Development of chitosan based microencapsulated spray dried powder of tuna fish oil: oil load impact and oxidative stability

Abstract The impact of fish oil concentration on the oxidative stability of microcapsules through the spray drying process using chitosan and maltodextrin as wall material was studied. Emulsions were prepared with different Tuna fish oil (TFO) content (TFO-10%, TFO20%, TF030% TF0-40%) while wall material concentration was kept constant. Microencapsulated powder resulting from emulsion prepared with high fish oil load have high moisture content, wettability, total oil and low encapsulation efficiency, hygroscopicity and bulk tapped density. Oxidative stability was evaluated periodically by placing microcapsules at room temperature. Microcapsules prepared with TFO-10% presented high oxidative stability in terms of peroxide value (2.94±0.04) and anisidine value (1.54±0.02) after 30 days of storage. It was concluded that optimal amounts of fish oil for microencapsulation are 10% and 20% using chitosan and maltodextrin that extended its shelf life during study period.

Resumo Foi estudado o impacto da concentração de óleo de peixe na estabilidade oxidativa de microcápsulas por meio do processo de secagem por atomização, utilizando quitosana e maltodextrina como material de parede. As emulsões foram preparadas com diferentes teores de óleo de atum (TFO) (TFO-10%, TFO20%, TF030% TF0-40%), enquanto a concentração de material de parede foi mantida constante. O pó microencapsulado resultante da emulsão preparada com alta carga de óleo de peixe tem alto teor de umidade, molhabilidade e óleo total e baixa eficiência de encapsulação, higroscopicidade e densidade extraída a granel. A estabilidade oxidativa foi avaliada periodicamente colocando microcápsulas à temperatura ambiente. As microcápsulas preparadas com TFO-10% apresentaram alta estabilidade oxidativa em termos de valor de peróxido (2,94 ± 0,04) e valor de anisidina (1,54 ± 0,02) após 30 dias de armazenamento. Concluiu-se que as quantidades ideais de óleo de peixe para microencapsulação são de 10% e 20% usando quitosana e maltodextrina que prolongaram sua vida útil durante o período de estudo.

Increased yield performance of mutation induced Soybean genotypes at varied agro-ecological conditions

Abstract In soybean breeding program, continuous selection pressure on traits response to yield created a genetic bottleneck for improvements of soybean through hybridization breeding technique. Therefore an initiative was taken to developed high yielding soybean variety applying mutation breeding techniques at Plant Breeding Division, Bangladesh Institute of Nuclear Agriculture (BINA), Bangladesh. Locally available popular cultivar BARI Soybean-5 was used as a parent material and subjected to five different doses of Gamma ray using Co60. In respect to seed yield and yield attributing characters, twelve true breed mutants were selected from M4 generation. High values of heritability and genetic advance with high genotypic coefficient of variance (GCV) for plant height, branch number and pod number were considered as favorable attributes for soybean improvement that ensure expected yield. The mutant SBM-18 obtained from 250Gy provided stable yield performance at diversified environments. It provided maximum seed yield of 3056 kg ha-1 with highest number of pods plant-1 (56). The National Seed Board of Bangladesh (NSB) eventually approved SBM-18 and registered it as a new soybean variety named Binasoybean-5 for large-scale planting because of its superior stability in various agro-ecological zones and consistent yield performance.

Resumo No programa de melhoramento da soja, a pressão pela seleção contínua para a resposta das características de rendimento criou um gargalo genético para melhorias da soja por meio da técnica de melhoramento por hibridação. Portanto, foi desenvolvida uma variedade de soja de alto rendimento, aplicando técnicas de reprodução por mutação, na Divisão de Melhoramento de Plantas, no Instituto de Agricultura Nuclear de Bangladesh (BINA), em Bangladesh. A cultivar popular BARI Soybean-5, disponível localmente, foi usada como material original e submetida a cinco doses diferentes de raios gama usando Co60. Em relação ao rendimento de sementes e às características de atribuição de rendimento, 12 mutantes genuínos foram selecionados a partir da geração M4. Altos valores de herdabilidade e avanço genético com alto coeficiente de variância genotípico (GCV) para altura da planta, número de ramos e número de vagens foram considerados atributos favoráveis ao melhoramento da soja, garantindo, assim, a produtividade esperada. O mutante SBM-18, obtido a partir de 250Gy, proporcionou desempenho de rendimento estável em ambientes diversificados e produtividade máxima de sementes de 3.056 kg ha-1 com o maior número de vagens planta-1 (56). O Conselho Nacional de Sementes de Bangladesh (NSB) finalmente aprovou o SBM-18 e o registrou como uma nova variedade de soja, chamada Binasoybean-5, para plantio em larga escala por causa de sua estabilidade superior em várias zonas agroecológicas e desempenho de rendimento consistente.

Development of chitosan based microencapsulated spray dried powder of tuna fish oil: oil load impact and oxidative stability / Desenvolvimento de pó microencapsulado por pulverização de óleo de atum à base de quitosana: impacto da carga de óleo e estabilidade oxidativa

Abstract The impact of fish oil concentration on the oxidative stability of microcapsules through the spray drying process using chitosan and maltodextrin as wall material was studied. Emulsions were prepared with different Tuna fish oil (TFO) content (TFO-10%, TFO20%, TF030% TF0-40%) while wall material concentration was kept constant. Microencapsulated powder resulting from emulsion prepared with high fish oil load have high moisture content, wettability, total oil and low encapsulation efficiency, hygroscopicity and bulk tapped density. Oxidative stability was evaluated periodically by placing microcapsules at room temperature. Microcapsules prepared with TFO-10% presented high oxidative stability in terms of peroxide value (2.94±0.04) and anisidine value (1.54±0.02) after 30 days of storage. It was concluded that optimal amounts of fish oil for microencapsulation are 10% and 20% using chitosan and maltodextrin that extended its shelf life during study period.

