are spent on the formulation development as well as on a robust, scaleable process for a successful transfer to a manufacturing facility. However, what recourses does the on-site technical services scientist have if the transfer does not go as expected? This one day course explores the use of statistically based tools for designing experiments (DoE) and evaluating data as it relates to technology transfer, optimization and troubleshooting. The mathematical basis for DoE will be reviewed and various real world examples will be analyzed. Limited to 35 participants.
Presented By Emerson Resources: An organization servicing the pharmaceutical and biotech industries. The company has three areas of focus: 1) Scientific Affairs-providing delivery system development, analytical services and clinical supplies manufacturing; 2) Innovation Materials Technology (IMTech) provides value-added coating ingredients; 3) The Science Center offers innovative, experience-based training in: Formulation Development, Operator Training, Science-Based Tablet Development, Experimental Design, Solid Dosage Forms for Non-Technical Professionals, as well as customized courses. |
| |
|
|
| Workshop Outline: |
|
|
- What is “Design of Experiments”
- Basic Statistics
- Central Tendency
- Dispersion
- The Normal Distribution
- Central Limit Theorem
- Statistical Significance
- Analysis of Variance
|
|
- Full Factorials
- Fractional Factorials
- Independent Variables (examples)
- Dependent Variables (examples)
- Case Study 1 – Hardness Optimization
- Case Study 2 – Roller Compaction
- Case Study 3 – Extrusion Spheronization
- Case Study 4 – Coating System Optimization
|
|
Work Shop Leaders: Mr. Aaron Barkley and Mr. Rob Tuohy
|
•Mr. Aaron Barkley (Emerson Resources Inc.) |
Mr. Aaron Barkley: Mr. Barkley holds a Bachelor of Science degree in Biology from Waynesburg College. Aaron has been actively involved in the pharmaceutical industry for 10 years and has played a critical role in the function and growth of two product development laboratories. His latest responsibilities included the design and execution of an 8000 ft2 contract manufacturing facility as well as the implementation of systems to establish ongoing contract manufacturing opportunities. Aaron has been with Emerson Resources, Inc. since its inception in 2000 and is now a member of the Business Development team. He has been involved in all phases of solid dose development and is experienced with a wide variety of equipment and manufacturing techniques for the production of instant and controlled release dosage forms.
|
|
|
|
Mr. Robert Tuohy (Emerson Resources Inc.) |
Mr. Robert Tuohy (Emerson Resources Inc.): Mr. Tuohy offers extensive knowledge relative to the design and development of various oral solid dosage forms including immediate/control release coatings, extrusion/spheronization technology, tablet compaction optimization, unique granulation approaches, formulation rationalization through experimental design, encapsulation and more. Rob has vast experience in performing all pertinent analytical techniques required to successfully develop a viable commercial dosage form. Rob has actively served as an onsite process validation consultant and has extensive knowledge of regulatory requirements coupled with an understanding of the technical aspects of operations. Mr. Tuohy holds a Bachelor of Science in Chemical Engineering from Virginia Polytechnic Institute & State University. He as work with DuPont Pharmaceuticals and is member of the AAPS, NJPHAST and American institute of Chemical Engineers. This is Rob’s 1st year speaking at ExcipientFest Europe.
|
|
|
|
|
|
DAY-ONE: ExcipientFest Educational Sessions
|
|
|
|
Day-One: Presentation 1
10:00-10:45 AM - (45 min.)
|
New Opportunities in the Formulation of Oral Solid Dosage
|
Abstract:
Direct compression is the preferred choice in the formulation of solid dosage forms. Excipients suitable for direct compression have to fulfil certain requirements. Ideally, the powder provides good flowability, low hygroscopic nature, excellent chemical and physical stability, no incompatibilities or interaction with active ingredient or other Excipients, which would affect bioavailability, prevention of segregation, good compression force – tablet hardness profile, high dilution potential, a pleasant taste and affordable costs. Over the past years, BENEO-Palatinit has introduced galenIQ™ (isomalt PhEur, BP, USP-NF), a bulk excipient range of tailor-made grades for the formulation of oral solid dosage forms. Widely fulfilling the above mentioned requirements, especially the direct compressible grades galenIQ™ 720 and 721 are gaining interest in the pharmaceutical industry due to excellent powder and tabletting properties. Both grades are ideal bases for any kind of tablets. Due to higher solubility, galenIQ™ 721 is especially interesting for chewable tablets or formulations where faster disintegration is required. galenIQ™ 720 is the preferred choice for suckable tablets, which shall release APIs in the oral cavity rather slow as well as for swallowable tablets, which shall erode or dissolve within several minutes. Frame formulations, which reflect the ideal filler-binder properties provided by galenIQ™, such as high dilution potential and excellent content uniformity in tablets will be shared.
