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[PMID]:28626902
[Au] Autor:Teo E; Lockhart K; Purchuri SN; Pushparajah J; Cripps AW; van Driel ML
[Ad] Endereço:Emergency Department, Concord Repatriation General Hospital, Hospital Road, Concord, Sydney, New South Wales, Australia, 2137.
[Ti] Título:Haemophilus influenzae oral vaccination for preventing acute exacerbations of chronic bronchitis and chronic obstructive pulmonary disease.
[So] Source:Cochrane Database Syst Rev;6:CD010010, 2017 06 19.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Chronic bronchitis and chronic obstructive pulmonary disease (COPD) are serious conditions in which patients are predisposed to viral and bacterial infections resulting in potentially fatal acute exacerbations. Chronic obstructive pulmonary disease is defined as a lung disease characterised by obstruction to lung airflow that interferes with normal breathing. Antibiotic therapy has not been particularly useful in eradicating bacteria such as non-typeable Haemophilus influenzae (NTHi) because they are naturally occurring flora of the upper respiratory tract in many people. However, they can cause opportunistic infection. An oral NTHi vaccine has been developed to protect against recurrent infective acute exacerbations in chronic bronchitis. OBJECTIVES: To assess the effectiveness of an oral, whole-cell NTHi vaccine in protecting against recurrent episodes of acute exacerbations of chronic bronchitis and COPD in adults. To assess the effectiveness of NTHi vaccine in reducing NTHi colonising the respiratory tract during recurrent episodes of acute exacerbations of COPD. SEARCH METHODS: We searched the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 1), MEDLINE (1946 to January 2017), Embase (1974 to January 2017), CINAHL (1981 to January 2017), LILACS (1985 to January 2017), and Web of Science (1955 to January 2017). We also searched trials registries and contacted authors of trials requesting unpublished data. SELECTION CRITERIA: We included randomised controlled trials comparing the effects of an oral monobacterial NTHi vaccine in adults with recurrent acute exacerbations of chronic bronchitis or COPD when there was overt matching of the vaccine and placebo groups on clinical grounds. The selection criteria considered populations aged less than 65 years and those older than 65 years. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data from original records and publications for incidence and severity of bronchitis episodes and carriage rate of NTHi measured in the upper respiratory tract, as well as data relevant to other primary and secondary outcomes. MAIN RESULTS: We identified six placebo-controlled randomised controlled trials with a total of 557 participants. These trials investigated the efficacy of enteric-coated, killed preparations of H influenzae in populations prone to recurrent acute exacerbations of chronic bronchitis or COPD. The vaccine preparation and immunisation regimen in all trials consisted of at least three courses of formalin-killed H influenzae in enteric-coated tablets taken at intervals (e.g. days 0, 28, and 56). Each course generally consisted of two tablets taken after breakfast over three consecutive days. In all cases the placebo groups took enteric-coated tablets containing glucose. Risk of bias was moderate across the studies, namely due to the lack of information provided about methods and inadequate presentation of results.Meta-analysis of the oral NTHi vaccine showed a small, non-statistically significant reduction in the incidence of acute exacerbations of chronic bronchitis or COPD (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.57 to 1.10; P = 0.16). There was no significant difference in mortality rate between the vaccine and placebo groups (odds ratio (OR) 1.62, 95% CI 0.63 to 4.12; P = 0.31).We were unable to meta-analyse the carriage levels of NTHi in participants as each trial reported this result using different units and tools of measurement. Four trials showed no significant difference in carriage levels, while two trials showed a significant decrease in carriage levels in the vaccinated group compared with the placebo group.Four trials assessed severity of exacerbations measured by requirement for antibiotics. Three of these trials were comparable and when meta-analysed showed a statistically significant 80% increase in antibiotic courses per person in the placebo group (RR 1.81, 95% CI 1.35 to 2.44; P < 0.001). There was no significant difference between the groups with regard to hospital admission rates (OR 0.96, 95% CI 0.13 to 7.04; P = 0.97). Adverse events were reported in five trials but were not necessarily related to the vaccine; a point estimate is suggestive that they occurred more frequently in the vaccine group, however this result was not statistically significant (RR 1.43, 95% CI 0.70 to 2.92; P = 0.87). Quality of life was not meta-analysed but was reported in two trials, with results at six months showing an improvement in quality of life in the vaccinated group (scoring at least two points better than placebo). AUTHORS' CONCLUSIONS: Analyses demonstrate that NTHi oral vaccination of people with recurrent exacerbations of chronic bronchitis or COPD does not yield a significant reduction in the number and severity of exacerbations. Evidence was mixed, and the individual trials that showed a significant benefit of the vaccine are too small to advocate widespread oral vaccination of people with COPD.
