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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


  2 / 5508 MEDLINE  
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[PMID]:29220334
[Au] Autor:Ferreira AO; Brandão MAF; Raposo FJ; Polonini HC; Raposo NRB
[Ad] Endereço:BF-Fox Technologies, Matias Barbosa, MG, Brazil. bffoxtec@gmail.com.
[Ti] Título:Orodispersible Films for Compounding Pharmacies.
[So] Source:Int J Pharm Compd;21(6):454-461, 2017 Nov-Dec.
[Is] ISSN:1092-4221
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Orodispersible film can be defined as a solid pharmaceutical form intended for the delivery and rapid local or systemic release of active ingredients, consisting of a water-soluble polymer film that hydrates rapidly, adhering and dissolving immediately when placed on the tongue or in the oral cavity (oral, palatal, gingival, lingual, or sublingual), without the need for water administration or mastication. Due to its outstanding importance in cases of emergency, practicality of use by patients in transit, and high adherence, orodispersible film has evolved in popularity and success among consumers. It is a promising dosage form for compounding pharmacies, as simpler technologies are being developed to make the compound process easier and faster for the pharmacist. This article aims to explore some of the basics on orodispersible film and the main possible preparations to be developed in compounding pharmacies worldwide.
[Mh] Termos MeSH primário: Sistemas de Liberação de Medicamentos
Polímeros/química
[Mh] Termos MeSH secundário: Administração Oral
Química Farmacêutica
Formas de Dosagem
Composição de Medicamentos
Farmácias
Solubilidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Dosage Forms); 0 (Polymers)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180220
[Lr] Data última revisão:
180220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171209
[St] Status:MEDLINE


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[PMID]:28740040
[Au] Autor:Kawano Y; Otsu S; Bamba T; Hanawa T
[Ad] Endereço:Faculty of Pharmaceutical Sciences, Tokyo University of Science.
[Ti] Título:[Study of Interaction between Fluorinated Coating Glass and the Medicines].
[So] Source:Yakugaku Zasshi;137(11):1409-1417, 2017 Nov 01.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:The adsorption of active pharmaceutical ingredients on the surface of medical devices such as polyvinl chloride, ethylene-vinyl acetate copolymer and glass often prevent the acuurate dose of drug. At dispensing of pharmaceuticals, mètre glass (MG) has been widely used for dispensing syrup. When measuring the viscous syrup, it often takes long time to dispense the accurate volume due to their adhesiveness on the glass surface. In this study, we investigate the adhesion of various syrups to MG made with uncoated glass or glass with a strongly hydrophobic silicone or fluorinated coating in terms of the following formulation parameters: viscosity, surface tension, contact angle, and surface free energy. The contact angles for syrups on the coated glass surfaces were significantly higher than those on the uncoated glass surface. In addition, the relationship between surface tension and contact angle was examined. We found that the contact angle was independent of surface tension for the uncoated glass, while it increased with increasing surface tension for the coated glasses. These results can be explained as follows: the silicone or fluorinated coatings inhibit the hydrogen bonding that usually takes place between water and silanol and siloxane groups at glass surfaces. The coatings reduced the surface free energy and increased the hydrophobicity of the glass, reduced its wettability by the syrups, and thus reduced the adhesion loss for the syrups. It was considered that as for the hydrophobic action, properties of matter of sample influence the coated device by coating in order that it is reinforced.
[Mh] Termos MeSH primário: Adesividade
Formas de Dosagem
Polímeros de Fluorcarboneto
Vidro
Interações Hidrofóbicas e Hidrofílicas
Propriedades de Superfície
[Mh] Termos MeSH secundário: Ligações de Hidrogênio
Silanos
Silicones
Siloxanas
Viscosidade
Água
Molhabilidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Dosage Forms); 0 (Fluorocarbon Polymers); 0 (Silanes); 0 (Silicones); 0 (Siloxanes); 059QF0KO0R (Water); 079V3J9O3X (silanol)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180103
[Lr] Data última revisão:
180103
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170726
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00108


