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Pesquisa : D26.650.700.419 [Categoria DeCS]
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  1 / 9762 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


  2 / 9762 MEDLINE  
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[PMID]:29441997
[Au] Autor:Bhunchu S; Muangnoi C; Rojsitthisak P; Rojsitthisak P
[Ti] Título:Curcumin diethyl disuccinate encapsulated in chitosan/alginate nanoparticles for improvement of its cytotoxicity against MDA-MB-231 human breast cancer cells.
[So] Source:Pharmazie;71(12):691-700, 2016 Dec 01.
[Is] ISSN:0031-7144
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:Curcumin diethyl disuccinate (CDD) is a succinate prodrug of curcuminoids that has better stability in human plasma and improved in vitro cytotoxicity compared to curcumin. Therefore, CDD has the potential for further development as an anticancer agent. In this study, we focused on optimization of the formulation of CDD-loaded chitosan/alginate nanoparticles using Box-Behnken statistical design to enhance the therapeutic efficacy of CDD. Oil-in-water emulsification followed by ionotropic gelification was used to prepare the CDD-loaded chitosan/ alginate nanoparticles. A formulation with a 0.05:1 chitosan/alginate mass ratio, 0.65% (w/v) Pluronic F127 and 1.5 mg/ml CDD was found to be optimal. FTIR, TGA and XRD confirmed the encapsulation of CDD molecules in the nanoparticles. In vitro cytotoxicity and cellular uptake studies showed that CDD-loaded chitosan/alginate nanoparticles had significantly higher cytotoxicity and cellular uptake in human breast adenocarcinoma MDA-MB-231 cells, compared to free CDD. Physical and chemical stability studies indicated that the optimally formulated CDD-loaded chitosan/alginate nanoparticles were stable at 4 °C for 3 months.
[Mh] Termos MeSH primário: Alginatos/química
Antineoplásicos Fitogênicos/administração & dosagem
Antineoplásicos Fitogênicos/farmacologia
Neoplasias da Mama/tratamento farmacológico
Quitosana/química
Curcumina/análogos & derivados
Excipientes/química
Nanopartículas
Succinatos/administração & dosagem
Succinatos/farmacologia
[Mh] Termos MeSH secundário: Antineoplásicos Fitogênicos/farmacocinética
Neoplasias da Mama/metabolismo
Linhagem Celular Tumoral
Curcumina/administração & dosagem
Curcumina/farmacocinética
Curcumina/farmacologia
Composição de Medicamentos
Estabilidade de Medicamentos
Emulsões
Feminino
Seres Humanos
Poloxâmero
Pró-Fármacos
Succinatos/farmacocinética
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Alginates); 0 (Antineoplastic Agents, Phytogenic); 0 (Emulsions); 0 (Excipients); 0 (Prodrugs); 0 (Succinates); 0 (curcumin diethyl disuccinate); 106392-12-5 (Poloxamer); 9012-76-4 (Chitosan); IT942ZTH98 (Curcumin)
[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.2016.6105


  3 / 9762 MEDLINE  
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[PMID]:29224351
[Au] Autor:Luan Q; Zhou W; Zhang H; Bao Y; Zheng M; Shi J; Tang H; Huang F
[Ad] Endereço:Oil Crops Research Institute of the Chinese Academy of Agricultural Sciences , Oil Crops and Lipids Process Technology National & Local Joint Engineering Laboratory, Key Laboratory of Oilseeds Processing, Ministry of Agriculture, Hubei Key Laboratory of Lipid Chemistry and Nutrition, Wuhan 43006
[Ti] Título:Cellulose-Based Composite Macrogels from Cellulose Fiber and Cellulose Nanofiber as Intestine Delivery Vehicles for Probiotics.
[So] Source:J Agric Food Chem;66(1):339-345, 2018 Jan 10.
[Is] ISSN:1520-5118
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Cellulose-based composite macrogels made by cellulose fiber/cellulose nanofiber (CCNM) were used as an intestine delivery vehicle for probiotics. Cellulose nanofiber (CNF) was prepared by a 2,2,6,6-tetramethylpiperidine-1-oxyl radical (TEMPO)-mediated oxidation system, and the carboxyl groups in CNF acted as pore size and pH responsibility regulators in CCNMs to regulate the probiotics loading and controlled release property. The macrogel presented a porosity of 92.68% with a CNF content of 90%, and the corresponding released viable Lactobacillus plantarum (L. plantarum) was up to 2.68 × 10 cfu/mL. The porous structure and high porosity benefited L. plantarum cells to infiltrate into the core of macrogels. In addition, the macrogels made with high contents of CNF showed sustainable release of L. plantarum cells and delivered enough viable cells to the desired region of intestine tracts. The porous cellulose macrogels prepared by a green and environmental friendly method show potential in the application of fabricating targeted delivery vehicles of bioactive agents.
[Mh] Termos MeSH primário: Sistemas de Liberação de Medicamentos/métodos
Intestinos/efeitos dos fármacos
Lactobacillus plantarum/química
Probióticos/química
[Mh] Termos MeSH secundário: Celulose/química
Excipientes/química
Géis/química
Seres Humanos
Intestinos/microbiologia
Lactobacillus plantarum/fisiologia
Nanofibras/química
Probióticos/farmacologia
[Pt] Tipo de publicação:EVALUATION STUDIES; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Excipients); 0 (Gels); 9004-34-6 (Cellulose)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180205
[Lr] Data última revisão:
180205
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171212
[St] Status:MEDLINE
[do] DOI:10.1021/acs.jafc.7b04754