Resumo Foi estudado o impacto da concentração de óleo de peixe na estabilidade oxidativa de microcápsulas por meio do processo de secagem por atomização, utilizando quitosana e maltodextrina como material de parede. As emulsões foram preparadas com diferentes teores de óleo de atum (TFO) (TFO-10%, TFO20%, TF030% TF0-40%), enquanto a concentração de material de parede foi mantida constante. O pó microencapsulado resultante da emulsão preparada com alta carga de óleo de peixe tem alto teor de umidade, molhabilidade e óleo total e baixa eficiência de encapsulação, higroscopicidade e densidade extraída a granel. A estabilidade oxidativa foi avaliada periodicamente colocando microcápsulas à temperatura ambiente. As microcápsulas preparadas com TFO-10% apresentaram alta estabilidade oxidativa em termos de valor de peróxido (2,94 ± 0,04) e valor de anisidina (1,54 ± 0,02) após 30 dias de armazenamento. Concluiu-se que as quantidades ideais de óleo de peixe para microencapsulação são de 10% e 20% usando quitosana e maltodextrina que prolongaram sua vida útil durante o período de estudo.

Increased yield performance of mutation induced Soybean genotypes at varied agro-ecological conditions / Aumento no desempenho de rendimento de genótipos de soja induzidos por mutação em condições agroecológicas variadas

Abstract In soybean breeding program, continuous selection pressure on traits response to yield created a genetic bottleneck for improvements of soybean through hybridization breeding technique. Therefore an initiative was taken to developed high yielding soybean variety applying mutation breeding techniques at Plant Breeding Division, Bangladesh Institute of Nuclear Agriculture (BINA), Bangladesh. Locally available popular cultivar BARI Soybean-5 was used as a parent material and subjected to five different doses of Gamma ray using Co60. In respect to seed yield and yield attributing characters, twelve true breed mutants were selected from M4 generation. High values of heritability and genetic advance with high genotypic coefficient of variance (GCV) for plant height, branch number and pod number were considered as favorable attributes for soybean improvement that ensure expected yield. The mutant SBM-18 obtained from 250Gy provided stable yield performance at diversified environments. It provided maximum seed yield of 3056 kg ha-1 with highest number of pods plant-1 (56). The National Seed Board of Bangladesh (NSB) eventually approved SBM-18 and registered it as a new soybean variety named 'Binasoybean-5' for large-scale planting because of its superior stability in various agro-ecological zones and consistent yield performance.

Resumo No programa de melhoramento da soja, a pressão pela seleção contínua para a resposta das características de rendimento criou um gargalo genético para melhorias da soja por meio da técnica de melhoramento por hibridação. Portanto, foi desenvolvida uma variedade de soja de alto rendimento, aplicando técnicas de reprodução por mutação, na Divisão de Melhoramento de Plantas, no Instituto de Agricultura Nuclear de Bangladesh (BINA), em Bangladesh. A cultivar popular BARI Soybean-5, disponível localmente, foi usada como material original e submetida a cinco doses diferentes de raios gama usando Co60. Em relação ao rendimento de sementes e às características de atribuição de rendimento, 12 mutantes genuínos foram selecionados a partir da geração M4. Altos valores de herdabilidade e avanço genético com alto coeficiente de variância genotípico (GCV) para altura da planta, número de ramos e número de vagens foram considerados atributos favoráveis ​​ao melhoramento da soja, garantindo, assim, a produtividade esperada. O mutante SBM-18, obtido a partir de 250Gy, proporcionou desempenho de rendimento estável em ambientes diversificados e produtividade máxima de sementes de 3.056 kg ha-1 com o maior número de vagens planta-1 (56). O Conselho Nacional de Sementes de Bangladesh (NSB) finalmente aprovou o SBM-18 e o registrou como uma nova variedade de soja, chamada 'Binasoybean-5', para plantio em larga escala por causa de sua estabilidade superior em várias zonas agroecológicas e desempenho de rendimento consistente.

Effects of environmental stability and phycoperiphyton structure on the macroinvertebrate community of regulated Andean rivers

Introduction: The variability in the structure of aquatic communities is frequently attributed to environmental changes; however, in stable environments such as regulated rivers, trophic interactions could be another key environmental factor determining the structure of these communities. These alterations could cause a greater growth of algae, and in turn, changes in the functional groups and in the composition of the macroinvertebrate community favoring the dominance of certain groups of organisms. Objective: To identify the effects of environmental variations and changes in the structure of the phycoperiphyton on the macroinvertebrate community of regulated Andean rivers. Methods: We analyzed environmental and biological data collected in quarterly samples carried out between 2010 and 2018 in two rivers of the Central Andes (Antioquia - Colombia), for a total of 27 samples. Sample collections used standardized methods. Different statistical models were used to establish spatial and temporal patterns of the environmental variables, of the abundance and/or density and diversity of phycoperiphyton and macroinvertebrates, as well as the trophic relationships that exists between them. Results: We found that regulated rivers present relatively little environmental variability. The environmental parameters with the greatest variation were temperature, turbidity, and orthophosphates; these last two were the abiotic variables with the greatest contribution to benthic instability. Conclusion: The presence of scraping and foraging macroinvertebrates was more affected by the stability of the phycoperiphyton density than by environmental variables, showing the importance of trophic interactions in regulated rivers and the bottom up control in these ecosystems.

Introducción: La variabilidad en la estructura de las comunidades acuáticas se atribuye frecuentemente a cambios ambientales, no obstante, en ambientes estables como ríos regulados, las interacciones tróficas podrían ser otro factor ambiental clave determinante de la estructura de estas comunidades. Estas alteraciones podrían provocar un mayor crecimiento de algas y, a su vez, cambios en los grupos funcionales y en la composición de la comunidad de macroinvertebrados favoreciendo la dominancia de determinados grupos de organismos. Objetivo: Identificar el efecto de los cambios ambientales y de la estructura del ficoperifiton sobre la comunidad de macroinvertebrados de ríos Andinos regulados. Métodos: Se analizaron datos ambientales y biológicos recolectados en muestreos trimestrales realizados entre 2010 y 2018 en dos ríos de los Andes Centrales (Antioquia - Colombia), para un total de 27 muestras. La recolección de muestras empleó métodos estandarizados. Se utilizaron diferentes modelos estadísticos para establecer patrones espaciales y temporales de las variables ambientales, de la abundancia y/o densidad y diversidad de ficoperifiton y de los macroinvertebrados, así como las relaciones tróficas que existen entre ellos. Resultados: Se encontró que los ríos regulados presentan relativamente poca variabilidad ambiental. Los parámetros ambientales con mayor variación fueron: temperatura, turbidez y ortofosfatos; las dos últimas variables abióticas fueron las que más aportaron a la inestabilidad bentónica. Conclusión: La presencia de macroinvertebrados raspadores y recolectores fue más afectada por la estabilidad de la densidad del ficoperifiton que por las variables ambientales, evidenciando la importancia de las interacciones tróficas en ríos regulados y el control bottoom up en estos ecosistemas.

