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https://www.readbyqxmd.com/read/28088371/a-quality-by-design-qbd-study-on-enoxaparin-sodium-loaded-polymeric-microspheres-for-colon-specific-delivery
#1
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...
January 11, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28039572/formulation-and-optimization-of-multiparticulate-drug-delivery-system-approach-for-high-drug-loading
#2
Neha Shah, Tejal Mehta, Mukesh Gohel
The aim of the present work was to develop and optimize multiparticulate formulation viz. pellets of naproxen by employing QbD and risk assessment approach. Mixture design with extreme vertices was applied to the formulation with high loading of drug (about 90%) and extrusion-spheronization as a process for manufacturing pellets. Independent variables chosen were level of microcrystalline cellulose (MCC)-X 1, polyvinylpyrrolidone K-90 (PVP K-90)-X 2, croscarmellose sodium (CCS)-X 3, and polacrilin potassium (PP)-X 4...
December 30, 2016: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28032517/integrating-biopharmaceutics-risk-assessment-and-in-vivo-absorption-model-in-formulation-development-of-bcs-class-i-drug-using-the-qbd-approach
#3
Naseem A Charoo, Rodrigo Cristofoletti, Sun K Kim
OBJECTIVE: Clinically relevant critical quality attributes (CQA's) were identified for the development of generic drug products containing fluconazole and potential design spaces relevant to the clinical application of the drug candidate was explored. SIGNIFICANCE: A simplified scoring system for the biopharmaceutics risk assessment roadmap (BioRAM) is proposed to guide product development. METHODS: Factorial design of experiments was employed to study the effect of formulation and process variables on CQA's...
December 29, 2016: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28012940/development-of-nanostructured-lipid-carriers-containing-salicyclic-acid-for-dermal-use-based-on-the-quality-by-design-method
#4
A Kovács, Sz Berkó, E Csányi, I Csóka
The aim of our present work was to evaluate the applicability of the Quality by Design (QbD) methodology in the development and optimalization of nanostructured lipid carriers containing salicyclic acid (NLC SA). Within the Quality by Design methology, special emphasis is layed on the adaptation of the initial risk assessment step in order to properly identify the critical material attributes and critical process parameters in formulation development. NLC SA products were formulated by the ultrasonication method using Compritol 888 ATO as solid lipid, Miglyol 812 as liquid lipid and Cremophor RH 60® as surfactant...
December 21, 2016: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28011342/understanding-and-predicting-the-impact-of-critical-dissolution-variables-for-nifedipine-immediate-release-capsules-by-multivariate-data-analysis
#5
A Mercuri, M Pagliari, F Baxevanis, R Fares, N Fotaki
In this study the selection of in vivo predictive in vitro dissolution experimental set-ups using a multivariate analysis approach, in line with the Quality by Design (QbD) principles, is explored. The dissolution variables selected using a design of experiments (DoE) were the dissolution apparatus [USP1 apparatus (basket) and USP2 apparatus (paddle)], the rotational speed of the basket/or paddle, the operator conditions (dissolution apparatus brand and operator), the volume, the pH, and the ethanol content of the dissolution medium...
December 20, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27995464/pat-based-control-of-fluid-bed-coating-process-using-nir-spectroscopy-to-monitor-the-cellulose-coating-on-pharmaceutical-pellets
#6
Venkata Ramana Naidu, Rucha S Deshpande, Moinuddin R Syed, Piyush Deoghare, Dharamvir Singh, Pravin S Wakte
Current endeavor was aimed towards monitoring percent weight build-up during functional coating process on drug-layered pellets. Near-infrared (NIR) spectroscopy is an emerging process analytical technology (PAT) tool which was employed here within quality by design (QbD) framework. Samples were withdrawn after spraying every 15-Kg cellulosic coating material during Wurster coating process of drug-loaded pellets. NIR spectra of these samples were acquired using cup spinner assembly of Thermoscientific Antaris II, followed by multivariate analysis using partial least squares (PLS) calibration model...
