CLINICAL ASPECTS OF DIFFERENT PHARMACEUTICAL FORMULATIONS OF PROPRANOLOL IN THE TREATMENT OF INFANTILE HEMANGIOMA

Abstract

Infantile hemangiomas are one of the most common benign vascular tumors in infants and children.Because hemangiomas can resolve spontaneously, they usually do not require specific treatment unless theproliferation interferes with normal function or causes interference with the function of essential vital organs. Thereare several types of therapy, but in recent decades the use of propranolol has become more common due to itsexcellent effectiveness.The purpose of this paper is to analyze different pharmaceutical formulations of propranolol in the treatment ofinfantile hemangioma, including technological differences of the oral and topical pharmaceutical dosage forms ofpropranolol. The European Medicines Agency (EMA) has approved the commercially available oral propranololtherapy in the countries of the European Union, but this is not yet happened in our country. Recommendations tofollow and use the protocols for the oral application of propranolol in the treatment of this disease are difficult dueto the fact that this drug formulation is not registered in our country and patients are forced to obtain it fromcountries where it is registered.The use of syrup as an oral form of therapy has been clinically proven and has a high percentage of efficiency ininfantile hemangioma, but side effects such as sleep disturbance, bronchospasm, hypoglycemia, hypotension.The goal of this publication is to propose the most appropriate topical formulation of propranolol for external use ininfantile hemangioma through a review of relevant published data on the use of various pharmaceutical formulationsof propranolol in clinical studies and documents from the European Medicines Agency,In this paper, we used compilation and comparison methods, as most useful for a high-quality critical evaluation ofthe literature regarding problematic topics, in our case the pharmaceutical formulation of propranolol, the effect ofclinical treatment and the required legislation, and which have the potential to promote clearer, sharedunderstandings and accelerate advances in the research.Our results were focused on obtained and published data related to pharmaceutical-technological aspects ofproduction of topical formulations and the effect of clinical application, especially when it is necessary to defineexactly the amount of the released active compound from the topical form (cream, ointment or gel) and itsabsorption through the skin.Topical form of propranolol avoids the side effects of oral administrated propranolol, can help maintain a high levelof active ingredient in a local or focal region, and has an easy way of administration.The obtained research data showed that the topical application and penetration of propranolol through the skin isgood and has a lower and controlled systemic absorption. To achieve this, the choice of the formulation and theexcipients used are particularly important. Lipophilic formulations have limited release and penetration ofpropranolol. The best results are achieved by using a hydrophilic cream.After the research done, we can conclude that the production of topical formulations containing specific activecomponents with a strong systemic effect, such as propranolol, can be carried out in galenic laboratories or hospitalpharmacies. For this, already existing validated equipment and excipients that are readily available can be used.We believe that the use of topical pharmaceutical forms for local application, even in children such as the case ofpropranolol in infantile hemangioma, is justified, especially to the fact that so far no side effects have beenregistered even after long-term therapy.