Introduction—Include additional requirements for particulate matter content for injections, and add the intracameral route to Figure 1. Delete the Note regarding informational chapters.
Ophthalmic Dosage Forms—Add the option of using a special packaging system that maintains sterility instead of employing an antimicrobial preservative. Clarify how injections are defined. In the Drug–Device Combination Products section, add that light sources can activate photoresponsive drugs.
Drug Product Quality—In the Particulate and Foreign Matter section, clarify the requirements according to the route of administration. In the Antimicrobial Preservatives section, add that antimicrobial preservatives are not necessary if the packaging system can maintain sterility of the product during its shelf life. In the Leachables and Extractables section, add a reference to Plastic Packaging Systems and Their Materials of Construction 〈661〉. In the Added Substances section, add that the use of ingredients to impart a color is permitted when it is needed to visualize the administration location of the product.
Ophthalmic products are sterile products that are intended for application to any ocular structure, including any space adjacent to an ocular structure and its immediate surrounding spaces.
The routes of administration of ophthalmic products fall into three general categories: topical, intraocular injections, and extraocular injections. Topical drug products are intended to be administered to an ocular surface component, such as the eyelid, conjunctiva, or cornea, and can produce local or systemic effects. Intraocular and extraocular injections are administered through external boundary tissue. ▲Due to the potential sensitivity of some ocular tissues, injections have additional requirements for subvisible particulate matter content (see Particulate and Foreign Matter).▲ (USP 1-Dec-2022)The ophthalmic routes of administration include, but are not limited to: topical, subconjunctival, sub-Tenons, subretinal, subchoroidal, intracorneal, intrascleral, suprachoroidal, intravitreal, intracameral, juxtascleral, and retrobulbar routes (see Figure 1). Ophthalmic products are administered to the eye in a wide variety of dosage forms, including but not restricted to: solutions, suspensions, ointments, gels, emulsions, strips, injections, inserts, and implants.
Source from USP and Please refer to USP for details:
RTU(ready to use) 2ml COP vial
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