Ophthalmic Product Development

Ophthalmic Formulation Experience

Common challenges with ophthalmic formulation development are API solubility, API stability and poor penetration through the ocular tissue. At Dow we focus exclusively on topical products, so our formulation scientists have overcome these challenges. Our goal for your API is to develop stable, non-irritating prototype formulations and select appropriate packaging components that will deliver the optimum drop size. Our Analytical Sciences group is highly experienced with ophthalmic products. They will develop and validate your analytical test methods and will conduct your GMP stability studies.

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In vitro Ocular Drug Deposition and Penetration Studies

Ocular penetration of multiple prototype formulations is evaluated in our on-site in vitro Laboratory. This unique newborn bovine ocular penetration model significantly improves our ability to evaluate drug penetration through ocular tissue. Fresh scleral, corneal, and/or conjunctival tissue is isolated from newborn bovine eyes obtained from local sources, and is used to screen, optimize, evaluate and select ophthalmic formulations for further development.

Dow’s Unique In Vitro Drug Testing Model Using Tissue Isolated From Newborn Bovine Eyes

Tissue from rabbit or adult bovine eyes are most commonly used for ocular drug penetration studies. Tissue from rabbit eyes are appropriate for corneal investigation, but are not large enough for scleral testing. Adult bovine eyes are of adequate size for scleral testing, but the corneas tend to be damaged. Newborn bovine eyes are of a much higher quality than adult bovine eyes, and are of sufficient size for both scleral and corneal testing of drug permeation.

Using the Bronaugh flow-through diffusion cell system and the bovine in vitro model developed at Dow, we can screen multiple prototype formulations for ocular penetration. To ensure uniformity, we use freshly excised bovine ocular tissue prepared by our own personnel. Concurrently we evaluate physical and chemical stability and compatibility with packaging components. If required, we further optimize for enhanced penetration and work with you to select a lead formulation and a back-up for further development.

Manufacturing, Labeling and Distribution to Clinical Sites

Non-clinical supplies are manufactured at Dow and sterile filtered at the study sites. Clinical supplies are manufactured at one of our audited and qualified sterile ophthalmic product vendors, which can be managed by Dow. We also label and distribute your clinical supplies worldwide.

Ophthalmic Development Services

Our ophthalmic product development team has accumulated years of experience in R&D at major eye care companies, resulting in successful formulations for a variety of indications. Coordinated by a project manager, in one location you have a full team of specialists to provide formulation development and optimization, in vitro ocular penetration studies, analytical method development and validation, stability, manufacturing of toxicology supplies, labeling and distribution to your clinical sites. All these services in one location should save you time and money.

To Learn More

Please contact Karen Hanley, Associate Director of Business Development, Tel 707-793-2600 (x 665) for additional information. We encourage you to visit our facilities. Tel: 707.793.2600 to schedule an appointment.

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