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  1 / 19118 MEDLINE  
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[PMID]:29358154
[Au] Autor:Turner AD; Waack J; Lewis A; Edwards C; Lawton L
[Ad] Endereço:Centre for Environment, Fisheries and Aquaculture Science, Barrack Road, The Nothe, Weymouth, Dorset DT4 8UB, United Kingdom. Electronic address: andrew.turner@cefas.co.uk.
[Ti] Título:Development and single-laboratory validation of a UHPLC-MS/MS method for quantitation of microcystins and nodularin in natural water, cyanobacteria, shellfish and algal supplement tablet powders.
[So] Source:J Chromatogr B Analyt Technol Biomed Life Sci;1074-1075:111-123, 2018 Feb 01.
[Is] ISSN:1873-376X
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:A simple, rapid UHPLC-MS/MS method has been developed and optimised for the quantitation of microcystins and nodularin in wide variety of sample matrices. Microcystin analogues targeted were MC-LR, MC-RR, MC-LA, MC-LY, MC-LF, LC-LW, MC-YR, MC-WR, [Asp3] MC-LR, [Dha7] MC-LR, MC-HilR and MC-HtyR. Optimisation studies were conducted to develop a simple, quick and efficient extraction protocol without the need for complex pre-analysis concentration procedures, together with a rapid sub 5min chromatographic separation of toxins in shellfish and algal supplement tablet powders, as well as water and cyanobacterial bloom samples. Validation studies were undertaken on each matrix-analyte combination to the full method performance characteristics following international guidelines. The method was found to be specific and linear over the full calibration range. Method sensitivity in terms of limits of detection, quantitation and reporting were found to be significantly improved in comparison to LC-UV methods and applicable to the analysis of each of the four matrices. Overall, acceptable recoveries were determined for each of the matrices studied, with associated precision and within-laboratory reproducibility well within expected guidance limits. Results from the formalised ruggedness analysis of all available cyanotoxins, showed that the method was robust for all parameters investigated. The results presented here show that the optimised LC-MS/MS method for cyanotoxins is fit for the purpose of detection and quantitation of a range of microcystins and nodularin in shellfish, algal supplement tablet powder, water and cyanobacteria. The method provides a valuable early warning tool for the rapid, routine extraction and analysis of natural waters, cyanobacterial blooms, algal powders, food supplements and shellfish tissues, enabling monitoring labs to supplement traditional microscopy techniques and report toxicity results within a short timeframe of sample receipt. The new method, now accredited to ISO17025 standard, is simple, quick, applicable to multiple matrices and is highly suitable for use as a routine, high-throughout, fast turnaround regulatory monitoring tool.
[Mh] Termos MeSH primário: Cromatografia Líquida de Alta Pressão/métodos
Cianobactérias/química
Suplementos Nutricionais/análise
Microcistinas/análise
Peptídeos Cíclicos/análise
Frutos do Mar/análise
[Mh] Termos MeSH secundário: Animais
Produtos Biológicos/análise
Produtos Biológicos/química
Bivalves
Contaminação de Alimentos
Limite de Detecção
Modelos Lineares
Reprodutibilidade dos Testes
Comprimidos
Espectrometria de Massas em Tandem/métodos
Poluentes Químicos da Água/análise
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biological Products); 0 (Microcystins); 0 (Peptides, Cyclic); 0 (Tablets); 0 (Water Pollutants, Chemical); 0979BIK2QU (nodularin)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180124
[St] Status:MEDLINE


  2 / 19118 MEDLINE  
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[PMID]:29198307
[Au] Autor:Harahap Y; Prasaja B; Lusthom W; Yusvita LY; Sinandang T; Hardiyanti
[Ti] Título:A bioequivalence study of quetiapine 25 mg film-coated tablets in healthy Indonesian subjects
.
[So] Source:Int J Clin Pharmacol Ther;56(1):38-42, 2018 Jan.
