Pharmacokinetic and safety evaluation of the use of ciprofloxacin on an isoniazid-rifampicin regimen in rabbits

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

In vitro and in vivo safety evaluation of Dipteryx alata Vogel extract

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

In Vitro Safety Evaluation of Caffeic Acid

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Evaluation of seafood quality market in Baixada Santista/SP

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Toxicologia dos cosméticos

Although not desirable, cosmetic products can cause some adverse effects in me user. Such effects can be due bom to individual factors and by inadequate use. So, the safety evaluation must precede the placement of the cosmetic product in the market. Once the consumer has free access to cosmetic product, it must be safe in normal conditions or reasonably previsible of use. Historically the evaluation tests were accomplished with animals (in vivo) but, at the moment, some research centers have been adopting new alternatives (in vitro) in order to replace me tests with animals. This article emphasizes me necessity of accomplishing toxicity assays for personal hygiene products, cosmetics and perfumes, an also presents the tests in vivo and in vitro used, approaching the necessity of alternative methods to the assays in vitro in the evaluation of security of them.

Ensaios biológicos para avaliação de segurança de produtos cosméticos

Despite efforts to the contrary, some cosmetic products can cause undesirable side effects in the users. These may often be due to individual factors or inappropriate use of the product. Thus, biological assays to assess the safety of a new cosmetic must precede its being placed on the market. Historically, these tests have always been carried out in vivo, in animals, since such tests can be used to evaluate many of the potential risks, such as irritation, allergy or systemic effects; but, recently, some research centers have been adopting in vitro alternatives, in order to replace the animal tests. This review emphasizes the need to employ biological assays to test the safety of cosmetic products, and reviews the main in vivo and in vitro tests used, focusing on the need to develop and use alternatives to the in vivo assays of product safety, so as to offer the consumers the maximum safety with the least possible risk, while ensuring the best conditions of use of the product.

Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos

Aim: This study aimed to compare the safety and analgesic efficacy of a new topical drug (in two different presentations: cream and aerosol) consisting of benzocaine, menthol and triclosan, in the curettage of molluscum contagiosum. Method: The study included 296 volunteers in different stages: 256 healthy adult volunteers for the safety evaluation, and 40 volunteers between 2 and 12 years old who presented Molluscum contagiosum, for the evaluation of tolerability and efficacy. Each volunteer represented two experimental units (left and right) where it was applied randomly the tested products (cream or aerosol) 30 minutes before the dermatological curettage, immediately after and twice a day during 7 days. Dermatological evaluations of safety and efficacy were performed immediately after the procedure, 3 and 7 days after the curettage. Results: During safety evaluation, the tested products showed no irritant, sensitizing, phototoxic or photosensitizing potential. Both presentations, cream and aerosol, were considered safe with no statistically significant differences between them. With respect to analgesic efficacy, the results showed that the medication promoted the reduction of painful symptoms and there was no statistically significant difference (p <0.05) between the two presentations. Conclusion: The tested product, in two different presentations, was considered safe and effective in controlling pain symptoms during and after the curettage of molluscum contagiosum. © Copyright Moreira Jr. Editora.

Desenvolvimento e caracterização físico-química de sistemas nanoestruturados contendo palmitato de retinol: controle microbiológico, avaliação da segurança e eficácia no tratamento do envelhecimento cutâneo

Pós-graduação em Ciências Farmacêuticas - FCFAR

Five Percent 5-Fluorouracil in a Cream or for Superficial Peels in the Treatment of Advanced Photoaging of the Forearms: A Randomized Comparative Study

BACKGROUND The antimetabolite 5-fluorouracil (5-FU) is used for topical treatment of actinic keratosis. Overall improvement in the skin is also observed. Additionally, 5-FU was reported to be used for superficial peels.OBJECTIVES To evaluate the efficacy and safety of 5% 5-FU cream compared with peels for photodamaged forearms.METHODS This interventional, randomized, comparative, evaluator-blind study included 32 patients with severe photoaging of forearms. The regimens comprised either application of 5% 5-FU cream everyday for 4 weeks on 1 forearm and 4 weekly peels on the other. Efficacy assessment included: clinical photodamage scores, opinion of patients and investigators, and blind photographic evaluation by independent observers. Skin biopsies were performed for histologic and immunohistochemical analysis. Safety evaluation comprised observation of adverse events.RESULTS Clinical and histologic findings confirmed the benefits of topical 5% 5-FU, in cream or peels, which improved skin appearance and decreased the dermal elastotic material. Immunohistochemistry showed reduced levels of epidermal p53 and increase in the level of procollagen I. Results were maintained after 6 months. Predictable adverse events occurred, with no differences between treatments. Patients reported better tolerability to peels.CONCLUSION Five percent 5-FU cream or peels was safe and effective for the treatment of photodamaged forearms. Decreased epidermal p53 levels and new dermal collagen were confirmed.

In vitro evaluation of the safety profile of cosmeceuticals containing growth factors and their analogues

Introduction: Aging skin is a condition that affects (or will affect) all people, and its treatment is considered a clinical challenge. Growth factors and their analogues are emerging as a promising therapeutic option. Objectives: To evaluate the safety profile of some dermocosmetic products with formulations based on growth factors - or their analogs intended for that purpose - using in vitro human skin cell culture models. Methods: Two types of cell cultures were studied, and the effects of the study products on the proliferation of melanoma cells and normal human fibroblasts were evaluated. Results: No significant morphological alterations were found in the cultured human melanoma, and no significant decrease in the number of healthy cells was verified in the normal fibroblasts culture. In some cases there was even a proliferation of those cells. Conclusions: These preliminary data demonstrate that cosmeceutical products containing growth factors as an active principle can be considered safe for topical application.