[Mh] Termos MeSH primário: Bronquite Crônica/prevenção & controle
Vacinas Anti-Haemophilus/administração & dosagem
Haemophilus influenzae/imunologia
Doença Pulmonar Obstrutiva Crônica/prevenção & controle
[Mh] Termos MeSH secundário: Administração Oral
Adulto
Idoso
Idoso de 80 Anos ou mais
Antibacterianos/administração & dosagem
Bronquite Crônica/mortalidade
Progressão da Doença
Seres Humanos
Meia-Idade
Doença Pulmonar Obstrutiva Crônica/mortalidade
Ensaios Clínicos Controlados Aleatórios como Assunto
Prevenção Secundária
Comprimidos com Revestimento Entérico
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Anti-Bacterial Agents); 0 (Haemophilus Vaccines); 0 (Tablets, Enteric-Coated)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170824
[Lr] Data última revisão:
170824
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170620
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD010010.pub3


  2 / 2211 MEDLINE  
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[PMID]:28603129
[Au] Autor:Zafar F; Shoaib MH; Ali H; Yousuf RI; Naqvi GR; Nisa Z; Shafiq Y
[Ad] Endereço:Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Pakistan / Faculty of Pharmacy, Ziauddin University Karachi, Pakistan.
[Ti] Título:Pharmaceutical and in vitro therapeutic equivalence studies of ketoprofen enteric coated 100 mg tablets.
[So] Source:Pak J Pharm Sci;30(1):179-186, 2017 Jan.
[Is] ISSN:1011-601X
[Cp] País de publicação:Pakistan
[La] Idioma:eng
[Ab] Resumo:The objective of this study was to assess the quality of six different brands of enteric coated Ketoprofen 100 mg tablets, KPB to KPB6 are available in commercial market of Karachi, Pakistan, while KPB1 was obtained from international source. We performed different physico-chemical assessments i.e. weight variation, diameter, hardness, friability, thickness, disintegration, content uniformity, assay and dissolution test. Results of all the investigations were found to be in adequate limits. Also pharmaceutical equivalence was determined by selecting different tests and assay assessment. Furthermore, in vitro therapeutic equivalence was also estimated at phosphate buffer pH 6.8 and 7.5. Results were evaluated by one way ANOVA, model independent and model dependent methods. ANOVA results showed that release behaviour were found to be similar as p values >0.05, also KPB - KPB followed Weibull model at different dissolution media. Results indicated that innovator and brands not only passes the pharmaceutical equivalence assessment but also comply with the in vitro therapeutic equivalence.
[Mh] Termos MeSH primário: Anti-Inflamatórios não Esteroides/química
Cetoprofeno/química
[Mh] Termos MeSH secundário: Anti-Inflamatórios não Esteroides/normas
Composição de Medicamentos
Dureza
Testes de Dureza
Concentração de Íons de Hidrogênio
Cetoprofeno/normas
Cinética
Modelos Químicos
Paquistão
Controle de Qualidade
Solubilidade
Comprimidos com Revestimento Entérico
Tecnologia Farmacêutica/métodos
Equivalência Terapêutica
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents, Non-Steroidal); 0 (Tablets, Enteric-Coated); 90Y4QC304K (Ketoprofen)
[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


  3 / 2211 MEDLINE  
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[PMID]:28337883
[Au] Autor:Qiao LW; Qu QS; Jiang X
[Ad] Endereço:Department of Kidney Transplantation, People’s Hospital of Zhengzhou, Zhengzhou, China.