|
Speaker:
|
Ms. Maj-Britt Babbel, PhD. (Sales & Technical Manager) Beneo-Palatinit GmbH
Dr. Maj-Britt Babbel joined the Suedzucker Group in 2001 and is now working as Sales and Technical Application Manager in the Pharmaceutical Sales Department of Beneo-Palatinit GmbH. She graduated as a Food Chemist from the Technical University of Berlin in 2001 and after a research period in the field of the Maillard Reaction at the Consejo Superior de Investigaciones Cientificas (CSIC) in Madrid, she joined the Central Department of Research, Development and Services of the Suedzucker AG for her PhD thesis. In 2005, she was offered an employment at Palatinit GmbH, a subsidiary of Suedzucker AG, where she was in charge of Technical Application Services concerning food and confectionery for customers in Europe and Latinamerica during the first years. This is Ms. Babbel’s 1st year speaking at ExcipientFest Europe..
|
|
|
Day-One: Presentation 2
10:00-10:45 AM - (45 min.)
|
Enteric coatings on Soft and Hard Gelatin Capsules Influences of Excipients and Technologies
|
Abstract:
In order to develop a flexible enteric coating for soft gelatin capsules, different plasticizers were tested concerning their compatibility with EUDRAGIT® L 30 D-55. In this study the advantages and disadvantages of the different plasticizers, for the coating process and the storage stability were investigated. Results of the NMR investigation of the applied enteric films showed that the behaviour of different plasticizers during the coating process and the storage time differs significantly. Plasticizers with small molecular weight and high volatility like Propylenglycol showed a significant loss during the coating process and the storage time compared to molecules with a lower volatility like PEG 20 000. Surprisingly the quality of the enteric coated capsules was not negatively influenced by the reduction of plasticizers during process and storage time.All formulations fulfill these requirements and shows enteric behavior over two hours under acidic conditions. All capsules disintegrated within 30 min. at pH 6.8. All investigated formulations leads to comparable storage stability data in the disintegration tests. The PEG 20000 formulation showed superior coating properties. Therefore PEG 20000 is an excellent alternative as a plasticizer for soft gelatin capsule coatings. This talk will cover all aspects of this investigation.
|
Speaker:
|
Mr. Thomas Fürst, PhD ( Technical Service Manager) Degussa Pharma Polymers Röhm GmbH
Mr. Thomas Fürst, is currently the Regional Tech Manager Europe, Middle East and South America, in charge of Technical Customer Service for EUDRAGIT for Evonik Röhm GmbH in Germany. He earned his master in Pharmaceutics at the School of Pharmacy, University of Frankfurt, Germany and soon after his PhD in 2005. Before Evonik, Dr. Fürst was trained in Retail Pharmacy in Frankfurt and then at Merck in Darmstadt. This is Mr. Fürst’s 1st year speaking at ExcipientFest Europe.
|
|
|
Day-One: Presentation 3
11:15 AM-12:00 PM - (45 min.)
