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1.
J Biomed Opt ; 28(11): 116501, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37937254

RESUMO

Significance: Understanding the optical transmission property of human hair, especially in the infrared regime, is vital in physical, clinical, and biomedical research. However, the majority of infrared spectroscopy on human hair is performed in the reflection mode, which only probes the absorptance of the surface layer. Aim: The direct transmission spectrum of individual hair without horizontal cut offers a rapid and non-destructive test of the hair cortex but is less investigated experimentally due to the small size and strong absorption of the hair. Approach: In this work, we conduct a transmission infrared micro-spectroscopic study on individual human hair with the help of Fourier-transform infrared microscope experimentally. Its high spatial resolution of infrared micro-spectroscopy further allows the comparison among different regions of hair. The geometry effect of the internal hair structure is also quantified using the finite-element simulation, which supports the experimental results. Results: By utilizing direct measurements of the transmission spectrum using a Fourier-transform infrared microscope, the human hair is found to display prominent band filtering behavior. In a case study of adult-onset Still's disease, the corresponding infrared transmission exhibits systematic variations of spectral weight as the disease evolves. Conclusions: Our work implies that the variation of spectral weight may relate to the disordered microscopic structure variation of the hair cortex during an inflammatory attack. Our work reveals the potential of hair infrared transmission spectrum in tracing the variation of hair cortex retrospectively.


Assuntos
Cabelo , Microscopia , Adulto , Humanos , Espectroscopia de Infravermelho com Transformada de Fourier/métodos , Estudos Retrospectivos , Espectrofotometria Infravermelho , Cabelo/diagnóstico por imagem
2.
Animals (Basel) ; 13(20)2023 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-37893951

RESUMO

This study was designed to determine if feeding ß-hydroxy-ß-methylbutyrate (HMB) to pregnant mice would improve birth weight uniformity and growth performance of offspring. Dams (Agouti Avy) were assigned to one of four treatments: control (CON; n = 13), low-level HMB (LL; 3.5 mg/g; n = 14), high-level HMB (HL; 35 mg/g; n = 15), and low-level pulse dose fed from gestational days 6 to 10 (PUL; 3.5 mg/g; n = 14). Randomly selected dams (n = 27) were euthanized on gestational day 18 to collect placentae and pup weights. The remaining dams gave birth and lactated for 28 days. Dams only received HMB during gestation. Dietary HMB did not influence the performance of dams. Dietary treatment during gestation did not affect litter size or birth weight of pups. Variation was not different among treatments in terms of birth weight of offspring. Placental weights were not affected by treatments. Overall, growth performance of offspring after weaning was similar among all treatments. Body composition of offspring at 5 and 8 weeks of age was similar regardless of HMB treatment during gestation. In conclusion, dietary HMB supplementation in pregnant mice did not affect birth weight, variations in birth weight, or growth performance of offspring.

3.
Endocrine ; 82(2): 296-302, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37668927

RESUMO

PURPOSE: Gestational diabetes mellitus (GDM) is the most common metabolic disease in pregnancy. It is known that GDM is a precursor to type 2 diabetes (T2D). There is evidence that excessive gestational weight variation (GWV) increases the risk of GDM. So, in this study, we aimed to evaluate the association between GWV and the persistence of diabetes in postpartum reclassification. METHODS: A retrospective observational study including pregnant women based on data from the Portuguese National Registry of Gestational Diabetes. Six-to-eight weeks after delivery, all women included underwent a reclassification test. We performed unadjusted and adjusted logistic regression models to evaluate the associations between GWV and diabetes diagnosis at the reclassification test. A subgroup analysis according to the pre-gestational BMI was also performed. RESULTS: We included 10,389 pregnant women, of which 19.6% had GDM in a previous pregnancy. The median of GWV was 10.0 [6.4, 14.0] kg and was found to be higher for those with a normal BMI. At the DM reclassification test, 1% of the women were diagnosed with T2D. We found a negative association between GWV and postpartum diabetes mellitus (DM). We also present a subgroup analysis, and these associations were only significant for the group with a normal pre-gestational BMI. CONCLUSION: Our results showed that women with normal pre-gestational BMI and lower GWV were more likely to have a diagnosis of DM in the postpartum reclassification test. This study helps to fill the gap in the effect of GWG on the persistence of diabetes in postpartum reclassification.