[Ti] Título:Evaluation of tolerance and safety of conversion from mycophenolate mofetil to enteric-coated mycophenolic acid in renal transplant recipients.
[So] Source:J Biol Regul Homeost Agents;31(1):141-146, 2017 Jan-Mar.
[Is] ISSN:0393-974X
[Cp] País de publicação:Italy
[La] Idioma:eng
[Ab] Resumo:This study was designed to evaluate the curative effect of conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium tablets (EC-MPS) and its safety. One hundred and twenty renal transplant recipients who developed MMF-associated chronic diarrhea were selected as research subjects and treated with EC-MPS. The patients were followed up for 12 months to compare the improvement of gastrointestinal symptoms and the indexes such as carbon dioxide combining power (CO2CP), serum sodium, serum potassium, serum creatinine (Scr) and 24-h urine protein before and after conversion treatment. One hundred and ten of the 120 patients tolerated the conversion treatment and the dose increment of EC-MPS at week 28. After initiating the conversion treatment, the improvement rate of diarrhea within 2 weeks was 95% (114/120). Indexes, such as CO2CP, serum sodium, serum potassium, after conversion treatment were higher than those before treatment (P less than 0.05). No acute rejection reactions were observed in the 12-month follow-up. Indexes of Scr and 24-h urine protein had significant improvement after conversion treatment compared to before conversion treatment (P less than 0.05). Compared to before treatment, the average values of indexes in gastrointestinal symptom rating scale in the 12th month remained stable, except for the increase of dose. For renal transplant recipients who received suboptimal EC-MPS treatment due to gastrointestinal symptoms, conversion from MMF to EC-MPS can significantly lower gastrointestinal symptom load, improve quality of life, relieve electrolyte disturbance and improve the injured functions of transplanted kidney, without increasing the risks of acute rejection reactions.
[Mh] Termos MeSH primário: Diarreia/prevenção & controle
Substituição de Medicamentos
Imunossupressores/efeitos adversos
Transplante de Rim
Ácido Micofenólico/efeitos adversos
Ácido Micofenólico/uso terapêutico
Insuficiência Renal Crônica/sangue
[Mh] Termos MeSH secundário: Adulto
Idoso
Doença Crônica
Creatinina/sangue
Diarreia/sangue
Diarreia/induzido quimicamente
Feminino
Rejeição de Enxerto/prevenção & controle
Seres Humanos
Imunossupressores/administração & dosagem
Rim/imunologia
Rim/metabolismo
Rim/patologia
Rim/cirurgia
Masculino
Meia-Idade
Ácido Micofenólico/administração & dosagem
Potássio/sangue
Estudos Prospectivos
Proteinúria/sangue
Insuficiência Renal Crônica/imunologia
Insuficiência Renal Crônica/patologia
Insuficiência Renal Crônica/cirurgia
Sódio/sangue
Comprimidos com Revestimento Entérico
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Immunosuppressive Agents); 0 (Tablets, Enteric-Coated); 9NEZ333N27 (Sodium); AYI8EX34EU (Creatinine); HU9DX48N0T (Mycophenolic Acid); RWP5GA015D (Potassium)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170601
[Lr] Data última revisão:
170601
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170325
[St] Status:MEDLINE


  4 / 2211 MEDLINE  
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[PMID]:28337667
[Au] Autor:Li W; Huo M; Sen Chaudhuri A; Yang C; Cao D; Wu Z; Qi X
[Ad] Endereço:Key Laboratory of Modern Chinese Medicines, China Pharmaceutical University, Nanjing, 210009, People's Republic of China.