December 19, 2016: AAPS PharmSciTech
https://www.readbyqxmd.com/read/27992309/advanced-implantable-drug-delivery-systems-via-continuous-manufacturing
#7
Mohammed Maniruzzaman, Ali Nokhodchi
Polymeric implantable drug delivery systems have remarkable potential for systemic delivery of various therapeutic agents. Generally, drug-loaded implants do not require a vehicle for delivery and can be used to attain prolonged delivery into the systemic circulation of active pharmaceutical ingredients (APIs) with enhanced drug bioavailability. Furthermore, implants can provide drug release ranging from months to years, which improves patient compliance, especially for poorly bioavailable and rapidly metabolized compounds...
2016: Critical Reviews in Therapeutic Drug Carrier Systems
https://www.readbyqxmd.com/read/27964940/the-role-of-physiologically-based-oral-absorption-modelling-in-formulation-development-under-a-quality-by-design-paradigm
#8
Filippos Kesisoglou
Within the last decade, Quality by Design (QbD) has been getting increased attention in its implementation in the development of pharmaceutical drug products. Understanding of the impact of formulation composition and process on clinical performance is a centerpiece of QbD. Physiologically based pharmacokinetic (PBPK) modeling incorporating biorelevant dissolution and a systems parameter approach to gastrointestinal absorption has been gaining increased traction in the pharmaceutical industry as an important tool to guide early formulation development...
December 10, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27956192/quality-by-design-qbd-enabled-development-of-aceclofenac-loaded-nano-structured-lipid-carriers-nlcs-an-improved-dermatokinetic-profile-for-inflammatory-disorder-s
#9
Neeraj K Garg, Gajanand Sharma, Bhupinder Singh, Pradip Nirbhavane, Rajeev K Tyagi, Rahul Shukla, O P Katare
Present study was designed to prepare and characterize aceclofenac loaded nanostructured lipid carriers (NLCs) employing Quality by Design (QbD)-oriented approach. The NLCs were evaluated for their transdermal penetration potential and stability. Aceclofenac loaded nanostructured lipid carriers (NLCs) were prepared & characterized, by employing Quality by Design (QbD)-oriented approach and further evaluated for transdermal penetration potential and stability. Different lipids and surfactants were chosen to prepare NLCs using microemulsion method as critical material attributes (CMAs)...
December 9, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27875913/development-and-optimization-of-a-meloxicam-%C3%AE-cyclodextrin-complex-for-orally-disintegrating-tablet-using-statistical-analysis
#10
Ahmad Ainurofiq, Syaiful Choiri
The purpose of this research was to develop an inclusion complex of meloxicam (MEL)/β-cyclodextrin (β-CD) incorporated into an orally disintegrating tablet (ODT), using statistical analysis to optimize the ODT formulation based on a quality by design (QbD) approach. MEL/β-CD complexation was performed by kneading, co-precipitation and spray drying methods under different molar ratios. Fourier transform infrared spectroscopy, X-ray diffraction and thermal analysis were utilized to evaluate the complexes. A central composite design (α = 2) was applied to optimize and assess the influence of Primojel, Primellose and crushing strength (CS) as independent variables on tablet friability, disintegration behavior, wicking properties and drug release...
December 8, 2016: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/27871989/quality-by-design-qbd-approach-of-pharmacogenomics-in-drug-designing-and-formulation-development-for-optimization-of-drug-delivery-systems
#11
REVIEW
Sumeet Gupta, Vikas Jhawat
Conventional approaches of drug discovery are very complex, costly and time consuming. But after the completion of human genome project, applications of pharmacogenomics in this area completely revolutionize the drug discovery and development process to produce a quality by design (QbD) approach based products. The applications of two areas of pharmacogenomics i.e. structural and functional pharmacogenomics excel the drug discovery process by employing genomic data in drug target identification and evaluation, lead optimization via high throughput screening, evaluation of drug metabolizing enzymes, drug transporters and drug receptors using computer aided technique and bioinformatics library data base...
