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https://www.readbyqxmd.com/read/28445422/bioactive-components-from-qingwen-baidu-decoction-against-lps-induced-acute-lung-injury-in-rats
#1
Qi Zhang, Hai-Min Lei, Peng-Long Wang, Zhi-Qiang Ma, Yan Zhang, Jing-Jing Wu, Jing Nie, Su-Juan Chen, Wen-Jie Han, Qing Wang, Dan-Yang Chen, Cheng-Ke Cai, Qiang Li
Qingwen Baidu Decoction (QBD) is an extraordinarily "cold" formula. It was traditionally used to cure epidemic hemorrhagic fever, intestinal typhoid fever, influenza, sepsis and so on. The purpose of this study was to discover relationships between the change of the constituents in different extracts of QBD and the pharmacological effect in a rat model of acute lung injury (ALI) induced by lipopolysaccharide (LPS). The study aimed to discover the changes in constituents of different QBD extracts and the pharmacological effects on acute lung injury (ALI) induced by LPS...
April 26, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28435075/development-of-oral-lyophilisates-containing-meloxicam-nanocrystals-using-qbd-approach
#2
Sonia Iurian, Cătălina Bogdan, Ioan Tomuță, Piroska Szabó-Révész, Anita Chvatal, Sorin E Leucuța, Mirela Moldovan, Rita Ambrus
The aim of this study was to develop oral lyophilisates with improved meloxicam (MEL) dissolution, optimizing each step of the preparation by design of experiments. First, meloxicam nanosuspensions were prepared by high-pressure homogenization (HPH), using PVP, Poloxamer or PEG as stabilizers and were subjected to freeze-drying using mannitol as cryoprotectant. The effects of the stabilizers and cryoprotectant were assessed and an optimal formulation was generated within the Design Space where the particle sizes and the PDIs are at their lowest values...
April 20, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28414149/nanosystem-trends-in-drug-delivery-using-quality-by-design-concept
#3
REVIEW
Jing Li, Yanjiang Qiao, Zhisheng Wu
Quality by design (QbD) has become an inevitable trend because of its benefits for product quality and process understanding. Trials have been conducted using QbD in nanosystems' optimization. This paper reviews the application of QbD for processing nanosystems and summarizes the application procedure. It provides prospective guidelines for future investigations that apply QbD to nanosystem manufacturing processes. Employing the QbD concept in this way is a novel area in nanosystem quality.
April 13, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28402220/implementation-of-quality-by-design-towards-processing-of-food-products
#4
Anurag S Rathore, Gautam Kapoor
Quality by design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control. It is an approach based on principles of sound science and quality risk management. As the food processing industry continues to embrace the idea of in-line, on-line and/or at-line sensors and real time characterization for process monitoring and control, the existing gaps with regards to our ability to monitor multiple parameters/variables associated with the manufacturing process will be alleviated over time...
April 12, 2017: Preparative Biochemistry & Biotechnology
https://www.readbyqxmd.com/read/28335023/qbd-driven-development-and-validation-of-liquid-chromatography-tandem-mass-spectrometric-method-for-the-quantitation-of-sildenafil-in-human-plasma
#5
M Saquib Hasnain, Shaukat Ali Ansari, Shireen Rao, Mohammad Tabish, Mukul Singh, Mohammad Syafiq Abdullah, Mohammed Tahir Ansari
The present work was employing the Quality by Design approach for the development and validation of a LC-MS-MS method to support the clinical advancement in determination of sildenafil in human plasma using lorazepam as an internal standard. Sample preparation involved solid phase extraction and calibration range observed between 3 and 1,700 ng/mL. The method was systematically optimized by employing Box-Behnken design and used mobile phase flow rate, pH and composition of mobile phase as the critical factors, and assessing the design for retention time and peak area as the responses...
February 27, 2017: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/28315084/multiple-lipid-nanoparticles-mln-a-new-generation-of-lipid-nanoparticles-for-drug-delivery-systems-lamivudine-mln-experimental-design
#6
Suellen M T Cavalcanti, Cláudia Nunes, Sofia A C Lima, José L Soares-Sobrinho, Salette Reis
PURPOSE: An optimized methodology for the development of a new generation of lipid nanoparticles, the multiple lipid nanoparticles (MLN) is described. MLN have characteristics between nanostructured lipid carriers (NLC) and multiple emulsions (W/O/W), but without the outer aqueous phase. METHODS: The production is based on a hot homogenization method combined with high shear and ultrasonication. The antiretroviral agent lamivudine (3TC), was loaded in the MLN. For comparison purposes, NLC-3TC formulation was also developed and physico-chemically characterized by the same parameters as MLN-3TC...
March 17, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28284763/validation-of-a-two-dimensional-liquid-chromatography-method-for-quality-control-testing-of-pharmaceutical-materials
#7
Samuel H Yang, Jenny Wang, Kelly Zhang
Despite the advantages of 2D-LC, there is currently little to no work in demonstrating the suitability of these 2D-LC methods for use in a quality control (QC) environment for good manufacturing practice (GMP) tests. This lack of information becomes more critical as the availability of commercial 2D-LC instrumentation has significantly increased, and more testing facilities begin to acquire these 2D-LC capabilities. It is increasingly important that the transferability of developed 2D-LC methods be assessed in terms of reproducibility, robustness and performance across different laboratories worldwide...
