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1.
Int J Med Robot ; 19(2): e2476, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36302228

ABSTRACT

BACKGROUND: Neonate patients have a reduced thoracic cavity, making thoracoscopic procedures even more challenging than their adult counterparts. METHODS: We evaluated five control strategies for robot-assisted thoracoscopic surgical looping in simulations and experiments with a physical robotic system in a neonate surgical phantom. The strategies are composed of state-of-the-art constrained optimization and a novel looping force feedback term. RESULTS: All control strategies allowed users to successfully perform looping. A user study in simulation showed that the proposed strategy was superior in terms of Physical demand p < 0.05 $\left(p< 0.05\right)$ and task duration p < 0.05 $\left(p< 0.05\right)$ . The cumulative sum analysis of inexperienced users shows that the proposed looping force feedback can speed up the learning. Results with surgeons did not show a significant difference among control strategies. CONCLUSIONS: Assistive strategies in looping show promise and further work is needed to extend these benefits to other subtasks in robot-aided surgical suturing.


Subject(s)
Robotic Surgical Procedures , Surgeons , Adult , Infant, Newborn , Humans , Robotic Surgical Procedures/methods , Computer Simulation , Sutures
2.
Viruses ; 14(11)2022 10 22.
Article in English | MEDLINE | ID: mdl-36366422

ABSTRACT

Although blood transfusion is an important therapeutic resource, transfusion-transmitted infections (TTIs) are still a cause for concern. Measures to mitigate this risk involve improvement of donor screening criteria and improvements in laboratory tests, especially the use of nucleic acid test (NAT). In this retrospective study we evaluated HIV, HTLV, HCV and HBV infection rates in blood donors of the Hematology and Hemotherapy Foundation of Bahia (Hemoba), Brazil, through serological and NAT results and the characteristics of donors. From February/2008 to December/2017, 777,446 blood donations were made. Most donors were male, aged 25-44 years, black and mixed race, and single or divorced. The density-type incidence (DTI; per 100,000) for each virus was 91.1 for HBV; 66.5 for HCV; 54.3 for HIV; and 33.9 for HTLV, with a decreasing trend observed over the period studied, except in the last biennium. NAT detected only 1 donor in immunological window for HIV (0.46/100,000 donations) and 3 donors in immunological window for HBV (1.8/100,000 donations). Serological positivity for all viruses studied was higher in the metropolitan region of Salvador, the state capital. Conclusion: DTI rates show a decreasing trend over the years studied, with a predominance of HBV infection. NAT allowed the detection of donors in immunological window periods, having an important role in improving transfusion safety.


Subject(s)
HIV Infections , Hepatitis B , Hepatitis C , Female , Humans , Male , Blood Donors , Brazil/epidemiology , Hepatitis B/diagnosis , Hepatitis B/epidemiology , Hepatitis B virus/genetics , Hepatitis C/diagnosis , Hepatitis C/epidemiology , HIV Infections/diagnosis , HIV Infections/epidemiology , Retrospective Studies , Adult
3.
Braz. J. Pharm. Sci. (Online) ; 58: e19423, 2022. tab, graf
Article in English | LILACS | ID: biblio-1384001

ABSTRACT

Abstract This work aims to ascertain the comprehensiveness of dissolution tests for oral suspensions registered in Brazil and the USA. After consulting literature since 1994, a paucity of information about dissolution methods for suspensions was detected. It makes it difficult to establish the most appropriate test parameters. In January, 2019, there were 46 drugs registered in Anvisa (Brazil) as oral suspension, being 47 reference, 173 generic and 114 interchangeable similar (IS) medicines; while in the USA, 90 drugs were registered as oral suspension by FDA, 235 Abreviatted New Drug Application and 111 New Drug Application medicines. Out of 46 and 90, only six and 15 drugs as oral suspension had a pharmacopeial dissolution test, corresponding to 70 (20.9%) and 82 (23.7%) products in Brazil and the USA, respectively. Dissolution studies were found for 17 drugs as oral suspension in the non-compendial literature. Dissolution test conditions were established to few marketable oral suspension drugs, most of which are BCS class II or IV. Thus, investing in dissolution studies could subsidize the registration of these products by regulators, especially for generic and IS drugs, by comparing dissolution profiles, and predicting their in vivo behavior to avoid exposure of healthy individuals to clinical research.