Assuntos
Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Gravidez em Diabéticas , Gravidez , Feminino , Humanos , Diabetes Gestacional/epidemiologia , Diabetes Mellitus Tipo 2/epidemiologia , Aumento de Peso , Período Pós-Parto , Estudos Retrospectivos , Índice de Massa Corporal
4.
Arch Cardiovasc Dis ; 116(8-9): 403-410, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37574401

RESUMO

BACKGROUND: In heart failure, weight loss predicts dismal prognosis. Weight variations have not been addressed in obese patients with heart failure. AIM: To study the impact of weight variation on heart failure mortality according to body mass index strata. METHODS: Retrospective study of patients with chronic heart failure with left ventricular ejection fraction<50%. Only patients with ≥1 year of follow-up were included. Patients with missing data for body mass index at the index and 1-year appointments were excluded. Patients were classified into three groups according to weight variation: weight gain>5%; weight loss>5%; and weight stability. Follow-up was set from the 1-year appointment. Cox-regression analysis was used to assess the prognostic impact of weight variation. RESULTS: We studied 589 patients: 69.8% male; mean age, 69 years. Over 1 year, 148 patients (25.1%) gained>5% weight, 97 (16.5%) lost>5% weight and the remaining 344 were weight-stable. During 49 months of median follow-up, 248 patients died. Patients who lost>5% of their weight presented a higher death risk than the others (hazard ratio 1.61, 95% confidence interval 1.18-2.19). After multivariable adjustment, the hazard ratio for death for low/normal-weight patients who lost>5% of their weight was 1.81 (95% confidence interval 1.02-3.21; P=0.04) compared with the others. Among the overweight, those who lost>5% of their weight had a hazard ratio of 2.34 (95% confidence interval 1.32-4.12). In the initially obese subgroup, weight loss>5% was not associated with prognosis (hazard ratio 1.08, 95% confidence interval 0.53-2.19). CONCLUSIONS: Weight loss predicted mortality in low/normal-weight and overweight patients with heart failure. However, in obese patients, significant weight loss did not predict poorer survival. Weight loss should not be discouraged in obese patients with heart failure.


Assuntos
Insuficiência Cardíaca , Sobrepeso , Humanos , Masculino , Idoso , Feminino , Sobrepeso/complicações , Volume Sistólico , Estudos Retrospectivos , Função Ventricular Esquerda , Obesidade/complicações , Obesidade/diagnóstico , Índice de Massa Corporal , Prognóstico , Redução de Peso
5.
Eur J Pharm Sci ; 184: 106412, 2023 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-36828037

RESUMO

Bilayer tablets offer various drug release profiles for individual drugs incorporated in each layer of a bilayer tablet, which is rarely achievable by conventional tablets. These tablets also help avoid physicochemical incompatibilities between drugs and excipients. Successful manufacturing of such more complex dosage forms depends upon screening of material attributes of API and excipients as well as optimization of processing parameters of individual unit operations of the manufacturing process that must be strictly monitored and controlled to obtain an acceptable drug product quality and performance in order to achieve safety and efficacy per regulatory requirements. Optimizing formulation attributes and manufacturing processes during critical stages, such as blending, granulation, pre-compression, and main compression, can help avoid problems such as weight variation, segregation, and delamination of individual layers, which are frequently faced during the production of bilayer tablets. The main objective of this review is to establish the basis for the implementation of Quality by Design (QbD) system principles for the design and development of bilayer tablets, encompassing the preliminary and systematic risk assessment of critical material attributes (CMAs) and critical process parameters (CPPs) with respect to in-process and finished product critical quality attributes (CQAs). Moreover, the applicability of the QbD methodology based on its purpose is discussed and complemented with examples of bilayer tablet technology.


Assuntos
Excipientes , Tecnologia Farmacêutica , Comprimidos , Liberação Controlada de Fármacos , Tecnologia Farmacêutica/métodos , Composição de Medicamentos/métodos
6.
Cardiovasc Diabetol ; 21(1): 247, 2022 11 17.
Artigo em Inglês | MEDLINE | ID: mdl-36397092

