requests-for-proposal

Time-Delayed Release of Drugs

Request Number REQ9358580
Due Date December 15, 2017
Author Seh-Rin Sung
Request for Proposal Details
RFP Title
Time-Delayed Release of Drugs
RFP Description

NineSigma, representing a major consumer healthcare company, invites proposals for a technology that can be applied to an existing drug product, so that it will allow a user to take a medication at bedtime but it will not start to have an effect until just before the user wakes. It should delay the drug release for a minimum of four hours and be suitable for use with either tablets or powder-containing capsules.

Background

If a consumer is currently using one of our client’s products, the earliest that they can currently take a tablet or pill is first thing in the morning, as soon as they wake up. It will then take a little time for the medication to have an effect. This means that there is a time early in the morning when it is not currently possible for the user to easily obtain the benefits of the product that they are using.

 

In order to address this, it would be convenient if the consumer could take some of the product before they retire to bed. The therapeutic effect is then delayed for a few hours until shortly before they wake up, so that when they do wake up the product has already started to work.

 

The client would like to be able to introduce a “night-time” version of their current product, which would have a delayed action of least four hours, and ideally 4-6 hours. After this time delay, the product would behave as if it had just been taken by the consumer. In other words, there is an “immediate release” of the drug, rather than a controlled or “sustained release”.

 

The client is flexible on exactly what time delay the technology should be capable of delivering, so long as the four hour minimum is met. Of more importance is that the time delay should be reproducible, so that the consumer experience when taking the product is consistent from one night to another.

 

 

Key Success Criteria

The successful technology will:

  • Delay drug release by a minimum of four hours
    • Ideally 4-6 hours
    • Immediate release of the drug after time delay
    • Highly reproducible time delay is desirable
  • The time delay should not be dependent upon the physiological conditions, such as:
    • pH
    • Presence of enzymes
  • Be compatible with/use known and approved drug excipients
  • Be unaffected by food
  • Be compatible with a solid formulation, either tablets or capsules containing powder
  • Have a shelf life of 24 months minimum, 36 months preferred
  • Ideally have a taste that is not unpleasant to the user
  • Have at least reached in-vitro proof of concept stage, if not yet commercialised
    • Results from clinical studies would be desirable

 

 

 

 

Possible Approaches

Possible approaches might include, but are not limited to:

  • Polymer coatings/membranes
  • Functional film coatings
  • Other coatings that erode and/or rupture
  • Capsule caps/plugs that temporarily block release of contents
  • Novel microencapsulation systems

 

 

Approaches not of interest

The following approaches are not of interest:

  • Approaches that rely upon a liquid formulation
  • Solutions that are not GRAS
  • Technologies that offer controlled/modified release (instead of immediate release) after a time delay

 

 

Preferred Collaboration types
  • Joint Development
  • Technology Licensing
  • Technology Acquisition
  • Supply Agreement
  • To Be Negotiated
Items to be submitted

 

Anticipated Project Phases or Project Plan

Our client is looking for a partner than can provide a suitable time-delay technology and then work with the client to apply the time delay technology to their product, which is already commercially available. It is anticipated that the development and approval cycle for the “night-time” version will take approximately five years to bring to market, and so they are seeking an organisation that is willing to enter into a partnership with our client for such a period of time.

 

Phase 1 – Time-delay technology evaluation with our client’s existing therapeutic product

  • Testing performance of time-delay functionality
  • Testing for excipient compatibility

 

Phase 2 – Development of new “night-time” therapeutic product

For this much longer phase, our client would be open to following one of two possible paths:

1.   Our client supplies therapeutic product samples to the technology provider, who then develops the modified “night-time” product version

2.   The technology supplier works to transfer the IP and know-how to our client and then works in an advisory capacity as our client develops the new version of the product 

 

Items to Be Submitted:

 

Your response should address the following:

  • Non-confidential description of proposed technology
    • Information regarding suitability/non-suitability for specific drug types, tablet/capsule sizes, etc. would be helpful
  • Technical maturity of the approach (prototype, ready to commercialize, commercialized)
    • Results of tests conducted with pharmaceutical materials
    • Details of any clinical trials
  • Team description and related experience
  • Preferences in terms of arrangement to modify the existing commercial product
    • Capability to undertake this development work, if appropriate

 

Appropriate responses to this Request

Responses are welcomed from both commercial organisations and research institutes.

 

 

Area of Interest
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