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[PMID]:27771050
[Au] Autor:Kirtane AR; Langer R; Traverso G
[Ad] Endereço:Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts 02139; The David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts 02139.
[Ti] Título:Past, Present, and Future Drug Delivery Systems for Antiretrovirals.
[So] Source:J Pharm Sci;105(12):3471-3482, 2016 Dec.
[Is] ISSN:1520-6017
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The human immunodeficiency virus has infected millions of people and the epidemic continues to grow rapidly in some parts of the world. Antiretroviral (ARV) therapy has provided improved treatment and prolonged the life expectancy of patients. Moreover, there is growing interest in using ARVs to protect against new infections. Hence, ARVs have emerged as our primary strategy in combating the virus. Unfortunately, several challenges limit the optimal performance of these drugs. First, ARVs often require life-long use and complex dosing regimens. This results in low patient adherence and periods of lapsed treatment manifesting in drug resistance. This has prompted the development of alternate dosage forms such as vaginal rings and long-acting injectables that stand to improve patient adherence. Another problem central to therapeutic failure is the inadequate penetration of drugs into infected tissues. This can lead to incomplete treatment, development of resistance, and viral rebound. Several strategies have been developed to improve drug penetration into these drug-free sanctuaries. These include encapsulation of drugs in nanoparticles, use of pharmacokinetic enhancers, and cell-based drug delivery platforms. In this review, we discuss issues surrounding ARV therapy and their impact on drug efficacy. We also describe various drug delivery-based approaches developed to overcome these issues.
[Mh] Termos MeSH primário: Fármacos Anti-HIV/administração & dosagem
Antirretrovirais/administração & dosagem
Terapia Antirretroviral de Alta Atividade/tendências
Sistemas de Liberação de Medicamentos/tendências
[Mh] Termos MeSH secundário: Animais
Terapia Antirretroviral de Alta Atividade/métodos
Dispositivos Anticoncepcionais Femininos/tendências
Formas de Dosagem
Sistemas de Liberação de Medicamentos/métodos
Previsões
Infecções por HIV/diagnóstico
Infecções por HIV/tratamento farmacológico
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Anti-HIV Agents); 0 (Anti-Retroviral Agents); 0 (Dosage Forms)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171201
[Lr] Data última revisão:
171201
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE


  5 / 5508 MEDLINE  
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[PMID]:28865757
[Au] Autor:Menotti J; Alanio A; Sturny-Leclère A; Vitry S; Sauvage F; Barratt G; Bretagne S
[Ad] Endereço:Institut Pasteur, CNRS, Molecular Mycology unit, URA3012 Paris, France; Laboratory of Parasitology-Mycology, Saint-Louis Lariboisière Fernand Widal hospitals, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France; Paris-Diderot, Sorbonne Paris Cité University, Paris, France; Laboratory of Par
[Ti] Título:A cell impedance-based real-time in vitro assay to assess the toxicity of amphotericin B formulations.
[So] Source:Toxicol Appl Pharmacol;334:18-23, 2017 Nov 01.
[Is] ISSN:1096-0333
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Aerosolized liposomal amphotericin B (L-AmB) has been investigated as prophylaxis against invasive aspergillosis. However, the clinical results are controversial and some trials suggest that toxicity could be a limitation for wider use. Our aim was to assess the dynamics of cell toxicity induced in a human alveolar epithelial cell line (A549) after exposure to L-AmB (50 to 400µg/ml) or amphotericin B deoxycholate (D-AmB; 50 to 200µg/ml) by monitoring real-time A549 cell viability using an impedance-based technology. Results were expressed as cell index values integrating cell adhesion, proliferation, and survival. In parallel, the gene expression of proinflammatory cytokines was quantified at 6 and 24h after drug addition by real-time RT-PCR on cell lysates. No sustained reduction of cell indexes was observed with L-AmB or empty liposomes, even at 400µg/ml. Only the highest concentration tested of L-AmB (400µg/ml) yielded transient significant 6-fold and 4-fold induction of TNF-α and IL-8 mRNAs, respectively. In contrast, D-AmB induced a decrease in cell indexes and only the 50µg/ml concentration of D-AmB was followed by cell recovery, higher concentrations leading to cell death. Significant 4-fold, 7-fold and 3-fold inductions of TNF-α, IL-8 and IL-33 mRNAs were also observed at 6h with 50µg/ml of D-AmB. In conclusion, continuous cell impedance measurement showed no toxicity on overall cellular behavior although a slight proinflammatory cytokine expression is possible after L-AmB challenge. Real-time kinetics of cell impedance is an interesting tool for initial screening of cell toxicity.
[Mh] Termos MeSH primário: Aerossóis/toxicidade
Anfotericina B/toxicidade
Antifúngicos/toxicidade
Ácido Desoxicólico/toxicidade
Impedância Elétrica
Células Epiteliais/efeitos dos fármacos
[Mh] Termos MeSH secundário: Células A549
Anfotericina B/química
Antifúngicos/química
Adesão Celular/efeitos dos fármacos
Proliferação Celular/efeitos dos fármacos
Sobrevivência Celular/efeitos dos fármacos
Citocinas/genética
Citocinas/metabolismo
Formas de Dosagem
Combinação de Medicamentos
Regulação da Expressão Gênica/efeitos dos fármacos
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Aerosols); 0 (Antifungal Agents); 0 (Cytokines); 0 (Dosage Forms); 0 (Drug Combinations); 0 (liposomal amphotericin B); 005990WHZZ (Deoxycholic Acid); 7XU7A7DROE (Amphotericin B); 87687-70-5 (amphotericin B, deoxycholate drug combination)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171017
[Lr] Data última revisão:
171017
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170904
[St] Status:MEDLINE