RESUMO

BACKGROUND: Cardiovascular risk and body-weight management are both emerging challenges of type 1 diabetes care. We evaluated the association between intraindividual variability of body-weight and risk of cardiovascular events in people with type 1 diabetes. METHODS: We analyzed 1,398 participants from the DCCT/EDIC studies. Five indices of intraindividual variability of body-weight were calculated for each participant taking into account body-weight measures obtained during the DCCT follow-up (average 6 ± 2 years). The Average Successive Variability (ASV) index, the main variable of interest, was defined as the average absolute difference between successive body-weight measures. The primary outcome was a composite of major adverse cardiovascular events (MACE: nonfatal myocardial infarction or stroke, or cardiovascular death) occurring during the subsequent EDIC follow-up (20 ± 3 years). All-cause death was a secondary outcome. Risk of outcomes were assessed by Cox proportional hazards regression analyses, adjusted for traditional cardiovascular risks factors, including BMI. RESULTS: The cumulative incidence of MACE and all-cause death during follow-up were 5.6% (n = 79) and 6.8% (n = 95), respectively. The adjusted Hazard Ratio (HR) for MACE by every increase of 1 standard deviation (SD) of ASV was 1.34 (95% CI, 1.06-1.66), p = 0.01. For all-cause death, the adjusted HR for 1 SD increase of ASV was 1.25 (1.03-1.50), p = 0.03. Similar results were observed when considering the other indices of intraindividual variability of body-weight. CONCLUSIONS: High body-weight variability (body-weight cycling) is associated with increased risk of MACE and all-cause death in people with type 1 diabetes, independently of the BMI and traditional cardiovascular risk factors.


Assuntos
Sistema Cardiovascular , Diabetes Mellitus Tipo 1 , Infarto do Miocárdio , Humanos , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 1/complicações , Estudos Retrospectivos , Fatores de Risco , Peso Corporal , Infarto do Miocárdio/complicações
7.
Obes Res Clin Pract ; 16(5): 400-406, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36088251

RESUMO

AIM: The current pediatric obesity health challenge necessitates a better understanding of the factors affecting weight loss success during interventions. The aim of this observational study was to test the impact of the rate of initial weight loss and body weight variability on weight loss during a 9-month residential, multidisciplinary weight loss program in adolescents with obesity. METHODS: This retrospective study considered a whole sample of 510 adolescents with obesity (12-16 years, 435 girls). Body weight assessment was performed before (T0) and each week during the 9 months of a multidisciplinary weight loss program. Initial weight change (week 4-W4) and overall weight change at week 12 (T1) and the end of the intervention (T2) were considered. Participants were divided into three groups (tertiles), based on their percentage of weight loss between T0 and W4; and weight variability was expressed by the root mean square error (RMSE) around each participant's regression line at each considered period (W4, T1, T2). RESULTS: Adolescents with lower initial weight loss at W4 (tertile 3) displayed the lesser weight loss at T1 and T2 compared with adolescents in tertile 1 and 2. The RMSE was positively associated with the percentage of weight loss of the period considered, but when the analyses were adjusted for age and initial body weight, there was no more significant association. CONCLUSIONS: The rate of weight loss during the first few weeks is crucial for weight loss success, and weight variability is positively associated with weight loss in adolescents with obesity. Overall, results show that initial body weight is a determinant characteristic to consider during a lifestyle intervention. Further studies are thus needed to better understand the relationship between body weight change patterns and weight loss during the dynamic state that is adolescence.


Assuntos
Obesidade Infantil , Programas de Redução de Peso , Criança , Adolescente , Feminino , Humanos , Obesidade Infantil/terapia , Estudos Retrospectivos , Redução de Peso , Programas de Redução de Peso/métodos , Peso Corporal , Índice de Massa Corporal
8.
Transl Anim Sci ; 5(3): txab039, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34723136

