Commercial ophthalmic manufacturing
The known advantages of the ocular route of drug administration is that it ensures that the drug substance is available in higher concentrations than oral administration. As the population ages, ophthalmic solutions are increasingly in demand. Recently there has been success of a number of drugs, both utilizing NCEs and previously approved APIs for alternate indications, to treat ocular diseases which has resulted in an increased interest in ocular drug discovery.
Bora’s Taoyuan facility, the first FDA-approved ophthalmic site in Taiwan, further strengthens Bora’s position as a global CDMO leader. The facility established in 2014, specializes in sterile ophthalmic products and can produce all the main sterile ophthalmic forms, such as, multi-dose with preservatives, multi-dose without preservatives, gels, creams, and ointments.
Nano-emulsions and nano-solutions are considered some of the most promising routes of delivery of ophthalmic drugs
These novel approaches emphasize on the benefits of various ocular drug delivery systems, for example, eye ointments, gels and use of viscosity enhancers, prodrugs, penetration enhancers, microparticles, liposomes, nanoparticles, nanosuspension, and micro-emulsion. In addition to acting as a carrier to deliver poorly water soluble API and reducing the oxidative degradation of API, ointment products can cover the wound for postoperative patients and prolong the protection and release of the API.
- Administration of poorly water soluble API
- Increased Bioavailability
- Improved Stability
- Topical ocular extended/controlled release
- Reduced Side Effect of API
State-of-the-art manufacturing, filling, packaging, and serialization
At our Taoyuan ophthalmic manufacturing facility, customers’ products are manufactured in a controlled environment (ISO 5 for filling operation) that minimizes contact with airborne contaminants. Our customized suites include one-way air flow, high-efficiency particulate air (HEPA) filters, isolators/ restricted access barrier systems (RABS), automated handling systems operated by trained and experienced staff. The automated handling system incorporates the aseptic operations from filling, nozzle insertion, and capping, and the packaging operations for labeling and encasing. Bora currently fills liquid form products from 2.5 mL to 15 mL in different sizes and shapes of eye-drop bottles. Among the semi-solid dosage form, we are able to produce ointment, cream and gel products and fill 1 gm to 5 gm in different sizes of aluminum or laminated tubes. Ophthalmic products require the primary and secondary packaging to be completed and inspected with the same care as the manufacturing of the product itself.