Presenting a live 90-minute webinar with interactive Q&A Drug Substance Patents: Leveraging New FDA Guidance, Protecting Composition of Matter Patents, Drafting Solid Form Claims TUESDAY, NOVEMBER 1, 2016 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Eyal H. Barash, Barash Law , Lafayette, Ind. Dr. Steef Boerrigter, Senior Research Investigator, Materials Science, SSCI , West Lafayette, Ind. The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .
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v Drug Substance Patents Dr. Steef Boerrigter stephan.boerrigter@amriglobal.com
SSCI - AMRI • Solid State Chemical Information • Founded by Prof. Stephen Byrn, Purdue University, 1991 • Specializes in solid-state aspects in drug development • ~100 employees • West Lafayette, IN • Affiliate of Albany Molecular Research, Inc. 5
Solid Forms • Various solid forms available for the development of an API • Different Forms have different properties such as solubility , dissolution rate, bioavailability, stability. SOLID FORM non-crystalline crystalline mesophase amorphous complexes, multi-component salts salts single component material dispersions 6
Polymorphism of ROY 2-(2-Nitroanalino)-5-Methyl-3-Thiophenecarbonitrile Red – Orange – Yellow Crystals of different depending on conformation polymorphs 7
Multi-component Crystals Different types of molecules incorporated in the crystal structure Various Forms of acetaminophen: 2 "neat" polymorphs, dihydrate, trihydrate, piperazine solvate, theophylline co-crystal 8
Revised new regulatory FDA guidance on co-crystals • Will be treated as "polymorph" • Performance modulation of API many more options 27-fold solubility enhancement tp pterostilbene; sustained over 5 hours Schultheiss (2010) 1:1 pterostilbene:caffeine co-crystal 9
Eyal H. Barash, J.D. eyal.barash@ebarashlaw.com www.ebarashlaw.com www.ssci-inc.com November 1, 2016
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