  6 / 5508 MEDLINE  
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[PMID]:28845950
[Au] Autor:Efremov EA; Kasatonova EV; Melnik YI; Nikushina AA
[Ad] Endereço:Department of Andrology and Human Reproduction, N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology branch of NMRRC of Minzdrav of Russia, Moscow, Russia.
[Ti] Título:[PDE-5 inhibitors: patients preferences].
[So] Source:Urologiia;(3):120-126, 2017 Jul.
[Is] ISSN:1728-2985
[Cp] País de publicação:Russia (Federation)
[La] Idioma:rus
[Ab] Resumo:To date, multidisciplinary approach is commonly used to treat erectile dysfunction (ED), and the first line of ED pharmacotherapy, despite its multiple causes, is phosphodiesterase inhibitors of type 5 (PDE-5). They are considered an effective and well tolerated treatment option [1-4]. Concurrently, sildenafil has the largest evidence base for efficacy and safety [5]. The satisfaction of patients with ED therapy is a complex and personal matter, and there are no clearly established and reliable criteria for showing preferences when choosing a PDE-5. Adherence of patients to the PDE-5 therapy is determined not only by the erectile response and side effects, but also by how well the treatment meets the needs and expectations of patients and how it affects the relationship between the partners. This review examines the tolerability and efficacy of the various types of PDE-5 available for treating ED, with a special emphasis on the patient's preferences, and in particular on the new sildenafil orodispersible films. As an alternative route of drug administration, films quickly dissolve in the mouth [6] and have several advantages, improve sexual health and the sense of psychological well-being of patients and their partners.
[Mh] Termos MeSH primário: Disfunção Erétil/tratamento farmacológico
Preferência do Paciente
Inibidores da Fosfodiesterase 5/uso terapêutico
Citrato de Sildenafila/uso terapêutico
[Mh] Termos MeSH secundário: Formas de Dosagem
Seres Humanos
Masculino
Satisfação do Paciente
Inibidores da Fosfodiesterase 5/administração & dosagem
Inibidores da Fosfodiesterase 5/efeitos adversos
Saúde Reprodutiva
Citrato de Sildenafila/administração & dosagem
Citrato de Sildenafila/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Dosage Forms); 0 (Phosphodiesterase 5 Inhibitors); BW9B0ZE037 (Sildenafil Citrate)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171109
[Lr] Data última revisão:
171109
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170829
[St] Status:MEDLINE


