OXProfen™ - Ibuprofen Case Study

 
 
 
 
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OXProfen™

OXProfen™ is the ibuprofen implementation of the OXPzero™ platform, engineered to deliver rapid onset while maintaining controlled systemic exposure.

Clinical Evidence
• Bioequivalent to standard ibuprofen for AUC and Cmax
• Median Tmax ≈30 minutes in a direct head-to-head human PK study versus fast-acting ibuprofen lysine (Tmax ≈40–45 minutes)
• Demonstrates that rapid onset can be achieved without increasing Cmax beyond standard ibuprofen exposure levels
• Intrinsic taste masking enabling consumer-relevant formats
• Early endoscopy data suggest reduced irritation potential relative to standard formulations

Illustrative Applications
This case study illustrates the platform's potential relevance to both prescription and OTC formulation contexts, illustrating the breadth of application achievable through the underlying LDH technology.

Regulatory Pathway
OXProfen™ illustrates how the platform's underlying reformulation approach can, in principle, be applied within established regulatory frameworks such as 505(b)(2) in the United States, leveraging the existing safety profile of a well-characterised API.


Platform Breadth
The same underlying LDH technology has also been applied to naproxen, with human PK studies demonstrating bioequivalence to naproxen acid, illustrating the platform's applicability beyond a single API.



Intellectual Property – Oxford PharmaScience holds background intellectual property underpinning the OXPzero™ platform, including patents covering LDH composition, manufacture, and drug delivery applications. Specific product development — including any new formulation, clinical, or regulatory IP arising from further work on a given application — is carried out and owned by the development partner taking that application forward.

Contact: contact@pharmascience.co.uk