Formulation of ophthalmologic forms in hospital

The preparation of ophthalmologic forms in the hospital mainly concerns eye drops but can also involve solutions for intraocular, intravitreous and intracamerular injections. In hospital, this means meeting a need expressed by ophthalmologists that has not been fulfilled by the pharmaceutical industry.

The formulation of an ophthalmic solution must meet 3 main objectives: sterility before and after opening, tolerance at the site of administration and physical and chemical stability over time. That will determine the characteristics of the solution and the choice of the excipients. The formulation must take account of the optimisation of the solvent, of the pH and of the isotonics but may also include the viscosity, surface tension and chemical stability (anti-oxidant).

The manufacturing process must take account of the method used to obtain sterility and the choice of an antimicrobial preservative will be linked to the type of packaging adopted (single or multi-doses).

Thought must also be given to the nature of the active principle – a pharmaceutical raw material or an injectable speciality. Even if French Good Preparation Practices give pride of place to the latter solution, the question must be raised, taking account of various factors such as the quantity manufactured, the production facilities available and the intrinsic characteristics of the active principle and of the injectable speciality.