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[PMID]:28817689
[Au] Autor:Brown TL; Petrovski S; Hoyle D; Chan HT; Lock P; Tucci J
[Ad] Endereço:La Trobe Institute for Molecular Science, La Trobe University, Bundoora, VIC, Australia.
[Ti] Título:Characterization and formulation into solid dosage forms of a novel bacteriophage lytic against Klebsiella oxytoca.
[So] Source:PLoS One;12(8):e0183510, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:AIM: To isolate and characterize bacteriophage lytic for the opportunistic pathogen Klebsiella oxytoca and their formulation into a range of solid dosage forms for in-vitro testing. METHODS AND RESULTS: We report the isolation, genomic and functional characterization of a novel bacteriophage lytic for Klebsiella oxytoca, which does not infect the closely related Klebsiella pneumoniae. This bacteriophage was formulated into suppositories and troches and shown to be released and lyse underlying Klebsiella oxytoca bacteria in an in-vitro model. These bacteriophage formulations were stable for at least 49 days at 4°C. CONCLUSIONS: The successful in-vitro assay of these formulations here suggests that they could potentially be tested in-vivo to determine whether such a therapeutic approach could modulate the gut microbiome, and control Klebsiella oxytoca overgrowth, during antibiotic therapy regimes. SIGNIFICANCE AND IMPACT OF THE STUDY: This study reports a novel bacteriophage specific for Klebsiella oxytoca which can be formulated into solid dosage forms appropriate for potential delivery in testing as a therapy to modulate gut microbiome during antibiotic therapies.
[Mh] Termos MeSH primário: Bacteriófagos/fisiologia
Formas de Dosagem
Klebsiella oxytoca/virologia
[Mh] Termos MeSH secundário: Bacteriófagos/genética
Bacteriófagos/ultraestrutura
Genes Virais
Microscopia Eletrônica de Transmissão
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Dosage Forms)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171013
[Lr] Data última revisão:
171013
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170818
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0183510


  8 / 5508 MEDLINE  
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[PMID]:28707494
[Au] Autor:Foppoli AA; Maroni A; Cerea M; Zema L; Gazzaniga A
[Ad] Endereço:a Dipartimento di Scienze Farmaceutiche, Sezione di Tecnologia e Legislazione Farmaceutiche 'M.E. Sangalli' , Università degli Studi di Milano , Milano , Italy.
[Ti] Título:Dry coating of solid dosage forms: an overview of processes and applications.
[So] Source:Drug Dev Ind Pharm;43(12):1919-1931, 2017 Dec.
[Is] ISSN:1520-5762
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Dry coating techniques enable manufacturing of coated solid dosage forms with no, or very limited, use of solvents. As a result, major drawbacks associated with both organic solvents and aqueous coating systems can be overcome, such as toxicological, environmental, and safety-related issues on the one hand as well as costly drying phases and impaired product stability on the other. The considerable advantages related to solventless coating has been prompting a strong research interest in this field of pharmaceutics. In the article, processes and applications relevant to techniques intended for dry coating are analyzed and reviewed. Based on the physical state of the coat-forming agents, liquid- and solid-based techniques are distinguished. The former include hot-melt coating and coating by photocuring, while the latter encompass press coating and powder coating. Moreover, solventless techniques, such as injection molding and three-dimensional printing by fused deposition modeling, which are not purposely conceived for coating, are also discussed in that they would open new perspectives in the manufacturing of coated-like dosage forms.
[Mh] Termos MeSH primário: Dessecação/métodos
Excipientes/administração & dosagem
Pós/química
Tecnologia Farmacêutica/métodos
[Mh] Termos MeSH secundário: Formas de Dosagem
Excipientes/química
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Dosage Forms); 0 (Excipients); 0 (Powders)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171018
[Lr] Data última revisão:
171018
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170715
[St] Status:MEDLINE
[do] DOI:10.1080/03639045.2017.1355923