Novel custom designed toric piggyback intraocular lens for the correction of residual postoperative astigmatism

We report the outcomes of a custom-designed toric piggyback intraocular lens in a patient with high postoperative residual astigmatism. A 60-year-old male patient underwent customized toric piggyback IOL for postoperative residual astigmatism of 13 D, with follow-up examinations for IOL stability and refractive outcomes. The refractive error stabilized at two months and remained stable at one year, with a correction of nearly 9 D of astigmatism. The IOP remained within normal limits, and there were no postoperative complications. The IOL remained stable in the horizontal position. To our knowledge, this is the first case report of correction of unusually high astigmatism by a novel smart toric design of piggyback IOL.

The effect of Phytosphingosine and bioactive glass-ceramics in preventing dental enamel erosion

Abstract This study evaluated the effect of phytosphingosine (PHS) and bioactive glass-ceramic (Biosilicate) on dental enamel in terms of color alteration (ΔE), microhardness, and surface roughness when submitted to erosive challenge (EC). Sixty specimens of bovine teeth (6×6×2mm) were obtained. Initial color (Easyshade, VITA), KHN (HMV-2, Shimadzu), and Ra (SJ-201P, Mitutoyo) measurements were performed. Specimens were separated into groups according to treatments: PHS, 10% Biosilicate, PHS+10% Biosilicate, and artificial saliva (control) and submitted to EC with Coca-Cola for 2 min. This cycle was repeated 4 times daily/15 days. Between cycles, specimens remained in artificial saliva (2 h/37°C). After daily cycles, they were also stored in artificial saliva at 37ºC. Final color, microhardness, and surface roughness measurements were done. Color and KHN data were analyzed by one-way ANOVA, Tukey's test; and Ra, by 2-way ANOVA, repeated measures, and Tukey's test (p<.05). The highest ΔE occurred in Saliva+EC (p<.05). Groups treated with PHS presented lower color change than Saliva+EC (p<.05). All the groups presented mean values above the 50:50% perceptibility (50:50%PT) and acceptability (50:50%AT) thresholds, except for control that showed mean value above 50:50%PT but below 50:50%AT. Biosilicate+EC showed higher relative microhardness than Saliva+EC (p<.05), but was similar to PHS+EC and PHS+Biosilicate+EC. Final enamel surface roughness increased for all the groups (p<.05), except for the control. The Biosilicate may prevent enamel mineral loss induced by erosion better than saliva. The PHS associated or not to Biosilicate demonstrated better color stability than saliva.

Resumo Este estudo avaliou o efeito da Fitoesfingosina (PHS) e da vitrocerâmica bioativa (Biosilicato) sobre o esmalte dental em termos de alteração de cor (ΔE), microdureza (KHN) e rugosidade superficial, quando submetido a desafio erosivo (DE). Sessenta espécimes de dentes bovinos (6×6×2mm) foram obtidos. Foram realizadas leituras de cor inicial (Easyshade, VITA), microdureza (HMV-2, Shimadzu) e rugosidade superfícial (SJ-201P, Mitutoyo). Os espécimes foram separados em grupos de acordo com os tratamentos: PHS, Biosilicato a 10%, PHS+Biosilicato a 10%, e saliva artificial (controle). Em seguida, foram submetidos a DE com Coca-Cola por 2 min. Esse ciclo foi repetido 4 vezes/dia por 15 dias. Entre os ciclos, as amostras foram mantidas em saliva artificial (2 h/37°C). Após os ciclos diários, os espécimes também foram armazenados em saliva artificial a 37ºC. Foram realizadas leituras finais de cor, microdureza e rugosidade superficial. Os dados de cor e microdureza foram analisados ​​por ANOVA de uma via, teste de Tukey; e dados de rugosidade superficial, por ANOVA de duas vias, teste de Tukey (p<.05). A maior ΔE ocorreu em Saliva+DE (p<.05). Grupos tratados com PHS apresentaram menor alteração de cor do que Saliva+DE (p<.05). Biosilicate+DE demonstrou valores intermediários, similar (p>.05) aos outros grupos, exceto Saliva+DE. Todos os grupos presentaram média acima dos limites 50:50% de perceptibilidade (50:50%LP) e aceitabilidade (50:50%LA) exceto o controle que demonstrou média acima do 50:50%LA mas abaixo do 50:50%LP. Biosilicate+DE mostrou maior microdureza realativa do que Saliva+DE (p<.05), mas similar a PHS+DE e PHS+Biosilicato+DE. A rugosidade de superfície do esmalte aumentou para todos os grupos, exceto para o controle que presentou a menor alteração (p<.05). O Biosilicato apode prevenir perda mineral do esmalte indizido pela erosão melhor que a saliva. O PHS associado ou não ao Biosilicato demonstrou melhor estabilidade de cor que a saliva.

Stability Study of Pashanbhedadi Churna Used in Treatment of Ashmari (Renal Calculi): with Respect to Baseline Microbial Diagnostic Modalities

Ashmari (Renal Calculi) is most common disease of urinary system. Ashmari or calculus looks like small gravels/stones hence they are termed as Ashmari. For the treatment of Ashmari Pashanbhedadi Churna was taken as a trial drug. As Pashanbhedadi Churna was trial drug it was necessary to check the stability. Stability of the drug is the time period from the drug production until the time it is intended to be consumed. So, present study was carried out to know the stability of Pashanbhedadi Churna and to check microbial contamination in the Pashanbhedadi Churna at different time interval. Pashanbhedadi Churna was stored in plastic bag. Microbial study of the drug was done at different climatic conditions, humidity and temperature set ups with regular intervals for a period of 11months to analyse mycological and bacteriological findings by wet mount preparation and Gram stain test respectively. Though in different climate, temperature and humidity conditions, at the end of microbial study, Churna has shown absence of microbes for approx.11 months of preparation of drug. So, it is showed that drug is stable in minimum 32°C temperature to maximum 38°C and minimum humidity 23% to maximum 74% humidity. That means stability duration of drug after preparation is approx. 11 months which showed that drug was in a standard condition. Hence it is concluded that stability test of Pashanbhedadi Churna with respect to microbiological findings was negative at room temperature, warm and cold, dry and humid conditions.