RESUMO

Cross-fostering is commonly used in commercial swine production to equalize litter sizes and/or adjust piglet birth weights within litters. However, there is limited published information on optimum cross-fostering procedures. This study evaluated the effects of within-litter birth weight variation after cross-fostering (using litters of 14 piglets) on piglet preweaning mortality (PWM) and weaning weight (WW). An RCBD was used (blocking factors were day of farrowing and sow parity, body condition score, and functional teat number) with an incomplete factorial arrangement of the following two treatments: 1) birth weight category (BWC): light (<1.0 kg), medium (1.0 to 1.5 kg), or heavy (1.5 to 2.0 kg); 2) litter composition: uniform, all piglets in the litter of the same BWC [uniform light (14 light piglets); uniform medium (14 medium piglets); uniform heavy (14 heavy piglets)]; mixed, piglets in the litter of two or more BWC [L+M (seven light and seven medium piglets); M+H (seven medium and seven heavy piglets); L+M+H (three light, six medium, and five heavy piglets)]. Piglets were weighed at 24 h after birth and randomly allotted to litter composition treatment from within BWC; all piglets were cross-fostered. There were 47 blocks of six litters (total 282 litters and 3,948 piglets). Weaning weights were collected at 18.7 ± 0.64 d of age; all PWM was recorded. Individual piglet WW and PWM data were analyzed using PROC MIXED and PROC GLIMMIX of SAS, respectively; models included fixed effects of BWC, litter composition, and the interaction, and random effects of sow within the block. There was litter composition by BWC interactions (P ≤ 0.05) for WW and PWM. Within each BWC, WW generally increased and PWM generally decreased as littermate weight decreased. For example, WW was greatest (P ≤ 0.05) for light piglets in uniform light litters, for medium piglets in L+M litters, and for heavy piglets in L+M+H litters. Preweaning mortality was lowest (P ≤ 0.05) for medium piglets in L+M litters, and for heavy piglets in L+M+H litters; however, litter composition had no effect (P > 0.05) on PWM of light piglets. In conclusion, increasing the average birth weight of littermates after cross-fostering generally decreased WW and increased PWM for piglets of all birth weight categories. This implies that the optimum approach to cross-fostering that maximizes piglet preweaning growth and survival is likely to vary depending on the birth weight distribution of the population.

9.
Chem Pharm Bull (Tokyo) ; 69(9): 896-904, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34470954

RESUMO

This study investigated the effect of manufacturing process variables of mini-tablets, in particular, the effect of process variables concerning fluidized bed granulation on tablet weight variation. Test granules were produced with different granulation conditions according to a definitive screening design (DSD). The five evaluated factors assigned to DSD were: the grinding speed of the sample mill at the grinding process of the active pharmaceutical ingredient (X1), microcrystalline cellulose content in granules (X2), inlet air temperature (X3), binder concentration (X4) and the spray speed of the binder solution (X5) at the granulation process. First, the relationships between the evaluated factors and the granule properties were investigated. As a result of the DSD analysis, the mode of action of granulation parameters on the granule properties was fully characterized. Subsequently, the variation in tablet weight was examined. In addition to mini-tablets (3 mm diameter), this experiment assessed regular tablets (8 mm diameter). From the results for regular tablets, the variation in tablet weight was affected by the flowability of granules. By contrast, regarding the mini-tablets, no significant effect on the variation of tablet weight was found from the evaluated factors. From this result, this study further focused on other important factors besides the granulation process, and then the effect of the die-hole position of the multiple-tip tooling on tablet weight variation was proven to be significant. Our findings provide a better understanding of manufacturing mini-tablets.


Assuntos
Desenho de Fármacos , Avaliação Pré-Clínica de Medicamentos , Peso Molecular , Tamanho da Partícula , Comprimidos/síntese química , Comprimidos/química
10.
Spectrochim Acta A Mol Biomol Spectrosc ; 261: 120032, 2021 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-34111836

RESUMO

Although Dietary supplements are readily accessible and extensively used worldwide, they are inadequately regulated and consumers are victims of manufacturers' fraud. Thus, quality regulations are required to ensure safety of products available to the public. We propose the first native spectrofluorimetric quality control assay of raspberry ketone, a popular dietary supplement ingredient for weight loss. This work relies on the constant wavelength synchronous scan of the Raspberry Ketone native fluorescence, overcoming the demerits of conventional excitation/ emission spectra. For the best measurement conditions, several parameters were optimized including Δλ value, diluting solvent, medium pH and the effect of surfactants/ macromolecules. In aqueous medium (Δλ = 110 nm), a linear relationship exists between synchronous fluorescence intensity at peak maximum 405.6 nm and solution concentration in the range 300-1500 ng/mL. Method sensitivity was recorded with LOD and LOQ values 60.63 and 183.72 ng/mL; respectively. Validation was done in accordance to International Conference on Harmonization (ICH) guidelines. This simple procedure was successfully applied to the analysis of Raspberry Ketone in commercially available dietary supplement capsules with average recovery 98.67% ± 1.74 and further extended to weight variation testing following the official United States Pharmacopeial (USP) guidelines. Finally, green assessment was done using the ''Analytical Eco-scale'' tool. The total score was 89/100 points revealing excellent greenness of our proposal. Our proposal is simple, eco-friendly and cheap. It can be conveniently adopted for routine quality control practices especially in developing countries.