Subject(s)
Suspensions/pharmacology , Therapeutic Equivalency , Dissolution , Reference Standards , Pharmaceutical Preparations/supply & distribution , Brazilian Health Surveillance Agency , Methods
4.
Article in English | LILACS, Index Psychology - journals | ID: biblio-1340282

ABSTRACT

Abstract In the academic literature there is lack of studies on teenage pregnancy in young people who have not experienced pregnancy. This article aimed to investigate and analyze the meanings of teenage pregnancy for adolescents without a gestation history. The participants were 37 adolescents with no pregnancy history (22 males and 15 females), aged between 12 and 18 years old. The thematic design-story procedure was used as instrument, in which the young individuals were asked to draw "a pregnant adolescent in their Community". To systematize the data, Bardin's content analysis was used. Thirteen themes were observed, the most frequent being related to families, relationships and/or friends and very early pregnancies, showing the relevance of these themes for adolescents. It is concluded that teenage pregnancy, in its majority, was seen as disadvantageous, but also as desired by some young individuals, pointing to the ambiguity of the phenomenon.


Resumo Na literatura acadêmica, são escassos os estudos sobre gravidez na adolescência em jovens que não vivenciaram a gestação. Este artigo teve como objetivo investigar e analisar os significados da gravidez na adolescência para adolescentes sem histórico de gestação. Participaram 37 adolescentes sem histórico de gravidez (22 homens e 15 mulheres) entre 12 e 18 anos. Foi utilizado como instrumento o procedimento desenho-estória temático, tendo sido solicitado que os jovens desenhassem "uma adolescente grávida na sua comunidade". Para sistematização dos dados, utilizou-se a análise de conteúdo de Bardin. Observaram-se 13 temas, sendo os mais frequentes relacionados às famílias, às relações amorosas e/ou amizades e à gravidez muito cedo, demonstrando a relevância desses temas para os adolescentes. Conclui-se que a gravidez na adolescência, em sua maioria, foi vista como desvantajosa, mas também como desejada por alguns jovens, apontando para a ambiguidade do fenômeno.


Resumen En la literatura académica faltan estudios sobre el embarazo adolescente en jóvenes que todavía no lo han experimentado. Este artículo tuvo como objetivo investigar y analizar los significados del embarazo en la adolescencia para adolescentes sin antecedentes de gestación. Participaron 37 adolescentes sin antecedentes de embarazo (22 hombres y 15 mujeres) de entre 12 y 18 años de edad. Se utilizó como instrumento el procedimiento dibujo-historia temático, habiéndose solicitado que los jóvenes dibujaran "una adolescente embarazada en su comunidad". Para sistematizar los datos se utilizó el análisis de contenido de Bardin. Se observaron 13 temas, siendo los más frecuentes los relacionados con las familias, relaciones amorosas y/o amistades y embarazo muy temprano, lo que demuestra la relevancia de estos temas para las adolescentes. Se concluye que el embarazo adolescente, en su mayoría, fue visto como desventajoso, pero también como deseado por algunos jóvenes, lo que apunta a la ambigüedad del fenómeno.