March 1, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28259457/optimization-of-ion-exchange-sigmoidal-gradients-using-hybrid-models-implementation-of-quality-by-design-in-analytical-method-development
#8
Varsha S Joshi, Vijesh Kumar, Anurag S Rathore
Thorough product understanding is one of the basic tenets for successful implementation of Quality by Design (QbD). Complexity encountered in analytical characterization of biotech therapeutics such as monoclonal antibodies (mAbs) requires novel, simpler, and generic approaches towards product characterization. This paper presents a methodology for implementation of QbD for analytical method development. Optimization of an analytical cation exchange high performance liquid chromatography (CEX-HPLC) method utilizing a sigmoidal gradient has been performed using a hybrid mechanistic model that is based on Design of experiment (DOE) based studies...
March 31, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28250343/evaluating-the-properties-of-poly-lactic-co-glycolic-acid-nanoparticle-formulations-encapsulating-a-hydrophobic-drug-by-using-the-quality-by-design-approach
#9
Masato Kozaki, Shin-Ichiro Kobayashi, Yukihiro Goda, Haruhiro Okuda, Kumiko Sakai-Kato
We applied the Quality by Design (QbD) approach to the development of poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulations encapsulating triamcinolone acetonide, and the critical process parameters (CPPs) were identified to clarify the correlations between critical quality attributes and CPPs. Quality risk management was performed by using an Ishikawa diagram and experiments with a fractional factorial design (ANOVA). The CPPs for particle size were PLGA concentration and rotation speed, and the CPP for relative drug loading efficiency was the poor solvent to good solvent volume ratio...
2017: Chemical & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28247292/design-and-development-of-clopidogrel-bisulfate-gastroretentive-osmotic-formulation-using-quality-by-design-tools
#10
Nilesh Desai, Ravindra Purohit
Clopidogrel bisulfate (CBS) is antiplatelet drug and it is becoming a drug of choice in the treatment and management of prevention of heart attacks and strokes. CBS is stable and soluble in acidic pH; therefore, retention in stomach for prolonged period appears to be beneficial for controlling the bioavailability. The gastroretentive osmotic system (GROS) facilitates prolonged retention of drug in stomach and provides zero-order drug release. A complex formulation like GROS poses many challenges, and QbD tools can help in designing robust formulation which takes all aspects of product and process development in order to deliver a robust product...
February 28, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28231048/original-research-paper-formulation-and-pharmaceutical-development-of-quetiapine-fumarate-sustained-release-matrix-tablets-using-a-qbd-approach
#11
COMPARATIVE STUDY
Alexandru Gavan, Alina Porfire, Cristina Marina, Ioan Tomuta
The main objective of the present study was to apply QbD methodology in the development of once-a-day sustained release quetiapine tablets. The quality target product profile (QTPP) was defined after the pharmaceutical properties and kinetic release of the innovator product, Seroquel XR 200 mg. For the D-optimal experimental design, the level and ratio of matrix forming agents and the type of extragranular diluent were chosen as independent inputs, which represented critical formulation factors. The critical quality attributes (CQAs) studied were the cumulative percentages of quetiapine released after certain time intervals...
March 1, 2017: Acta Pharmaceutica
https://www.readbyqxmd.com/read/28213278/identifying-overarching-excipient-properties-towards-an-in-depth-understanding-of-process-and-product-performance-for-continuous-twin-screw-wet-granulation
#12
N Willecke, A Szepes, M Wunderlich, J P Remon, C Vervaet, T De Beer
The overall objective of this work is to understand how excipient characteristics influence the process and product performance for a continuous twin-screw wet granulation process. The knowledge gained through this study is intended to be used for a Quality by Design (QbD)-based formulation design approach and formulation optimization. A total of 9 preferred fillers and 9 preferred binders were selected for this study. The selected fillers and binders were extensively characterized regarding their physico-chemical and solid state properties using 21 material characterization techniques...
February 14, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28208251/rapid-method-development-in-hydrophilic-interaction-liquid-chromatography-for-pharmaceutical-analysis-using-a-combination-of-quantitative-structure-retention-relationships-and-design-of-experiments
#13
Maryam Taraji, Paul R Haddad, Ruth I J Amos, Mohammad Talebi, Roman Szucs, John W Dolan, Chris A Pohl
A design-of-experiment (DoE) model was developed, able to describe the retention times of a mixture of pharmaceutical compounds in hydrophilic interaction liquid chromatography (HILIC) under all possible combinations of acetonitrile content, salt concentration, and mobile-phase pH with R(2) > 0.95. Further, a quantitative structure-retention relationship (QSRR) model was developed to predict retention times for new analytes, based only on their chemical structures, with a root-mean-square error of prediction (RMSEP) as low as 0...