Operational safety: Development of electronic system for dynamic balance evaluation of farm tractors

The present study aimed at the development and evaluation of a low cost electronic device in order to provide safety for farm tractor users. The major accident occurrence in agricultural surroundings is from farm tractor side bending. Therefore, this sensor was designed to detect and alert about it. The results were satisfying. © 2013 Taylor & Francis Group.

Evaluation of a propolis water extract using a reliable RP-HPLC methodology and in vitro and in vivo efficacy and safety characterisation

Since the beginning of propolis research, several groups have studied its antibacterial, antifungal, and antiviral properties. However, most of these studies have only employed propolis ethanolic extract (PEE) leading to little knowledge about the biological activities of propolis water extract (PWE). Based on this, in a previous study, we demonstrated the anti-inflammatory and immunomodulatory activities of PWE. In order to better understand the equilibrium between effectiveness and toxicity, which is essential for a new medicine, the characteristics of PWE were analyzed. We developed and validated an RP-HPLC method to chemically characterize PWE and PEE and evaluated the in vitro antioxidant/antimicrobial activity for both extracts and the safety of PWE via determining genotoxic potential using in vitro and in vivo mammalian micronucleus assays. We have concluded that the proposed analytical methodology was reliable, and both extracts showed similar chemical composition. The extracts presented antioxidant and antimicrobial effects, while PWE demonstrated higher antioxidant activity and more efficacious for the most of the microorganisms tested than PEE. Finally, PWE was shown to be safe using micronucleus assays. © 2013 Bruno Alves Rocha et al.

Oncological Safety of Autologous Fat Grafting after Breast Conservative Treatment: A Prospective Evaluation

Autologous fat graft to the breast is a useful tool to correct defects after breast conservative treatment (BCT). Although this procedure gains popularity, little is known about the interaction between the fat graft and the prior oncological environment. Evidences of safety of this procedure in healthy breast and after post-mastectomy reconstruction exist. However, there is paucity of data among patients who underwent BCT which are hypothetically under a higher risk of local recurrence (LR). Fifty-nine patients, with prior BCT, underwent 75 autologous fat graft procedures using the Coleman's technique, between October 2005 and July 2008. Follow-up was made by clinical and radiologic examination at least once, after 6 months of the procedure. Mean age was 50 +/- 8.5 years, and mean follow-up was 34.4 +/- 15.3months. Mean time from oncological surgery to the first fat grafting procedure was 76.6 +/- 30.9months. Most of patients were at initial stage 0 (11.8%), I (33.8%), or IIA (23.7%). Immediate complication was observed in three cases (4%). Only three cases of true LR (4%) associated with the procedure were observed during the follow-up. Abnormal breast images were present in 20% of the postoperative mammograms, and in 8% of the cases, biopsy was warranted. Autologous fat graft is a safe procedure to correct breast defects after BCT, with low postoperative complications. Although it was not associated with increased risk of LR in the group of patients studied, prospective trials are needed to certify that it does not interfere in patient's oncological prognosis.

Evaluation of clinical safety and anthelmintic efficacy of aurixazole administed orally at 24 mg/kg in cattle

The current study evaluated, in vivo, the clinical safety and the anthelmintic efficacy of 24% aurixazole (24 mg/kg), administered orally, in bovines. Two experiments were conducted: the first one evaluating the clinical safety of 24% aurixazole (24 mg/kg) in cattle, and a second one evaluating the anthelmintic efficacy of aurixazole (24 mg/kg) against gastrointestinal nematodes on naturally infected cattle. Based on the results of clinical safety, no alterations on clinical and haematological signs and on the biochemical values obtained in animals treated orally with aurixazole 24 mg/kg were observed. Regarding the results of reduction or efficacy, obtained by eggs per gram of faeces (EPG) counts, the formulation of aurixazole reached values superior to 99% (arithmetic means) in all post-treatment dates. In two occasions, this formulation reached maximum efficacy (100%). Comparing these results with the reduction percentages obtained by EPG counts, it is possible to verify that the values obtained by all three formulations were compatible with the efficacy results. Aurixazole reached maximum efficacy (100%) against Haemonchus placei, Cooperia spatulata and Oesophagostomum radiatum. Against Cooperia punctata, this formulation reached an efficacy index of 99.99%. Regarding aurixazole, no specific trials were conducted on the field in order to evaluate the behaviour of this molecule against helminths that are resistant to other molecules, specially isolated levamisole and disophenolat: Due to this fact, future studies will be necessary to assess the effectiveness of aurixazole against strains of nematodes that are resistant to levamisole and disophenolat, but the results of clinical safety and efficacy described in this study allow us to conclude that the aurixazole molecule, concomitantly with other measures and orally administered formulations, can be another important tool in the control of nematodes parasitizing bovines. (C) 2014 Published by Elsevier Ltd.

Evaluation of the Genotoxicity of Chitosan Nanoparticles for Use in Food Packaging Films

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)