November 19, 2016: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/27842845/qbd-based-synthesis-and-characterization-of-polyacrylamide-grafted-corn-fibre-gum
#12
Akashdeep Singh, Bhumika Mangla, Sheshank Sethi, Sunil Kamboj, Radhika Sharma, Vikas Rana
The aim of present investigation was to utilize quality by design approach for the synthesis of polyacrylamide corn fibre gum (PAAm-g-CFG) from corn fibre gum (CFG) by varying concentration of acrylamide and initiator. The spectral analysis (ATR-FTIR, (1)H NMR, DSC, X-ray and Mass spectroscopy) was conducted to assure grafting copolymerization of CFG with acrylamide. The powder flow properties confirm the porous nature of PAAm-g-CFG. The grafted copolymer dispersion showed shear thinning behaviour that follows Herschel Bulkley model...
January 20, 2017: Carbohydrate Polymers
https://www.readbyqxmd.com/read/27813291/exploring-the-linkage-between-cell-culture-process-parameters-and-downstream-processing-utilizing-a-plackett-burman-design-for-a-model-monoclonal-antibody
#13
Cyrus D Agarabi, Brittany K Chavez, Scott C Lute, Erik K Read, Sarah Rogstad, David Awotwe-Otoo, Matthew R Brown, Michael T Boyne, Kurt A Brorson
Linkage of upstream cell culture with downstream processing and purification is an aspect of Quality by Design crucial for efficient and consistent production of high quality biopharmaceutical proteins. In a previous Plackett-Burman screening study of parallel bioreactor cultures we evaluated main effects of 11 process variables, such as agitation, sparge rate, feeding regimens, dissolved oxygen set point, inoculation density, supplement addition, temperature, and pH shifts. In this follow-up study, we observed linkages between cell culture process parameters and downstream capture chromatography performance and subsequent antibody attributes...
November 4, 2016: Biotechnology Progress
https://www.readbyqxmd.com/read/27788618/optimization-of-prednisolone-loaded-long-circulating-liposomes-via-application-of-quality-by-design-qbd-approach
#14
Bianca Sylvester, Alina Porfire, Dana-Maria Muntean, Laurian Vlase, Lavinia Lupuţ, Emilia Licarete, Alina Sesarman, Marius Costel Alupei, Manuela Banciu, Marcela Achim, Ioan Tomuţă
Quality by design principles (QbD) were used to assist the formulation of prednisolone-loaded long-circulating liposomes (LCL-PLP) in order to gain a more comprehensive understanding of the preparation process. This approach enables us to improve the final product quality in terms of liposomal drug concentration, encapsulation efficiency and size, and to minimize preparation variability. A 19-run D-optimal experimental design was used to study the impact of the highest risk factors on PLP liposomal concentration (Y1- μg/ml), encapsulation efficiency (Y2-%) and size (Y3-nm)...
November 16, 2016: Journal of Liposome Research
https://www.readbyqxmd.com/read/27785590/role-of-knowledge-management-in-development-and-lifecycle-management-of-biopharmaceuticals
#15
REVIEW
Anurag S Rathore, Oscar Fabián Garcia-Aponte, Aydin Golabgir, Bibiana Margarita Vallejo-Diaz, Christoph Herwig
Knowledge Management (KM) is a key enabler for achieving quality in a lifecycle approach for production of biopharmaceuticals. Due to the important role that it plays towards successful implementation of Quality by Design (QbD), an analysis of KM solutions is needed. This work provides a comprehensive review of the interface between KM and QbD-driven biopharmaceutical production systems as perceived by academic as well as industrial viewpoints. A comprehensive set of 356 publications addressing the applications of KM tools to QbD-related tasks were screened and a query to gather industrial inputs from 17 major biopharmaceutical organizations was performed...