[Is] ISSN:0946-1965
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:AIM: This study was conducted in order to compare the bioavailability of two film-coated tablets containing 25 mg of quetiapine. METHODS: 24 subjects were enrolled in and completed a single-center, randomized, single-dose, open-label, two-way crossover study with a 1-week washout period. Plasma samples were collected up to 24 hours following drug administration; thus, quetiapine was determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with turbo-ion-spray mode. The pharmacokinetic parameters used for bioequivalence assessment were AUC0-t, AUC0-∞, and Cmax. The 90% confidence intervals were obtained by analysis of variance for AUC0-t, AUC0-∞, and Cmax. RESULTS: The results were all within the range of 80.00 - 125.00%. CONCLUSION: Bioequivalence between formulations was concluded both in terms of rate and extent of absorption.
.
[Mh] Termos MeSH primário: Antipsicóticos/farmacocinética
Fumarato de Quetiapina/farmacocinética
[Mh] Termos MeSH secundário: Adolescente
Adulto
Cromatografia Líquida
Estudos Cross-Over
Feminino
Seres Humanos
Masculino
Meia-Idade
Comprimidos
Espectrometria de Massas em Tandem
Equivalência Terapêutica
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antipsychotic Agents); 0 (Tablets); 2S3PL1B6UJ (Quetiapine Fumarate)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171205
[St] Status:MEDLINE
[do] DOI:10.5414/CP202975


  3 / 19118 MEDLINE  
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[PMID]:29441998
[Au] Autor:Saab M; Issa M; Samy W; El-Maradny H
[Ti] Título:Alternative approaches in formulating floating hollow tablets sublimation technique; a platform tailored drug release profile.
[So] Source:Pharmazie;71(12):701-708, 2016 Dec 01.
[Is] ISSN:0031-7144
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:The aim of this study was to formulate floating hollow tablets of salbutamol sulphate with a platform tailored drug release profile to attain a controllable drug release. Eight formulations (F1-F8) were prepared using sublimation technique. L-menthol was directly compressed as sublimable core followed by compression coating of hydroxypropylmethyl cellulose (HPMC-K15M) or polyethylene oxide (PEO-WSR301) as release retarding polymer coat. Tablets were then subjected to heat to allow sublimation of the core. The effect of polymer type and that of different drug coat/core distribution on swelling and drug release profile was studied. FTIR and DSC revealed the absence of any drug-excipients interaction. Tablets showed a hollow morphology, resulting in low density tablets that floated for over 24 hours without lag time. Moreover, different drug coat/core distribution resulted in controllable release profiles. Based on these results, an optimum drug release behavior was recorded for HPMC-based hollow tablets consisting of 2:1 drug coat/core distribution ratio (F4), revealing a zero order drug release for over 14 hours. Furthermore, F4 showed no changes in drug content, floating properties and drug release profile upon exposure to accelerated stability conditions.
[Mh] Termos MeSH primário: Preparações de Ação Retardada/química
Comprimidos/química
[Mh] Termos MeSH secundário: Varredura Diferencial de Calorimetria
Química Farmacêutica
Composição de Medicamentos
Liberação Controlada de Fármacos
Estabilidade de Medicamentos
Excipientes
Dureza
Derivados da Hipromelose
Mentol/administração & dosagem
Mentol/química
Solubilidade
Espectroscopia de Infravermelho com Transformada de Fourier
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Delayed-Action Preparations); 0 (Excipients); 0 (Tablets); 1490-04-6 (Menthol); 3NXW29V3WO (Hypromellose Derivatives)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180227
[Lr] Data última revisão:
180227
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180215
[St] Status:MEDLINE
[do] DOI:10.1691/ph.2016.5186


  4 / 19118 MEDLINE  
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[PMID]:29441996
[Au] Autor:Ayoub BM; Abdel-Aziz O
[Ti] Título:A guide for using experimental design in chromatographic method development: applied to the analysis of selected anti-diabetic pharmaceutical combinations.
