Ophthalmic preparations are sterile preparations that are used directly in the eye to exert therapeutic effects, mainly for the treatment of dry eye, trachoma, ocular inflammation, retinopathy, glaucoma and so on. Since ophthalmic preparations do not undergo systemic absorption and onset of action, it is difficult to evaluate the bioequivalence between generic drugs and RLDs by traditional methods, which is also the difficulty of consistency evaluation of ophthalmic preparations.
Our Services
As a professional generic drug consistency evaluation company, Alfa Chemistry focuses on providing comprehensive services to clients to ensure that generic ophthalmic drugs match RLD in terms of safety, efficacy and quality. Our services cover the entire process of RLD selection and reverse engineering, to generic drug development, stability examination, and ultimately application for market access.
Market Research
We begin with an in-depth study of the ophthalmic drug market to provide our clients with background, safety and efficacy data on the global launch of RLDs and existing generics, as well as post-market monitoring of adverse reactions.
Pharmacological Equivalence Studies
We conduct detailed pharmacological equivalence studies on the active ingredients, dosage forms, specifications, and stability of RLDs and generics to ensure that the physical and chemical properties of generics are highly consistent with those of RLDs.
Bioequivalence Studies
Methods for evaluating the bioequivalence of generic ophthalmic drugs include clinical endpoint tests, pharmacokinetic tests, pharmacokinetic tests, in vitro tests, etc.
For true solution-type eye drops, the requirements of the US, EU, China and Japan are basically the same because there is no dissolution and release process for the drug. The in vivo bioequivalence test can be exempted when the concentration, specification, type of excipient, and dosage of excipient of the generic formulation and the RLD are the same, and the results of the comparison of physical and chemical properties meet the requirements.
We generally refer to the production and quality requirements of injectables to carry out studies on generic eye drops, focusing on physicochemical properties including pH, relative density, buffer capacity, weight molar osmolality concentration and viscosity.
- Semisolid ophthalmic formulations
Semi-solid ophthalmic formulations include ophthalmic emulsions, ointments, and gels. We adopt different requirements for formulation development, quality control and bioequivalence depending on the type of semi-solid formulation.
For ophthalmic ointments, FDA's bioequivalence guidelines are consistent with those for solution-based eye drops because they are homogeneous systems. The PMDA evaluates the bioequivalence of ophthalmic ointments generally on the basis of comparative PK and PD results in experimental model animals.
The physicochemical properties of ophthalmic ointments that we investigate include appearance, pH, rheological properties, droplet size and particle size distribution.
The FDA bioequivalence guidance for ophthalmic emulsions is generally consistent with that for solution-based eye drops. We compared generic ophthalmic emulsions to RLDs for physicochemical properties including droplet distribution, viscosity, pH, zeta potential, osmolality molar concentration, and surface tension.
Suspended eye drops include glucocorticoid medications, medications for glaucoma, and medications for high intraocular pressure. Because of the suspension-type eye drops on the ocular surface after the administration of the drug, there is still a dissolution and release process. The particle size of the drug, the dissolution rate and the type of solubilizing agent can affect the release of the drug and its clinical efficacy. Therefore, the bioequivalence evaluation of suspended eye drops needs to be analyzed individually according to the characteristics of the specific drug.
Regulatory Compliance and Documentation
We assist our clients in planning market access strategies for generic ophthalmic formulations, ensuring that all research and manufacturing processes comply with the regulatory requirements of the region in which the client operates. We prepare all documents required for drug registration and conduct pre-reviews according to the requirements of drug regulatory authorities.
Ongoing Monitoring and Support
After the successful launch, we continuously monitor the safety and efficacy of the drug and improve the product based on market feedback and regulatory requirements. In addition, we answer customers' questions about generic drugs, as well as help them solve problems encountered during the use of generic drugs.
We provide efficient, flexible and compliant solutions for the pharmacological equivalence evaluation and bioequivalence evaluation of generic ophthalmic drugs, assisting pharmaceutical companies to complete the generic drug consistency evaluation process in a shorter time.