Subject(s)
Humans , Adolescent , Perception , Pregnancy in Adolescence , Family , Friends
5.
Int J Comput Assist Radiol Surg ; 15(8): 1257-1265, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32445129

ABSTRACT

PURPOSE: The manual generation of training data for the semantic segmentation of medical images using deep neural networks is a time-consuming and error-prone task. In this paper, we investigate the effect of different levels of realism on the training of deep neural networks for semantic segmentation of robotic instruments. An interactive virtual-reality environment was developed to generate synthetic images for robot-aided endoscopic surgery. In contrast with earlier works, we use physically based rendering for increased realism. METHODS: Using a virtual reality simulator that replicates our robotic setup, three synthetic image databases with an increasing level of realism were generated: flat, basic, and realistic (using the physically-based rendering). Each of those databases was used to train 20 instances of a UNet-based semantic-segmentation deep-learning model. The networks trained with only synthetic images were evaluated on the segmentation of 160 endoscopic images of a phantom. The networks were compared using the Dwass-Steel-Critchlow-Fligner nonparametric test. RESULTS: Our results show that the levels of realism increased the mean intersection-over-union (mIoU) of the networks on endoscopic images of a phantom ([Formula: see text]). The median mIoU values were 0.235 for the flat dataset, 0.458 for the basic, and 0.729 for the realistic. All the networks trained with synthetic images outperformed naive classifiers. Moreover, in an ablation study, we show that the mIoU of physically based rendering is superior to texture mapping ([Formula: see text]) of the instrument (0.606), the background (0.685), and the background and instruments combined (0.672). CONCLUSIONS: Using physical-based rendering to generate synthetic images is an effective approach to improve the training of neural networks for the semantic segmentation of surgical instruments in endoscopic images. Our results show that this strategy can be an essential step in the broad applicability of deep neural networks in semantic segmentation tasks and help bridge the domain gap in machine learning.


Subject(s)
Machine Learning , Neural Networks, Computer , Robotic Surgical Procedures/education , Simulation Training , Databases, Factual , Endoscopy , Humans , Image Processing, Computer-Assisted/methods , Phantoms, Imaging
6.
Braz. J. Pharm. Sci. (Online) ; 56: e17737, 2020. tab, graf
Article in English | LILACS | ID: biblio-1132050

ABSTRACT

The aim of this work was to perform solubility studies for fexofenadine hydrochloride and establish dissolution conditions for this drug in oral suspension dosage form. The solubility study was executed through the shake-flask method, below 37 ºC±1 ºC, at 100 rpm stirring for 12 h in three buffer solutions: hydrochloric acid pH 2.0, acetate pH 4.5 and phosphate pH 6.8. The dissolution test was developed in vessels containing 900 mL of the same buffer, employing the paddle apparatus in speed of 25 and 50 rpm, below 37 ºC±0.5 ºC. The drug was classified as low solubility according to the Biopharmaceutics Classification System, since the dose/solubility ratio was higher than 250 mL in all media tested (326.55 mL in buffer pH 2.0; 2,456.33 mL in buffer pH 4.5 and 1,021.16 mL in buffer pH 6.8). The dissolution test showed that a release of 85% in 30 min could be established. The rotation speed of 25 rpm, media volume of 900 mL and insertion of the samples through weighted syringes are adequate. The buffered media pH 2.0 could be chosen as dissolution media.


Subject(s)
Solubility , Suspensions/pharmacology , Dissolution/methods , Biopharmaceutics , Pharmaceutical Preparations/analysis , Chromatography, High Pressure Liquid/methods , Dosage Forms
7.
Int J Med Robot ; 15(1): e1953, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30117272

ABSTRACT

BACKGROUND: Integrating simulators with robotic surgical procedures could assist in designing and testing of novel robotic control algorithms and further enhance patient-specific pre-operative planning and training for robotic surgeries. METHODS: A virtual reality simulator, developed to perform the transsphenoidal resection of pituitary gland tumours, tested the usability of robotic interfaces and control algorithms. It used position-based dynamics to allow soft-tissue deformation and resection with haptic feedback; dynamic motion scaling control was also incorporated into the simulator. RESULTS: Neurosurgeons and residents performed the surgery under constant and dynamic motion scaling conditions (CMS vs DMS). DMS increased dexterity and reduced the risk of damage to healthy brain tissue. Post-experimental questionnaires indicated that the system was well-evaluated by experts. CONCLUSION: The simulator was intuitively and realistically operated. It increased the safety and accuracy of the procedure without affecting intervention time. Future research can investigate incorporating this simulation into a real micro-surgical robotic system.


