Invitation to Tender
Formulation Design and Prototype Services
This work is part funded through Innovate UK, part of UK Research and Innovation
Background
PFLH design, manufacture and sell products for relief of snoring and sleep disordered breathing The products are sold under the Snoreeze brand in the UK and in the EU under the Snoreeze and DouceNuit brand and in Australia under the SleepDoctor brand. Products are a throat spray and 2 throat lozenges, a nasal spray, nasal strips and nasal dilators and an oral device which also treats OSA. Products are either Class IIa or I Medical Devices in the EU. Historically its ‘lead products’ have been throat and nasal spray formulations
Requirement
PFLH have initiated a project to redesign and enhance its existing throat and nasal spray formulations and to test and evaluate the outcomes from this process. PFLH have already identified a series of potential improvements which range from new/additional ‘active’ ingredients to ingredient, structure and manufacturing process changes intended to extend the duration of time that the formulations remain on mucosal tissue.
‘Active’ ingredients will be taken from an existing identified list of ideas generated within business based on literature review over previous 3 years.
Ingredient, structure and manufacturing process changes will build on the existing spray formulations use of two phase formulations incorporating microsphere encapsulation in one phase and thermos-gelling characteristics in the second phase.
Project scope will be:
- Creation of a range of up to 4X microsphere encapsulations with different size and release/degradation characteristics in size from 10nm up to 1mm. Polarity will be an additional factor to be incorporated meaning potentially 3 polarity variants of each microsphere will need to be created or as a minimum a preferred polarity will be identified
- Creation of a range of up to 4X thermo-gelling phases with different flow, gelling and adherence characteristics
- Evaluation of combination of 4X microsphere and 4X thermos-gelling phase being 16 formulations against criteria for flow, adherence and release/degradation characteristics
- Incorporation into identified preferred combination of up to 5X range of alternative ‘active’ ingredients (already identified by PFLH). And 1X current ‘active’ ingredients
Supplier needs to be skilled and have equipment capable of rapid prototyping of formulations which includes ability and experience with producing relatively complex microspheres and combine with poloxamer based thermos-gel carrier. Supplier will also need appropriate validation equipment and as a minimum will require:
- Rapid prototyping using dispersive mixing technology or similar
- UV-Vis spectroscopy or similar like refraction technology
- laser diffraction techniques or alternative to measure the particle size and particle size distribution
- Familiarity with artificial mucus and artificial mucosa on glass slide techniques
All work needs to be conducted with an understanding of design file requirements for Medical Device products (as a minimum) with appropriate documentation.
Deliverable Timescale
Due to funding constraints project will need to commence by 23/01/2023 with completion by 24/03/2023.
Indicative Budget
This is an initial prototyping phase with an anticipated budget of £18,000 to £22,000. Following 6month evaluation by PFLH it is anticipated that a further phase incorporating regulatory parameter requirements will be required.
Evaluation Criteria
Quotations will be assessed and scored on the following criteria:
- Quality/Technical Merit (50%)
Do the services offered fit the scope of the project?
Does the supplier have the required knowledge and experience to deliver the project?
- Delivery Timescale (25%)
Can the supplier meet the timescales/deadline?
- Cost/Value for Money (25%)
Is the price good value for money? This is not necessarily the cheapest option
Scoring Methodology
| 4 Excellent | Proposal meets and in some places, exceeds the required standard |
| 3 Good | Proposal meets required standard |
| 2 Acceptable | Proposal meets the required standard in most respects, but is lacking or inconsistent in others |
| 1 Poor | Proposal falls short of expected standard |
| 0 Unacceptable | Completely or significantly fails to meet required standard or does not provide the relevant answer |
Proposal Format
Proposals should clearly demonstrate how they meet the requirement set out above.
Deadline and Submission
Proposals are required by 5pm on 17/01/2023 electronically to [email protected] Informal conversation prior to the deadline is encouraged by contacting Richard Wiffen on 07747588926
Date Published
22/12/2022