[Ti] Título:Self-assembled polyelectrolyte complexes films as efficient compression coating layers for controlled-releasing tablets.
[So] Source:J Mater Sci Mater Med;28(5):67, 2017 May.
[Is] ISSN:1573-4838
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Currently, polysaccharide-based hydrogels are widely studied macromolecular networks to modify drug dissolution from controlled-releasing matrix tablets. Among them, polyelectrolyte complexes (PEC) films consisted of chitosan (CS) and sodium alginate (SA) could be obtained via spontaneously assembling under physiological gastrointestinal environment. Here, we utilized these self-assembled PEC films as an efficient coating materials to develop controlled-released matrix tablets through compression coating process, with paracetamol (APAP) as model drug. The constitutive and morphology characteristic studies on these PEC films illustrated that the mixture of CS and SA with the weight ratio of 1:1 would be an promising outer layer for compression-coating tablets. In addition, the in vitro drug releasing behavior experiments demonstrated that the optimized compression coating tablets displayed satisfied zero-order drug releasing profits. Furthermore, the in vivo pharmacokinetic studies of these APAP loaded compression-coated tablets in New Zealand rabbits gave that the T (12.32 ± 1.05 h) was significantly prolonged (p < 0.01), compared to that (0.89 ± 0.26 h) of common APAP tablets (Jinfuning ) after oral administration. These studies suggest that the compression-coated tablets with self-assembled PEC film as coating outer layer may be a promising strategy for peroral controlled release delivery system of water soluble drugs.
[Mh] Termos MeSH primário: Preparações de Ação Retardada/química
Preparações de Ação Retardada/farmacocinética
Polieletrólitos/química
Comprimidos com Revestimento Entérico/química
Comprimidos com Revestimento Entérico/farmacocinética
[Mh] Termos MeSH secundário: Acetaminofen/administração & dosagem
Acetaminofen/química
Acetaminofen/farmacocinética
Administração Oral
Animais
Varredura Diferencial de Calorimetria
Química Farmacêutica
Preparações de Ação Retardada/administração & dosagem
Hidrogéis
Técnicas In Vitro
Microscopia Eletrônica de Varredura
Modelos Biológicos
Polissacarídeos/química
Coelhos
Espectroscopia de Infravermelho com Transformada de Fourier
Propriedades de Superfície
Comprimidos com Revestimento Entérico/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Delayed-Action Preparations); 0 (Hydrogels); 0 (Polyelectrolytes); 0 (Polysaccharides); 0 (Tablets, Enteric-Coated); 362O9ITL9D (Acetaminophen)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171021
[Lr] Data última revisão:
171021
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170325
[St] Status:MEDLINE
[do] DOI:10.1007/s10856-017-5886-7


  5 / 2211 MEDLINE  
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[PMID]:28330645
[Au] Autor:Luo D; Kim JH; Park C; Oh E; Park JB; Cui JH; Cao QR; Lee BJ
[Ad] Endereço:College of Pharmacy, Ajou University, Suwon, 16499, Republic of Korea.
[Ti] Título:Design of fixed dose combination and physicochemical characterization of enteric-coated bilayer tablet with circadian rhythmic variations containing telmisartan and pravastatin sodium.
[So] Source:Int J Pharm;523(1):343-356, 2017 May 15.