[So] Source:Pharmazie;71(12):683-690, 2016 Dec 01.
[Is] ISSN:0031-7144
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:A guide experimental design in chromatographic method development was described and applied successfully to the analysis of different recently approved anti-diabetic pharmaceutical combinations. Enhancement of UHPLC analysis of alogliptin benzoate either with pioglitazone hydrochloride or with metformin hydrochloride was achieved. The optimal chromatographic conditions were not attained by trial and error that requires a large number of experiments. Alternatively, a computer program was used as a systematic optimization strategy for the design of the experiment which accurately predicts the combined effect of different factors simultaneously. Resolution between peaks was studied by the proposed fractional factorial design approach performed by the Minitab® Program using screening and optimization steps. Application of the central composite design was implemented. A Pareto chart was used to exclude the insignificant variables. Linearity ranges were found to be 0.5-40 µg ml-1, 1-20 µg ml-1 and 1-32 µg ml-1 for alogliptin benzoate, pioglitazone hydrochloride and metformin hydrochloride, respectively. The proposed method is applicable for the analysis of six pharmaceutical dosage forms namely, Nesina®, Actos®, Glucophage®, Oseni®, Kazano® and Actoplus MET® tablets.
[Mh] Termos MeSH primário: Cromatografia Líquida de Alta Pressão/métodos
Hipoglicemiantes/análise
[Mh] Termos MeSH secundário: Formas de Dosagem
Combinação de Medicamentos
Desenho de Equipamento
Metformina/análise
Piperidinas/análise
Padrões de Referência
Reprodutibilidade dos Testes
Soluções
Comprimidos/análise
Tiazolidinedionas/análise
Uracila/análogos & derivados
Uracila/análise
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Dosage Forms); 0 (Drug Combinations); 0 (Hypoglycemic Agents); 0 (Piperidines); 0 (Solutions); 0 (Tablets); 0 (Thiazolidinediones); 56HH86ZVCT (Uracil); 9100L32L2N (Metformin); JHC049LO86 (alogliptin); X4OV71U42S (pioglitazone)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180227
[Lr] Data última revisão:
180227
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180215
[St] Status:MEDLINE
[do] DOI:10.1691/ph.2016.6095


  5 / 19118 MEDLINE  
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[PMID]:29311459
[Au] Autor:Mitsuboshi S; Yamada H; Nagai K; Okajima H
[Ad] Endereço:Department of Pharmacy, Kaetsu Hospital.
[Ti] Título:[Low Continuity Rate of Sucroferric Oxyhydroxide among Japanese Hemodialysis Patients with High Phosphate Binder Pill Burden].
[So] Source:Yakugaku Zasshi;138(1):135-139, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:This prospective observational study was conducted to evaluate the continuity, efficacy, and tolerability of sucroferric oxyhydroxide (SO) among hemodialysis (HD) patients who switched to SO from sevelamer hydrochloride (SH) or bixalomer (BX). Participants were 9 HD patients in Kaetsu Hospital who had been receiving more than 9 tablets/d of SH or BX and were switched to SO 750 mg/d. All the participants were men. Over a 6-month observational period, 6 of the 9 patients (67%) discontinued SO because of adverse events, including diarrhea, atheroma, and polycythemia. Although the diarrhea and atheroma were mild, the affected patients did not wish to restart SO. On the other hand, 3 of the 9 patients (33%) continued taking SO throughout the observation period. These patients tended to have increased levels of serum calcium, hematocrit, and serum ferritin; a decreased number of phosphate binder tablets (from 21 tablets/d to 8 tablets/d); and a decreased dosage of erythropoiesis-stimulating agents. Serum phosphate levels tended to decrease in continuers, but tended to increase in discontinuers. It may be preferable to increase the SO dosage gradually rather than switching from SH or BX all at once, and patients who switch to SO should be carefully monitored.
