requests-for-proposal

Extending the Life of Topical Analgesic Active Ingredients

Request Number REQ8287999
Due Date June 22, 2015
Author Nick Kacsandi
Request for Proposal Details
RFP Title
Extending the Life of Topical Analgesic Active Ingredients
RFP Description

NineSigma, representing a Global Specialty Products Manufacturer, invites proposals for novel solutions to extend the life of menthol and similar active ingredients when applied to human skin. In particular, the client is seeking to achieve a pain relieving effect of at least 6 hours from the point of initial application.

Background

Topical delivery mechanisms are routinely employed in the treatment a range of conditions and ailments, including infections, inflammation, and musculoskeletal pain. The crucial element to any topical application is the degree, rate and efficiency with which the active ingredients are able to penetrate the skin prior to evaporation or degradation.  In the client’s field of products, traditional active ingredients such as menthol, lidocaine and salicylic acid are delivered via a variety of media applied to the skin to relieve pain and swelling. Variations in the loading concentration of these actives does not necessarily increase the duration of pain relief and irritation.

 

NineSigma’s client seeks to identify technologies that can measurably enhance the effects of their product beyond simply adjusting the amount of active ingredient in the end-product. Any technologies that could extend the pain relieving properties of active ingredients are of significant interest, including – but not limited to – technologies to enhance the transfer of actives through skin and/or technologies to increase the duration of exposure on skin. The client is open to funding or collaborating on work related to development or validation of regulatory claims / clinical trials.

 

 

Anticipated Project Phases or Project Plan

Phase 1 – Initial discussions under NDA

  • Mutual NDA to be enacted for detailed technical discussion

 

Phase 2 – Proof of technical concept

  • Full technical report that demonstrates efficacy and  includes safety / toxicology data
  • Samples

 

Phase 3 – Commercialization and optimization of technical solution, including:

  • Identification of regulatory pathway
  • Sourcing of readily available components
  • Verification and validation of a scalable manufacturing process

 

 

Key Success Criteria

The successful technology will:

  • Enhance the duration of pain relief for topically applied ingredients via one or more of the following:
    • Slow or prolong release of actives applied on skin
    • Create a reservoir to improve retention of actives/menthol either in or on the skin
    • Slow or prolong absorption of actives/menthol through the skin
  • Enable a lasting active effect of at least 6 hours post-application
  • Be compatible with or adaptable to menthol loading concentrations of 1.25% up to 16%
  • Integrate with products that conform to FDA, EU and other regulatory guidelines, in the end application
  • Evidence or method to demonstrate efficacy of longevity prior to initiating clinical trials.

 

Possible Approaches

Possible approaches might include, but are not limited to:

  • Controlled release or extended release technologies for metered delivery of actives
  • Nanotechnologies or nanomaterial solutions
  • Nano- / micro-encapsulations
  • Drug delivery solutions
  • Film-forming technologies
  • Pre-treatment technologies to enable enhanced pain relief by preparing the application area prior to administering the active ingredient
  • Cross-functional technologies adapted from other topical treatments, including but not limited to:
    • Antifungals
    • Antimycotics
    • Anti-inflammatories
    • Analgesics
  • Cross-industrial technologies adapted from other industries, including but not limited to:
    • Food & Beverage
    • Cosmetics
    • Healthcare & Medicine
    • Oral Medicine & Dental Care
    • Personal Care
    • Veterinary Medicine

 

Approaches not of interest

The following approaches are not of interest:

  • Investigational or developmental drugs
  • Solutions that are not compatible with applications to human skin
  • Technologies that require continuous or ongoing applications to maintain efficacy
  • Solution based on electronic or mechanical devices

 

 

Preferred Collaboration types
Items to be submitted

To respond, please make sure you are registered in NineSights, as it will prompt you to log in. Then, use the Response options at the top or bottom of the page. You may submit supplemental files in addition to your completed response form.

 

Appropriate responses will use the response template and address the following:

  • Non-confidential description of proposed technology
  • Technical maturity of the approach (conceptual, prototype, industrial proof of concept, commercialized)
  • Sample availability
  • Commercialization pathway (if available)
    • Scalability
    • Regulatory information / pathway
    • Supply chain
  • Team description and related experience

 

 

Area of Interest
Request Priority
Attachments
This page does not have file attachments.
This page does not have file attachments.
Comments