Evaluation of Quality Characteristics and Storage Stability of Peanut Beverage Added Ginger, Moringa Leaf Powder and Lime

Peanut seeds were roasted at 800C for 20 min milled and blended with ginger (GI),with moringa leaf powder (MP), with lime (LI) with moringa leaf powder and ginger (MG) with lime and moringa leaf powder (LM) with lime and ginger (LM) into paste. Heated water (at 800C) was added to the paste while stirring for 30 min. The mixture was further heated in a boiling bath and filtered with muslin cloth cooled to obtain a drink which was flavored with pineapple, banana and milk flavor and sucrose was also added. The results showed moisture content of GI ranged from 79.87 – 83.95 %, with sample LI having the highest value was not significantly different () from MO, MG, LM and LG but sample GI having the lowest value, which was significantly () difference form LI, MG and LG. The ash content ranged from 1.92 – 2.41 %, with sample GI having the highest value which was significantly () different from LI and MG but not significantly () different from other samples. The crude fat content ranged from 2.92 -3.07 %, of which sample GI having the highest value and sample LI having the lowest value which are not significantly () different from one another. The crude protein ranged from 4.01 – 4.74 % of which sample GI having the highest value and sample LG having the least value which are not significantly () different from one another. The carbohydrate contents ranged from 3.49 – 6.49 % with sample LI had the highest value which was not significantly () different from sample GI and MO and sample MG having the lowest value which was significantly () difference from other sample except LG. pH of beverages decreased from 7.90 MG week 1 to 3.21 in LM in week 3.Total titretable acidity present in the beverages were GI in week 1; (0.13), MO(0.17), LI(0.18), MG(0.12), LM(0.19) and LG(0.16).At week 3, GI(0.18), MO(0.23), LI(O.24), MG(0.82), LM(0.24) and LG(0.24). The beverages contained low number of total plate counts (1.9 x 102 - 2.8 x 104) and fungi/yeasts counts (1.2 x 104- 4.2 X 106). Overall acceptability was high for all samples.

Estabilidade de cor de diferentes sistemas cerâmicos fresados no CAD/CAM e polidos com diferentes métodos / Color stability of different ceramic systems milled in CAD/CAM and polished with different methods

A descoloração ou perda de translucidez dos materiais cerâmicos usados em odontologia ainda hoje é um problema, especialmente pelo comprometimento estético. Com o objetivo de comparar a estabilidade de cor, blocos de dissilicato de lítio (IPS e.max CAD HT) e de silicato de lítio reforçado com zircônia (Vita Suprinity HT) fresados no desenho de um disco com dimensões de 1,5 × 7 × 12 mm3 (n = 120) foram preparados usando 3 procedimentos de acabamento de superfície: glaze, polimento mecânico e coloração externa e glaze. Em seguida, cada grupo foi dividido em 2 subgrupos de armazenamento, chá preto e café (n = 10/grupo). As mensurações de cor foram medidas com espectrofotômetro (VITA Easyshade) no estágio inicial e após 1 semana, 2 semanas, 1 mês, 2 meses de armazenamento. As alterações de cor (ΔE) foram calculadas e analisadas estatisticamente usando ANOVA (α < 0,05). Observamos que, para ambos os materiais cerâmicos, o procedimento de glaze apresentou valores de mudança de cor estatisticamente menores do que os outros grupos (p < 0,05) após o armazenamento em ambas as bebidas. Os grupos de dissilicato de lítio apresentaram valores de alteração de cor estatisticamente menores em relação aos grupos de silicato de lítio reforçados com zircônia. Conclui-se que, o glaze sozinho levou a uma maior estabilidade de cor em relação ao polimento mecânico e coloração externa o dissilicato de lítio apresentou maior estabilidade de cor em comparação com o silicato de lítio reforçada com zircônia.

The discoloration or loss of translucency of ceramic materials used in dentistry is still a problem today, especially due to aesthetic compromise. In order to compare color stability, lithium disilicate (IPS e.max CAD HT) and zirconia-reinforced lithium silicate (Vita Suprinity HT) blocks were milled into a disc design with dimensions of 1.5 × 7 × 12 mm3 (n = 120). The specimens were prepared using 3 surface finishing procedures: glaze, mechanical polishing and external staining and glaze. Then, each group was divided into 2 storage subgroups, black tea and coffee (n = 10/group). Color measurements were measured with a spectrophotometer (VITA Easyshade) at the initial stage and after 1 week, 2 weeks, 1 month, 2 months of storage. Color changes (ΔE) were calculated and statistically analyzed using ANOVA (α < 0.05). We observed that, for both ceramic materials, the glaze procedure presented statistically lower color change values ​​than the other groups (p < 0.05) after storage in both beverages. The lithium disilicate groups showed statistically lower color change values ​​than the zirconia-reinforced lithium silicate groups. It is concluded that, glaze alone led to greater color stability compared to mechanical polishing and external staining, lithium disilicate showed greater color stability compared to zirconia-reinforced lithium silicate.

