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Electron Microscopy Sciences

EMS Academy Applications

Pharma 3M Workshoparrow13Pharmaceutical Microscopy Workshop: Polymorphism

This workshop covers the use of the microscope in both early pharmaceutical development when the form is chosen and in later stages of development where the form is monitored for stability.Sign Up

Examples of the Microscopy of Pharmaceuticals


Caffeine Form 2 by polarized light microscopy with crossed polars and a full lambda waveplate. The large blue particle is cellulose.
 
Caffeine Hydrate by SEM. Caffeine hydrate readily converts to the metastable Form 1 which, in turn, converts readily to Form 2 - the stable form at ambient conditions.

RG12525 Form 1 by SEM. The Form 1 habit is acicular and could not be altered using any of the attempted recrystallization techniques. Milling produced small fibers with poor flow properties.
 
RG12525 Form 2 by SEM. The Form 2 habit is twinned blocks. Milling produced small irregular particles with good flow properties.

Fusion of acetyl salicylic acid with phenactin.  Acetylsalicylic acid is on the right and phenactin on the left. The eutectic forms in the middle mixing zone.
 
Schematic energy vs. temperature diagram for three polymorphs. Forms I and II are enantiotropically related whereas forms I and III are monotropically related. Forms II and III are also are also monotropically related. Thermal microscopy can be used to generate such diagrams.

Benzyl fusion preparation by PLM in crossed polars. Benzyl exhibits anomalous interference colors which can be used for form identification purposes.
 
Image of trehalose anhydrate from the melt of trihydrate. Polarized light microscopy with polars and full lambda waveplate.

Details

Tuesday - Thursday
October 24 - 26, 2017
8:00 a.m. - 4:30 p.m.
Hatfield, Pennsylvania, USA

Facility

The EMS Microscopy Academy
Located in Hatfield, Pennsylvania, the Academy provides electron microscopy classes, workshops and training sessions for all fields of microscopy, including materials science and biological science.

Targeted Participants

This course is designed for the skilled analyst who is familiar with the basic pharmaceutical microscopy instruments. The emphasis of the workshop is on the practical application of microscopy in the analysis of polymorphism.

Scope of Class

The choice of the optimum solid-state form is critical for successful pharmaceutical development. Broadly defined, form includes polymorphs, hydrates, solvates, salts, co-crystals etc.  Microscopy is well- suited to the study of solid-state form.

This workshop covers the use of the microscope in both early pharmaceutical development when the form is chosen and in later stages of development where the form is monitored for stability.

It covers the material in Chapter 8 Pharmaceutical Microscopy (Springer, 2011) along with selections from other chapters. The course emphasizes how microscopy is used in conjunction with other analytical techniques for form selection and analysis.

Format

Lecture, demonstration and hands-on practice, as well as round table table tips and tricks discussion. Participants are encouraged to bring their own samples, if possible.

Main Curriculum

The material in this workshop is broadly separated by development phase into form discovery and form understanding. Form discovery usually occurs before first time in human (FTIH) into Phase 1. Form understanding generally occurs in Phase 1 and Phase 2, although some work extends into Phase 3.

This workshop emphasizes the role of microscopy in each aspect of form understanding. Although we will discuss solid-state theory and fundamentals, the workshop relies heavily on case studies, demonstrations, and instrument usage.

Instruments Available

Polarizing Light Microscope Hitachi S3500 SEM Image Analysis Software
Linkam Thermal Microscope Bruker Esprit (SDD) IR and Raman Microscopes

Faculty

Robert Carlton
Robert worked for nearly 40 years in the research and development of fiberglass insulation, orthopedics, and pharmaceuticals. His specialty is solid-state analysis with a particular interest in microscopy. Robert retired from full-time employment in early 2016. He is now teaching microscopy and consulting on solid-state analysis in pharmaceutical development. Robert's education is in chemistry, with a Ph.D. from Lehigh University. He has taken numerous courses at McCrone Research Institute on microscopy from Skip Palenik and Walter McCrone. Robert worked for pharmaceutical companies Rhone-Poulenc Rorer (Aventis, Sanofi), Elan (Nanocrystal), and GlaxoSmithKline in microscopy and solid-state analysis for 24 years. He published a book on Pharmaceutical Microscopy in 2011 with Springer.