[Mh] Termos MeSH primário: Quelantes/administração & dosagem
Esquema de Medicação
Substituição de Medicamentos/métodos
Compostos Férricos/administração & dosagem
Poliaminas
Diálise Renal
Sevelamer
Sacarose/administração & dosagem
[Mh] Termos MeSH secundário: Idoso
Grupo com Ancestrais do Continente Asiático
Quelantes/efeitos adversos
Combinação de Medicamentos
Compostos Férricos/efeitos adversos
Seres Humanos
Masculino
Meia-Idade
Fosfatos/sangue
Estudos Prospectivos
Sacarose/efeitos adversos
Comprimidos
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Chelating Agents); 0 (Drug Combinations); 0 (Ferric Compounds); 0 (Phosphates); 0 (Polyamines); 0 (Tablets); 0 (sucroferric oxyhydroxide); 3160WY51LV (bixalomer); 57-50-1 (Sucrose); 9YCX42I8IU (Sevelamer)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180110
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00180


  6 / 19118 MEDLINE  
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[PMID]:29362772
[Au] Autor:Pitman B
[Ad] Endereço:Distinguished Scholar in Residence, Edith O'Donnell Institute of Art History, Dallas, Texas.
[Ti] Título:Pharma Art-Abstract Medication in the Work of Beverly Fishman.
[So] Source:JAMA;319(4):326-328, 2018 Jan 23.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Medicina nas Artes
Pinturas
Preparações Farmacêuticas
Escultura
[Mh] Termos MeSH secundário: Cápsulas
Pessoas Famosas
História do Século XX
História do Século XXI
Medicina nas Artes/história
Pinturas/história
Escultura/história
Comprimidos
[Pt] Tipo de publicação:BIOGRAPHY; HISTORICAL ARTICLE; JOURNAL ARTICLE
[Ps] Nome de pessoa como assunto:Fishman B
[Nm] Nome de substância:
0 (Capsules); 0 (Pharmaceutical Preparations); 0 (Tablets)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180131
[Lr] Data última revisão:
180131
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180125
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.18675


  7 / 19118 MEDLINE  
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[PMID]:29337669
[Au] Autor:Kim JI; Park SW; Lim JJ; Sohn SI; Shin JS; Park SC; Jang YP; Chung EK; Lee HW; Lee KT
[Ad] Endereço:1Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, 26, Kyungheedae-ro Dongdaemun-gu, Seoul, 02447, Korea Republic of.
[Ti] Título:Gastroprotective effects of the isopropanol extract of Artemisia princeps and its gastroretentive floating tablets on gastric mucosal injury.
[So] Source:Acta Pharm;67(4):479-494, 2017 Dec 20.
[Is] ISSN:1846-9558
[Cp] País de publicação:Croatia
[La] Idioma:eng
[Ab] Resumo:In this study, we investigated the gastroprotective effect of an isopropanol extract from the aerial parts of Artemisia princeps (IPAP) and developed a gastroretentive floating tablet of IPAP (IPAP-FR) for maximized local gastroprotective effects. Pre-treatment with IPAP ameliorated the gastric mucosal hemorrhagic lesions in ethanol/HCl- or indomethacin- treated rats. IPAP decreased mucosal hemorrhage of gastric ulcers induced by ethanol or indomethacin plus pyloric ligation in rats. The optimized floating tablet, IPAP-FR, floated on medium surface with more sustained eupatilin release compared to the non-floating control tablet. X-ray photographs in beagle dogs showed that IPAPFR was retained for > 2 h in the stomach. In the ethanol-induced gastric ulcer rat model, the gastric hemorrhagic lesion was improved more substantially with IPAP-FR compared to the non-floating control tablet. Based on these data, our data suggest that IPAP-FR has an improved therapeutic potential for the treatment of gastric ulcer.