Assuntos
Butanonas , Suplementos Nutricionais , Controle de Qualidade , Espectrometria de Fluorescência
11.
Brief Bioinform ; 22(5)2021 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-33415328

RESUMO

Triple-negative breast cancer (TNBC) has been a challenging breast cancer subtype for oncological therapy. Normally, it can be classified into different molecular subtypes. Accurate and stable classification of the six subtypes is essential for personalized treatment of TNBC. In this study, we proposed a new framework to distinguish the six subtypes of TNBC, and this is one of the handful studies that completed the classification based on mRNA and long noncoding RNA expression data. Particularly, we developed a gene selection approach named DGGA, which takes correlation information between genes into account in the process of measuring gene importance and then effectively removes redundant genes. A gene scoring approach that combined GeneRank scores with gene importance generated by deep neural network (DNN), taking inter-subtype discrimination and inner-gene correlations into account, was came up to improve gene selection performance. More importantly, we embedded a gene connectivity matrix in the DNN for sparse learning, which takes additional consideration with weight changes during training when obtaining the measurement of the relative importance of each gene. Finally, Genetic Algorithm was used to simulate the natural evolutionary process to search for the optimal subset of TNBC subtype classification. We validated the proposed method through cross-validation, and the results demonstrate that it can use fewer genes to obtain more accurate classification results. The implementation for the proposed method is available at https://github.com/RanSuLab/TNBC.


Assuntos
Proteínas de Neoplasias/genética , Redes Neurais de Computação , RNA Longo não Codificante/genética , RNA Mensageiro/genética , Neoplasias de Mama Triplo Negativas/classificação , Neoplasias de Mama Triplo Negativas/genética , Algoritmos , Antineoplásicos/uso terapêutico , Feminino , Regulação Neoplásica da Expressão Gênica , Redes Reguladoras de Genes , Humanos , Proteínas de Neoplasias/metabolismo , Medicina de Precisão , RNA Longo não Codificante/metabolismo , RNA Mensageiro/metabolismo , Neoplasias de Mama Triplo Negativas/tratamento farmacológico , Neoplasias de Mama Triplo Negativas/patologia
12.
Neotrop. ichthyol ; 19(2): e200097, 2021. tab, graf
Artigo em Inglês | LILACS, VETINDEX | ID: biblio-1279487

RESUMO

Although biotelemetry studies bring useful information, tagging is a highly invasive procedure. For this reason, we assess if intracoelomic tagging alters survivorship, weight gain and/or reproductive capacity of a neotropical migratory fish. In August 2016, 60 fish were equally and randomly distributed among 3 treatments: Control (anesthesia), sham surgery (anesthesia and surgery), and true surgery (anesthesia, surgery and tagging). Surveys for weight and tag expulsion were performed periodically from surgery through spawning (November/2016), with a final survey occurring in May/2017. Mortality was higher in true surgery (25% died) and for males. Twenty percent expelled tags, and initial weight loss followed by gain were verified for all treatments. Females of all treatments spawned, and fecundity and fertility were not different. Then, future studies should consider the losses due to death and tag expulsion when defining the sample number. We also encourage further investigations about differences in mortality between sex and weight variation, as well as any other factor that leads to increase in mortality. This is the first study that investigated tagging effects in reproduction of neotropical fishes, and since the methods and tags used are not species-specific, we infer that similar effects could occur in other species.(AU)


Embora estudos de biotelemetria gerem informações úteis, processos de marcação são invasivos. Por isso, avaliamos se a marcação intracelomática altera sobrevivência, ganho de peso e/ou capacidade reprodutiva de um peixe migrador neotropical. Em agosto de 2016, 60 peixes foram distribuídos igualmente e aleatoriamente entre os tratamentos controle (anestesia), cirurgia-falsa (anestesia e cirurgia) e cirurgia-verdadeira (anestesia, cirurgia e marcação). Vistorias para pesagem e observação de expulsão de marcas foram realizadas periodicamente da cirurgia até a desova (novembro/2016), com uma vistoria final em maio/2017. A mortalidade foi maior nos peixes marcados (25% morreram) e entre machos. Vinte por cento expulsaram as marcas e, para todos os tratamentos, foi observado perda de peso inicial com posterior recuperação. Fêmeas de todos os tratamentos desovaram; fecundidade e fertilidade não foram diferentes. Novos estudos devem considerar as perdas de marcas por mortalidade e rejeição na definição do número amostral. Também recomendamos estudos que investiguem a mortalidade diferencial entre sexos e variação de peso, bem como fatores causadores de mortalidade. Este é o primeiro estudo que investigou efeitos da marcação na reprodução de peixes neotropicais e, uma vez que métodos e marcas utilizadas não são espécie-específicos, inferimos que efeitos similares podem ocorrer em outras espécies.(AU)


