Ophthalmic Drug Development
Preclinical Support
We assist our clients' needs utilizing a team and network of partners with extensive ophthalmic experience in the identification, characterization, support of in-vivo studies, and acquisition of compounds:
- Pre-formulation evaluation of drug solubility and excipient compatibility
- Extensive knowledge base of existing ophthalmic compounds and drug delivery technologies
- Formulation and design of prototype formulations to optimize success for chemical and physical stability
- Pilot scale manufacturing to scale up
- Dedicated internal staff and a state of the art cGMP lab facility dedicated to supply the needs of preclinical studies
Ophthalmic Dosage Forms
We have significant experience in developing the optimal ophthalmic drug forms and delivery technologies for your product.
- Solutions
- Suspensions
- Ointments/Gels
- Emulsions
- Prefilled syringes
- Depot and sustained release technologies
- Lyophilized products
Ophthalmic Drug Delivery
We have an extensive working knowledge of currently available and proprietary drug delivery systems which can be utilized to assist our development partners in their unique drug delivery and therapeutic objectives. In past projects we have assisted our partners to enhance ophthalmic drug delivery by:
- Increasing ocular surface residence
- Improving therapeutic efficacy
- Reducing active ingredient concentration
- Reducing off target systemic exposure
- Extending market exclusivity/life cycle management
- Enhancing delivery to the posterior of the eye
Clinical Supplies and Manufacturing Support
We have a long history of working with aseptic contract manufacturing facilities world-wide and we will assist in the selection with the scaleup and transfer of formulations to a contract manufacturing facility. We assist our clients by utilizing our deep knowledge of today's regulatory requirements.
- Process development and validation
- Stability studies
- Project activity
- Product support
- Technical writing of regulatory filings