Propranolol is used as the first-line treatment for infantile
hemangiomas (IHs). As oral formulations can cause systemic
adverse drug reactions (ADRs), we prepared topical
propranolol formulations and evaluated their pharmaceutical profiles. We also present three cases of pediatric patients with IHs who were treated with the
propranolol formulations.
Propranolol cream (hydrophilic cream, 1, 3, and 5%) and
gels (carboxyvinyl
polymer,
hydroxypropyl methylcellulose,
gellan gum, 1%) were prepared. The in vitro skin permeability of these formulations was assessed using Franz-type diffusion cells. The pharmaceutical profiles, including
propranolol content, pH, and ductility, of the
propranolol creams were evaluated. For the stability test, similar pharmaceutical evaluations were performed after the creams were stored at 25 °C and 56% relative humidity for 3 months. We examined three patients treated with
propranolol cream to investigate the
clinical course of IH and adverse events after the
propranolol cream was applied for 5-12 months. In the in vitro skin permeability assay, topical
propranolol formulations made of hydrophilic cream and
gellan gum permeated the most. The amount of
propranolol that permeated increased with
propranolol concentration. After storage for 3 months, no substantial changes were observed in any pharmaceutical profile. The IHs were discolored in all patients.
Tumor size also decreased in some patients. Furthermore, no adverse events caused by
propranolol cream were observed during application. In conclusion,
propranolol cream can be prepared as a hospital formulation with adequate quality. Topical
propranolol therapy is effective in reducing the incidence of systemic ADRs.