Drug Substance Patents: Leveraging New FDA Guidance, Protecting - - PowerPoint PPT Presentation

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Drug Substance Patents: Leveraging New FDA Guidance, Protecting - - PowerPoint PPT Presentation

Mar 09, 2023 379 likes •921 views

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 |

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Drug Substance Patents: Leveraging New FDA Guidance, Protecting Composition of Matter Patents, Drafting Solid Form Claims

Today’s faculty features:

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

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.

TUESDAY, NOVEMBER 1, 2016

Presenting a live 90-minute webinar with interactive Q&A Eyal H. Barash, Barash Law, Lafayette, Ind.

  • Dr. Steef Boerrigter, Senior Research Investigator, Materials Science, SSCI,

West Lafayette, Ind.

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Continuing Education Credits

In order for us to process your continuing education credit, you must confirm your participation in this webinar by completing and submitting the Attendance Affirmation/Evaluation after the webinar. A link to the Attendance Affirmation/Evaluation will be in the thank you email that you will receive immediately following the program. For additional information about continuing education, call us at 1-800-926-7926

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FOR LIVE EVENT ONLY

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v

Drug Substance Patents

  • Dr. Steef Boerrigter

stephan.boerrigter@amriglobal.com

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  • 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.

SSCI - AMRI

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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 crystalline non-crystalline amorphous material complexes, dispersions salts mesophase single component multi-component salts

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2-(2-Nitroanalino)-5-Methyl-3-Thiophenecarbonitrile

Polymorphism of ROY

Red – Orange – Yellow depending on conformation Crystals of different polymorphs

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Different types of molecules incorporated in the crystal structure

Multi-component Crystals

Various Forms of acetaminophen: 2 "neat" polymorphs, dihydrate, trihydrate, piperazine solvate, theophylline co-crystal

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  • Will be treated as "polymorph"
  • Performance modulation of API  many more options

Revised new regulatory FDA guidance on co-crystals

27-fold solubility enhancement tp pterostilbene; sustained over 5 hours Schultheiss (2010)

1:1 pterostilbene:caffeine co-crystal

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Eyal H. Barash, J.D. eyal.barash@ebarashlaw.com www.ebarashlaw.com www.ssci-inc.com November 1, 2016

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