19/20 March 2024
The considerably expanded draft monograph <771> in the American pharmacopeia includes topical ophthalmic products like eye drops as well as ophthalmic preparations for injection purposes. These products are manufactured using terminal sterilisation, sterile filtration and aseptic filtration. An overview lists and describes the different pharmaceutical forms in more detail: solutions, suspensions, ointments, gels, emulsions, strips, injections, inserts and implants. However, the part on product quality is particularly interesting, especially the general tests. According to this, all ophthalmic preparations are to undergo a test to determine the integrity of the packaging and to test for visible particles. A 100% test is only mentioned for ophthalmic preparations for injections in transparent containers. If this is not possible due to the characteristics of the containers, reference is made to random sample tests in monograph <790>. The requirements with regard to subvisible particles are depending on the route of adminstration: According to the draft, products for intraocular use are to correspond with the the monograph Particulate Matter in Ophthalmic Solutions <789>, products for extraocular use should comply with the monograph Particulate Matter in Injections <788>.
The inclusion of a limit value for invisible particles in ophthalmic preparations is currently being discussed in Europe, too. You can find information on the discussion of expanding monograph 1163 on the EDQM homepage.
Further sections in the USP monograph discuss sterility, preservatives and endotoxins (in injectable products). The requirements described for leachables/extractables that may come from the packaging are also new. It is pointed out that a risk assessment of leachables/extractables is not easy to perform, as there is little data about substances that can be absorbed via the eye. Therefore, data that has been determined for other routes of administration can be used for the risk analysis.
Furthermore, the special tests that may be relevant for ophthalmic preparations are listed, such as viscosity, particle size distribution (in suspensions/emulsions) and drop size.
The planned changes to monograph <771> can be found in the Pharmacopeial Forum. Access is free, all you have to do is register once free of charge. Comments may be submitted until 30 November 2015.