Michael Kostrna
Michael was the program director of the Electron Microscopy Technician program at Madison Area Technical College and has more than 35 years in EM technical education and research experience. He has been training EM students for 29 years and has developed curricula and lab exercises for TEM, SEM, OLM, lab safety, introductory and advanced biological EM, EM, maintenance, and x-Ray microanalysis. He has worked with companies such as SC Johnson Polymer, Dow Chemicals, Io Genetics, Virent Technologies, ABS Global, NanoOnocology, and Microscopy Inovations, and in the process gained insight to the various applications of EM.

Al Coritz
Al has been working in the Electron Microscopy field for 38 years, beginning at the Yale School of Medicine and ending up on the commercial side with several key EM companies. His specialty is Cryo-techniques and Thin Film Technology: i.e. Freeze Fracture/Rotary Shadowing, High Pressure Freezing, and more. He is currently with Electron Microscopy Sciences where he has been the Technical Director for over 20 years.

Schedule

Tuesday, October 24, 2017
Polymorphism theory, Early stage form discovery and selection, Practice in identifying forms using PLM, TM, IR, Raman, etc.
8:00-8:30 Introduction of staff and participants
8:30-10:00 Polymorphism in drug development; Solid-state theory; Methods of form identification
10:00-10:30 Coffee break
10:30-12:00 Demonstrations related to form identification using PLM, TM, IR, and Raman
12:00-1:00 Provided lunch
1:00-2:30 Early stage form discovery studies
2:30-3:00 Break
3:00-4:30 Demonstrations of methods for generating new forms
6:30 Hosted Dinner

Wednesday, October 25, 2017
Considerations in the choice of optimum form for development including salts, hydrates and solvates as well as polymorphs. Polymorph and form relationship theory. Methods for determining the thermodynamic stability relationships of polymorphs.
8:00-8:30 Recap and questions from previous day
8:30-10:00 Form selection principles, Thermodynamic principles of polymorphism: monotropism and enantiotropism
10:00-10:30 Coffee break
10:30-12:00 Demonstrations of methods used in form selection
12:00-1:00 Provided lunch
1:00-2:30 Methods for determining the stable form at ambient conditions
2:30-3:00 Break
3:00-4:30 Demonstration of polymorph stability methods

Thursday, October 26, 2017
Regulatory requirements for polymorphism, polymorphism case studies, caffeine polymorphism as model for polymorphism studies, quantitative analysis of polymorphs in drug substance.
8:00-8:30 Recap and questions from previous day
8:30-10:00 Regulatory requirements, case studies, quantitative analysis in drug product
10:00-10:30 Coffee break
10:30-12:30 Demonstration of some case study examples
12:30-1:30 Provided lunch and assessment feedback on workshop
1:30-2:30 Discussion of caffeine polymorphism
2:30-4:30 Demonstrations of caffeine polymorphism

Lodging

Participants are responsible for making their own hotel reservations. The following hotel has been designated as the host hotel:

Homewood Suites
1200 Pennbrook Parkway
Lansdale, PA 19446
Phone: 215-362-6400

The special rates are $119.00 per night (plus tax) which includes a hot breakfast and a light dinner in the evening.

Please make your reservations and mention you are participating in the EMS Workshop.
GROUP CODE: EMS WORKSHOP

Everyone should plan to arrive the evening of October 23rd.

Enrollment Note

Registration will be limited to a maximum of 15 participants.
EMS will provide samples to those who prefer not to bring their own.

Registration Fee $995.00

Includes

A workshop syllabus, all supplies, reagents and solutions, lunches, coffee, tea, and dinner on the first evening of the workshop.

Online Registration

Add your registration to your cart using the links below to use our secure checkout and pay by credit card.

During checkout please indicate:

  • The name of the course
  • Will you bring your own specimens? Yes / No
  • What samples you are bringing and are most interested in?

Checkout Instructions
If only registering for a class, select any method of shipment to proceed, as shipping charges will not apply.

If ordering products in addition to registration, select desired shipping method.

Regular Tuition Registration: $995.00 Pharmaceutical Microscopy Workshop: Polymorphism

Pay by Check

Make payable to EMS and reference "Pharmaceutical Microscopy Workshop, Polymorphism".

Return your registration to:
Stacie Kirsch
1560 Industry Road
Hatfield, PA 19440 USA

Please contact Stacie Kirsch for more information.
Phone: 215-412-8400 Fax: 215-412-8450
E-Mail: stacie@ems-secure.com