TUESDAY
15 May
8:30am-5:30pm

WORKSHOP

UNDERSTANDING AMORPHOUS PHARMACEUTICAL MATERIALS
Organizer: Dr. Shawn Yin
Bristol-Myers Squibb Company, New Brunswick, NJ, USA

8:30-9:00am

Introduction – Amorphous Materials and Pharmaceutical Applications

Shawn Yin
Bristol-Myers Squibb Company, New Brunswick, NJ, USA

9:00-10:00am

Amorphous Basics

Lian Yu
University of Wisconsin,
Madison, WI, USA

10:00-10:30am

BREAK

10:30-11:30am

Making Amorphous API

Ann Newman
Seventh Street Development Group, Lafayette, IN, USA

11:30-12:30pm

Ultrafast Lasers for the Detection and Quantification of Trace Crystallinity in Amorphous Formulations by SONICC

Garth Simpson
Purdue University,
West Layette, IN, USA

12:30-1:15pm

LUNCH

1:15-3:15pm

Using PXRD for Amorphous Materials

Simon Bates
Triclinic Labs Inc.,
West Lafayette, IN, USA

3:15-3:45pm

BREAK

3:45-4:45pm

Using Thermal Techniques for Amorphous Materials

Ann Newman
Seventh Street Development Group, Lafayette, IN, USA

4:45-5:30pm

The Strategy for Quantitation of Residual Amorphous in Crystalline API

Peter Varlashkin
Physical Properties, GSK
Durham, NC, USA

WEDNESDAY
16 May
8:30am-4:30pm

SYMPOSIUM – * asterisk signifies presenter

8:30-8:45am

WELCOMING REMARKS & INTRODUCTIONS FROM THE PROGRAM CHAIR
Dr. Cyrus E. Crowder
International Centre for Diffraction Data, Newtown Square, PA, USA

AMORPHOUS, ACTIVATED AND NANOMATERIALS
Chair: Dr. Peter Varlashkin
Physical Properties, GlaxoSmithKline, Durham, NC, USA

P21

8:45-9:45am

Invited – AMORPHOUS ORGANIC SOLIDS AND THEIR CRYSTALLIZATION

Lian Yu
University of Wisconsin, Madison, WI, USA

P14

9:45-10:15am

THE STUDY OF MICRONIZATION INDUCED DISORDER OF ACTIVE PHARMACEUTICAL INGREDIENTS BY XRPD LINE BROADENING ANALYSES

G. Williams*, R. Forcino, J. Brum, F. Vogt
GlaxoSmithKline, King of Prussia, PA, USA

10:15-10:45am

BREAK – exhibits open

P2

10:45-11:15am

AMORPHOUS QUANTITATION STRATEGY FOR CRYSTALLINE DRUG SUBSTANCE – A GSK PERSECTIVE

P. Varlashkin
GlaxoSmithKline, Durham, NC, USA

P13

11:15-11:45am

ADDRESSING THE AMORPHOUS CONTENT ISSUE IN QUANTITATIVE PHASE ANALYSIS: THE CERTIFICATION OF NIST STANDARD REFERENCE MATERIAL 676A

J. Cline*, J. J. Filliben
NIST, Gaithersburg, MD, USA
R. B. Von Dreele
Argonne National Laboratory, Argonne, IL, USA
R. Winburn
Minot State University, Minot, ND, USA
P. W. Stephens
State University of New York at Stony Brook, Stony Brook, NY, USA

P23

11:45-12:15pm

WITHDRAWN - UTILIZING BENCH-TOP PXRD INSTRUMENTATION FOR QUANTITATIVE ANALYSES OF SPRAY DRIED SOLID DISPERSION PHARMACEUTICAL FORMULATIONS: FROM MANUFACTURING TO PERFORMANCE TESTING

J. Gautschi
Agere Pharmaceuticals, Inc., Bend, OR, USA

P3

12:15-12:45 pm

AN ALTERNATIVE METHOD FOR QUANTITATIVE XRPD ANALYSIS – PLS REGRESSION TO QUANTIFY AMORPHOUS CONTENT AND PHASE MIXTURES

D. Beckers
PANalytical B.V., Almelo, The Netherlands

12:45-2:00pm

LUNCH – Exhibits open.

FORMULATION & PRODUCT DEVELOPMENT
Chair: Dr. Detlef Beckers
PANalytical B.V., Almelo, The Netherlands

P16

2:00-3:00pm

Invited – STRUCTURAL CHARACTERIZATION OF SOLID COMPOSITE MATERIALS AS A TOOL FOR DRUG PRODUCT FORMULATION AND DEVELOPMENT

Peter Wildfong
Duquesne University, Pittsburgh, PA, USA

3:00-3:30pm

BREAK – exhibits open

P4

3:30-4:00pm

PHARMACEUTICAL APPLICATIONS OF TOTAL DIFFRACTION ANALYSIS TO ASSESS SINGLE AND MULTI-COMPONENT SYSTEMS

A. Sheikh*, S. Chen, J. Roth, T. Borchardt
Abbott Labs, North Chicago, IL, USA

P11

4:00-4:30pm

MATERIAL IDENTIFICATION AND CHARACTERIZATION: 10 YEARS OF DEVELOPMENTS, THE PDF-4/ORGANICS DATABASE

T. G. Fawcett*, S.N. Kabbekodu, F. Needham, C. E. Crowder
International Centre for Diffraction Data, Newtown Square, PA, USA

