High purity excipients for ophthalmic drug delivery

Super Refined™ excipients for ophthalmic drug delivery

The eye naturally provides a complex delivery route for drug actives, as it is necessary to circumvent its protective barriers without causing damage to the sensitive eye tissues. Developing an ophthalmic drug product requires focus on key factors, such as drug stabilisation, irritation minimisation and meeting low endotoxin level requirements. These factors can impact final formulation success. High purity excipients can maximise the success rate of drug development by offering enhanced API stability, reduced cellular irritation and minimised endotoxin contribution to the final formulation. 

High purity excipients for ophthalmic drug delivery

Our proprietary Super Refining process yields highly purified excipients that can maximise drug product value and are indicated to stabilise, solubilise and optimise the active ingredients in the formulation.

Reduced peroxide values

Our Super Refining process removes potentially hazardous species such as peroxides and carbonyls. Our high purity and Super Refined excipients provide increased API stability, reduced cellular irritation and improved patient compliance due to their low impurity profiles.

Reduced cellular irritation

Formaldehyde is a known cellular irritant, with high levels of formaldehyde being indicative of greater cellular irritation. Our Super Refined Polysorbate 20 has lower formaldehyde levels compared to its standard compendial grade counterpart, lowering the potential of cellular irritation and improving patient comfort. 

Reduced endotoxin levels

With strict guidelines for endotoxin testing on the final drug product, there is a need to formulate with ingredients that have minimal contribution to the total endotoxin level. The Super Refining process yields a reduction in the endotoxin units (EU/ml) of the high purity excipients within this product range, helping you formulate with confidence.

Ophthalmic drug value:

• Optimised drug performance
• Increased patient compliance
• Decreased formulation development time
• Increased speed to market.

Benefits and features of our products for ophthalmic drug delivery:

• LAL testing on each batch
• Low peroxide levels
• Low moisture
• Multi-compendial - USP/NF, Ph. Eur., JPE/JP and ChP.