Initial Feasibility:
Our product development scientists specializing in ocular semi-solid and liquid formulations select excipients from the FDA’s IID (inactive ingredient database) as appropriate for application to the eye. These ingredients and their levels are chosen and evaluated with the active pharmaceutical ingredient (API) to support the solubility of the API as well as stability (to be sure that the excipients do not adversely affect API stability.)
Development:
After pre-formulation studies and concurrent analytical method development, additional ingredients are then included, and multiple formulation prototypes are developed in an iterative fashion to achieve appropriate pH, viscosity, residence time, and osmolality (tonicity) to promote patient comfort and prevent damage to ocular tissues.
Drug product prototypes include gels, ointments, suspensions and solutions. A preservative system is typically included if the product is multi-use; single-use products may be preservative-free. Primary packaging may be droppers, tubes, vials, syringes, bottles or pumps, comprised of materials compatible with the compound and the product, and selected as appropriate for application for the condition to be treated.
Products are developed for therapeutic indications including glaucoma, dry eye, diabetic retinopathy, pain, infection and inflammation (keratisis, uveitis, post-surgery.)
Ways in which we help our clients advance their ophthalmic product programs:
- Prototype formulations are developed and R&D stability data is generated to support selection of a lead formulation and to support an IND filing. Non-sterile supplies for GLP (IND-enabling animal safety studies) are then prepared, which may then be terminally sterilized, or sterile-filtered at the study site prior to use.
- For compounds and products that are stable to either heat (autoclave) or radiation (gamma, e.g.), clinical supplies are manufactured and filled non-sterile in our GMP production suites and then terminally sterilized before use in the clinic. Product release testing includes sterility, pH, osmolality, viscosity, appearance, and assay of active compound (HPLC).
- Small scale product manufacturing and filling (up to 40 kg scale), coupled with terminal sterilization and packaging, labeling and distribution, are conducted for use of the product in the clinic (Phase I, II or III studies) or for commercial use.