Assuntos
Animais , Reprodução , Aumento de Peso , Characidae/cirurgia , Characidae/crescimento & desenvolvimento , Telemetria , Redução de Peso , Peixes
13.
Cureus ; 12(11): e11348, 2020 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-33304683

RESUMO

The objective of this study is to conduct in-vitro quality control testing of diclofenac sodium tablets involves weight variation test, drug assay, friability test, and the disintegration and dissolution test. Two brands of diclofenac sodium tablets were used in the study, named Brand A and Brand B. Quality control (QC) test results for diclofenac sodium tablets show that both Brand A and Brand B conform to the United States Pharmacopeia (USP) standards. In terms of weight variation, Brand A and B have an above the mean weight limit variation of 2.79% and 2.05%, respectively. The lower mean weight limit variations are 1.21% and 1.27%, respectively, which are within the 10% standard limits of USP. Friability tests show that Brands A and B have an average friability of 0.062% and 0.01% mass loss, which are within the 1% mass loss limits of USP. In terms of drug assay, both Brands A and B fall under the USP parameter of 85%-115%, respectively. The disintegration test shows that Brand A and Brand B fall within a 15-minute time interval segment with disintegration time calculated as 6.69 min and 7.02 min for Brands A and B, respectively. Brand B of Diclofenac Sodium has a drug dissolution percentage of 90.7% within a 45-min sampling time interval. Brands A and B pass the pharmacopeia limits set under the USP standards. The friability test shows that the loss of mass for both Brands A and B was within the 1% standard limit. Similarly, with regard to weight variation, both brands conform under the normal limit of 10% above or lower the mean weight. In terms of drug assay, both brands' drug availability was within the specified 85%-115% standard range. They passed the disintegration and dissolution test within a time limit of less than 15 minutes and 45 minutes, respectively.

14.
Drug Des Devel Ther ; 14: 5119-5128, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33262573

RESUMO

BACKGROUND: The use of ineffective and poor quality drugs endangers therapeutic treatment and may lead to treatment failure. For desired therapeutic effect, drugs should contain the appropriate amount of active pharmaceutical ingredient and the required physical characteristics. AIM: The aim of this study was to evaluate quality as well as physicochemical bioequivalence of different brands of furosemide tablets marketed in Bahir Dar, Northwest Ethiopia. METHODS: Five different brands of furosemide tablets were purchased from community pharmacies in Bahir Dar city, Northwest Ethiopia. The quality control parameters of furosemide tablets were determined by identification, weight variation, disintegration, assay and dissolution tests and the results were compared with USP and BP pharmacopoeial standards. Difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements. RESULTS: Identification test results revealed that all samples contained the stated active pharmaceutical ingredients. The results of weight variation tests indicated that all samples complied with USP specification limits. The active pharmaceutical ingredients quantitative assay showed that all the brands of furosemide tablets were between the 90% and 105% limit of label claim. Similarly, all samples fulfilled disintegration time (i.e., ≤30 min) and dissolution tolerance limits (i.e., Q ≥80% at 60 min). Hence, none of the samples were found to be counterfeit and/or substandard. Difference factor (f1) values were <15 and similarity factor (f2) values were >50 for all the tested brands of furosemide tablets. CONCLUSION: This study revealed that all the furosemide brands met the quality specification of weight variation, hardness, friability, dissolution, disintegration and assay. The study also indicated similarity in the dissolution profile of the brands of furosemide tablets with the innovator product. Hence, all of these generic brands could be substituted with the innovator product in clinical practice.