  9 / 5508 MEDLINE  
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[PMID]:28603125
[Au] Autor:Adel-Kader MS; Alwahebi NWH; Alam P
[Ad] Endereço:Department of Pharmacognosy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia / Department of Pharmacognosy, College of Pharmacy, Alexandria University, Alexandria, Egypt.
[Ti] Título:Estimation of yohimbine base in complex mixtures by quantitative HPTLC application.
[So] Source:Pak J Pharm Sci;30(1):149-154, 2017 Jan.
[Is] ISSN:1011-601X
[Cp] País de publicação:Pakistan
[La] Idioma:eng
[Ab] Resumo:The indole alkaloid Yohimbine has been used for over two centuries in the treatment of erectly dysfunction. Several formulations containing yohimbine salts, yohimbe bark power or extract are marketed worldwide. Determination of the amount of yohimbine in such formulation is a challenging task due to their complex nature. Extraction followed by acid-base purification resulted in a relatively pure alkaloids containing fractions. The exact amounts of yohimbine free base in different formulations were determined by densitometric HPTLC validated methods using silica gel TLC plates. Standard curve for yohimbine was generated using yohimbine hydrochloride subjected to the same acid-base treatment as the used samples. All formulations found to contain yohimbine though some with less concentration than the labeled amount.
[Mh] Termos MeSH primário: Antagonistas de Receptores Adrenérgicos alfa 2/análise
Cromatografia em Camada Delgada/métodos
Tecnologia Farmacêutica/métodos
Ioimbina/análise
[Mh] Termos MeSH secundário: Calibragem
Cromatografia em Camada Delgada/normas
Densitometria
Formas de Dosagem
Composição de Medicamentos
Limite de Detecção
Modelos Lineares
Padrões de Referência
Reprodutibilidade dos Testes
Sílica Gel/química
Tecnologia Farmacêutica/normas
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; VALIDATION STUDIES
[Nm] Nome de substância:
0 (Adrenergic alpha-2 Receptor Antagonists); 0 (Dosage Forms); 2Y49VWD90Q (Yohimbine); 60650-90-0 (Silica Gel)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171103
[Lr] Data última revisão:
171103
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170613
[St] Status:MEDLINE


  10 / 5508 MEDLINE  
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[PMID]:28603108
[Au] Autor:Venkateswarlu K; Rangareddy A; Narasimhaiah K; Sharma H; Bandi NMR
[Ad] Endereço:Department of Pharmaceutics, JNTUA- Oil Technological and Pharmaceutical Research Institute, Ananthapuramu, Andhra Pradesh, India.
[Ti] Título:A validated stability indicating RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product.
[So] Source:Pak J Pharm Sci;30(1):23-28, 2017 Jan.
[Is] ISSN:1011-601X
[Cp] País de publicação:Pakistan
[La] Idioma:eng
[Ab] Resumo:The main objective of present study was to develop a RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product. The method was developed for Armodafinil estimation and base hydrolytic products were characterized. The separation was carried out on C18 column by using mobile phase as mixture of water and methanol (45:55%v/v). Eluents were detected at 220nm at 1ml/min. Stress studies were performed with milder conditions followed by stronger conditions so as to get sufficient degradation around 20%. A total of five degradation products were detected and separated from analyte. The linearity of the proposed method was investigated in the range of 20-120µg/ml for Armodafinil. The detection limit and quantification limit was found to be 0.01183µg/ml and 0.035µg/ml respectively. The precision % RSD was found to be less than 2% and the recovery was between 98-102%. Armodafinil was found to be more sensitive to the base hydrolysis and yielded its carboxylic acid as degradant. The developed method was stability indicating assay, suitable to quantify Armodafinil in presence of possible degradants. The drug was sensitive to acid, base &photolytic stress and resistant to thermal &oxidation.
[Mh] Termos MeSH primário: Compostos Benzidrílicos/análise
Cromatografia Líquida de Alta Pressão
Cromatografia de Fase Reversa
Tecnologia Farmacêutica/métodos
Promotores da Vigília/análise
[Mh] Termos MeSH secundário: Calibragem
Cromatografia Líquida de Alta Pressão/normas
Cromatografia de Fase Reversa/normas
Formas de Dosagem
Composição de Medicamentos
Contaminação de Medicamentos
Estabilidade de Medicamentos
Hidrólise
Modelos Lineares
Padrões de Referência
Reprodutibilidade dos Testes
Tecnologia Farmacêutica/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE; VALIDATION STUDIES
[Nm] Nome de substância:
0 (Benzhydryl Compounds); 0 (Dosage Forms); 0 (Wakefulness-Promoting Agents); V63XWA605I (armodafinil)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171103
[Lr] Data última revisão:
171103
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170613
[St] Status:MEDLINE



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BIREME/OPAS/OMS - Centro Latino-Americano e do Caribe de Informação em Ciências da Saúde