Development of a validated stability-indicating HPLC- DAD method for dasabuvir and the characterization of its degradation products using LC-QToF-MS/MS

Abstract A stability-indicating HPLC-DAD method was developed and validated for the simultaneous determination of dasabuvir and its degradation products in the pharmaceutical formulation. The proposed method utilized a Symmetry® C18 (4.6 x 75 mm, 3.5 µm) column, and the mobile phase consisted of an isocratic elution of formic acid (0.1%) and acetonitrile (55:45, v/v), at a flow of 1 mL min-1; analytes were detected at 244 nm. Dasabuvir was submitted to different stress degradation conditions, such as acidic, alkaline, neutral, thermal, oxidative and photolytic, and the structural elucidation of degradation products was performed using LC-QToF-MS/MS. The HPLC-DAD stability-indicating method was validated for selectivity, linearity, limit of detection and quantification, accuracy, precision and robustness, according to ICH guidelines. Dasabuvir produced two degradation products (DP1 and DP2) from the alkaline stress conditions, which were characterized in negative ion mode. Dasabuvir was linear in the range 9.78 to 136.92 µg mL-1, and DP and DP were linear in the range 2.9 to 20.2 µg mL-1 and 1.3 to 14.9 µg mL-1, respectively. The 1 2 recovery ranged between 99.16 and 100.86%, while precision ranged from 1.02 to 2.89%. As the method can effectively separate the dasabuvir from its degradation products and quantitate them, it may be employed as a stability-indicating method for the pharmaceutical formulation.

Effect of Lyophilization on Stability of PEG-Protein Conjugate: A Case Study with Peginterferon alfa-2b

Abstract The purpose of the present study was to develop stable lyophilized formulation of peginterferon alfa-2b which is acquiescent to the short lyophilization process. The present study evaluates the effect of buffering components and cryoprotectant(s) on depegylation of the peginterferon alfa-2b in combination with lyophilization process. Finally, a short lyophilization process was identified which can produce a stable pharmaceutical form of peginterferon alfa-2b without any depegylation during long-term storage. Formulations were analyzed mainly for depegylation by HP-size exclusion chromatography and in-vitro antiviral activity. Residual moisture content in the lyophilized product was also used as a key indicating parameter to check its role with respect to depegylation upon storage under various temperature conditions. It was observed that the peginterferon alfa-2b when formulated in presence of cryoprotectant like sucrose requires longer lyophilization process of about 5 days, irrespective of the buffering components used, to reduce the level of residual moisture content and thereby to produce the stable formulation without depegylation. A stable formulation in presence of high concentration of lactose as a cryoprotectant was developed which can withstand stresses exerted to protein-polymer conjugate during lyophilization phases without any significant depegylation. A short lyophilization process of about 48 hours can be utilized for peginterferon alfa-2b when formulated in presence of lactose as a cryoprotectant through which a stable lyophilized formulation can be produced as against longer process required when sucrose is used a cryoprotectant, which is essential from commercial point of view as lyophilization is a costly process.

Desenvolvimento de compostos de coordenação para aplicação foliar e elucidação do mecanismo de absorção / Development of coordination compounds for foliar application and elucidation of the absorption mechanism

O objetivo geral desse trabalho foi desenvolver compostos de coordenação com os metais cobre, manganês, zinco, cobalto, níquel e magnésio com os aminoácidos L- ácido aspártico e glutâmico para aplicação como fertilizantes foliares e elucidação de seus prováveis mecanismos de absorção pela planta. Como plano de trabalho, pretendeu-se produzir alguns complexos metálicos com agentes complexantes que confiram características específicas: alta estabilidade termodinâmica e cinética quando comparado a quelatos usados comercialmente dos mesmos metais; alta solubilidade; compatibilidade com herbicidas e fungicidas e alta estabilidade frente a variações de pH. Os compostos foram caracterizados no estado sólido e/ou em solução aquosa, através de técnicas disponíveis em nosso laboratório, na Central Analítica do IQ-USP e/ou nos laboratórios da ICL América do Sul Ind. e Com. SA. Com o desenvolvimento dos compostos de coordenação, foram avaliados alguns parâmetros considerados imprescindíveis para garantia da qualidade do produto gerado, que foram então comparados aos de quelatos de EDTA (ácido etilenodiaminotetraacético) comercializados atualmente e que demonstraram vantagens. Para avaliar a eficiência dos produtos gerados foi realizada aplicação foliar em ao menos uma cultura e verificado o teor de cada nutriente após período de absorção e resposta produtiva, evidenciando e determinando o mecanismo de absorção realizado pela planta. Como resultado, desenvolveu-se uma série de produtos com alta tecnologia agregada que trouxeram benefícios nutricionais, sustentando uma nutrição de qualidade além de serem ecologicamente favoráveis (eco-friendly portfolio)

This project aims the development of copper, manganese, zinc, cobalt, nickel and iron metal complexes with L-amino acids aspartic and glutamic acids for application as foliar fertilizers and elucidation of the probable incorporation/absorption mechanism by plants. As a work plan, it was intended to produce these metal complexes with complexing agents that provide specific characteristics: high thermodynamic and kinetic stabilities when compared to the corresponding EDTA chelates; high solubility; compatibility with herbicides and fungicides and high stability against pH variations. With the development of such coordination compounds, some parameters considered indispensable to quality assurance were then evaluated, in comparison to that of currently available commercial EDTA chelates. To evaluate the performance of the obtained compounds, two foliar applications in the same crop were carried out. Further, the content of each nutrient after the production period and the productive capacity were evaluated, aiming to elucidate the absorption mechanism of the plant. As a result, elaborated products with high added technology were obtained, capable of ameliorating the nutritional benefits, that can support an eco-friendly portfolio

Chromatographic study of sitagliptin and ertugliflozin under quality-by-design paradigm

Abstract The present study entails the systematic development and validation of a stability-indicating RP-HPLC method for the analysis of sitagliptin and ertugliflozin in a fixed-dose combination. Analytical quality by design (AQbD) concepts were used to define critical method variables, employing Pareto risk assessment and a Placket-Burman screening design, preceded by a Box-Behnken design with response surface analysis to optimise critical method parameters such as % acetonitrile (X1), buffer pH (X2) and column oven temperature (X3). Multiple response optimisation (Derringer's desirability) of variables was accomplished by studying critical analytical attributes, such as resolution, retention time and theoretical plates. The title analytes were separated effectively on a PRONTOSIL C18 column at 37 °C using a mobile phase of acetonitrile:acetate buffer, pH 4.4 (36:64 percent v/v), pumped at a flow rate of 1 mL/min, and UV detection at 225 nm. Linearity was observed over a concentration range of 25-150 µg/mL and 3.75-22.5 µg/mL at retention times of 2.82 and 3.92 min for sitagliptin and ertugliflozin, respectively. The method obeyed all validation parameters of the ICH Q2(R1) guidelines. The proposed robust method allows the study of the selected drugs in pharmaceutical dosage forms as well as in drug stability studies under various stress conditions.