February 7, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28178596/automated-2d-hplc-method-for-characterization-of-protein-aggregation-with-in-line-fraction-collection-device
#14
Abasha Williams, Erik K Read, Cyrus D Agarabi, Scott Lute, Kurt A Brorson
Monoclonal antibodies are mainly produced by mammalian cell culture, which due to its complexity, results in a wide range of product variants/isoforms. With the growing implementation of Quality by Design (QbD) and Process Analytical Technology (PAT) in drug manufacturing, monitoring and controlling quality attributes within a predefined range during manufacturing may provide added consistency to product quality. To implement these concepts, more robust analytical tools could reduce the time needed for monitoring quality attributes during upstream processing...
January 25, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28176518/main-quality-attributes-of-monoclonal-antibodies-and-effect-of-cell-culture-components
#15
Fatemeh Torkashvand, Behrouz Vaziri
The culture media optimization is an inevitable part of upstream process development in therapeutic monoclonal antibodies (mAbs) production. The quality by design (QbD) approach defines the assured quality of the final product through the development stage. An important step in QbD is determination of the main quality attributes. During the media optimization, some of the main quality attributes such as glycosylation pattern, charge variants, aggregates, and low-molecular-weight species, could be significantly altered...
February 8, 2017: Iranian Biomedical Journal
https://www.readbyqxmd.com/read/28166428/design-of-experiments-doe-in-pharmaceutical-development
#16
Stavros N Politis, Paolo Colombo, Gaia Colombo, Dimitrios M Rekkas
At the beginning of the twentieth century, Sir Ronald Fisher introduced the concept of applying statistical analysis during the planning stages of research rather than at the end of experimentation. When statistical thinking is applied from the design phase, it enables to build quality into the product, by adopting Deming's profound knowledge approach, comprising system thinking, variation understanding, theory of knowledge, and psychology. The pharmaceutical industry was late in adopting these paradigms, compared to other sectors...
June 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28160714/estimation-of-the-critical-quality-attributes-for-hydroxypropyl-methylcellulose-with-near-infrared-spectroscopy-and-chemometrics
#17
Qingli Guo, Lei Nie, Lian Li, Hengchang Zang
With the implementation of quality by design (QbD), critical attributes of raw material (drug substance and excipients) are of significantly importance in pharmaceutical manufacturing process. It is desirable for the quality control of critical material attributes (CMAs) of excipients to ensure the quality of end product. This paper explored the feasibility of an at-line method for the quantitative analysis of hydroxypropoxy group in hydroxypropyl methylcellulose (HPMC) with near infrared spectroscopy (NIRS)...
April 15, 2017: Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy
https://www.readbyqxmd.com/read/28138223/computational-intelligence-models-to-predict-porosity-of-tablets-using-minimum-features
#18
Mohammad Hassan Khalid, Pezhman Kazemi, Lucia Perez-Gandarillas, Abderrahim Michrafy, Jakub Szlęk, Renata Jachowicz, Aleksander Mendyk
The effects of different formulations and manufacturing process conditions on the physical properties of a solid dosage form are of importance to the pharmaceutical industry. It is vital to have in-depth understanding of the material properties and governing parameters of its processes in response to different formulations. Understanding the mentioned aspects will allow tighter control of the process, leading to implementation of quality-by-design (QbD) practices. Computational intelligence (CI) offers an opportunity to create empirical models that can be used to describe the system and predict future outcomes in silico...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28123989/formulation-development-and-evaluation-of-zolmitriptan-oral-soluble-films-using-2-2-factorial-designs
#19
Poluri Koteswari, G Puja Sravanthi, M Mounika, S K Mohammed Rafi, K Nirosha
OBJECTIVE: The present investigation involves the development of zolmitriptan oral soluble film (OSF) formulations and optimization with quality by design (QBD) using natural polymers and evaluation. MATERIALS AND METHODS: Initially, various natural polymers such as sodium alginate, pectin, and gelatin were screened by casting films using solvent casting technique and the prepared films were evaluated. Based on the physical and mechanical properties, sodium alginate was selected as best film former and zolmitriptan-loaded films were casted...
October 2016: International Journal of Pharmaceutical Investigation
https://www.readbyqxmd.com/read/28088371/a-quality-by-design-qbd-study-on-enoxaparin-sodium-loaded-polymeric-microspheres-for-colon-specific-delivery
#20
Dana Hales, Laurian Vlase, Sebastian Alin Porav, Andreea Bodoki, Lucian Barbu-Tudoran, Marcela Achim, Ioan Tomuță
The aim of this study was to apply quality by design (QbD) for pharmaceutical development of enoxaparin sodium microspheres for colon-specific delivery. The Process Parameters (CPPs) and Critical Quality Attributes (CQAs) were identified. A central composite experimental design was used in order to develop the design space of microspheres for colon-specific delivery that have the desired Quality Target Product Profile (QTPP). The CPPs studied were Eudragit® FS-30D/Eudragit® RS-PO ratio, poly(vinyl alcohol) (PVA) concentration and sodium chloride (NaCl) concentration...
March 30, 2017: European Journal of Pharmaceutical Sciences
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