Nanomaterials on Drug Products Katherine Tyner, PhD FDA/CDER/DARS - - PowerPoint PPT Presentation

▶
nanomaterials on drug products
SMART_READER_LITE
LIVE PREVIEW

Nanomaterials on Drug Products Katherine Tyner, PhD FDA/CDER/DARS - - PowerPoint PPT Presentation

Nov 19, 2022 362 likes •497 views

Considerations Regarding the Impact of Nanomaterials on Drug Products Katherine Tyner, PhD FDA/CDER/DARS January 14, 2013 Why Apply Nanotechnology to Drugs ? Combination of size and surface effects novel properties Increase

slide-1
SLIDE 1

Considerations Regarding the Impact of Nanomaterials on Drug Products

Katherine Tyner, PhD FDA/CDER/DARS January 14, 2013

slide-2
SLIDE 2

Why Apply Nanotechnology to Drugs?

Combination of size and surface effects → novel properties

  • Increase bioavailability
  • Change biodistribution
  • Increased drug action
  • Stabilize easily degradable

drugs

  • Deliver drugs

– Targeted/controlled/smart delivery of API

  • Multifunctional capabilities

Liversidge GG & Cundy KC. International Journal of Pharmaceutics. 1995 125, 91-97

slide-3
SLIDE 3

Diversity of Nanomaterials

Makes regulatory activities complex

Route of Administration Platform

Sadrieh, N. 2012 Overview of CDER Experience with Nanotechnology-related Drugs. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM315773.pdf

Material

slide-4
SLIDE 4

Considerations for Nano-Drug Formulations

  • There is no FDA definition for “nanotechnology” or related terms
  • Regulations and Law do NOT separate nanotechnology products
  • All nano-drugs are treated on a case by case basis
  • Look to regulations and guidances

– Part 314: Applications for FDA approval to market a new drug

  • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=314

– Part 58: Good laboratory practices for nonclinical laboratory studies

  • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58

– Part 211: Current good manufacturing practices for finished pharmaceuticals

  • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211

What are the common challenges in developing nanomedicines from manufacturing and regulatory (CMC) perspective?

slide-5
SLIDE 5

Characterization of Nano-Drug Formulations

  • 21 CFR 314.50(d) requires:

– Full description of physical and chemical characteristics and stability for the drug substance – Identity – Strength – Quality – Purity – Potency – Bioavailability

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314&showFR=1&subpartNode=21:5.0.1.1.4.2

slide-6
SLIDE 6

Suggested Minimal Characterization of Nanomaterials

  • Particle size/size distribution
  • Agglomeration/aggregation
  • Chemical composition
  • Crystal structure/crystallinity
  • Purity
  • Shape
  • Surface area
  • Porosity
  • Endotoxin content
  • Solubility
  • Stability
  • Concentration
  • Surface charge
  • Surface chemistry
  • Zeta potential
  • Surface energy
  • Catalytic properties
  • Dustiness
  • Oleophilicity/hydrophilicity
  • Grain size
  • Photocatalytyic activity
  • Octanol-water partition

coefficient

  • Redox potential
  • Radical formation potential

Card and Magnuson, J. Food Sci., 74, vi-vii, 2009; MinCHAR project; www.characterizationmatters.org http://www.toxicology.org/isot/ss/nano/docs/Ostraat_guest_presentation.pdf

slide-7
SLIDE 7

Characterization for Nano-Drug Formulations

  • 21 CFR 314.50(d) requires:

– Full description of physical and chemical characteristics and stability for the drug substance – Identity – Strength – Quality – Purity – Potency – Bioavailability

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314&showFR=1&subpartNode=21:5.0.1.1.4.2

slide-8
SLIDE 8

Considerations for Nano-Drugs Formulations

Tyner KM et al Journal of Controlled Release. 95 (3) 501-514 (2004). Time ---

slide-9
SLIDE 9

Session 2—Key Thoughts & Questions

Key Thoughts

  • Look to regulations and guidances

when developing nanodrugs

  • Manufacturing and characterization

techniques may be specific for individual nano-drugs

  • Consider all parts of a product’s

properties and design tests accordingly

Key Questions

  • What are the challenges in

developing nano-drugs from manufacturing and regulatory (CMC) perspectives?

  • How are nano methods being

integrated into the drug manufacturing process?

  • What current limitations are

encountered with today’s nanomaterials and how is the next generation of nano-products expected to address these limitations?

slide-10
SLIDE 10

Session 2 — Overview

  • Analytical Considerations for the characterization of

nanomaterial drug products

– Christie Sayes, PhD—RTI International

  • Panel discussion on manufacturing considerations

for nanomaterials in drug products

– Marcus Brewster, PhD—Janssen Research and Development – Neil Desai, PhD—Celgene – Donna Cabral-Lilly, PhD—Celator Pharmaceuticals Inc. – Lawrence Tamarkin, PhD, CytImmune

slide-11
SLIDE 11

Break out sessions

  • A: Analytical methods used for the characterization of

nanomaterials: limitations and need for additional research

  • B: Current and emerging technologies for manufacturing

stable nanomaterial containing drug products

  • Each session will be run twice, and you are encouraged to

attend each session

  • Speakers and panelists will be participating in these session
  • Time for extended discussion and Q & A