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https://www.readbyqxmd.com/read/28629981/retrospective-quality-by-design-rqbd-applied-to-the-optimization-of-orodispersible-films
#1
Branca M A Silva, Sílvia Vicente, Sofia Cunha, Jorge F J Coelho, Cláudia Silva, Marco Seabra Reis, Sérgio Simões
The study demonstrates the application of QbD based on historical data for a product at a later development stage - retrospective QbD (rQbD). More specifically, it is investigated the root-cause for the observed slower drug release in Orodispersible Films (ODFs) during storage. Risk assessment tools were used to identify parameters affecting ODFs critical quality attributes, namely percent drug release and residual water content. The parameters room temperature, room relative humidity, drying temperature and mixing equipment were used in the statistical modeling of the available data...
June 16, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28593514/influence-of-formulation-factors-on-the-aerosol-performance-of-suspension-and-solution-metered-dose-inhalers-a-systematic-approach
#2
Poonam Sheth, Dennis Sandell, Denise S Conti, Jay T Holt, Anthony J Hickey, Bhawana Saluja
Metered dose inhalers (MDIs) are complex drug-device combination products widely used to treat pulmonary disorders. The efficacy, driven by aerosol performance of the products, depends on a multitude of factors including, but not limited to, the physicochemical properties of drug and nature and amount of excipient(s). Under the quality by design (QbD) paradigm, systematic investigations are necessary to understand how changes in critical quality attributes (CQAs) of formulation, device, and manufacturing process influence key product performance parameters, such as delivered dose (DD) and fine particle dose (FPD)...
June 7, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28579758/development-of-antiproliferative-long-circulating-liposomes-co-encapsulating-doxorubicin-and-curcumin-through-the-use-of-a-quality-by-design-approach
#3
Lucia Ruxandra Tefas, Bianca Sylvester, Ioan Tomuta, Alina Sesarman, Emilia Licarete, Manuela Banciu, Alina Porfire
The aim of this work was to use the quality-by-design (QbD) approach in the development of long-circulating liposomes co-loaded with curcumin (CUR) and doxorubicin (DOX) and to evaluate the cytotoxic potential of these liposomes in vitro using C26 murine colon carcinoma cell line. Based on a risk assessment, six parameters, namely the phospholipid, CUR and DOX concentrations, the phospholipid:cholesterol molar ratio, the temperature during the evaporation and hydration steps and the pH of the phosphate buffer, were identified as potential risk factors for the quality of the final product...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28579542/modeling-in-the-quality-by-design-environment-regulatory-requirements-and-recommendations-for-design-space-and-control-strategy-appointment
#4
Jelena Djuris, Zorica Djuric
Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies...
June 1, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28579437/quality-by-design-of-nano-pharmaceuticals-a-state-of-the-art
#5
REVIEW
T Bastogne
Pharmaceutical Quality-by-Design is a risk-based approach of drug development relying on the understanding of both the product and the process. This state of the art analyzes 24 studies published during the last ten years. A risk modeling of the nanomaterial formulation and manufacturing is firstly presented. After a brief history of the QbD approach, its basic components are recalled in a second part. The most critical material attributes, process parameters, quality variables and measurement technologies are reviewed...
June 1, 2017: Nanomedicine: Nanotechnology, Biology, and Medicine
https://www.readbyqxmd.com/read/28549972/quality-by-design-approach-for-studying-the-impact-of-formulation-and-process-variables-on-product-quality-of-oral-disintegrating-films
#6
Sonal Mazumder, Naresh Pavurala, Prashanth Manda, Xiaoming Xu, Celia N Cruz, Yellela S R Krishnaiah
The present investigation was carried out to understand the impact of formulation and process variables on the quality of oral disintegrating films (ODF) using Quality by Design (QbD) approach. Lamotrigine (LMT) was used as a model drug. Formulation variable was plasticizer to film former ratio and process variables were drying temperature, air flow rate in the drying chamber, drying time and wet coat thickness of the film. A Definitive Screening Design of Experiments (DoE) was used to identify and classify the critical formulation and process variables impacting critical quality attributes (CQA)...
May 23, 2017: International Journal of Pharmaceutics
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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 19, 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
#14
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
#15
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
#16
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
#17
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.
June 28, 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
#18
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
#19
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...
July 1, 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
#20
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
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