Assuntos
Furosemida/análise , Etiópia , Furosemida/farmacocinética , Dureza , Peso Molecular , Controle de Qualidade , Solubilidade , Comprimidos , Equivalência Terapêutica
15.
Chem Pharm Bull (Tokyo) ; 68(10): 981-988, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32999150

RESUMO

Recently, owing to their pharmaceutical and clinical utility, mini-tablets have been well studied by researchers. Mini-tablets are usually manufactured by compression molding using a multiple-tip tool in a rotary tableting machine. Owing to their special structure, ensuring uniformity is a very important challenge in the manufacturability of mini-tablets using the multiple-tip tool. In this study, we aimed to evaluate the weight variation in mini-tablets produced by a multiple-tip tool, which is considered to be the root cause affecting the uniformity, and to investigate the physical properties of drug granules and tableting conditions in a rotary tableting machine that could reduce this weight variation. In addition, the relationship between these factors and response was visualized using response surface analysis. It was shown that the weight variation in mini-tablets produced by a multiple-tip tool was reduced when using a forced feeder compared with an open feeder. Furthermore, in the case of an open feeder, the optimal range of the average particle size diameter of drug granules and the rotational speed of the rotating disc in the rotary tableting machine were determined from response surface analysis. It was suggested that it is possible to reduce the weight variation in the mini-tablets by selecting drug granules with an average particle size diameter of 100-150 µm and using tableting conditions with a rotational speed of 40-60 rpm. This study elucidated the factors that affect uniformity and determined their optimal range for the manufacture of mini-tablets.


Assuntos
Excipientes/química , Comprimidos/química , Celulose/análogos & derivados , Celulose/química , Composição de Medicamentos , Lactose/química , Manitol/química , Tamanho da Partícula , Pressão , Amido/química , Ácidos Esteáricos/química , Propriedades de Superfície
16.
Data Brief ; 32: 106220, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32923542

RESUMO

As one of critical process steps during pharmaceutical tabletting, rotary die filling is still not well understood. To address this issue, a model rotary die filling system with a paddle feeder was developed to closely mimic the industrial process. Using this model system, the performance of various pharmaceutical powders at different turret and paddle speeds was evaluated, and the dependence of fill variation on process conditions and material properties was examined. A comprehensive dataset was created and reported here to show the effects of material and process parameters on the die filling performance and the filling consistency. It is believed that the data can also be used for data-driven process modelling and for developing robust machine learning models for pharmaceutical manufacturing.

17.
Transl Anim Sci ; 4(1): 307-315, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32704990

RESUMO

Two studies were conducted to determine whether dietary fat fed to pigs of different weight categories differentially influences growth performance. Both experiments were conducted in a 2 × 3 factorial arrangement with main effects of dietary fat addition (0 or 6% choice white grease) and sort weight category (HEAVY, LIGHT, or MIXED). In experiment 1, 1,032 pigs (initially 30.7 kg) were individually weighed and sorted into two body weight (BW) groups with one group consisting of pigs greater than median BW and the other group less than median BW. Pens were then formed by randomly selecting pigs: 1) only from heavy group (HEAVY), 2) only from light group (LIGHT), or 3) from both heavy and light groups to create a normal distribution around barn BW mean (simulation of unsorted pigs; MIXED). In experiment 2, 1,176 pigs (initially 35.1 kg) were visually sorted into BW groups and assigned to HEAVY, LIGHT, and MIXED pen weight categories. Overall in experiment 1, adding 6% dietary fat increased average daily gain (ADG) of LIGHT pigs, but not HEAVY pigs (HEAVY vs. LIGHT × fat interaction, P = 0.03), but increased (P < 0.05) ADG regardless of sort category in experiment 2. In both experiments, HEAVY pigs had greater (P < 0.05) overall ADG and average daily feed intake (ADFI), but decreased (P < 0.05) G:F compared with LIGHT pigs. However, when HEAVY and LIGHT treatment groups were combined, growth performance and carcass characteristics were similar to MIXED pigs. Sorting decreased coefficient of variation (CV) of final BW but did not affect CV of ADG. In conclusion, because adding fat to the diets of lightweight pigs improved ADG in both experiments, dietary fat could be used selectively in the barn to increase the weight of the lightest 50% of the pigs. However, the sorting pigs into light and heavy weight groups did not improve growth performance or carcass characteristics.

