Title: 

Pharmaceutical composition for topical application and its use in the treatment of hemangiomas among children. 

Protection status: 

Patent application No. P.442316 

Subject: 

The subject of the invention is a pharmaceutical composition for topical use – a non-sterile prescription drug administered on the skin, based on cellulose hydrogel, containing a beta-adrenergic receptor antagonist and a corticosteroid, and its use in the treatment of hemangiomas among children. 

Benefits: 

The pharmaceutical composition according to the invention is applied topically, in the affected area, which significantly reduces the systemic effects of the drugs used so far (oral preparations, injections) – minimizing the risk of side effects of the drugs used, and thus their adverse effects on the children’s health. The possibility of applying the formulation at home, so the patient’s hospitalization and the involvement of specialized personnel is not required with the possible risk of local and general complications. 

Two substances from two different therapeutic groups (beta-adrenergic receptor antagonist and corticosteroid), which were previously used separately, were combined in one formulation, thus avoiding the use of several preparations at the same time, without knowing the effects of their interaction (antagonism, synergism), which affected the safety of the drug.  

The pharmaceutical composition according to the invention makes it possible to reduce drug doses when administered topically (externally), since it is not necessary to saturate the entire body of the patient to achieve such a concentration of the drug to reach the lesion.  

The results of in vitro studies of the synergism of the combined drugs effects (corticosteroid and betablocker) at appropriate concentrations, made it possible to reduce their doses and increase their potency compared to the standard concentrations of the drugs administered separately – the addition synergism was achieved. 

Stage of work: 

In vitro laboratory tests are being conducted. 

Application: 

The formulations are dedicated to pediatric patients aged 1 month to 3 years. The formulation for children aged 1-6 months contains triamcinolone acetonide at a concentration of 0.02% and labetalol chrolovodide at a concentration of 0.07%, while the formulation for children aged 1-3 years contains triamcinolone acetonide at a concentration of 0.03% and labetalol chrolovodide at a concentration of 0.12%. 

Contact: 

@:  sylwia.grzelak@umed.lodz.pl, tel.: 502 447 575