  4 / 9762 MEDLINE  
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[PMID]:29202305
[Au] Autor:Palazzoli F; Citti C; Licata M; Vilella A; Manca L; Zoli M; Vandelli MA; Forni F; Cannazza G
[Ad] Endereço:Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica, Università di Modena e Reggio Emilia, Largo del pozzo 71, 41125 Modena, Italy.
[Ti] Título:Development of a simple and sensitive liquid chromatography triple quadrupole mass spectrometry (LC-MS/MS) method for the determination of cannabidiol (CBD), Δ -tetrahydrocannabinol (THC) and its metabolites in rat whole blood after oral administration of a single high dose of CBD.
[So] Source:J Pharm Biomed Anal;150:25-32, 2018 Feb 20.
[Is] ISSN:1873-264X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:The investigation of the possible conversion of cannabidiol (CBD) into Δ -tetrahydrocannabinol (THC) in vivo after oral administration of CBD is reported herein since recent publications suggested a rapid conversion in simulated gastric fluid. To this end, single high dose of CBD (50mg/kg) was administered orally to rats and their blood was collected after 3 and 6h. A highly sensitive and selective LC-MS/MS method was developed and fully validated in compliance with the Scientific Working Group of Forensic Toxicology (SWGTOX) standard practices for method validation in forensic toxicology. This method also involved the optimization of cannabinoids and their metabolites extraction in order to remove co-eluting phospholipids and increase the sensitivity of the MS detection. Neither THC nor its metabolites were detected in rat whole blood after 3 or 6h from CBD administration. After oral administration, the amount of CBD dissolved in olive oil was higher than that absorbed from an ethanolic solution. This could be explained by the protection of lipid excipients towards CBD from acidic gastric juice.
[Mh] Termos MeSH primário: Canabidiol/sangue
Cromatografia Líquida/métodos
Dronabinol/sangue
Espectrometria de Massas em Tandem/métodos
[Mh] Termos MeSH secundário: Administração Oral
Animais
Canabidiol/administração & dosagem
Canabidiol/análise
Dronabinol/análise
Etanol/química
Excipientes/química
Masculino
Azeite de Oliva/química
Ratos
Ratos Sprague-Dawley
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE; VALIDATION STUDIES
[Nm] Nome de substância:
0 (Excipients); 0 (Olive Oil); 19GBJ60SN5 (Cannabidiol); 3K9958V90M (Ethanol); 7J8897W37S (Dronabinol)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180130
[Lr] Data última revisão:
180130
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171205
[St] Status:MEDLINE