[Is] ISSN:1873-3476
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:The aim of this study was to investigate a fixed dose combination (FDC) of telmisartan (TEL) and pravastatin sodium (PRA) in enteric-coated bilayer tablets, which was designed for once-daily bedtime dose in order to match circadian rhythmic variations of hypertension and cholesterol synthesis and optimize the patient friendly dosing treatment. Due to the poor aqueous solubility of TEL, ternary solid dispersions (SD) consisting of TEL, polyethylene glycol 6000 (PEG 6000) and magnesium oxide (MgO) were designed to enhance its dissolution rate in intestinal fluid. MgO was added as an effective alkalizer to maintain the high microenvironmental pH of the saturated solution in the immediate vicinity of TEL particles because TEL is known to be ionizable but poorly soluble in intestinal fluid. In contrast, PRA is known to be very unstable in low pH conditions. In the SD system, TEL was present in an amorphous structure and formed an intermolecular hydrogen bonding with MgO, giving complete drug release without precipitation in intestinal fluid. In addition, the amount of hydrophilic carrier (PEG 6000) was also a factor. In the design of tablet formulation, the diluents and superdisintegrants could play a key role in release profiles. Then, to fulfill the unmet needs of the two model drugs and match circadian rhythmic variations of hypertension and cholesterol synthesis, enteric-coated bilayer tablet consisting of TEL SD and PRA was finally prepared using Acryl-EZE as an enteric coating material. Prior to enteric coating, a seal coating layer (Opadry , 2% weight gains) was firstly introduced to separate the core bilayer tablet from the acidic enteric coating polymers to avoid premature degradation. Dissolution profiles of finished tablets revealed that enteric-coated bilayer tablets with 6% weight gains remained intact in acidic media (pH 1.0) for 2h and then released drugs completely within 45min after switching to the intestinal media (pH 6.8). It was observed that enteric-coated bilayer tablets were stable during 3 month under the accelerated condition of 40°C/75% RH. The delayed drug release and bedtime dosage regimen using enteric-coated bilayer tablet containing TEL and PRA, matching the circadian rhythms of hypertension and hyperlipidemia can provide therapeutic benefits for elderly patients in terms of maximizing the therapeutic effects.
[Mh] Termos MeSH primário: Anticolesterolemiantes/química
Anti-Hipertensivos/química
Benzimidazóis/química
Benzoatos/química
Pravastatina/química
[Mh] Termos MeSH secundário: Anticolesterolemiantes/administração & dosagem
Anti-Hipertensivos/administração & dosagem
Benzimidazóis/administração & dosagem
Benzoatos/administração & dosagem
Cronoterapia Farmacológica
Combinação de Medicamentos
Liberação Controlada de Fármacos
Estabilidade de Medicamentos
Difração de Pó
Pravastatina/administração & dosagem
Comprimidos com Revestimento Entérico
Difração de Raios X
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anticholesteremic Agents); 0 (Antihypertensive Agents); 0 (Benzimidazoles); 0 (Benzoates); 0 (Drug Combinations); 0 (Tablets, Enteric-Coated); KXO2KT9N0G (Pravastatin); U5SYW473RQ (telmisartan)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170807
[Lr] Data última revisão:
170807
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170324
[St] Status:MEDLINE


  6 / 2211 MEDLINE  
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[PMID]:28228058
[Au] Autor:AlHajri L
[Ad] Endereço:1 Higher Colleges of Technology, Dubai, UAE.
[Ti] Título:Enteric-Coated, Extended-Release and Sustained-Release Formulations of NSAIDs.
[So] Source:Ann Pharmacother;51(4):354-356, 2017 Apr.
[Is] ISSN:1542-6270
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The scaffold of this commentary is oriented to gravitate toward shedding light on the misconception regarding the use of enteric-coated, extended-release or sustained-release forms of nonsteroidal anti-inflammatory drugs (NSAIDs) and the reduction in gastrointestinal (GI) risks. Although evidence is sufficiently available with regard to the inability of these forms to ameliorate GI risks, it has been widely neglected by health care professionals. This dilemma will be approached and elaborated by uncovering historical evidence about the topic of interest followed by theoretical pharmacological explanations.
