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

Abstract

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.

Polyethyleneimine and Chitosan Polymer-Based Mucoadhesive Liquid Crystalline Systems Intended for Buccal Drug Delivery

“…All of the formulations had twice the hardness and compressibility values of the commercial formulation, which is interesting because compressibility is a measure of the work required to break the physical bonds within the formulation. These data therefore indicate that molecules within the formulation have rigid bonds with each other which increased the physical stability of the formulation (61).…”

Topical Application of 0.5% Timolol Maleate Hydrogel for the Treatment of Superficial Infantile Hemangioma

“…All samples were collected at different time points (0, 4, 8, and 12 h after the treatment) and dissolved in 20 ml solution (ethanol: distilled water = 4:1) for detection of timolol maleate. The detector wavelength was adjusted to 296 nm according to the UV spectra of timolol (17) and optical density (OD) values of different groups were recorded. Permeation rate was calculated as follows: (OD values at 0 h − OD values at 4 h/8 h/12 h) × 100%/OD values at 0 h.…”

Infantile hemangioma: Efficacy of low‐dose propranolol and of intralesional bleomycin injection for propranolol non‐response

“…They are often invisible at birth and become apparent in the first couple weeks after birth, reaching 80% of their final size in 3–5 months . The rapidly growing proliferative phase is followed by a slow involution phase . Most lesions have spontaneous regression, while medical treatment is indicated in only 10–20% of cases …”

“…Infantile hemangiomas (IH) are benign vascular tumors characterized by endothelial cell proliferation that occurs in the first months of life. 1 IH occur in 5-10% of children <1 year of age, 2 and are located in the head-neck region in 60% of cases, on the trunk in 25% and on the extremities in 15%. 3 They are often invisible at birth and become apparent in the first couple weeks after birth, reaching 80% of their final size in 3-5 months.…”

“…4 The rapidly growing proliferative phase is followed by a slow involution phase. 1 Most lesions have spontaneous regression, 2 while medical treatment is indicated in only 10-20% of cases. 5,6 Treatment is recommended for rapidly growing lesions or in those in such areas as the face, eyelids or nose, where there is cosmetic risk, and for lesions associated with severe complications, such as hemorrhage, ulceration, infection and pain.…”