Overview:
yet2’s client, a multinational supplier of Over the Counter (OTC) medicines is looking to develop controlled release API in a liquid-based delivery platform. The API must remain stable in the liquid when on the shelf, without leaching or degradation, and when ingested must release over a 12-hour extended-release time period.
Background:
Oral liquid formulations are easier to swallow, allow simple dose adjustment, and often provide faster absorption than solid dosage forms. The API to be delivered has a short half-life of 1-2 hours in the body, and is highly dissolvable/hydrophilic & hence needs to release over in a sustained/ controlled way to deliver the API over a period of 12 hours from a liquid format to achieve once every 12 hour dosing.
Requirements
The solution will:
- Maintain shelf stability (e.g. no leaching or degradation of API while in the liquid) for a minimum of 18 months preferably up to 2 years & beyond.
- Deliver a sustained release of an active ingredient over 12 hours with tuneable dissolution profiles.
- Be compatible with hydrophilic small molecules
- Proven safe in humans using APIs or functional ingredients
- Have pleasant mouthfeel, be pourable
Nice to have:
- Clinical data on APIs that have used with this technology
- IP protection
- Demonstrated scalability
Possible Solution Areas, but open to other recommendations:
- Unique suspending agent
- Hydrogels
- Microemulsions
- Solid-in-Oil-in-Water emulsion
- Microspheres
Desired outcome of the solution:
Our client is looking for partners with whom to develop a new liquid format with a controlled release API for use in an OTC product.
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