Wednesday
16 May Evening
6:00-8:00pm

POSTER SESSION, RECEPTION, EXHIBITS

P9

STRUCTURE DETERMINATION OF XYLAZINE HYDROCHLORIDE ANHYDROUS CRYSTALLINE FORMS USING POWDER X-RAY DIFFRACTOMETRY DATA

A. Zvirgzdiņš*, A. Actiņš
University of Latvia, Rīga, Latvia

P17

NIST STANDARD REFERENCE MATERIALS FOR X-RAY METROLOGY

J. P. Cline*, D. Windover, A. Henins
NIST, Gaithersburg, MD, USA

P18

IMIPENEM MONOHYDRATE X-RAY POWDER DIFFRACTION

F. Needham*, C. E. Crowder, T. G. Fawcett
International Centre for Diffraction Data, Newtown Square, PA, USA

P26

DIGITAL PATTERN ANALYSES

T. G. Fawcett*, S.N. Kabbekodu, F. Needham, C. E. Crowder
International Centre for Diffraction Data, Newtown Square, PA, USA

P7

A THIRD PHASE EFFECT ON THE PHASE TRANSITION OF XYLAZINE HYDROCHLORIDE

K. Krūkle-Bērziņa*, A. Actiņš
University of Latvia, Rīga, Latvia

THURSDAY
17 May
8:30am-5:45pm

SYMPOSIUM

XRPD STRUCTURAL TECHNIQUES
(Acquisition and Use of XRPD Data, Indexing, Structure Determination, Rietveld Refinement)
& CRYSTAL STRUCTURE PREDICTION
Chairs: Dr. Arnt Kern, Bruker AXS GmbH, Karlsruhe, Germany
Dr. Timothy Fawcett, International Centre for Diffraction Data, Newtown Square, PA

P10

8:30-9:30am

Invited – CRYSTAL STRUCTURE SOLUTION FROM POWDER MIXTURES: THE PXRD-BTEM-RIETVELD METHOD

Marc Garland*, L.Guo, M. Schreyer, S. Thirunahari
ICES, Jurong Island, Singapore

P22

9:30-10:00am

TRIADS XRPD INDEXING ALGORITHM AND ITS USE IN PHARMACEUTICAL DEVELOPMENT

R. B. McClurg
SSCI, a Division of Aptuit, West Lafayette, IN, USA

10:00-10:30am

BREAK – exhibits open

P25

10:30-11:30am

Invited – MOLECULAR COCRYSTALS AND SALTS: ‘FULL’ STRUCTURAL CHARACTERIZATION FROM POWDER DIFFRACTION DATA

Maryjane Tremayne*, L. Thompson, A. Cowell, G. Cutts,  D. Bell
University of Birmingham, Edgbaston, Birmingham, UK

P12

11:30-12:30pm

Invited – CRYSTAL STRUCTURE PREDICTION: SYNERGY BETWEEN THEORY AND EXPERIMENT

James A. Kaduk
Illinois Institute of Technology, Chicago IL, USA

12:30-1:45pm

LUNCH – Exhibits open.

COMPLEMENTARY TECHNIQUES
Chair: Dr. Fangling Needham
International Centre for Diffraction Data, Newtown Square, PA

P20

1:45-2:45pm

Invited – NUCLEATION AND THE DIFFERING CRYSTALLIZATION BEHAVIOR OF ENANTIOMERS

Gregory A. Stephenson*, C. D. Wolfangel
Eli Lilly and Company, Indianapolis, IN, USA

P19

2:45-3:15pm

SONICC AND TPE-UVF ANALYSIS OF APIS AND COMMON EXCIPIENTS

S. Toth*, G. J. Simpson J. T. Madden, L. S. Taylor,
College of Pharmacy, Purdue University, West Lafayette, IN, USA
P. Marsac
Merck & Co., Inc., West Point, PA, USA

P6

3:15-3:45pm

DESOLVATION OF DROPERIDOL ISOSTRUCTURAL SOLVATES

A. Bērziņš, A. Actiņš, T. Rēķis, I. Sarceviča
University of Latvia, Rīga, Latvia

3:45-4:15pm

BREAK – exhibits open

POLYMORPH & SALT SCREENING
Chair: Dr. Gregory A. Stephenson
Eli Lilly and Company, Indianapolis, IN, USA

P15

4:15-5:15pm

Invited -  SOLID-FORM SCREENING AND SELECTION: STRATEGIES AND CHALLENGES OF DIFFICULT MOLECULES

Pingyun (P.Y.) Chen,* J. Bis, S. Carino, R. Couch, D. Igo, L.
Katrincic, D. Kinder, B.Norton, S. Sukumar
OptiformTM Technologies, Catalent Pharma Solutions, Research Triangle Park, NC, USA

P8

5:15-5:45pm

DETECTING TRACE AMOUNTS OF THE THERMODYNAMICALLY STABLE POLYMORPH IN A MIXTURE OF POLYMORPHS

R. Bobrovs*, A. Actiņš
University of Latvia, Rīga, Latvia

FRIDAY
18 May
8:30am-11:30am

SYMPOSIUM

REGULATORY AND PATENT ISSUES &
NEW FRONTIERS IN XRD IN PHARMACEUTICAL R&D
Chairs: Dr. Shawn Yin, Bristol-Myers Squibb Company, New Brunswick, NJ,
Dr. Cyrus Crowder, International Centre for Diffraction Data, Newtown Square, PA, USA

P24

8:30-9:30am

Invited – REGULATORY CONSIDERATIONS ON PHARMACEUTICAL SOLIDS: POLYMORPHS AND CO-CRYSTALS

Andre S. Raw
FDA, Rockville, Maryland, USA

P5

9:30-10:00am

NEW INSTRUMENTATION FOR PHARMACEUTICAL XRD

B. He
Bruker AXS, Madison, WI, USA

10:00-10:15am

BREAK

10:15-11:30am

ROUND TABLE DISCUSSION FOR CONFERENCE ORGANIZERS AND INTERESTED ATTENDEES

Symposium Adjourned