Subject(s)
Brain Neoplasms/diagnostic imaging , Brain Neoplasms/surgery , Computer Simulation , Robotic Surgical Procedures/methods , Virtual Reality , Algorithms , Brain/diagnostic imaging , Equipment Design , Humans , Motion , Movement , Neurosurgery , User-Computer Interface
8.
Cancer Epidemiol ; 54: 133-136, 2018 06.
Article in English | MEDLINE | ID: mdl-29727806

ABSTRACT

BACKGROUND: HIV-infected patients are at a higher risk to develop malignancies than general population. Although AIDS-related malignancies are a common feature of late-stage disease, patients under successful antiretroviral therapy also have an increased risk for development of non-AIDS malignancies. OBJECTIVE: To compare the frequency and characteristics of adults HIV-infected patients and general population who died of malignancies in Bahia, Brazil from January 2000 to December 2010. METHODS: National Information System on Mortality (SIM) was searched to identify all deaths in the study period caused by malignancies in general population and in HIV patients. The frequency of malignancies in these two groups was compared. For HIV patients we also recorded the last HIV-1 RNA plasma viral load and CD4+ cells count, retrieved from oficial databases on laboratory monitoring for HIV patients. RESULTS: In the study period 733,645 deaths were reported, 677,427 (92.3%) of them in individual older than 13 years. Malignancies were the cause of death in 77,174 (11.4%) of them, and 5156 (0.8%) were associated to HIV/Aids. Among deaths of HIV/Aids patients, Kaposi´s sarcoma was the most prevalent malignancy (OR: 309.7; 95% CI: 177-544), followed by non-Hodgkin lymphoma (OR: 10.1; 95% CI: 5.3-19.3), Hodgkin´s lymphoma (OR: 4.3; 95% CI: 2.2-8.4), and cranial nervous malignancies (OR: 3.3; 95% CI:1.6-7.0). HIV patients died at a significantly lower age (43.7 years), than general population (64.5 years, p < 0.0001). Patients who had a diagnosis of Aids-related malignancies had lower CD4+ cells count than those with non-AIDS relates malignancies (p = 0.04). CONCLUSION: HIV infection is a clear risk fator for development of some malignancies, and is associated with early mortality, compared to general population. The level of CD4+ cells count predicts the type of malignancies causing death in this population.


Subject(s)
HIV Infections/complications , Lymphoma, Non-Hodgkin/epidemiology , Neoplasms/epidemiology , Sarcoma, Kaposi/epidemiology , Acquired Immunodeficiency Syndrome/complications , Acquired Immunodeficiency Syndrome/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Brazil/epidemiology , Female , HIV Infections/epidemiology , HIV-1/isolation & purification , Hodgkin Disease/epidemiology , Humans , Male , Middle Aged , Neoplasms/mortality , Retrospective Studies , Viral Load , Young Adult
9.
Psicol. soc. (Online) ; 30: e179670, 2018. tab, graf
Article in Portuguese | LILACS | ID: biblio-976660

ABSTRACT

Resumo Os termos Violência Doméstica (VD) e Violência Intrafamiliar (VI) são identificados na literatura com significados ora semelhantes, ora distintos. O objetivo deste trabalho foi identificar, analisar e compreender o uso dos termos VD e VI em artigos acadêmicos na área da psicologia. O método utilizado foi a revisão sistemática. Os termos VD e VI foram pesquisados nos artigos on-line da Revista Psicologia & Sociedade. Identificaram-se 46 artigos, sendo o uso do termo VD unânime quando se refere à violência de gênero e contra a mulher; já quando a violência se refere às crianças e adolescentes, observou-se uma maior diversidade no uso dos termos, e com relação à violência contra idosos, a prevalência foi do termo VI. Conclui-se sobre a importância de não reduzir o significado dos termos culminando em uma compreensão limitada ao âmbito microssocial, mas ampliando as reflexões acerca dos conceitos de forma a englobar também dimensões macrossociais.


