Doramectina: um breve estudo sobre sua degradação em estoque
Data
2021-01-28
Autores
Costa, Cintia Martins 
Orientadores
Craveiro, Marcus Vinicius
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
O mercado nacional de produtos para saúde animal em 2018 rendeu um faturamento líquido de 5,9 bilhões de reais para o seguimento, sendo que a classe terapêutica dos antiparasitários obteve crescimento representativo de 6% entre os anos de 2014 a 2018, tornando-se uma classe importante para investimento de produto para a indústria farmacoquímica. O estudo da degradação dos princípios ativos é essencial para diminuir os prejuízos causados na formulação de produtos, pois o impacto financeiro é menor quando se utiliza a matéria prima degradada. Nesse sentido o presente trabalho consiste em realizar um breve estudo sobre a degradação da matéria prima doramectina medindo-se o seu teor após ser submetida a diferentes temperaturas de armazenagem (-20°C, 4°C, 25°C ambiente, 40°C e 50°C), bem como seu impacto no custo da produção de medicamentos que utilizem a mesma após seu período útil de utilização. Coletou-se uma amostra de um lote e em seguida dividiu-se em cinco vials, inseriu-se os mesmos em câmaras de refrigeração (-20°C, 4°C), câmara aquecimento (40°C), estufa (50°C) e exposição à temperatura ambiente. Ao total de três semanas (T1, T2 e T3) realizaram-se a análise dos teores de doramectina e os produtos de degradação de cada vial, semanalmente, por cromatografia líquida de alta eficiência (HPLC). Para o teor inicial ou T0 realizou-se as análises qualitativas/quantitativas antes do acondicionamento das amostras em diferentes temperaturas. Após as análises realizou-se estudo estatístico extrapolando-se os teores de doramectina pós-degradação utilizando a lei de velocidade de reação. Através deste estudo inferiu-se a degradação para longos períodos, uma vez que o período avaliado é curto para uma degradação considerável, verificando assim seu tempo de vida útil. A partir dos resultados obtidos dos teores de doramectina conclui-se que não houve diferenças significativas entre os valores de degradação para as diferentes temperaturas. Os valores dos teores da doramectina foram coerentes e de decaimento suave, sendo a ordem de velocidade de decaimento da reação igual a um. O resultado da extrapolação dos dados nos deu valores de teor de até 83%, considerando-se um tempo de armazenamento de dois anos. Considerando um exemplo de produção de um lote de 4.000 litros, podem-se calcular prejuízos de até R$ 47 mil reais de gasto extra com doramectina.
The national market for animal health products in 2018 yielded net revenue of 5.9 billion reais for the follow-up, with the therapeutic class of antiparasitic agents having grown by 6% between the years 2014 to 2018, becoming an important class for product investment for the pharma-chemical industry. The study of the degradation of the active ingredients is essential to reduce the losses caused in the formulation of products, since the financial impact is less when using the degraded raw material. In this sense, the present work consists of carrying out a brief study on the degradation of doramectin raw material, measuring its content after being subjected to different storage temperatures (-20 ° C, 4 ° C, 25 ° C ambient, 40 ° C and 50 ° C), as well as its impact on the cost of producing drugs that use it after its useful period of use. A sample was collected from a batch and then divided into five vials, placed in refrigeration chambers (-20 ° C, 4 ° C), heating chamber (40 ° C), oven (50 ° C) and exposure to room temperature. For a total of three weeks (T1, T2 and T3) the analysis of doramectin levels and the degradation products of each road were performed weekly by high performance liquid chromatography (HPLC). For the initial content or T0, qualitative / quantitative analyzes were carried out before packing the samples at different temperatures. After the analyzes, a statistical study was carried out, extrapolating the levels of post-degradation doramectin using the reaction speed law. Through this study, the degradation for long periods was inferred, since the evaluated period is short for a considerable degradation, thus verifying its useful life. From the results obtained from the doramectin levels it is concluded that there were no significant differences between the values of degradation for the different temperatures. The doramectin content values were coherent and smoothly decayed, with the order of reaction decay speed equal to one. The results of extrapolating the data gave us content values of up to 83%, considering a storage time of 2 years. Considering an example of producing a batch of 4,000 liters, it is possible to calculate losses of up to R $ 47 thousand reais in extra spending on doramectin.
The national market for animal health products in 2018 yielded net revenue of 5.9 billion reais for the follow-up, with the therapeutic class of antiparasitic agents having grown by 6% between the years 2014 to 2018, becoming an important class for product investment for the pharma-chemical industry. The study of the degradation of the active ingredients is essential to reduce the losses caused in the formulation of products, since the financial impact is less when using the degraded raw material. In this sense, the present work consists of carrying out a brief study on the degradation of doramectin raw material, measuring its content after being subjected to different storage temperatures (-20 ° C, 4 ° C, 25 ° C ambient, 40 ° C and 50 ° C), as well as its impact on the cost of producing drugs that use it after its useful period of use. A sample was collected from a batch and then divided into five vials, placed in refrigeration chambers (-20 ° C, 4 ° C), heating chamber (40 ° C), oven (50 ° C) and exposure to room temperature. For a total of three weeks (T1, T2 and T3) the analysis of doramectin levels and the degradation products of each road were performed weekly by high performance liquid chromatography (HPLC). For the initial content or T0, qualitative / quantitative analyzes were carried out before packing the samples at different temperatures. After the analyzes, a statistical study was carried out, extrapolating the levels of post-degradation doramectin using the reaction speed law. Through this study, the degradation for long periods was inferred, since the evaluated period is short for a considerable degradation, thus verifying its useful life. From the results obtained from the doramectin levels it is concluded that there were no significant differences between the values of degradation for the different temperatures. The doramectin content values were coherent and smoothly decayed, with the order of reaction decay speed equal to one. The results of extrapolating the data gave us content values of up to 83%, considering a storage time of 2 years. Considering an example of producing a batch of 4,000 liters, it is possible to calculate losses of up to R $ 47 thousand reais in extra spending on doramectin.