[Mh] Termos MeSH primário: Anti-Inflamatórios não Esteroides/administração & dosagem
Anti-Inflamatórios não Esteroides/efeitos adversos
Trato Gastrointestinal/efeitos dos fármacos
Úlcera Péptica Hemorrágica/induzido quimicamente
Úlcera Péptica/induzido quimicamente
[Mh] Termos MeSH secundário: Preparações de Ação Retardada
Seres Humanos
Risco
Comprimidos com Revestimento Entérico
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents, Non-Steroidal); 0 (Delayed-Action Preparations); 0 (Tablets, Enteric-Coated)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170811
[Lr] Data última revisão:
170811
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170224
[St] Status:MEDLINE
[do] DOI:10.1177/1060028016678007


  7 / 2211 MEDLINE  
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[PMID]:28155991
[Au] Autor:Wong CY; Martinez J; Carnagarin R; Dass CR
[Ad] Endereço:School of Pharmacy, Curtin University, Bentley, WA, Australia.
[Ti] Título:In-vitro evaluation of enteric coated insulin tablets containing absorption enhancer and enzyme inhibitor.
[So] Source:J Pharm Pharmacol;69(3):285-294, 2017 Mar.
[Is] ISSN:2042-7158
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: The aim of this study was to develop an enteric coated insulin tablet formulation using polymers, absorption enhancer and enzyme inhibitor, which protect the tablets in acidic pH and enhance systemic bioavailability. METHODS: In this study, the influence of coating by cellulose acetate hydrogen phthalate solution and chosen excipients on Glut-4 transporter translocation in C2C12 skeletal muscle cells was examined. Following the determination of optimum number of coating layers, two dissolution buffers such as 0.01 m hydrochloric acid, pH 2, and 50 mm phosphate, pH 7.4, were employed to determine the in-vitro release of insulin. KEY FINDINGS: Insulin was protected by the coating during the dissolution process. Five (5-CL) coating layers and eight (8-CL) coating layers had minimal insulin release in hydrochloric acid, but not three (3-CL) coating layers. Glut-4 translocation in C2C12 cells was promoted by the chosen excipients. No detrimental metabolic effects were observed in these cells. CONCLUSION: To date, limited studies combine the overall effectiveness of multiple excipients. Our study showed that the coated tablets have an immediate release effect in phosphate buffer. In Glut-4 translocation assay, insulin was still functional after releasing from the tablet. Such tablet formulation can be potentially beneficial to type 1 diabetes patients.
[Mh] Termos MeSH primário: Inibidores Enzimáticos/química
Insulina/química
Comprimidos com Revestimento Entérico/química
[Mh] Termos MeSH secundário: Tampões (Química)
Celulose/análogos & derivados
Celulose/química
Química Farmacêutica/métodos
Excipientes/química
Seres Humanos
Concentração de Íons de Hidrogênio
Polímeros/química
Solubilidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Buffers); 0 (Enzyme Inhibitors); 0 (Excipients); 0 (Insulin); 0 (Polymers); 0 (Tablets, Enteric-Coated); 9004-34-6 (Cellulose); 9004-38-0 (cellulose acetate phthalate); 9004-44-8 (cellulose, hydrogen phthalate)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170608
[Lr] Data última revisão:
170608
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170204
[St] Status:MEDLINE
[do] DOI:10.1111/jphp.12694


  8 / 2211 MEDLINE  
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[PMID]:28142202
[Au] Autor:Taher AT; Origa R; Perrotta S; Kourakli A; Ruffo GB; Kattamis A; Goh AS; Cortoos A; Huang V; Weill M; Merino Herranz R; Porter JB
[Ad] Endereço:American University of Beirut Medical Center, Beirut, Lebanon.
[Ti] Título:New film-coated tablet formulation of deferasirox is well tolerated in patients with thalassemia or lower-risk MDS: Results of the randomized, phase II ECLIPSE study.
[So] Source:Am J Hematol;92(5):420-428, 2017 May.