[Mh] Termos MeSH primário: Artemisia/química
Mucosa Gástrica/efeitos dos fármacos
Extratos Vegetais/farmacologia
[Mh] Termos MeSH secundário: 2-Propanol
Animais
Antiulcerosos/farmacologia
Cães
Etanol/efeitos adversos
Flavonoides/farmacologia
Indometacina/efeitos adversos
Ligadura/efeitos adversos
Masculino
Úlcera Péptica Hemorrágica/induzido quimicamente
Úlcera Péptica Hemorrágica/etiologia
Úlcera Péptica Hemorrágica/prevenção & controle
Extratos Vegetais/administração & dosagem
Ratos
Ratos Sprague-Dawley
Úlcera Gástrica/induzido quimicamente
Úlcera Gástrica/complicações
Úlcera Gástrica/prevenção & controle
Comprimidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Ulcer Agents); 0 (Flavonoids); 0 (Plant Extracts); 0 (Tablets); 3K9958V90M (Ethanol); 4D58O05490 (eupatilin); ND2M416302 (2-Propanol); XXE1CET956 (Indomethacin)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180131
[Lr] Data última revisão:
180131
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180117
[St] Status:MEDLINE


  8 / 19118 MEDLINE  
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[PMID]:29337668
[Au] Autor:Badawi AA; Hegazy MM; Louis D; Eldegwy MA
[Ad] Endereço:1Department of Pharmaceutics and Industrial Pharmacy Faculty of Pharmacy, Cairo University Cairo, Egypt.
[Ti] Título:Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up.
[So] Source:Acta Pharm;67(4):511-525, 2017 Dec 20.
[Is] ISSN:1846-9558
[Cp] País de publicação:Croatia
[La] Idioma:eng
[Ab] Resumo:L-carnitine-L-tartrate, a non-essential amino acid, is hygroscopic. This causes a problem in tablet production due to pronounced adhesion of tablets to punches. A 33 full factorial design was adopted to suggest a tablet formulation. Three adsorbents were suggested (Aerosil 200, Aerosil R972, talc) to reduce stickiness at three concentrations (1, 3 and 5 %), and three fillers (mannitol, Avicel PH 101, Dibasic calcium phosphate) were chosen to prepare 27 formulations. Micromeritic properties of formulations were studied, and tablets were prepared by wet granulation. Absence of picking, sticking or capping, recording of sufficient hardness, acceptable friability and tablet ejection force indicated formulation success. The resulting formulation prepared using Avicel PH 101 and 1 % Aerosil 200 was submitted to further investigation in order to choose the most suitable compression conditions using a 33 full factorial design. Variables included compression force, tableting rate and magnesium stearate (lubricant) concentration. The formulation prepared at compression force of 25 kN, using 2 % magnesium stearate, at a production rate of 30 tablets/ minute, was found to be the most appropriate scale up candidate.
[Mh] Termos MeSH primário: Carnitina/síntese química
Comprimidos/síntese química
Tartaratos/síntese química
[Mh] Termos MeSH secundário: Química Farmacêutica/métodos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Tablets); 0 (Tartrates); S7UI8SM58A (Carnitine); W4888I119H (tartaric acid)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180131
[Lr] Data última revisão:
180131
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180117
[St] Status:MEDLINE


  9 / 19118 MEDLINE  
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[PMID]:28956647
[Au] Autor:Chen K; Wen H; Yang F; Yu Y; Gai X; Wang H; Li P; Pan W; Yang X
[Ad] Endereço:a Department of Pharmaceutics , School of Pharmaceutical Sciences, Shenyang Pharmaceutical University , Shenyang , China.
[Ti] Título:Study of controlled-release floating tablets of dipyridamole using the dry-coated method.
[So] Source:Drug Dev Ind Pharm;44(1):116-124, 2018 Jan.