Resumen Los términos Violencia Doméstica (VD) y Violencia Intrafamiliar (VI) son identificados en la literatura con significados similares y distintos. El objetivo de este trabajo fue identificar, analizar y comprender el uso de los términos VD y VI en artículos académicos en el área de la psicología. El método utilizado fue la revisión sistemática. Los términos VD y VI fueron investigados en todos los artículos en línea de la Revista Psicologia & Sociedade. Se identificó 46 artículos, siendo el uso del término VD unánime cuando se refiere la violencia de género y contra la mujer. Ya cuando la violencia se refiere a los niños y adolescentes, se observó una mayor diversidad en el uso de los términos y con relación a la relación violencia contra los ancianos, la prevalencia fue del término VI. La conclusión enfatiza la importancia de no reducirse el significado de los términos, culminando en una comprensión limitada en ámbito microsocial, sino ampliando las reflexiones sobre los conceptos de modo a englobar también dimensiones macrosociales.


Abstract The terms Domestic Violence (VD) and Family Violence (VI) are identified in the literature with both similar and distinct meanings. The aim of this work was to understand the use of the terms VD and VI in academic articles in the field of psychology. The method used was the systematic review. The terms VD and VI were searched in every online article of the Psicologia & Sociedade journal. We identified 46 papers, and it was noted that the use of the term VD was unanimous when referring to gender violence and violence against women, although when referring to violence against children and adolescents, a greater diversity in the use of terms was found, and in relation to violence against the elderly, the term VI was the most used. We concluded that it is important not to reduce the meaning of terms, which culminates in a deterministic and restricted understanding of the micro-social sphere, but rather to broaden the reflections on concepts in order to encompass macrosocial dimensions.


Subject(s)
Review , Domestic Violence , Terminology
10.
Rev Rene (Online) ; 19: e3313, jan. - dez. 2018.
Article in English | LILACS, BDENF - Nursing | ID: biblio-883213

ABSTRACT

Objetivo: compreender a percepção dos enfermeiros da assistência hospitalar sobre o ensino de enfermagem. Métodos: estudo qualitativo, realizado em 19 instituições hospitalares, com 56 enfermeiros. Para a coleta de dados foi utilizada a entrevista semiestruturada e, na análise, o software Atlas.ti®. Resultados: emergiram como unidades de análise: aspectos positivos e negativos do ensino de enfermagem em contexto teórico; e aspectos positivos e negativos do ensino de enfermagem em contexto prático. A percepção dos enfermeiros sobre o ensino de enfermagem está relacionada, essencialmente, à existência de processos formativos muito diversificados. Conclusão: apesar da evolução da enfermagem enquanto disciplina e profissão, os enfermeiros reconhecem que, no âmbito do ensino, muitas das fragilidades estão alicerçadas nas diferenças entre as escolas de enfermagem, sendo evidente a necessidade de maior aproximação da teoria à prática, o que implica, entre outras estratégias, o acompanhamento dos estudantes durante os estágios pelos docentes da Escola. (AU)


Subject(s)
Clinical Clerkship , Education, Nursing , Nursing , Teaching
11.
ISRN Hematol ; 2013: 904201, 2013.
Article in English | MEDLINE | ID: mdl-24288620

