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Robert A. Casper, Ph.D
David L. Gardner, Ph.D

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Phone (919) 781-6315

email
devices@mindspring.com

Design, Development, and Evaluation of Pulmonary Drug Delivery Systems


  • Respiratory Device Development
  • Respiratory Device Evaluation
  • Metered Dose Inhaler Testing
  • Dry Powder Inhaler Testing
  • 510(K) Testing
  • Accelerated Stability Testing
  • Device Re-Engineering
  • Prototyping
  • Intellectual Property Assessment
  • Due Diligence
Innovative Engineering Approaches

Innovative Devices, LLC (IDL) was established in January, 1995 as a resource to the medical and health care industries, with particular emphasis on the design, development and evaluation of respiratory drug delivery systems. IDL is a biomedical engineering company focused on applying innovative engineering approaches toward solving difficult drug delivery problems.

Experience

IDL has experience in a wide variety of respiratory devices and products:

  • Metered Dose Inhalers (MDIs)
  • Dry Powder Inhalers (DPIs)
  • Nebulizers
  • Nasal Inhalers
  • Spacers, MDI adapters and other MDI accessories
  • Respiratory Therapy Devices
  • Dose Counters
  • Clinical Research Tools such as Peak Flow Meters, Electronic Dataloggers, etc.

IDL distinguishes itself from traditional contract analytical laboratories by providing in-house expertise in the areas of:

  • Chemical Engineering
  • Electrical Engineering
  • Aerosol Physics
  • Materials Science
  • Controlled Drug Delivery
  • Physiology
  • Biomechanics



Design and Development

IDL provides engineering services for design review and manufacturing strategies, including bench testing and early feasibility studies to establish device performance parameters. Also provided is consultation in the design and implementation of testing programs for submission to federal regulatory agencies, typically targeted at the preparation of a 510(k), IDE or NDA submission to the FDA.

IDL offers a complete range of pharmaceutical aerosol development services including:

  • Respiratory Device Design
  • Device Evaluation
  • 510(k) Testing
  • Device Re-Engineering
  • Intellectual Property Assessment
  • Prototyping
  • Materials Selection
  • Accelerated Stability Testing
  • Clinical Research Tools

Testing and Evaluation

IDL evaluates the design and performance of inhalation devices and provides pharmaceutical aerosol manufacturing and process validation services through professional associates.

The following tests are routinely performed in support of client regulatory submissions:


  • Particle Size Distribution via Cascade Impaction
  • Plume Geometry
  • Unit Spray Content
  • Valve Delivery
  • Appearance
  • Particle Size Assessment via Light Microscopy
  • Droplet Size Distribution
  • Spray Pattern
  • Dose Uniformity/Over Content Life
  • Loss of Prime
  • Cyr Test
  • Drug Identification
  • Drug Content in Entire Container
  • Water Content
  • Leakage
  • Degradation Products/Extractables, including Nitrosamines and PNA's