This article reports the results concerning the design and manufacture of a novel polymeric film for ocular administration
of acetazolamide (AZM), and a patent document presented to INPI- National Institute of Industrial/Intelectual
Property. The system was designed using mucoadhesive polymers, such as carbomer (CB974P) and sodium carboxymethylcellulose
(NaCMC), combined with the poloxamer (POL407) which behaves as a swelling modulator, surfactant
and slightly plasticizer. The maximum amount of AZM to be incorporated without loss of homogeneity or precipitation
of the drug, was 0.04 mg AZM/mg of the film. The addition of a polymeric coating based on Eudragit RSPO (cationic
permeable polymethacrylate polymer) allowed optimizing drug release. The coating in a proportion of 10% (determined
as percentage of total weight of the film) seemed to be the most adequate, since 80% of controlled drug release was
achieved along 240 minutes. This coating membrane did not affect the mucoadhesive properties of the swellable polymers.
Thus, the system obtained, showed good efficiency and the intra ocular pressure (IOP) decreased according to the
results derived from in vivo studies performed on normotensive rabbits. Finally, irritation scored studies demonstrated that
these systems were not irritant for rabbit´s ocular mucosa.