|
Mannitolised Microcrystalline Cellulose: A Novel Approach to Enhanced Lubricant Resistance
|
Abstract:
Microcrystalline cellulose is the most effective direct compression binder but, in common with other plastically deforming excipients, is sensitive to lubricants. Most common pharmaceutical lubricants, such as magnesium stearate, are boundary lubricants, which easily shear under pressure to yield thin films between the tablet and tooling surfaces to reduce friction and sticking. Unfortunately the lubricant film can also build up on the surface of the other particles in the compression mix, substantially reducing compactability, especially with plastically deforming materials, which do not form fresh surface areas during compaction. Formulators are well aware of the adverse effects of lubricants and try to avoid such problems by minimizing the amount of lubricant. Unfortunately this strategy may give rise to subsequent sticking and picking problems in Production due to under-lubrication. Mannitol normally requires more lubricant and is less compactable than microcrystalline cellulose but surprisingly when co-spraydried there is a synergistic increase in lubricated compactability. Mannitolised MCC therefore offers a novel approach to the formulators dilemma in balancing compactability with lubrication. Tablet development can be optimized and accelerated with assurance of reduced sticking problems on full-scale manufacture.
|
Speaker:
|
Mr. Brian Carlin, PhD. -(Global R&D Director) FMC BioPolymer:
Dr. Carlin is the Global R&D Director for FMC BioPolymer’s Pharmaceutical Division. Dr. Carlin’s academic background includes a pharmacy degree from the University of Aston in Birmingham and a PhD from the School of Pharmacy in London. During his 23 years of Pharmaceutical development experience, Dr. Carlin has developed a broad range of expertise covering the spectrum of pharmaceutical formulation development from solid to liquid, OTC to ethical, and pre-Formulation to production. He has used his extensive knowledge and experience to help our customers on a wide range of pharmaceutical formulation issues. Dr. Carlin has spoken numerous times at ExcipientFest in Puerto Rico and in Europe. |
|
|
Day-One: Presentation 4
1:30-2:15 PM - (45 min.)
|
The Effects of Increasing Super-Disintegrant (Polyplasdone XL) in Tablet Formulation on the Ease of Film coating Using Atomic Force Microscopy to Evaluate Surface Effects Mr. Phil Hadfield - ISP Europe
|
Abstract:
An investigation into the effects of increasing super-disintegrant (Polyplasdone XL) in a placebo tablet formulation on the ease of film coating using atomic force microscopy to evaluate surface effects: It is thought that the inclusion of super-disintegrant into a tablet formula makes it difficult to aqueously film coat and achieve a good quality finish. Placebo tablets were prepared with increasing levels of a super-disintegrant (Polyplasdone XL) (0, 2, 5, 7.5, 10, 15 and 20%) and compressed to a standard tablet hardness. These tablets were then film coated with an aqueous film coating system (Advantia Prime) using standard coating conditions. The tablets were visually assessed for quality of finish and the surface roughness of the tablets before and after coating measured using an atomic force microscope. This talk will cover the matrix of this investigation.
|
Speaker:
|
Mr. Phil Hadfield (Technical Manager)ISP Europe.
Philip J Hadfield is Pharmaceutical Technical Manager – Film Coating EMEA for International Specialty Products (ISP). He has over 35 years experience working in the pharmaceutical and support industries specializing in film coating and has presented widely on film coating technology. This is Mr. Hadfield’s 2nd year speaking at ExcipientFest Europe.
|
|
|
Day-One: Presentation 5
2:15-3:00 PM - (45 min.)
|
Supply Chain Integrity in Excipient Distribution – Issues and Answers
|
Abstract:
In 2006 and 2007, there were many major headlines regarding recalls of everyday products which contained contaminated or mislabeled raw materials. While the majority of the highly-publicized incidents involved raw materials manufactured in emerging economies, without stricter controls and industry self-regulation, such incidents could easily occur in the US and/or Europe. While some may view chemical distributors as a potential “weak link” in the supply chain, in fact the opposite is true, especially in the distribution of excipients. Distributors who follow IPEC and other accepted industry guidelines can be a valuable source of information regarding the chain of custody of excipients and their quality. This presentation will outline the existing guidelines for ensuring the integrity of the excipient distributor’s supply chain, additional guidance being considered by FDA, IPEC, and the industry, and how to verify that a distributor is protecting the integrity of the supply chain so that the end user can be comfortable with the quality of the materials supplied.
