Estudos de medicamentos biosimilares

In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acronym in Portuguese) is fully satisfied with the evidence of their quality, efficacy and safety, presented by a pharmaceutical industry that strive for this registration. With the patent expiration, pharmaceutical companies are attracted to produce biological medicines called biosimilar or biogenerics or simply generics, whose approval may result in reduced treatment costs. But it is necessary that the biosimilar be, at least, equally efective and safe and without contaminants in relation to the original. Recent consensus guidelines aim to establish criteria for efcacy and safety of these medicines. Preclinical studies in vitro and in vivo, the origin of raw materials and clinical studies phase I, II and III are recommended for biosimilar medicine registration in the international market. Low molecular weight heparins are found in this situation. In this review we specifcally addressed this type of medicine, which could serve as a benchmark for other biosimilar medicines.

Ampolas de Vidro: Riscos e Benefícios

Background and objectives: Glass ampoules have been widely used in packaging injection drugs. Glass has important characteristics that allow it to be widely used in fabrication of recipients for drugs and other sterile substances. However, contamination of solutions with glass microparticles on breaking open glass ampoules, the presence of metals, percutaneous injury, and biological contamination justify the need of educational materials to orient the manipulation of ampoules. Contents: Glass microparticles generated in the snap-opening of ampoules, as well as metals that contaminate their contents can be aspirated and injected through several routes. Exogenous contaminations by glass and metals can reach several sites in the organism. They trigger organic reactions that may give rise to injuries. Opening ampoules can expose professionals to the risk of percutaneous injuries. These lesions increase the biological risk as they are the gateway for viruses and bacteria. Ampoules opening systems (VIBRAC and OPC) have been developed to reduce the incidence of such accidents. Alternative materials to glass may represent an interesting strategy to increase safety. The use of prefilled syringes may represent an evolution regarding safety. Conclusions: Team training and information provided by the pharmaceutical industry on the use of ampoules are fundamental in the prophylaxis of accidents and contaminations. The search for safer materials to replace glass is also important. © 2011 Elsevier Editora Ltda.

Caracterização radiométrica de ácidos fosfóricos e seus produtos industriais

The addition of phosphoric acids and their (by)products became a common practice in areas like metal treatment, detergent production, water and effluent treatment, as well by food, beverage and pharmaceutical industries. The phosphoric acids exhibit different radionuclides activity concentration, being important to evaluate the implications for the human and animal health. The 238U concentration in almost all raw acid phosphoric are within the worldwide range and the mean exposure rate for the filtration cake is 10 nGy/h, which is mainly attributed to 40K. The results obtained for total and (bio)available uranium concentration in filtration cake indicate that only 40% is (bio)available for plants. The radionuclides present in phosphoric acid food grade and filtration cake do not raise their concentration in human food chain or soils to harmful levels, consequently, not offering hazard to the ecosystem and animal or human health.

ANTIOXIDANT ACTIVITY OF ROSEMARY EXTRACT IN SOYBEAN OIL UNDER THERMOXIDATION

This study examined the antioxidant activity of lyophilized rosemary extract added to soybean oil, subjected to thermoxidation conditions and also its synergistic effect with the synthetic antioxidant tertiary butylhydroquinone (TBHQ). Soybean oil samples with no antioxidant added (SO), 3,000mg/kg rosemary extract (RE), 50mg/kg TBHQ (TBHQ), and a mixture of those two antioxidants (RE+TBHQ) were heated to 180C for 20h. After 0, 10 and 20h, the oxidative stability, total polar compounds, tocopherol content and fatty acid profile were determined. The addition of rosemary extract increased oxidative stability and resulted in a lower formation of total polar compounds and a higher retention of tocopherols. The RE treatment showed the highest amount of polyunsaturated fatty acids after 20h. There was not any synergy between TBHQ and rosemary extract in preventing oxidation of soybean oil. Rosemary extract showed a higher antioxidant potential when compared with TBHQ. PRACTICAL APPLICATIONS: Antioxidants are important ingredients in food processing because they have the capacity to protect foods, containing oils and fats, from damage caused by free radicals and reactive oxygen species. Synthetic antioxidants are widely used in the food industry; however, their utilization has been questioned because of toxicity. Therefore, there is a growing interest in the use of natural antioxidants to reduce or replace the synthetic antioxidants. Several species are used in cooking, medicine and by the pharmaceutical industry, standing out the rosemary. Being rich in compounds with high antioxidant activity, the rosemary extract can be used to replace synthetic antioxidants used in vegetable oils. © 2012 Wiley Periodicals, Inc.

