Toward the practical implementation of eye-related bioavailability prediction models.

Area of Science:

• Ophthalmology
• Pharmacokinetics
• Drug Development

Background:

• Reformulated ophthalmic products (OPs) necessitate specific bioavailability (BA) assessments.
• Existing BA algorithms for other administration routes, like oral, are not suitable for ophthalmic applications.
• Challenges exist in developing and registering OPs due to limitations in current BA testing methods.

Purpose of the Study:

• To analyze existing literature on nonclinical models for eye-related drug bioavailability.
• To propose future directions for developing high-capacity, cost-effective, and predictive nonclinical BA models for OPs.
• To facilitate routine use of these models in pharmaceutical research and development.

Main Methods:

• Literature review and analysis of current nonclinical models for ophthalmic drug bioavailability.
• Identification of key characteristics for effective nonclinical BA models (high-capacity, cost-effectiveness, predictability).
• Exploration of potential combinations of models for enhanced performance.

Main Results:

• Current literature highlights the inadequacy of standard BA algorithms for ophthalmic products.
• Several nonclinical models show promise but require further development for routine use.
• A combination of models may offer a more robust approach to ophthalmic BA assessment.

Conclusions:

• Advanced nonclinical models are crucial for the successful development and registration of reformulated ophthalmic products.
• Future research should focus on creating cost-effective, high-capacity, and predictive nonclinical models for ophthalmic drug BA.
• These models have the potential to streamline the development and registration process for OPs in the pharmaceutical industry.