Survival rate and stability of surface-treated and non-surface-treated orthodontic mini-implants: a randomized clinical trial

ABSTRACT Objectives: This clinical trial was conducted to evaluate the stability and failure rate of surface-treated orthodontic mini-implants and determine whether they differ from those of non-surface-treated orthodontic mini-implants. Trial Design: Randomized clinical trial with a split-mouth study design. Setting: Department of Orthodontics, SRM Dental College, Chennai. Participants: Patients who required orthodontic mini-implants for anterior retraction in both arches. Methods: Self-drilling, tapered, titanium orthodontic mini-implants with and without surface treatment were placed in each patient following a split-mouth design. The maximum insertion and removal torques were measured for each implant using a digital torque driver. The failure rates were calculated for each type of mini-implant. Results: The mean maximum insertion torque was 17.9 ± 5.6 Ncm for surface-treated mini-implants and 16.4 ± 9.0 Ncm for non-surface-treated mini-implants. The mean maximum removal torque was 8.1 ± 2.9 Ncm for surface-treated mini-implants and 3.3 ± 1.9 Ncm for non-surface-treated mini-implants. Among the failed implants, 71.4% were non-surface-treated mini-implants and 28.6% were surface-treated mini-implants. Conclusion: The insertion torque and failure rate did not differ significantly between the groups, whereas the removal torque was significantly higher in the surface-treated group. Thus, surface treatment using sandblasting and acid etching may improve the secondary stability of self-drilling orthodontic mini-implants. Trial registration: The trial was registered in the Clinical Trials Registry, India (ICMR NIMS). Registration number: CTRI/2019/10/021718

RESUMO Objetivos: Este ensaio clínico foi conduzido para avaliar a estabilidade e a taxa de falha de mini-implantes ortodônticos com superfície tratada, e determinar se elas diferem das dos mini-implantes ortodônticos sem superfície tratada. Desenho do estudo: Ensaio clínico randomizado com desenho de boca dividida. Instituição: Department of Orthodontics, SRM Dental College, Chennai/India. Participantes: Pacientes que necessitavam de mini-implantes ortodônticos para retração anterior em ambas as arcadas. Métodos: Mini-implantes ortodônticos autoperfurantes, cônicos, de titânio com ou sem tratamento de superfície, foram colocados em cada paciente, seguindo um desenho de boca dividida. Os torques máximos de inserção e de remoção foram medidos para cada mini-implante, usando um torquímetro digital. As taxas de falha foram calculadas para cada tipo de mini-implante. Resultados: O valor médio do torque máximo de inserção foi de 17,9 ± 5,6 Ncm para mini-implantes com superfície tratada e 16,4 ± 9,0 Ncm para mini-implantes sem superfície tratada. O valor médio do torque máximo de remoção foi de 8,1 ± 2,9 Ncm para mini-implantes com superfície tratada e 3,3 ± 1,9 Ncm para mini-implantes sem superfície tratada. Entre os implantes que falharam, 71,4% eram mini-implantes sem superfície tratada e 28,6% eram mini-implantes com superfície tratada. Conclusão: O torque de inserção e a taxa de falha não diferiram significativamente entre os grupos; porém, o torque de remoção foi significativamente maior no grupo com superfície tratada. Assim, o tratamento de superfície com jateamento e condicionamento ácido pode melhorar a estabilidade secundária dos mini-implantes ortodônticos autoperfurantes. Registro do estudo: Esse estudo foi registrado no Clinical Trials Registry, Índia (ICMR NIMS). Número de registro: CTRI/2019/10/021718

Effects of sling exercise on the core endurance and performance of basketball players / Efectos del ejercicio con sling en la resistencia del core y rendimiento de los jugadores de baloncesto / Efeitos do exercício com sling na resistência do core e desempenho de jogadores de basquetebol

ABSTRACT Introduction Strong core stability and strength enable the trunk to transfer the maximum amount of torque to the terminal segments, which is conducive to improving athletic performance. Because sling training is a new core exercise method, its effect on trunk endurance relative to basketball performance has rarely been studied. Objective To investigate whether a core exercise program in a specific sports group can improve core and sports-specific performance. Methods A total of 40 college students majoring in basketball were randomly assigned to training and control groups. A standardized set of core endurance and basketball-specific performance tests were used to determine and assess the effects of sling training on trunk strength, endurance, and control. Results Flexor, extensor, and right and left lateral trunk flexor muscles endurance were significantly greater in the training group than in the control group, and the time to complete the layup obstacle course was shorter than in the control group at the end of the training program, p<0.01. No differences between the two groups were found in the penalty shot, the fixed position shot, or the vertical jump and reach at the end of the training program. Conclusions Sling exercises can improve the core endurance and strength of basketball players and increase the speed of lay-ups over obstructions. Level of evidence I; Randomized clinical trial.

RESUMEN Introducción La sólida estabilidad y fuerza del core permiten que el tronco transfiera el torque máximo a los segmentos terminales, lo que conduce a mejorar el rendimiento deportivo. Como método novedoso de ejercicio para el core, se ha estudiado poco el efecto del entrenamiento con ejercicios con sling sobre la resistencia del tronco en relación con el rendimiento en el baloncesto. Objetivo Investigar si un programa de ejercicios para el core en un grupo deportivo específico puede mejorar el rendimiento del core y específico del deporte. Métodos Un total de 40 estudiantes universitarios con especialización en baloncesto fueron asignados aleatoriamente a grupos de entrenamiento y de control. Se utilizó una serie estandarizada de pruebas de resistencia del core y rendimiento específico del baloncesto para determinar y evaluar los efectos de los ejercicios con sling en la fuerza, la resistencia y el control del tronco. Resultados La resistencia de los músculos flexores, extensores y flexores laterales derecho e izquierdo del tronco fue significativamente mayor en el grupo de entrenamiento en comparación con el grupo de control, y el tiempo para completar la prueba de tiro con obstáculos fue menor que el del grupo de control al final del programa de entrenamiento, p<0,01. No hubo diferencias entre los dos grupos en lo que respecta a: tiro libre, lanzamiento en posición fija y salto vertical y alcance al final del programa de entrenamiento. Conclusiones Los ejercicios con sling pueden mejorar la resistencia y la fuerza del core en jugadores de baloncesto y aumentar la velocidad de los tiros con dribling. Nivel de evidencia I; Ensayo clínico aleatorizado.