[Is] ISSN:1520-5762
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Dipyridamole (DIP), having a short biological half-life, has a narrow absorption window and is primarily absorbed in the stomach. So, the purpose of this study was to prepare controlled-release floating (CRF) tablets of dipyridamole by the dry-coated method. The influence of agents with different viscosity, hydroxypropylmethylcellulose (HPMC) and polyvinylpyrollidon K30 (PVP K30) in the core tablet and low-viscosity HPMC and PVP K30 in the coating layer on drug release, were investigated. Then, a study with a three-factor, three-level orthogonal experimental design was used to optimize the formulation of the CRF tablets. After data processing, the optimized formulation was found to be: 80 mg HPMC K4M in the core tablet, 80 mg HPMC E15 in core tablet and 40 mg PVP K30 in the coating layer. Moreover, an in vitro buoyancy study showed that the optimized formulation had an excellent floating ability and could immediately float without a lag time and this lasted more than 12 h. Furthermore, an in vivo gamma scintigraphic study showed that the gastric residence time of the CRF tablet was about 8 h.
[Mh] Termos MeSH primário: Química Farmacêutica/métodos
Dipiridamol/química
Excipientes/química
Derivados da Hipromelose/química
Povidona/análogos & derivados
Povidona/química
Comprimidos/química
[Mh] Termos MeSH secundário: Preparações de Ação Retardada
Dipiridamol/farmacocinética
Meia-Vida
Comprimidos/farmacocinética
Viscosidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Delayed-Action Preparations); 0 (Excipients); 0 (Tablets); 0 (polyvinylpyrollidon K30); 3NXW29V3WO (Hypromellose Derivatives); 64ALC7F90C (Dipyridamole); FZ989GH94E (Povidone)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180111
[Lr] Data última revisão:
180111
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170929
[St] Status:MEDLINE
[do] DOI:10.1080/03639045.2017.1386198


  10 / 19118 MEDLINE  
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[PMID]:28832224
[Au] Autor:Chaudhary RS; Patel C; Sevak V; Chan M
[Ad] Endereço:a Apotex Inc., Technical Operations - Technical Support Services , Toronto , Canada.
[Ti] Título:Effect of Kollidon VA 64 particle size and morphology as directly compressible excipient on tablet compression properties.
[So] Source:Drug Dev Ind Pharm;44(1):19-29, 2018 Jan.
[Is] ISSN:1520-5762
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:The study evaluates use of Kollidon VA 64 and a combination of Kollidon VA 64 with Kollidon VA 64 Fine as excipient in direct compression process of tablets. The combination of the two grades of material is evaluated for capping, lamination and excessive friability. Inter particulate void space is higher for such excipient due to the hollow structure of the Kollidon VA 64 particles. During tablet compression air remains trapped in the blend exhibiting poor compression with compromised physical properties of the tablets. Composition of Kollidon VA 64 and Kollidon VA 64 Fine is evaluated by design of experiment (DoE). A scanning electron microscopy (SEM) of two grades of Kollidon VA 64 exhibits morphological differences between coarse and fine grade. The tablet compression process is evaluated with a mix consisting of entirely Kollidon VA 64 and two mixes containing Kollidon VA 64 and Kollidon VA 64 Fine in ratio of 77:23 and 65:35. A statistical modeling on the results from the DoE trials resulted in the optimum composition for direct tablet compression as combination of Kollidon VA 64 and Kollidon VA 64 Fine in ratio of 77:23. This combination compressed with the predicted parameters based on the statistical modeling and applying main compression force between 5 and 15 kN, pre-compression force between 2 and 3 kN, feeder speed fixed at 25 rpm and compression range of 45-49 rpm produced tablets with hardness ranging between 19 and 21 kp, with no friability, capping, or lamination issue.
[Mh] Termos MeSH primário: Excipientes/química
Povidona/química
Comprimidos/química
[Mh] Termos MeSH secundário: Dureza
Tamanho da Partícula
Povidona/análise
Pressão
Solubilidade
Tecnologia Farmacêutica
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Excipients); 0 (Tablets); FZ989GH94E (Povidone)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180111
[Lr] Data última revisão:
180111
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170824
[St] Status:MEDLINE
[do] DOI:10.1080/03639045.2017.1371735



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