ICEBREAKER

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A Clear Path To The Clinic

Objectives

a) Our Icebreaker service develops a clinical formulation for your poorly soluble compound that delivers maximum and reproducible bioavailability. This in turn minimizes the dose that needs to be administered

b) We provide an informed SWOT analysis of your formulation and manufacturing process. This should help you to circumvent any nasty surprises that could wreck your compound’s development

c) Icebreaker supplies you with product for testing to establish the best formulation strategy for your compound

Background

The development path for a poorly soluble compound heading to the clinic is rarely straightforward. Plotting a path to the clinic within a limited timeline and budget can be very testing indeed. Technical challenges for oral formulations may include:

• increasing drug load
• improving physical stability
• maximizing the bioavailability
• selecting a production technology suitable for use at a contract manufacturer

For intravenous formulations, there are the following challenges to consider:

• preventing precipitation after injection
• reducing irritation
• removal of undesirable excipients
• selecting a production technology suitable for use at contract manufacturers

One thing's certain; you need a strategy that is highly robust.

Strategy

Icebreaker helps by identifying and developing the most promising approaches to improve the delivery of your poorly soluble compound.

The suitability of the promising options is not just based on technical performance. It also takes into account IP and commercial aspects, such as cost of goods and freedom to operate.

Where possible, Icebreaker applies the most straightforward, no-nonsense approaches first. More sophisticated techniques are only engaged if these straightforward approaches founder.

Your compound is placed in the safe hands of our experienced technical team who have a remarkable track record of success. The team adds a magic touch to your program by thinking outside of the box to generate practical, scalable solutions.

Icebreaker is offered as fee for service.  

Equipment

• The ’Icebreaker’ Zone is dedicated to the processing of poorly soluble compounds into solid and semi solid/liquid dosage forms
• Icebreaker gives you direct access to development experts and an excellent state of the art infrastructure built up specifically for dealing with poorly soluble compounds
• Benefit from the investments we have made in state of the art physical testing - a corner stone for building up a reliable technical package for your poorly soluble compound. This is particularly critical in situations where amorphous or meta-stable systems have to be developed

Technologies

Using the Icebreaker service enables you to select the best delivery approach for your compound from a vast array of technologies for oral and parenteral administration.

The technologies employed in Icebreaker span conventional through to specialist techniques developed by Phares specifically for improving the delivery of poorly soluble compounds- giving you the best chances for success.

At this stage of development, if feasible crystalline forms are usually preferred. However, Solubilized systems may be applied if the drug load is not too high and chemical stability of the compound in the system is sufficient. Amorphous forms can be cautiously developed if crystalline or solubilized systems are inadequate. However, amorphous forms are typically more costly and riskier to develop because more extensive testing and time are required.

Time Frame

• Promising approaches explored and identified within 6 weeks
• Report and Supply within 12 weeks from receipt of compound
• Frequent communication on progress and results

You Need Icebreaker If...

• You are unhappy with your insoluble compound’s bioavailability which is low or variable and needs to increase
• You are using an excipient or formulation that cannot readily be taken forward into man
• You need to increase the drug load in your formulation
• Your compound undergoes physical changes upon storage or there is a change in solubilization or dissolution upon storage