Protetor solar: desenvolvimento farmacotÃcnico e avaliaÃÃo da eficÃcia e seguranÃa

AUTOR(ES)
DATA DE PUBLICAÇÃO

2005

RESUMO

Besides its physiologic functions, the skin has an important social function, as it could be associated with good health and well-being. Day by day, the skin is exposed to many hazardous factors, such as solar radiation. The understanding about harmful effects caused by excessive sun exposition increased the consumption of sunscreen lotions. Simultaneouls, it is necessary the development of more effective and safe sunscreen lotions, capable to promote effective skin protection front to variations of intensity of sun light, to skin type and age group. For such reason, the aim of the present study was to develop sunscreen formulations with low, medium and high sun protection factor (SPF) and evaluate the effectiveness and safety of the preparations. The first stage of the work was to evaluate several emollients, wich influence the solubility of sunscreen and affect the SPF and, consequently the formulation stability. We evaluate the influence of five different emollients (caprylic/capric triglyceride, alkyl benzoate, phenylethyl benzoate, isopropyl myristate and isopropyl palmitate) in formulations containing 7,5% (p/p) of octylmethoxycinnamate and 6,0% (p/p) of benzophenone-3, as chemical sunscreens. The results demonstrated that caprylic/capric triglyceride and the phenylethyl benzoate carried out very good solvent properties and kept the stability of the formulation at the time and temperature scheduled. In order to maintener the final quality of the product and following the parameters for sunscreen lotions registration, as described in the Resolution RDC n 237 of the AgÃncia Nacional de VigilÃncia SanitÃria (ANVISA), we verified relevant properties of the formulation which influence on SPF determination, water resistance and skin irritability. The incorporation of film forming agents (silicons and polymers), we obtained satisfactory results with the copolymer PVP/eicosene, when associated with polymeric emulsificants and emulsifyings with low hydrophilic character. The proposed formulations reached the expected values of SPF (8, 15 and 60) and no adverse reactions (redness, edema, wheal or vesicles) were detected in the skin application areas. In attempt to follow market tendencies, we evaluated the fotoprotection potencial of glycolic extracts of Calendula officinalis and Matricaria chamomilla incorporated on the formulation with FSP 15. We observed a better protection with M. chamomilla extract. Based on our results, we conclude that caprylic/capric triglyceride and the phenylethyl benzoate were the best solubilizants for benzophenone-3. The copolymer PVP/eicosene increased the O/W emulsion performance improving water resistance. The expected SPF values were obtained in both in vitro and in vivo, and no side effects were detected. The incorporation of Matricaria chamomilla glycolic extract increased the fotoprotection activity of the formulation

ASSUNTO(S)

protetor solar water resistance glicolics extracts calendula officinalis sunscreens patch testing extratos glicÃlicos emolientes fator de proteÃÃo solar (fps) emollients resistÃncia à Ãgua matricaria chamomilla farmacia teste de contato calendula officinalis sun protector factor (spf) matricaria chamomilla

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