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Request for Proposal
Status: RFP is Open

Controlled Sustained Release Mechanisms for Hydrogels

Request Number
RFP_2018_3862
Due Date
Nov 30
Program Manager

Opportunity

Licensing, product acquisition, contract research, proof of concept leading to scale-up to manufacturing, joint development, supplier agreement. The Client sponsor is open to any business arrangement that supports the goal of this RFP.

Timeline

Phase 1 – Feasibility evaluation, proof of concept

Phase 2 – Technology adaptation, optimization

Financials

All terms to be negotiated between the Solution Provider(s) and the Client sponsor, as warranted.

SOLUTION PROVIDER HELP DESK USA:
 

RFP Title

 

Controlled Sustained Release Mechanisms for Hydrogels
RFP Description

NineSigma, representing a Global Leader in medical devices, invites proposals for technologies that can be incorporated into, or onto, a hydrogel material to sustain release of polysaccharides from the surface of a medical device such as an ocular insert under specific conditions, and only when triggered by these conditions. The proposed approach must fulfill the condition that the device will be stored in aqueous media, potentially for an extended period of time, prior to use.

Background

The RFP sponsor is a manufacturer of medical devices and is seeking improvements in sustained release that can be applied to their products. The challenge is to design a sustained release mechanism that is triggered only when placed in an ocular environment, and not during pre-use storage in aqueous media. The approach must also be compatible with the manufacturing environment for medical devices, including autoclaving or other sterilization mechanism. Ideally, any proposed approach would allow for programmable release of the polysaccharide from the hydrogel surface or matrix.

Key Success Criteria

The desired technology must:

  • Include a mechanism of release that relies on a trigger when the medical device is placed on the eye.
  • Sustain release of a high molecular weight (>700K Da) carboxylic acid-containing polysaccharide from the hydrogel surface.
  • Be stable (not dissolve or degrade) during continuous storage in aqueous solution for an extended period of time, (i.e. 6 or more months) after which time it will provide the desired on-eye release as described in this RFP. The current storage solution is an aqueous system with a physiological pH (6.5 – 8.0) and physiological osmolarity 200 – 400 mOsm. The client is open to alternative storage parameters if they support the proposed approach AND are compatible for use in the human eye.
  • Be non-toxic and biocompatible with the ocular environment.

 

Preferred features

  • The approach should be compatible with common manufacturing practices, including the ability to withstand high temperature processing for short periods, such as autoclaving.
  • The proposed approach, when incorporated into the resulting medical device, must not result in a significant burst release of the polysaccharide after placement on eye. The desired result is for linear release (or nearly so) of the polysaccharide for over a targeted duration of time.
Possible Approaches

Possible approaches might include, but are not limited to:

  • Interpolymer complexing of the polysaccharide with another polymer that prevents its loss in solution during storage and sustains its release, possibly triggered by change in ionic strength, pH,  or competing proteins.
  • Matrix system based on a hydrophobic material where release of the polysaccharide is triggered by contact with tear (lacrimal) components that solubilize the matrix system.
  • Matrix system based on an enzymatically degradable polymer where release of the polysaccharide is triggered by contact with tear (lacrimal) enzymes.
  • Interpenetrating network of the polysaccharide with other polymers controlling its release and triggered by mechanical stress produced by blinking.
Approaches not of Interest

The following approaches are not of interest:

  • Approaches that exhibit a burst release of polysaccharide rather than a linear release profile.
  • Formulation based on hydrolytically degradable polymer (such as PLGA) that cannot be stored in aqueous solution.
  • Monolayer of polysaccharide attached to the hydrogel surface, or any other approach that cannot maintain a sustained release over a duration of time (~ 10 hours).
  • Electronic or mechanical approaches (e.g. microfluidics, pumps, etc.).
Items to be Submitted

Your response should address the following:

  • Non-confidential description of proposed technology and working principle
  • Availability of technical data
  • Technical maturity of the approach (concept, reduced to practice, prototype, ready to commercialize, ready to implement, commercialized)
  • Pathway to commercial scale including timing, estimated budget, and capacity for manufacture
  • Position on intellectual property including patent references
  • Desired relationship with sponsor
  • Team description and related experience
Preferred Collaboration Types
Area of Interest