On the application of nanostructured electrodes prepared by Ti/TiO2/WO3 template : A case study of removing toxicity of indigo using visible irradiation

New assays with HepG2 cells indicate that Indigo Carmine (IC), a dye that is widely used as additive in many food and pharmaceutical industries exhibited cytotoxic effects. This work describes the development of a bicomponent nanostructured Ti/TiO2/WO3 electrode prepared by template method and investigates its efficiency in a photoelectrocatalytic method by using visible light irradiation and applied potential of 1V. After 2h of treatment there are reduction of 97% discoloration, 62% of mineralization and formation of three byproducts assigned as: 2-amine-5-sulfo-benzoic acid, 2,3-dioxo-14-indole-5-sulfonic acid, and 2-amino-α-oxo-5-sulfo-benzeneacetic acid were identified by HPLC-MS/MS. But, cytotoxicity was completely removed after 120min of treatment. © 2013 Elsevier Ltd.

Kinetic parameters for thermal decomposition of supramolecular polymers derived from diclofenac-meglumine supramolecular adducts

Meglumine is an aminocarbohydrate able to form supramolecular adducts with organic acids. The recognition is based on hydrogen bonds and the structures resulting from the complexation have high solubility in water. This property has been exploited by the pharmaceutical industry in the improvement of existing drugs, and the successful example of this approach involves the poorly soluble non-steroidal anti-inflammatory drugs (NSAIDs). Investigation of the thermal behavior of adduct obtained from meglumine and the NSAID diclofenac revealed that a polymer-like material is formed from the self-assembly of diclofenac-meglumine adducts in the melt. This polymer showed a high molecular weight around 2.0×105kDa. The kinetic parameters for the thermal decomposition step of the polymer were determined by the Capela-Ribeiro non-linear isoconversional method. From data for the TG curves in nitrogen atmosphere and heating rates of 5, 10, 15 and 20°Cmin-1, the Eα and Bα terms could be determined, and consequently the pre-exponential factor, Aα, as well as the kinetic model, g(α). © 2012 Elsevier B.V.

Effect of Various Thickening Agents on the Rheological Properties of Oil-in-Water Emulsions Containing Nonionic Emulsifier

The knowledge of rheological characteristics can indicate the emulsions properties, thus, nowadays rheology is used in the cosmetic and pharmaceutical industries, even to study the influence of rheological additives on them. Ten emulsions were prepared with 5% and 10% of nonionic emulsifier. Two of them were used as controls while in the others were added thickening agents. Rheological analyses were performed. The results showed that all emulsions are non-Newtonian, thixotropics and viscoelastics fluids. The thickening agents could modify the rheological characteristics of the emulsions and knowing the influence of them is easy to adopt one to reach the desirable performance. © 2013 Copyright Taylor and Francis Group, LLC.

Desenvolvimento de métodos analíticos qualitativos para a análise de darunavir comprimidos

Darunavir is a protease inhibitor used in the treatment of HIV infection. It is a pillar of the drug cocktail for patients diagnosed with the virus. Quality control in the pharmaceutical industry, to verify the content of active substance and study the physicochemical characteristics of the drug, is essential to ensure final product quality. Until now, standardized methods for the analysis of darunavir have not been available in official compendia. This justifies new research, to develop and validate analytical methods, as well as physicochemical and pharmaceutical analysis for this drug, both as a raw material and a finished product. Thus, in this study, (a) the average weight of darunavir tablets and (b) the melting point of the pure drug were determined, and the following analytical techniques were performed: (c) thin-layer chromatography, (d) ultraviolet spectroscopy, (e) infrared spectroscopy and (f) high performance liquid chromatography. By developing the above techniques, it is possible to make a qualitative assessment of the quality of darunavir tablets.

Produção de biomassa, rendimento e composição do óleo essencial de manjericão (Ocimum basilicum L.) em função de reguladores vegetais

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

Efeito da modificação ácido-metanólica nas características estruturais e fisico-químicas de amidos de milho e mandioca

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

Pomada a base de óleo de semente de maracujá no tratamento de lesões cutâneas em coelhos

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Lei dos genéricos e concorrência na indústria farmacêutica brasileira: estudo de casos sobre a atuação das empresas transnacionais

Pós-graduação em Economia - FCLAR

Patentes e licenciamentos compulsórios de medicamentos: o marco regulatório internacional e a ação dos países em desenvolvimento

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Processo produtivo e relação capital / trabalho: um estudo sobre a indústria farmacêutica paulista no período recente

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

A internacionalização da P&D na indústria farmacêutica

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)