  5 / 9762 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


  6 / 9762 MEDLINE  
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[PMID]:28851247
[Au] Autor:Dai J; Long W; Liang Z; Wen L; Yang F; Chen G
[Ad] Endereço:a School of Pharmacy , Guangdong Pharmaceutical University , Guangzhou , China.
[Ti] Título:A novel vehicle for local protein delivery to the inner ear: injectable and biodegradable thermosensitive hydrogel loaded with PLGA nanoparticles.
[So] Source:Drug Dev Ind Pharm;44(1):89-98, 2018 Jan.
[Is] ISSN:1520-5762
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Delivery of biomacromolecular drugs into the inner ear is challenging, mainly because of their inherent instability as well as physiological and anatomical barriers. Therefore, protein-friendly, hydrogel-based delivery systems following local administration are being developed for inner ear therapy. Herein, biodegradable poly(lactic-co-glycolic acid) (PLGA) nanoparticles (NPs) containing interferon α-2 b (IFN α-2 b) were loaded in chitosan/glycerophosphate (CS/GP)-based thermosensitive hydrogel for IFN delivery by intratympanic injection. The injectable hydrogel possessed a physiological pH and formed semi-solid gel at 37 °C, with good swelling and deswelling properties. The CS/GP hydrogel could slowly degrade as visualized by scanning electron microscopy (SEM). The presence of NPs in CS/GP gel largely influenced in vitro drug release. In the guinea pig cochlea, a 1.5- to 3-fold increase in the drug exposure time of NPs-CS/GP was found than those of the solution, NPs and IFN-loaded hydrogel. Most importantly, a prolonged residence time was attained without obvious histological changes in the inner ear. This biodegradable, injectable, and thermosensitive NPs-CS/GP system may allow longer delivery of protein drugs to the inner ear, thus may be a potential novel vehicle for inner ear therapy.
[Mh] Termos MeSH primário: Quitosana/química
Orelha Interna/fisiologia
Excipientes/química
Glicerofosfatos/química
Hidrogel de Polietilenoglicol-Dimetacrilato/química
Interferon-alfa/química
Ácido Láctico/química
Nanopartículas/química
Ácido Poliglicólico/química
[Mh] Termos MeSH secundário: Animais
Sistemas de Liberação de Medicamentos
Cobaias
Proteínas Recombinantes/química
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Excipients); 0 (Glycerophosphates); 0 (Interferon-alpha); 0 (Recombinant Proteins); 0 (polylactic acid-polyglycolic acid copolymer); 25852-47-5 (Hydrogel, Polyethylene Glycol Dimethacrylate); 26009-03-0 (Polyglycolic Acid); 33X04XA5AT (Lactic Acid); 43K1W2T1M6 (interferon alfa-2b); 9012-76-4 (Chitosan)
[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:170831
[St] Status:MEDLINE
[do] DOI:10.1080/03639045.2017.1373803


  7 / 9762 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


  8 / 9762 MEDLINE  
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[PMID]:28743552
[Au] Autor:Liu R; Li L; Yin W; Xu D; Zang H
[Ad] Endereço:School of Pharmaceutical Sciences, Shandong University, Wenhuaxi Road 44, Jinan, 250012, China.
[Ti] Título:Near-infrared spectroscopy monitoring and control of the fluidized bed granulation and coating processes-A review.
[So] Source:Int J Pharm;530(1-2):308-315, 2017 Sep 15.
[Is] ISSN:1873-3476
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:The fluidized bed granulation and pellets coating technologies are widely used in pharmaceutical industry, because the particles made in a fluidized bed have good flowability, compressibility, and the coating thickness of pellets are homogeneous. With the popularization of process analytical technology (PAT), real-time analysis for critical quality attributes (CQA) was getting more attention. Near-infrared (NIR) spectroscopy, as a PAT tool, could realize the real-time monitoring and control during the granulating and coating processes, which could optimize the manufacturing processes. This article reviewed the application of NIR spectroscopy in CQA (moisture content, particle size and tablet/pellet thickness) monitoring during fluidized bed granulation and coating processes. Through this review, we would like to provide references for realizing automated control and intelligent production in fluidized bed granulation and pellets coating of pharmaceutical industry.
[Mh] Termos MeSH primário: Espectroscopia de Luz Próxima ao Infravermelho
Tecnologia Farmacêutica
[Mh] Termos MeSH secundário: Química Farmacêutica
Excipientes
Tamanho da Partícula
Comprimidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Excipients); 0 (Tablets)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180109
[Lr] Data última revisão:
180109
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170727
[St] Status:MEDLINE