ABSTRACT

Despite the benefits of HAART, HIV-infected patients are increasingly affected by different malignancies. We compared a 5-year-period survival time and prognostic factors for HIV-1-infected individuals diagnosed with non-Hodgkin lymphomas (NHL) in a nested case-control study, with non-HIV-infected individuals in Salvador, Brazil. Survival time and prognostic factors were compared to HIV-negative patients. 31 cases (versus 63 controls) had a significantly more advanced NHL at diagnosis and lower mean CD4 count (26 cells/mm(3)) than controls. Mean overall survival (OS) was 35.8 versus 75.4 months, for cases and controls, respectively (P < 0.001), while mean event-free survival time (EFS) was 34.5 months for cases, versus 68.8 for controls (P = 0.002). Higher IPI, increased LDH levels, bone marrow infiltration, lower absolute lymphocyte counts (<1,000 cells/mm(3)), and type B symptoms were associated with a shorter survival time for cases. Although patients without poorer prognostic factors at baseline had an OS comparable to controls, the mean CD4 cell count for cases was similar for patients with favorable and nonfavorable response to therapy. Our findings suggest that HIV-1 infection is significantly associated with a shorter survival time for patients with NHL, independently of other predictive factors and of disease stage.

12.
Article in Portuguese | LILACS | ID: lil-691783

ABSTRACT

Com base na RDC/ANVISA 67/2007, avaliou-se o serviço prestado na dispensação de sinvastatina cápsulas em farmácias magistrais. Vinte e quatro (16%) das 150 farmácias magistrais foram aleatoriamente selecionadas nas regiões de Belo Horizonte-MG, observando a distribuição geográfica. A qualidade do produto, os aspectos da dispensação e o custo foram considerados em estudos de correlação. Os resultados foram submetidos a análises estatísticas descritivas e inferenciais. Em apenas 25% destas farmácias, o fax da prescrição foi solicitado. Todos os pedidos foram entregues no prazo, porém sem comprovação da dispensação. Em uma das entregas, o medicamento era o incorreto. Seis (25%) dos produtos apresentaram rotulagem incompleta (ausência de posologia 16,3% ou de identificação do médico/paciente 8,7%). Apenas 11 (45,8%) das amostras apresentaram qualidade satisfatória. O custo do medicamento manipulado variou entre R$20,40 e R$44,00 com valor médio R$31,18. Não se observou associação entre a qualidade do medicamento e os aspectos do custo, prazo de entrega e localização geográfica. Verifica-se que a maioria das farmácias magistrais ainda precisa adequar-se à legislação para garantir à população uma assistência farmacêutica de qualidade.


The aim of the present study was to evaluate the dispensing of simvastatin capsules at compounding pharmacies in light of Brazilian public health regulations (RDC/ANVISA 67/2007). Twenty-four (16%) out of 150 compounding pharmacies were randomly selected in the city of Belo Horizonte based on geographic distribution among the different districts. Dispensing services, quality and cost were considered in the correlation studies. The results were submitted to descriptive and inferential statistical analyses. The prescription fax was requested in only 25% of the pharmacies. All orders were delivered on time, but without proof of dispensing. The medication was incorrect in one of the deliveries. Six (25%) product labels were incomplete (16.3% for absence of drug regimen; 8.7% for absence of physician/patient identification). Only 11 (45.8%) of the samples exhibited satisfactory quality. The cost of the compounded drug ranged from R$20.40 to R$44.00 (mean: R$31.18). No association was found between drug quality and cost, delivery or geographic location. In conclusion, the majority of compounding pharmacies need to make adjustments in order to meet the requirements of Brazilian legislation and ensure the quality of pharmaceutical services offered to the population.


Subject(s)
Capsules , Drug Compounding , Pharmacies/organization & administration , Pharmaceutical Services , Simvastatin
13.
ISRN Oncol ; 2012: 652682, 2012.
Article in English | MEDLINE | ID: mdl-22518331

ABSTRACT

Diffuse large B-cell lymphoma represents approximately 30%-40% of all diagnoses of non-Hodgkin's Lymphoma and may represent up to 80% of all lymphomas that arise in the palatine tonsils. Several studies have attempted to correlate clinical, laboratorial, and tissue factors with the prognosis of the lymphomas, such as the International Prognostic Index, the tissue expression of some proteins, and the lymphocyte count at the time of diagnosis, as well as to correlate Epstein-Barr virus (EBV) infection with worse prognoses. Patients with palatine tonsil DLBCL, from Salvador, Bahia, Brazil, were studied in order to identify prognostic factors. Twenty-four patients with DLBCL were studied. The factors that negatively influenced the patients' survival rates were the lymphocyte count at the time of diagnosis <1.000/mm(3) and the Bcl-2 protein expression. There was no CD5 expression in these lymphomas, and neither was there an association with EBV infection.