October 26, 2016: Pharmaceutical Research
https://www.readbyqxmd.com/read/27784991/development-of-a-microparticle-based-dry-powder-inhalation-formulation-of-ciprofloxacin-hydrochloride-applying-the-quality-by-design-approach
#16
Keyhaneh Karimi, Edina Pallagi, Piroska Szabó-Révész, Ildikó Csóka, Rita Ambrus
Pulmonary drug delivery of ciprofloxacin hydrochloride offers effective local antibacterial activity and convenience of easy application. Spray drying is a trustworthy technique for the production of ciprofloxacin hydrochloride microparticles. Quality by design (QbD), an up-to-date regulatory-based quality management method, was used to predict the final quality of the product. According to the QbD-based theoretical preliminary parameter ranking and priority classification, dry powder inhalation formulation tests were successfully performed in practice...
2016: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/27766224/improvement-of-meloxicam-solubility-using-a-%C3%AE-cyclodextrin-complex-prepared-via-the-kneading-method-and-incorporated-into-an-orally-disintegrating-tablet
#17
Ahmad Ainurofiq, Syaiful Choiri, Muhamad Ali Azhari, Chaterin Romauli Siagian, Bambang Budi Suryadi, Fea Prihapsara, Sholichah Rohmani
Purpose: The aim of this research was to formulate and develop an orally disintegrating tablet (ODT) that incorporated a MEL/β-CD complex, using a quality by design (QbD) approach to enhance solubility and drug release. Methods: Multiple regression linear analysis was conducted to develop the kneading process and ODT formulation. Mixing time and amount of solvent were used as independent variables in kneading process optimisation, while the superdisintegrants were used to obtain the desired formulation. Fourier transform infrared spectroscopy and differential scanning calorimetry were performed for complex characterization...
September 2016: Advanced Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/27693296/risk-management-and-statistical-multivariate-analysis-approach-for-design-and-optimization-of-satranidazole-nanoparticles
#18
Shalaka Dhat, Swati Pund, Chandrakant Kokare, Pankaj Sharma, Birendra Shrivastava
Rapidly evolving technical and regulatory landscapes of the pharmaceutical product development necessitates risk management with application of multivariate analysis using Process Analytical Technology (PAT) and Quality by Design (QbD). Poorly soluble, high dose drug, Satranidazole was optimally nanoprecipitated (SAT-NP) employing principles of Formulation by Design (FbD). The potential risk factors influencing the critical quality attributes (CQA) of SAT-NP were identified using Ishikawa diagram. Plackett-Burman screening design was adopted to screen the eight critical formulation and process parameters influencing the mean particle size, zeta potential and dissolution efficiency at 30min in pH7...
January 1, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27667516/establishment-and-reliability-evaluation-of-the-design-space-for-hplc-analysis-of-six-alkaloids-in-coptis-chinensis-huanglian-using-bayesian-approach
#19
Sheng-Yun Dai, Bing Xu, Yi Zhang, Jian-Yu Li, Fei Sun, Xin-Yuan Shi, Yan-Jiang Qiao
Coptis chinensis (Huanglian) is a commonly used traditional Chinese medicine (TCM) herb and alkaloids are the most important chemical constituents in it. In the present study, an isocratic reverse phase high performance liquid chromatography (RP-HPLC) method allowing the separation of six alkaloids in Huanglian was for the first time developed under the quality by design (QbD) principles. First, five chromatographic parameters were identified to construct a Plackett-Burman experimental design. The critical resolution, analysis time, and peak width were responses modeled by multivariate linear regression...
September 2016: Chinese Journal of Natural Medicines
https://www.readbyqxmd.com/read/27650190/scientific-and-regulatory-considerations-in-solid-oral-modified-release-drug-product-development
#20
Min Li, Sanna Sander, John Duan, Susan Rosencrance, Sarah Pope Miksinski, Lawrence Yu, Paul Seo, Bhagwant Rege
This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized...
November 2016: AAPS Journal
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