Reconstituted ocular gel for cystinosis treatment

Cystinosis is a rare genetic disorder that causes an accumulation of cystine into cells and its corneal crystal deposition. The main treatment for this ocular disorder remains the continuous administration of cysteamine, which may lead to non-compliance, especially in childhood. Reconstituted gels (RG) are described here as a possible alternative to the current formulations consisting of aqueous solutions of cysteamine salts. RG are dried powders containing cysteamine, tartaric acid, carbopol and a polyhydroxylated compound that are reconstituted at the time of use with water, thus obtaining immediately the final gel. The rheological behavior of the gels prepared with lactose and mannitol was pseudoplastic, while the gel prepared with sorbitol was not markedly pseudoplastic. All the formulations tested were physically and chemically stable for one year at 25 °C and cysteamine, present in the gel obtained after reconstitution, was stable for at least one week at 4 °C.