Physicochemical stability of a new topical timolol 0.5% gel formulation for the treatment of infant hemangioma.

Infant hemangioma (IH) is the most common tumor in infants, which affects 5-10% of white children. It is a tumor of vascular origin that appears in the first months of life. The indication for the treatment of the IH is not approved in the datasheet of the product, however it has been used in the infant hemangioma by topical administration as an alternative to oral propranolol, avoiding the main problems of the oral route (bradycardia and hypotension). The objective of this work is to study the physical and chemical (HPLC stability indicating method) stability of a 0.5% timolol gel for topical application during 60 days (considering the stability limit as 90% of initial concentration of timolol maleate). The gel was prepared with a polyacrylic acid derivative and the physical stability of the system was studied by visual control, rheological and mechanical characterization. The studied formulation guarantees the correct dose administering and stability after 60 days stored at 25 ± 2 °C and light protected (tube of aluminum). We have developed an easy topical gel for the treatment of infant hemangioma with physical and chemical stability higher than those provided by the majority of hospitals.