[Is] ISSN:1096-8652
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Once-daily deferasirox dispersible tablets (DT) have a well-defined safety and efficacy profile and, compared with parenteral deferoxamine, provide greater patient adherence, satisfaction, and quality of life. However, barriers still exist to optimal adherence, including gastrointestinal tolerability and palatability, leading to development of a new film-coated tablet (FCT) formulation that can be swallowed with a light meal, without the need to disperse into a suspension prior to consumption. The randomized, open-label, phase II ECLIPSE study evaluated the safety of deferasirox DT and FCT formulations over 24 weeks in chelation-naïve or pre-treated patients aged ≥10 years, with transfusion-dependent thalassemia or IPSS-R very-low-, low-, or intermediate-risk myelodysplastic syndromes. One hundred seventy-three patients were randomized 1:1 to DT (n = 86) or FCT (n = 87). Adverse events (overall), consistent with the known deferasirox safety profile, were reported in similar proportions of patients for each formulation (DT 89.5%; FCT 89.7%), with a lower frequency of severe events observed in patients receiving FCT (19.5% vs. 25.6% DT). Laboratory parameters (serum creatinine, creatinine clearance, alanine aminotransferase, aspartate aminotransferase and urine protein/creatinine ratio) generally remained stable throughout the study. Patient-reported outcomes showed greater adherence and satisfaction, better palatability and fewer concerns with FCT than DT. Treatment compliance by pill count was higher with FCT (92.9%) than with DT (85.3%). This analysis suggests deferasirox FCT offers an improved formulation with enhanced patient satisfaction, which may improve adherence, thereby reducing frequency and severity of iron overload-related complications.
[Mh] Termos MeSH primário: Benzoatos/administração & dosagem
Síndromes Mielodisplásicas/tratamento farmacológico
Talassemia/tratamento farmacológico
Triazóis/administração & dosagem
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Química Farmacêutica/métodos
Criança
Feminino
Seres Humanos
Masculino
Meia-Idade
Cooperação do Paciente
Qualidade de Vida
Comprimidos com Revestimento Entérico/administração & dosagem
Comprimidos com Revestimento Entérico/efeitos adversos
Comprimidos com Revestimento Entérico/química
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Benzoates); 0 (Tablets, Enteric-Coated); 0 (Triazoles); V8G4MOF2V9 (deferasirox)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170613
[Lr] Data última revisão:
170613
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170201
[St] Status:MEDLINE
[do] DOI:10.1002/ajh.24668


  9 / 2211 MEDLINE  
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[PMID]:28000299
[Au] Autor:Dzajkowska M; Hanna K; Anna M; Maja S; Dagmara D; Anna S; Malgorzata S
[Ad] Endereço:Department of Pharmaceutical Technology, Medical University of Gdansk, Gdansk, Poland.
[Ti] Título:Prolonged-release minitablets with carbamazepine - preliminary observations in vitro.
[So] Source:J Pharm Pharmacol;69(4):471-479, 2017 Apr.
[Is] ISSN:2042-7158
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: The aim was to develop prolonged-release minitablets (MT) with carbamazepine (CBZ). METHODS: Matrix-type 3-mm MT (5 mg CBZ) were prepared by direct compression using hydrophilic (hypromellose) or hydrophobic polymers (ethylcellulose, Kollidon SR, glyceryl behenate). Coated prolonged-release MT (2.5 mm/3 mg of CBZ) were produced using ethylcellulose or Eudragit RL/RS. The release tests were performed in a basket apparatus with water or 1% sodium lauryl sulphate solution as dissolution media. KEY FINDINGS: High-viscosity hypromellose used as a matrix polymer resulted in slow release of CBZ (80% released during 12 h). Dissolution was slower from hydrophobic matrices. Non-swelling MT cores were successfully coated with Eudragit RL/RS, which resulted in the prolonged release of CBZ (80%/14 h), depending on the film thickness and Eudragit composition. Careful choice of pore formers in the coating film allowed to reduce lag time. Ethylcellulose was unsuitable as coating polymer due to low permeability to CBZ and unsatisfying mechanical resistance of the films modified with hypromellose. CONCLUSION: Prolonged release of CBZ was obtained from both matrix-type and coated MT. Further development of MT as a single unit or multicompartment prolonged-release new dosage form especially suitable for children has been justified.
