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Utilization of risk-based predictive stability within regulatory submissions; industry’s experience 在提交的监管文件中利用基于风险的预测稳定性;行业的经验
AAPS Open
Pub Date : 2020-05-11 DOI: 10.1186/s41120-020-00034-7
Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, R. Bujalski, F. Qiu, Y. Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer, Donnie Pulliam
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引用次数: 10
Similarity assessment of quality attributes of biological medicines: the calculation of operating characteristics to compare different statistical approaches 生物药品质量属性的相似性评价:计算操作特性以比较不同的统计方法
AAPS Open
Pub Date : 2019-09-10 DOI: 10.1186/s41120-019-0033-9
T. Stangler, M. Schiestl
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引用次数: 6
Drug manufacturing and access to medicines: the West African story. A literature review of challenges and proposed remediation 药品生产和药品获取:西非的故事。挑战和建议的补救措施的文献综述
AAPS Open
Pub Date : 2019-08-05 DOI: 10.1186/s41120-019-0032-x
Abigail Ekeigwe
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引用次数: 15
Substandard and falsified medicine screening technologies 不合格和伪造的药物筛选技术
AAPS Open
Pub Date : 2019-07-08 DOI: 10.1186/s41120-019-0031-y
Lukas Roth, Kevin B. Biggs, D. Bempong
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引用次数: 16
Development and evaluation of taste masked dry syrup formulation of potassium chloride. 氯化钾掩味干糖浆配方的研制与评价。
AAPS Open
Pub Date : 2019-01-01 Epub Date: 2019-01-22 DOI: 10.1186/s41120-019-0030-z
Madhur Kulkarni, Brijesh Vishwakarma, Samik Sen, Sandhya Anupuram, Abhijit A Date

Potassium chloride (KCl) syrup is widely used for the oral treatment of the hypokalemia. However, it is associated with unacceptable taste. In the present study, we sought to develop a palatable and easy to reconstitute KCl dry syrup as a commercially viable alternative to currently available KCl syrup. We explored the potential of Eudragit E100 as a taste-masking polymer to coat and improve the palatability of the KCl. With the help of fluid bed processor, KCl was coated with the solution containing varying amounts of Eudragit E100 (4, 6, 10 and 15%). Coating with 10% polymer solution enabled optimal fluid bed processing, higher entrapment of the KCl (81%) and better in vitro release profile in 0.1 N HCl and pH 6.8 phosphate buffer. A dry syrup formulation containing Eudragit E100 coated KCl with good physical and chemical stability in dry and reconstituted state was developed. The palatability of the optimized formulation and commercially available KCl syrup was evaluated using the Electronic Taste Sensing Machine. The developed formulation showed~ 2-fold better taste-masking compared to the commercial KCl syrup. Thus, present investigation describes the development of an effective alternative to the current KCl syrup that can offer better palatability, stability and patient compliance.

氯化钾(KCl)糖浆广泛用于口服治疗低钾血症。然而，它与令人难以接受的味道联系在一起。在目前的研究中，我们试图开发一种可口且易于重组的KCl干糖浆，作为目前可用的KCl糖浆的商业上可行的替代品。我们探索了E100作为一种掩味聚合物的潜力，以包覆和改善KCl的适口性。在流化床处理机的帮助下，用不同含量的E100(4、6、10和15%)溶液涂覆KCl。包覆10%聚合物溶液的流化床处理效果最佳，KCl的包裹率更高(81%)，在0.1 N HCl和pH 6.8磷酸盐缓冲液中体外释放效果更好。研制了一种干粉糖浆配方，该配方在干燥状态和重构状态下具有良好的物理和化学稳定性。用电子味感仪对优化配方和市售KCl糖浆的适口性进行了评价。该配方的掩味效果比市售KCl糖浆好2倍。因此，目前的研究描述了一种有效的替代目前的KCl糖浆，可以提供更好的适口性，稳定性和患者依从性的发展。
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引用次数: 3
ANVISA: an introduction to a new regulatory agency with many challenges ANVISA:介绍一个面临许多挑战的新监管机构
AAPS Open
Pub Date : 2018-12-01 DOI: 10.1186/s41120-018-0029-x
Kim Huynh-Ba, Alexandra Beumer Sassi
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引用次数: 15
The journey to AAPS 2020: a reflection from strategic planning to PharmSci 360 AAPS 2020之旅:从战略规划到药学科学360的反思
AAPS Open
Pub Date : 2018-11-03 DOI: 10.1186/S41120-018-0028-Y
J. Polli, C. McCurdy, D. Wurster, Binodh S Desilva, A. Bak, R. Bendayan, B. Meibohm, Allen C. Templeton, William Weiser, for the Aaps Leadership
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引用次数: 3
Improving the safety of disposable auto-injection devices: a systematic review of use errors 提高一次性自动注射装置的安全性:对使用错误的系统回顾
AAPS Open
Pub Date : 2018-10-18 DOI: 10.1186/s41120-018-0027-z
T. Weinhold, Marzia Del Zotto, Jessica Rochat, Jessica Schiro, S. Pelayo, R. Marcilly
{"title":"Improving the safety of disposable auto-injection devices: a systematic review of use errors","authors":"T. Weinhold, Marzia Del Zotto, Jessica Rochat, Jessica Schiro, S. Pelayo, R. Marcilly","doi":"10.1186/s41120-018-0027-z","DOIUrl":"https://doi.org/10.1186/s41120-018-0027-z","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82001338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 14
Antibody-drug conjugates: integrated bioanalytical and biodisposition assessments in lead optimization and selection 抗体-药物偶联物:在先导物优化和选择中的综合生物分析和生物处置评估
AAPS Open
Pub Date : 2018-08-08 DOI: 10.1186/s41120-018-0026-0
M. Beaumont, D. Tomazela, D. Hodges, G. Ermakov, Edward Hsieh, I. Figueroa, O. So, Yaoli Song, Huiping Ma, S. Antonenko, Wondwessen Mengesha, Yi Wei Zhang, Shuli Zhang, S. Hseih, G. Ayanoglu, Xiaoyan Du, E. Rimmer, Michael Judo, F. Vives, J. Yearley, C. Moon, Anthony Manibusan, Nick A. Knudsen, Andrew Beck, D. Bresson, D. Gately, D. Neupane, E. Escandón
{"title":"Antibody-drug conjugates: integrated bioanalytical and biodisposition assessments in lead optimization and selection","authors":"M. Beaumont, D. Tomazela, D. Hodges, G. Ermakov, Edward Hsieh, I. Figueroa, O. So, Yaoli Song, Huiping Ma, S. Antonenko, Wondwessen Mengesha, Yi Wei Zhang, Shuli Zhang, S. Hseih, G. Ayanoglu, Xiaoyan Du, E. Rimmer, Michael Judo, F. Vives, J. Yearley, C. Moon, Anthony Manibusan, Nick A. Knudsen, Andrew Beck, D. Bresson, D. Gately, D. Neupane, E. Escandón","doi":"10.1186/s41120-018-0026-0","DOIUrl":"https://doi.org/10.1186/s41120-018-0026-0","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77764874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 6
Nano-formulations composed of cell membrane-specific cellular lipid extracts derived from target cells: physicochemical characterization and in vitro evaluation using cellular models of breast carcinoma 由靶细胞提取的细胞膜特异性细胞脂质提取物组成的纳米制剂:乳腺癌细胞模型的理化特性和体外评价
AAPS Open
Pub Date : 2018-07-23 DOI: 10.1186/s41120-018-0025-1
Hanan M Alharbi, R. B. Campbell
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引用次数: 3
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