  9 / 9762 MEDLINE  
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[PMID]:28450166
[Au] Autor:Wang Z; Gupta SK; Meenach SA
[Ad] Endereço:University of Rhode Island, College of Engineering, Department of Chemical Engineering, Kingston, RI 02881, USA.
[Ti] Título:Development and physicochemical characterization of acetalated dextran aerosol particle systems for deep lung delivery.
[So] Source:Int J Pharm;525(1):264-274, 2017 Jun 15.
[Is] ISSN:1873-3476
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Biocompatible, biodegradable polymers are commonly used as excipients to improve the drug delivery properties of aerosol formulations, in which acetalated dextran (Ac-Dex) exhibits promising potential as a polymer in various therapeutic applications. Despite this promise, there is no comprehensive study on the use of Ac-Dex as an excipient for dry powder aerosol formulations. In this study, we developed and characterized pulmonary drug delivery aerosol microparticle systems based on spray-dried Ac-Dex with capabilities of (1) delivering therapeutics to the deep lung, (2) targeting the particles to a desired location within the lungs, and (3) releasing the therapeutics in a controlled fashion. Two types of Ac-Dex, with either rapid or slow degradation rates, were synthesized. Nanocomposite microparticle (nCmP) and microparticle (MP) systems were successfully formulated using both kinds of Ac-Dex as excipients and curcumin as a model drug. The resulting MP were collapsed spheres approximately 1µm in diameter, while the nCmP were similar in size with wrinkled surfaces, and these systems dissociated into 200nm nanoparticles upon reconstitution in water. The drug release rates of the Ac-Dex particles were tuned by modifying the particle size and ratio of fast to slow degrading Ac-Dex. The pH of the environment was also a significant factor that influenced the drug release rate. All nCmP and MP systems exhibited desirable aerodynamic diameters that are suitable for deep lung delivery (e.g. below 5µm). Overall, the engineered Ac-Dex aerosol particle systems have the potential to provide targeted and effective delivery of therapeutics into the deep lung.
[Mh] Termos MeSH primário: Administração por Inalação
Aerossóis/química
Curcumina/administração & dosagem
Dextranos/química
[Mh] Termos MeSH secundário: Liberação Controlada de Fármacos
Excipientes/química
Pulmão/efeitos dos fármacos
Tamanho da Partícula
Pós
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Aerosols); 0 (Dextrans); 0 (Excipients); 0 (Powders); IT942ZTH98 (Curcumin)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180108
[Lr] Data última revisão:
180108
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE


  10 / 9762 MEDLINE  
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[PMID]:28461266
[Au] Autor:Bao Q; Shen J; Jog R; Zhang C; Newman B; Wang Y; Choi S; Burgess DJ
[Ad] Endereço:University of Connecticut, School of Pharmacy, Storrs, CT 06269, United States.
[Ti] Título:In vitro release testing method development for ophthalmic ointments.
[So] Source:Int J Pharm;526(1-2):145-156, 2017 Jun 30.
[Is] ISSN:1873-3476
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:It is essential as well as challenging to develop a reliable in vitro release testing method for determining whether differences in release profiles exist between qualitatively and quantitatively equivalent ophthalmic ointment formulations. There is a lack of regulatory guidance on in vitro release testing methods for ophthalmic formulations. Three different in vitro release testing methods 1) USP apparatus 4 with semisolid adapters; 2) USP apparatus 2 with enhancer cells; and 3) Franz diffusion cells were investigated. Qualitatively and quantitatively equivalent ointments were prepared via hot melting and simple mixing methods using four different sources of excipients (i.e. white petrolatum). The ointment formulations were characterized for content uniformity, particle size, and rheological parameters. All the formulations showed adequate content uniformity and similar particle size. The ointments prepared via the hot melting processes showed higher rheological parameters, as did the ointments prepared using 'white' petrolatum that exhibited a yellowish color. The three in vitro release testing methods were compared and evaluated for reproducibility, discriminatory capability, and correlation with the rheological parameters. Compared with the compendial methods, the non-compendial method (Franz diffusion cells) showed poorer reproducibility. All three methods possessed the ability to discriminate between the ophthalmic ointments with manufacturing differences. However, the USP apparatus 4 method displayed the largest margin of discrimination between the release profiles of the different ophthalmic ointments. In addition, the in vitro release rate obtained using the USP apparatus 4 method showed the strongest logarithmic linear correlation with the rheological parameters (Power law consistency index (K value) and crossover modulus) compared to the other two methods.
[Mh] Termos MeSH primário: Administração Oftálmica
Liberação Controlada de Fármacos
Excipientes/química
Pomadas/análise
[Mh] Termos MeSH secundário: Química Farmacêutica
Tamanho da Partícula
Reprodutibilidade dos Testes
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Excipients); 0 (Ointments)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180104
[Lr] Data última revisão:
180104
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170503
[St] Status:MEDLINE



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