[Mh] Termos MeSH primário: Carbamazepina/química
Carbamazepina/metabolismo
Química Farmacêutica/métodos
[Mh] Termos MeSH secundário: Preparações de Ação Retardada/química
Preparações de Ação Retardada/metabolismo
Formas de Dosagem
Composição de Medicamentos
Derivados da Hipromelose/química
Derivados da Hipromelose/metabolismo
Solubilidade
Comprimidos
Comprimidos com Revestimento Entérico
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Delayed-Action Preparations); 0 (Dosage Forms); 0 (Tablets); 0 (Tablets, Enteric-Coated); 33CM23913M (Carbamazepine); 3NXW29V3WO (Hypromellose Derivatives)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170719
[Lr] Data última revisão:
170719
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161222
[St] Status:MEDLINE
[do] DOI:10.1111/jphp.12670


  10 / 2211 MEDLINE  
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[PMID]:27873516
[Au] Autor:Lee SH; Park JB; Oh CK; Kim MS; Kim SJ; Ha J
[Ad] Endereço:Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
[Ti] Título:Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium in De Novo Kidney Transplantation.
[So] Source:Yonsei Med J;58(1):217-225, 2017 Jan.
[Is] ISSN:1976-2437
[Cp] País de publicação:Korea (South)
[La] Idioma:eng
[Ab] Resumo:PURPOSE: The increased tolerability of enteric-coated mycophenolate sodium (EC-MPS), compared to mycophenolate mofetil, among kidney transplant recipients has the potential to facilitate cyclosporine (CsA) minimization. Therefore, a prospective trial to determine the optimum EC-MPS dose in CsA-based immunosuppression regimens is necessary. MATERIALS AND METHODS: A comparative, parallel, randomized, open-label study was performed for 140 patients from four centers to compare the efficacy and tolerability of low dose CsA with standard dose EC-MPS (the investigational group) versus standard dose CsA with low dose EC-MPS (the control group) for six months in de novo kidney transplant recipients. Graft function, the incidence of efficacy failure [biopsy-confirmed acute rejection (BCAR), death, graft loss, loss to follow-up], and adverse events were compared. RESULTS: The mean estimated glomerular filtration rate (eGFR) of the investigational group at six months post-transplantation was non-inferior to that of the control group (confidence interval between 57.3 mL/min/1.73m² and 67.4 mL/min/1.73 m², p<0.001). One graft loss was reported in the control group, and no patient deaths were reported in either group. The incidence of BCAR of the investigational group was 8.7%, compared to 18.8% in the control group (p=0.137), during the study period. There were no significant differences (p>0.05) in the incidence of discontinuations and serious adverse events (SAE) between the groups. CONCLUSION: CsA minimization using a standard dose of EC-MPS kept the incidence of acute rejection and additional risks as low as conventional immunosuppression and provided therapeutic equivalence in terms of renal graft function and safety issues.
[Mh] Termos MeSH primário: Ciclosporina/administração & dosagem
Rejeição de Enxerto/prevenção & controle
Imunossupressores/administração & dosagem
Ácido Micofenólico/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Idoso
Feminino
Seres Humanos
Incidência
Transplante de Rim
Masculino
Meia-Idade
Estudos Prospectivos
Comprimidos com Revestimento Entérico
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Immunosuppressive Agents); 0 (Tablets, Enteric-Coated); 83HN0GTJ6D (Cyclosporine); HU9DX48N0T (Mycophenolic Acid)
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161123
[St] Status:MEDLINE
[do] DOI:10.3349/ymj.2017.58.1.217



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