18.
Int J Pharm ; 585: 119547, 2020 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-32569812

RESUMO

Rotary tabletting presses are widely used to produce tablets in the pharmaceutical industry. In the tabletting process using a rotary press, rotary die filling is one of critical process steps, as powder behaviour during die filling dictates the quality of final products, such as dosage and weight variations. It is hence of importance to understand powder flow behaviour during rotary die filling. The purpose of this study is to identify the critical process parameters and material attributes that determine the die filling performance. For this purpose, a model rotary die filling system with a paddle feeder was constructed to mimic the powder feeding process in a typical rotary press. Using this model system, the effects of powder properties, turret speed and paddle speed on die filling behaviour were investigated. Three grades of microcrystalline cellulose powders were considered. It was found that the turret speed has a more pivotal role in controlling the die filling performance than the paddle speed. In addition, it is demonstrated that powder flowability has a great impact on the fill weight variation, and a higher weight variation is induced for the powders with poorer flowability.


Assuntos
Celulose/química , Química Farmacêutica/métodos , Excipientes/química , Pós/química , Comprimidos/química
19.
Animals (Basel) ; 9(12)2019 Nov 21.
Artigo em Inglês | MEDLINE | ID: mdl-31766343

RESUMO

In this experiment, we proposed two hypotheses: birth weight variation would increase in litters from sows bred in summer, and dextrose supplementation during the wean to mate period would ameliorate this manifestation of seasonal infertility. Five hundred and ninety-one multiparous sows were allocated to Control; standard diet, or Dextrose; control +5% dextrose diets from weaning until insemination during summer and winter. Dextrose sows farrowed 1.0 and 1.4 more total pigs born and pigs born alive than Control sows, respectively (p < 0.05). There was a tendency for a higher co-efficient of variation (CV) birth weight in summer than winter (16.6 ± 0.4 versus 15.8 ± 0.4; p = 0.1), but no effect of treatment or interaction between treatment and season was observed. Piglet average daily gain was unaffected in those born to sows bred in summer, but when born to sows bred in winter, Dextrose piglets grew 23 g per day faster than Control (p < 0.05). This experiment identified evidence for increased birth weight CV in sows bred during the summer months despite the reduced litter size, suggesting that this is another way seasonal infertility can manifest.

20.
Appl Microbiol Biotechnol ; 103(11): 4363-4375, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30968163

RESUMO

Hyaluronic acid (HA) is a biopolymer with wide biomedical and cosmetic applications, wherein the molecular weight of HA (MWHA) is an important quality parameter that determines its suitability for the targeted application. To produce HA with desired molecular weight, it is important to identify parameters that offer tunability and control of MWHA at a desired value during fermentation. In this work, two tunable parameters, viz. glucose concentration and combination of HA biosynthetic genes expressed, were used to produce HA of different molecular weights. Three recombinant strains of Lactococcus lactis were constructed, using a combination of the has-operon genes from Streptococcus zooepidemicus (hasA, hasB, hasE) and the α-phosphoglucomutase gene (pgmA) from L. lactis. Batch fermentations of these recombinant strains at different initial glucose concentrations enabled production of HA with different molecular weights. Co-expression of hasABE was observed to be particularly effective in improving the MWHA. It was observed during batch fermentations of all these recombinant L. lactis cultures that the MWHA decreases steadily during the later part of the fermentation and the final value is 19-43% lower than the peak MWHA produced. Analysis of the fermentation data showed that the decrease in MWHA correlated strongly with the decrease in specific productivity of the culture. To overcome this decrease in MWHA, a glucostat strategy was successfully devised which could maintain a high value of specific productivity throughout the glucostat phase and result in constant-MW HA production. Glucostat processes were designed with the three recombinant L. lactis strains at two different glucose concentrations to produce constant molecular weight HA ranging from 0.4 to 1.4 MDa. This is the first report of its kind in literature that demonstrates production of controlled MW HA over a wide range by using a combination of tunable parameters and suitable process control strategies.


Assuntos
Adjuvantes Imunológicos/biossíntese , Adjuvantes Imunológicos/química , Ácido Hialurônico/biossíntese , Ácido Hialurônico/química , Lactococcus lactis/genética , Lactococcus lactis/metabolismo , Peso Molecular , Fermentação , Expressão Gênica , Engenharia Metabólica/métodos , Técnicas Microbiológicas/métodos , Proteínas Recombinantes/genética , Proteínas Recombinantes/metabolismo , Streptococcus equi/enzimologia , Streptococcus equi/genética
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