|
Speaker:
|
Ms. Linda Herzog (General Manager USA) Mutchler Inc. Pharmaceutical Ingredients
Linda Herzog is US General Manager of Mutchler Inc. Linda has been in the commercial side of the chemical and pharmaceutical industries for over 25 years. Since joining Mutchler in 2004, Linda has been active in advocating the regulation of Excipients and promoting Excipient GMP’s to both better assure the quality of pharmaceuticals and to “level the playing field” among Excipient producers operating in different countries. Linda has spent the majority of her career in the oleo-chemicals market where she has particular commercial and technical expertise. Linda is the Vice Chairperson of the Scholarship Committee of DCAT (Drugs, Chemicals & Associated Technologies). She holds a BA in Chemistry from the College of the Holy Cross and an MBA in Marketing & Finance from the University of Connecticut. This is Linda’s 1st year speaking at ExcipientFest Europe, although she has participated numerous times at ExcipientFest Americas.
|
|
|
Day-One: Presentation 6 (Pegasus 1&2)
3:30-4:15 PM - (45 min.)
|
The Influence of Coating Formulation on Vegetable Extract Tablets
|
Abstract:
Film coating has become an essential step in the manufacture of prescription, generic or nutraceutical oral solid dosage forms. In some cases the manufacturers of these dosage forms can face incompatibility issues between the film coating ingredients and the core ingredients. To evaluate the influence of film coating formulation on incompatibility issues two coating formulations based on food grade polymers, Lycoat® and HPMC, were compared on a green tea extract tablet core. The technical performance of these two polymers was assessed with a particular emphasis on incompatibility issues. Compared performances and stability study results will be reviewed.
|
Speaker:
|
Mr. Denis Simon (Technical Support Manager) Roquette Freres
Mr. Denis Simon is Technical support manager for ROQUETTE FRERES in charge of UK, Ireland, Scandinavian and the Indian sub continent (India, Pakistan, Nepal and Bangladesh) markets. He obtained his Doctorate in Pharmacy from Lille University, France and as well as a business degree. Past experiences include international marketing, Immunology Division at ROUSSEL UCLAF and QC responsibilities of LFB (a biotech company based in France). Mr. Simon joined ROQUETTE FRERES in 1996 as international technical support. This is Dr. Simon’s 2nd year speaking at ExcipientFest Europe.
|
|
|
Day-One: Presentation 7 (Pegasus 1&2)
4:15-5:00 PM - (45 min.)
|
New Applications of Low-Substituted Hydroxypropyl Cellulose (L-HPC) for Pharmaceutical Dosage Forms
|
Abstract:
L-HPC has been widely used as an excipient for solid dosage forms for 30 years mainly in Japan. Due to its low chemical modification level, L-HPC has totally different characteristics from HPC (Hydroxypropylcellulose), which has a higher hydroxypropyl level. Typical applications of L-HPC include disintegrant, dry binder, and anti-capping agent for tablets and pellets. Our recent study was focusing on development of new applications using this material, other than as a simple disintegrant. One approach is to use it for improvement of dissolution of tablets made by compressing spray-dried solid dispersions. Since the solid dispersions require a high amount of polymer, tabletting of the spray-dried powder results in slow release of API. By using L-HPC for the core particles for spray drying, the release of API was significantly increased. Another approach is to use it for film coating. Since L-HPC is insoluble but hydrophyllic, its aqueous dispersion was made using a high-shear homogenizer, and a film was obtained by casting the dispersion. Coating trials were made for tablets and the release of API showed time-dependent pulsing. This result suggests that this material can also be applicable to control-release formulations. In this presentation, other applications such as bi-layer tablet and a new grade under development, having better flowability and binding strength, will also be discussed.
|
Speaker:
|
Mr. Sakae Obara (Chief Researcher ) Shin-Etsu Co. (sponsored by RW Unwin )
Mr. Sakae Obara received a master’s degree in biopharmaceutics at Chiba University in Japan. He has been working for Specialty Chemicals Research Center of Shin-Etsu Chemical Co., Ltd. in Niigata, Japan for over 20 years. Since employed, he has been responsible for fundamental and application research for pharmaceutical excipients based on cellulose. This is his 1st year speaking at ExcipentFest Europe.
|
|
|
|
DAY-TWO: ExcipientFest Educational Sessions
|
|
| | |