RESUMO Introdução A sólida estabilidade e a força do core permitem que o tronco transfira o torque máximo para os segmentos terminais, o que é propício para melhorar o desempenho atlético. Como um novo método de exercício para o core, o efeito do treinamento com sling na resistência do tronco com relação ao desempenho no basquete tem sido pouco estudado. Objetivo Investigar se um programa de exercícios para o core em um grupo esportivo específico pode melhorar o desempenho do core e específico do esporte. Métodos Um total de 40 estudantes universitários formados em basquete foram aleatoriamente designados para grupos de treinamento e controle. Uma série padronizada de testes de resistência do core e desempenho específico do basquete foi usada para determinar e avaliar os efeitos dos exercícios com sling na força, resistência e controle do tronco. Resultados A resistência dos músculos flexores, extensores e flexores laterais direito e esquerdo do tronco foi significativamente maior no grupo treinamento em comparação ao grupo controle e o tempo para concluir o teste de bandeja com obstáculos foi menor que o do grupo controle no final do programa de treinamento, p < 0,01. Não houve diferenças entre os dois grupos quanto ao lance livre, arremesso em posição fixa e salto vertical e alcance no final do programa de treinamento. Conclusões Os exercícios com sling podem melhorar a resistência e a força do core em jogadores de basquete e aumentar a velocidade das bandejas com drible. Nível de evidência I; Estudo clínico randomizado.

Dedicated training of explosive strength in the abdominal core of soccer players / Treinamento dedicado da força explosiva no core abdominal dos jogadores de futebol / Entrenamiento específico de la fuerza explosiva en el core abdominal de futbolistas

ABSTRACT Introduction: Physical confrontation in soccer games presents greater demands on athletes' physical fitness. A soccer player's speed, strength, flexibility, coordination, endurance, and explosiveness can affect the body's fighting capacity. Objective: This study analyzes the relationship between strength training in soccer players' abdominal core and physical fitness. Methods: The effect of abdominal core stability strength training on performance improvement in volunteer soccer players selected as research subjects was verified by random division into two groups (experimental and control groups). Both groups performed daily training. The experimental group added special abdominal core training. Mathematical-statistical algorithms were used to statistically analyze the physical indicators of the two groups of volunteers. Results: The indices of physical fitness and body explosiveness of the two groups of athletes were significantly improved (P<0.05). After systematic training, the competition performance of the experimental group and the physiological and biochemical indicators were better than the control group (P<0.05). Conclusion: After abdominal core training, soccer players' physical fitness and explosive power indexes were improved. Research shows that strength training can help improve abdominal core performance in soccer players. It is recommended that coaches implement abdominal core strength training in the daily training of athletes. Level of evidence II; Therapeutic studies - investigation of treatment outcomes.

RESUMO Introdução: O confronto físico nos jogos de futebol apresenta maiores exigências quanto à aptidão física dos atletas. A velocidade, força, flexibilidade, coordenação, resistência e explosividade de um jogador de futebol podem afetar a capacidade de combate corporal. Objetivo: Este estudo visa analisar a relação entre o treinamento de força no core abdominal dos jogadores de futebol e sua aptidão física. Métodos: O efeito do treinamento de força da estabilidade do core abdominal sobre a melhoria do desempenho nos jogadores de futebol voluntários selecionados como objetos de pesquisa foi verificado por divisão aleatória em dois grupos (grupos experimentais e grupos de controle). Ambos os grupos realizavam treinamentos diários. O grupo experimental acrescentou treinamento especial de core abdominal. Foram utilizados algoritmos matemáticos-estatísticos para analisar os indicadores físicos dos dois grupos de voluntários de forma estatística. Resultados: Os índices de aptidão física e explosividade corporal dos dois grupos de atletas foram significativamente melhorados (P<0,05). Após o treinamento sistemático, o desempenho de competição do grupo experimental e os indicadores fisiológicos e bioquímicos foram melhores que os do grupo de controle (P<0,05). Conclusão: Após o treinamento do core abdominal, a aptidão física dos jogadores de futebol e os índices de potência explosiva foram melhorados. Pesquisas mostram que o treinamento da força pode ajudar a melhorar o desempenho do core abdominal nos jogadores de futebol. Recomenda-se aos treinadores a implementação do treino de força no core abdominal ao treinamento diário dos atletas. Nível de evidência II; Estudos terapêuticos - investigação dos resultados do tratamento.

RESUMEN Introducción: El enfrentamiento físico en los partidos de fútbol presenta mayores exigencias a la aptitud física de los atletas. La velocidad, la fuerza, la flexibilidad, la coordinación, la resistencia y la explosividad de un jugador de fútbol pueden afectar a la capacidad de combate del cuerpo. Objetivo: Este estudio tiene como objetivo analizar la relación entre el entrenamiento de la fuerza en el core de los jugadores de fútbol y su condición física. Métodos: El efecto del entrenamiento de la fuerza de la estabilidad del core abdominal sobre la mejora del rendimiento en jugadores de fútbol voluntarios seleccionados como sujetos de la investigación se verificó mediante la división aleatoria en dos grupos (grupo experimental y grupo de control). Ambos grupos realizaron un entrenamiento diario. El grupo experimental añadió un entrenamiento especial del core abdominal. Se utilizaron algoritmos matemático-estadísticos para analizar de forma estadística los indicadores físicos de los dos grupos de voluntarios. Resultados: Los índices de aptitud física y explosividad corporal de los dos grupos de atletas mejoraron significativamente (P<0,05). Tras el entrenamiento sistemático, el rendimiento en competición del grupo experimental y los indicadores fisiológicos y bioquímicos fueron mejores que los del grupo de control (P<0,05). Conclusión: Tras el entrenamiento del core abdominal, mejoraron la condición física y los índices de potencia explosiva de los futbolistas. Las investigaciones demuestran que el entrenamiento de fuerza puede ayudar a mejorar el rendimiento del core abdominal en los jugadores de fútbol. Se recomienda que los entrenadores implementen el entrenamiento de fuerza en el core abdominal al entrenamiento diario de los atletas. Nivel de evidencia II; Estudios terapéuticos - investigación de los resultados del tratamiento.

