Potential Use of the IPEC New Excipient Evaluation Procedure

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Potential Use of the IPEC New Excipient
Evaluation Procedure
Chris DeMerlis IPEC Regulatory Affairs
Committee Colorcon, Inc. January 26, 2006
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Definitions of New Excipients

• New Chemical Entity
• New route of administration or higher use level
  for existing excipients
• Physical/Chemical modification of an existing
  excipient
• Co-processed mixtures of existing excipients
• Synergy achieved by processing
• Physical interaction, not chemical reaction
• Food additive or GRAS substance used for the
  first time in a drug product

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Potential Uses of New Excipients

• Overcome compatibility problems with new drug
  substances
• Improve physicochemical and stability properties
  of drug product
• Minimize manufacturing costs
• Increase tablet machine speeds to reduce costs
• Use of new excipients for peptide and protein
  drug products (parenteral injection or infusion)

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Advantages of New Excipients in Drug Delivery
Technology

• Improve bioavailability of drug substances
• Use in controlled release dosage forms to modify
  dissolution and rate of absorption
• Patent life extension using functional
  excipients
• osmotic delivery
• fast dissolving/disintegrating tablets
• matrix tablets
• pulsed delivery
• Non-patent exclusivity

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Emerging Uses for New Excipients in Parenteral
Drug Products

• Drug targeting use
• Tissue/Cell-specific elucidation of drug response
• Complex entities proteins, antibodies, bacterial
  or viral vectors, microbial products

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Examples of New Excipients

• Many examples of modifications of existing
  excipients
• starch products
• polymers
• cellulosics
• Evaluate modifications, physical/chemical
  changes, specification changes etc.
• Bridge to existing toxicological data
• Evaluate effects on bioavailability

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IPEC Procedure How does it Work?

• Excipient manufacturer A does minor modification
  to food additive to improve flow
• Pharmaceutical company demands complete testing
  package
• Excipient company believes complete testing is
  not necessary
• IPEC Expert Committee would evaluate data package
  and resolve the differences of opinion thus
  potentially saving testing costs

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IPEC Procedure Will Encourage New Excipient
Development

• Standardize application of the FDA Guidance
• understand specific tests required
• Help define definition of new excipient
• Gives FDA reviewers independent expert third
  party evaluation of new excipient
• Accelerates approval of a drug application
  containing a new excipient
• FDA acknowledgement is critical

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Increase Awareness of theIPEC Procedure

• Controlled Release Society
• Parenteral Drug Association
• AAPS Polymer and Excipient Focus Groups
• Excipient Fest Puerto Rico
• Consult with other trade associations PhRMA,
  CHPA, GPhA
• Develop similar procedures in Europe and Japan