For more information on partnering opportunities, please contact:

bizdev@intranasal.com

Expertise

Product Identification

  • ITI develops new, differentiated and patent-protected formulations.
  • Product selection is based on thorough assessments of markets and therapies that include independent, expert evaluations.

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Formulation Science

  • ITI’s technology focuses on aseptic, patent-protected, nasally delivered medication.
  • Formulations are preservative-free, eliminating irritating and potentially toxic preservatives.
  • ITI is developing a platform formulation technology based upon a novel excipient which offers the ability to solubilize many APIs which have previously been difficult to formulate.

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Delivery Systems

  • ITI has the ability to use a variety of delivery systems to design, customize and match nasal spray systems and formulae.
  • ITI currently is working with unit and bi-dose spray systems developed by a major delivery technology supplier and who has granted ITI market exclusivity.
  • ITI holds the exclusive worldwide license to a novel, electronically controlled multiple unit dose nasal spray device designed by the University of Kentucky.

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Clinical and Regulatory Development

  • Clinical and regulatory research staff have extensive relevant industry experience, including management of clinical trials and regulatory submissions.
  • Strong links to external CRO network for efficient and effective clinical trial execution.

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Manufacturing

  • ITI has the ability to manufacture and fill materials for clinical supply needs for early clinical studies. Subsequent material supply needs will be met through either contract manufacturing organizations (CMOs) or partner companies. ITI will facilitate technology transfer to the appropriate manufacturing site.
  • The facility is designed to fully comply with the FDA’s current Good Manufacturing Practice regulations (“cGMPs”) and equivalent European Union standards.

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Commercialization Strategy

  • ITI can develop products for both internal and partnered marketing programs.
  • ITI can develop selected internal products and take them directly to market.
  • Partner-funded programs apply formulation technology, clinical development and manufacturing capabilities to partners’ drugs in R&D programs.
  • ITI plans to manufacture products not only for its own purposes, but for its pharmaceutical partners.

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