14.
Braz. j. pharm. sci ; 47(3): 495-502, July-Sept. 2011. ilus, graf, tab
Article in English | LILACS | ID: lil-602666

ABSTRACT

Simvastatin is commercially available as tablets and compounded capsules in Brazil. Very few reports regarding these capsules' quality, and consequently their efficacy, are available. The pharmaceutical quality of 30 batches of 20 mg simvastatin capsules from the market was evaluated by weight determination, content uniformity, disintegration (Brazilian Pharmacopeia), assay and dissolution test (USP32 tablet monograph). A HPLC method was developed for assay, content uniformity and dissolution test, and specifications were also established. Out of the 30 batches evaluated, 29 showed capsule disintegration within 45 min and individual weight variation was within ±10 percent or ±7.5 percent relative to average weight, for < or > 300 mg, respectively. Only 27 batches met dissolution test criteria with values >80 percent of the labeled amount in 45 min; 21 batches showed simvastatin content between 90.0-110.0 percent of the labeled amount and 19 batches had at least 9 out of 10 capsules with content uniformity values between 85.0-115.0 percent of the labeled amount with RSD<6.0 percent. Only 14 of all (30) batches fully met pharmacopeial quality standards. The establishment of test conditions and specification parameters for simvastatin capsules showed that there are relevant pharmacopeial quality differences between batches compounded by different pharmacies. For 53.33 percent of the tested products hypercholesterolemic treatment efficacy may be compromised.


No Brasil, a sinvastatina está comercialmente disponível na forma de comprimidos e cápsulas manipuladas. Poucos relatos estão disponíveis sobre a qualidade e, consequentemente, a eficácia dessas cápsulas. A qualidade de 30 lotes de sinvastatina 20 mg cápsulas do mercado foi avaliada através da determinação de peso, uniformidade de conteúdo, desintegração (Farmacopéia Brasileira), doseamento e teste de dissolução (monografia comprimidos USP32). Método por CLAE foi desenvolvido para o doseamento, uniformidade de conteúdo e teste de dissolução; além disso, especificações foram estabelecidas. Dos 30 lotes avaliados, 29 apresentaram desintegração da cápsula até 45 min e a variação do peso individual foi ± 10 por cento ou ± 7,5 por cento em relação ao peso médio, se < ou > 300 mg, respectivamente. Apenas 27 lotes preencheram os critérios do teste de dissolução com valores > 80 por cento da quantidade rotulada, em 45 min, 21 lotes apresentaram conteúdo de sinvastatina entre 90,0-110,0 por cento do valor rotulado e 19 lotes apresentaram pelo menos 9 em 10 cápsulas, com valores de uniformidade de conteúdo entre 85,0 -115,0 por cento da quantidade rotulada com RSD < 6,0 por cento. Apenas 14 de todos os lotes (30) atenderam completamente os padrões de qualidade farmacopéicos. O estabelecimento das condições para os testes e de especificações para os parâmetros das cápsulas de sinvastatina mostrou que houve diferenças relevantes na qualidade farmacopeica entre os lotes das cápsulas manipuladas por distintas farmácias. A eficácia do tratamento hipercolesterolêmico poderia estar comprometida para 53,33 por cento dos produtos testados.


Subject(s)
/statistics & numerical data , Chemistry, Pharmaceutical/statistics & numerical data , Simvastatin/chemistry , Analysis of Variance , Chromatography, High Pressure Liquid , Capsules/analysis , Quality Control
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