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https://www.readbyqxmd.com/read/28532031/screening-of-process-variables-to-enhance-the-solubility-of-famotidine-with-2-hydroxypropyl-%C3%AE-cyclodextrin-pvp-k-30-by-using-plackett-burman-design-approach
#1
Umakant Verma, Jitendra B Naik, Jayesh S Patil, Sunil K Yadava
In the present work, inclusion complex of famotidine (FMT) was prepared with (2-HydroxyPropyl)-β-Cyclodextrin (HP-β-CyD) and polyvinylpyrrolidone K-30 (PVP K-30) by spray drying technique to enhance the solubility of famotidine. FMT is a potent histamine H2-receptor antagonist having low solubility as well as oral bioavailability. In order to enhance the solubility of FMT, a quality by design (QbD) approach has been used by employing Plackett-Burman design (PBD). With the application of PBD, seven independent process variables were investigated and optimized for maximum solubility...
August 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
https://www.readbyqxmd.com/read/28526986/implementation-of-quality-by-design-for-formulation-of-rebamipide-gastro-retentive-tablet
#2
Jung-Myung Ha, Jeong-Woong Seo, Su-Hyeon Kim, Ju-Young Kim, Chun-Woong Park, Yun-Seok Rhee, Eun-Seok Park
The purpose of the present study was to develop a rebamipide (RBM) gastro-retentive (GR) tablet by implementing quality by design (QbD). RBM GR tablets were prepared using a sublimation method. Quality target product profile (QTPP) and critical quality attributes (CQAs) of the RBM GR tablets were defined according to the preliminary studies. Factors affecting the CQAs were prioritized using failure mode and effects analysis (FMEA). Design space and optimum formulation were established through a mixture design...
May 19, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28524720/surface-tailored-nanomixed-micelles-containing-quercetin-salicylic-acid-physical-complex-for-enhanced-cellular-and-in-vivo-activities-a-quality-by-design-perspective
#3
Premjeet Singh Sandhu, Rajendra Kumar, O P Katare, Bhupinder Singh
AIM: The development of surface-tailored quercetin (QCT)-salicylic acid (SA) physical complex for effective treatment of skin carcinoma. MATERIALS & METHODS: QCT-SA nanomixed micelles were prepared by the self-assembly method employing the Quality by Design (QbD) approach and evaluated for various in vitro, ex vivo and in vivo parameters. RESULTS: The optimized formulation showed enhanced percent permeation (Q24), in other words, 78.12 ± 0...
May 19, 2017: Nanomedicine
https://www.readbyqxmd.com/read/28505230/degradation-and-impurity-profile-study-of-ciclopirox-olamine-after-pre-column-derivatization-a-risk-based-approach
#4
Madhuri Baghel, Sadhana Rajput
The present study focus on ICH prescribed stress degradation of ciclopirox olamine after precolumn derivatization. For establishing stability-indicating assay, the reaction solutions in which different degradation products were formed were mixed, and the separation was optimized by applying principle of QbD. A risk-analysis tools based on cause-effect risk assessment matrix with control-noise-experimentation (CNX) approach was utilized for identifying the high risk variable affecting the analytical attributes...
May 13, 2017: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/28502896/a-quality-by-design-qbd-twin-screw-extrusion-wet-granulation-approach-for-processing-water-insoluble-drugs
#5
Mohammed Maniruzzaman, Steven A Ross, Tumpa Dey, Arun Nair, Martin J Snowden, Dennis Douroumis
In this study, a Quality by Design (QbD) approach was used to identify the effect of formulation parameters in a twin screw wet extrusion granulation process for the manufacturing of ibuprofen (IBU) granules with increased dissolution rates. A fractional factorial Design of Experiment (DoE) was used to investigate the effect of the excipient composition, binder amount and liquid to solid (L/S) ratio (independent variables) on drug dissolution rates, median particle size diameter and specific surface area (dependent variables)...
May 11, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28502895/nanostructured-lipid-carriers-employing-polyphenols-as-promising-anticancer-agents-quality-by-design-qbd-approach
#6
Ketki Bhise, Sushil Kumar Kashaw, Samaresh Sau, Arun K Iyer
Cancer is one of the leading causes of death worldwide. There are several hurdles in cancer therapy because of side-effects which limits its usage. Nanoparticulate drug delivery systems have been tested against cancer in a range of scientific studies. In the recent years, advanced research on Nanostructured Lipid Carriers (NLCs) has garnered considerable attention owing to the advantages over their first-generation counterparts, Solid Lipid Nanoparticles (SLN). NLCs facilitate efficient loading of poorly water soluble drugs with simple methods of drug loading...
May 11, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28480773/new-gentle-wing-high-shear-granulator-impact-of-processing-variables-on-granules-and-tablets-characteristics-of-high-drug-loading-formulation-using-design-of-experiment-approach
#7
Mohamed H Fayed, Sayed I Abdel-Rahman, Fars K Alanazi, Mahrous O Ahmed, Hesham M Tawfeek, Ramadan I Al-Shdefat
The aim of this work was to study the application of design of experiment (DoE) approach in defining design space for granulation and tableting processes using a novel gentle-wing high shear granulator. According to quality-by-design (QbD) prospective, critical attributes of granules and tablets should be ensured by manufacturing process design. A face centered central composite design has been employed in order to investigate the effect of water amount (X1), impeller speed (X2), wet massing time (X3) and water addition rate (X4) as independent process variables on granules and tablets characteristics...
May 8, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28462699/pegylated-liposomes-of-meloxicam-optimization-by-quality-by-design-in-vitro-characterization-and-cytotoxicity-evaluation
#8
Jessy Shaji, Ipshita Menon
BACKGROUND: Chemoprevention is a strategy which uses therapeutic agents which are essentially not anti-cancer drugs but, however, impedes the carcinogenesis. Meloxicam (MLX) is one such agent which has the potential to be employed in the chemopreventive therapy of colorectal cancer. However, MLX poses shortcomings with respect to its dose required for cytotoxicity. To improve the formulation, we used Quality by design (QbD) for optimization. QbD is a method that employs quality-improving scientific methods that build quality into the formulation by isolating the factors which affect the critical quality attributes the formulation...
April 28, 2017: Pharmaceutical Nanotechnology
https://www.readbyqxmd.com/read/28445422/bioactive-components-from-qingwen-baidu-decoction-against-lps-induced-acute-lung-injury-in-rats
#9
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
#10
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
#11
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-toward-processing-of-food-products
#12
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, online, and/or at-line sensors and real-time characterization for process monitoring and control, the existing gaps with regard 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
#13
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
#14
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...
June 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28284763/validation-of-a-two-dimensional-liquid-chromatography-method-for-quality-control-testing-of-pharmaceutical-materials
#15
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...
April 7, 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
#16
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
#17
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
#18
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
#19
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
#20
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
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