Impacts of core strength training on balance in martial arts athletes / Impactos do treino de resistência do core sobre o equilíbrio em atletas de artes marciais / Impacto del entrenamiento de la fuerza del core en el equilibrio de los atletas de artes marciales

ABSTRACT Introduction: Physical conditioning is an essential component of sports skills. The main routine training methods for skill enhancement in martial arts players should be based on traditional movements. Core strength training has also been shown to be valid for the physical conditioning of martial arts players. Objective: This paper studies the qualitative changes in the balance of martial arts athletes caused by the insertion of core strength training. Methods: This paper selects 24 martial arts players by sampling and randomly divides them into control and experimental groups. The biomarkers of the volunteers were stored and processed under statistical methods to organize and display the data. Results: The experimental and control groups showed high statistical significance in each index after testing (P<0.05). The results show that the methods used in the experimental and control groups can effectively improve their performance in core and key explosive movements during exercise. There were very significant changes in the extensor muscle peak in both groups. The experimental group showed more significant improvement than the standard group (P<0.05). The experimental group's flexor peaks showed a more significant difference than the control group. In contrast, the experimental group showed a more remarkable improvement than the standard group (P<0.05). Conclusion: Core resistance exercise can effectively promote a center of gravity balance in martial arts athletes. Level of evidence II; Therapeutic studies - investigation of treatment outcomes.

RESUMO Introdução: O condicionamento físico é um componente essencial das habilidades esportivas. Os principais métodos de treino de rotina para aumento da habilidade dos jogadores de artes marciais devem ser baseados em movimentos tradicionais. O treinamento de resistência do core também já se mostrou válido sobre o condicionamento físico dos jogadores de artes marciais. Objetivo: Este artigo estuda as alterações qualitativas sobre o equilíbrio dos atletas de artes marciais provocadas pela inserção do treino de resistência do core. Métodos: Este artigo seleciona 24 jogadores de artes marciais por amostragem e os divide aleatoriamente em grupos controle e experimental. Os biomarcadores dos voluntários foram armazenados e processados sob métodos estatísticos para organizar e exibir os dados. Resultados: Os grupos experimentais e de controle apresentaram alta significância estatística em cada índice após o teste (P<0,05). Os resultados mostram que os métodos utilizados nos grupos experimentais e de controle podem melhorar efetivamente seu desempenho no core e nos principais movimentos explosivos durante o exercício. Houveram mudanças muito significativas no pico dos músculos extensores em ambos os grupos. O grupo experimental apresentou melhora mais significativa do que o grupo padrão (P<0,05). Em comparação com o grupo controle, os picos de flexores do grupo experimental apresentaram uma diferença mais significativa. Em contrapartida, o grupo experimental apresentou uma melhora mais notável do que o grupo padrão (P<0,05). Conclusão: O exercício de resistência do core pode efetivamente promover a equilíbrio do centro de gravidade nos atletas de artes marciais. Nível de evidência II; Estudos terapêuticos - investigação dos resultados do tratamento.

RESUMEN Introducción: El acondicionamiento físico es un componente esencial de las habilidades deportivas. Los principales métodos de entrenamiento rutinario para aumentar la capacidad de los jugadores de artes marciales deben basarse en los movimientos tradicionales. El entrenamiento de la fuerza del core también ha demostrado su validez en el acondicionamiento físico de los jugadores de artes marciales. Objetivo: Este trabajo estudia los cambios cualitativos en el equilibrio de los atletas de artes marciales causados por la inserción del entrenamiento de resistencia del core. Métodos: Este artículo selecciona 24 jugadores de artes marciales por muestreo y los divide aleatoriamente en grupos de control y experimental. Los biomarcadores de los voluntarios se almacenaron y procesaron con métodos estadísticos para organizar y mostrar los datos. Resultados: Los grupos experimental y de control mostraron una alta significación estadística en cada índice tras la prueba (P<0,05). Los resultados muestran que los métodos utilizados en los grupos experimental y de control pueden mejorar eficazmente su rendimiento en los movimientos explosivos centrales y principales durante el ejercicio. Hubo cambios muy significativos en el pico muscular extensor en ambos grupos. El grupo experimental mostró una mejora más significativa que el grupo estándar (P<0,05). En comparación con el grupo de control, los picos flexores del grupo experimental mostraron una diferencia más significativa. En cambio, el grupo experimental mostró una mejora más notable que el grupo estándar (P<0,05). Conclusión: El ejercicio de resistencia del core puede promover eficazmente el equilibrio del centro de gravedad en los atletas de artes marciales. Nivel de evidencia II; Estudios terapéuticos - investigación de los resultados del tratamiento.

Preformulation studies for the development of a microemulsion formulation from Ambrosia peruviana All, with anti-inflammatory effect

Abstract Natural products are considered an important source of the therapeutic arsenal currently available. Among these alternatives are the seeds of Ambrosia peruviana (altamisa), whose extract has shown an anti-inflammatory effect. The main objective of this work was to perform a preformulation study of Ambrosia peruviana seeds ethanolic extract, where the main factors that affect the physical, chemical, and pharmacological stability of the extract were evaluated, as well as a compatibility study by differential scanning calorimetry (DSC) analysis against different excipients. A dry extract was obtained by rotary evaporation of the seeds macerated with 96% ethanol. The anti-inflammatory activity was determined by measuring its effect on NO production in RAW 264.7 macrophages, stimulated with LPS. The results showed that the dry extract maintained its stability over time when stored at a temperature of 4 and 25ºC, demonstrating its biological activity, the content of phenolic compounds, and its physicochemical parameters remain practically invariable. However, when exposed to high temperatures (60 ºC) it was affected. The thermal analysis revelated that the behavior of most of the selected excipients and the dry extract was maintained, which indicates that it did not present incompatibilities, therefore they can be candidates for formulating a microemulsion.