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https://www.readbyqxmd.com/read/27875913/development-and-optimization-of-a-meloxicam-%C3%AE-cyclodextrin-complex-for-orally-disintegrating-tablet-using-statistical-analysis
#1
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...
November 22, 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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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...
September 28, 2016: 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
#10
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
#11
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...
September 20, 2016: AAPS Journal
https://www.readbyqxmd.com/read/27631558/a-quality-by-design-approach-to-developing-and-manufacturing-polymeric-nanoparticle-drug-products
#12
Greg Troiano, Jim Nolan, Donald Parsons, Christina Van Geen Hoven, Stephen Zale
The translation of nanomedicines from concepts to commercial products has not reached its full potential, in part because of the technical and regulatory challenges associated with chemistry, manufacturing, and controls (CMC) development of such complex products. It is critical to take a quality by design (QbD) approach to developing nanomedicines-using a risk-based approach to identifying and classifying product attributes and process parameters and ultimately developing a deep understanding of the products, processes, and platform...
September 8, 2016: AAPS Journal
https://www.readbyqxmd.com/read/27627681/quality-by-design-qbd-process-analytical-technology-pat-and-design-of-experiment-applied-to-the-development-of-multifunctional-sunscreens
#13
Daniela D'Almeida Peres, Maira Bueno Ariede, Thalita Marcilio Candido, Tania Santos de Almeida, Felipe Rebello Lourenço, Vladi Olga Consiglieri, Telma Mary Kaneko, Maria Valéria Robles Velasco, André Rolim Baby
Multifunctional formulations are of great importance to ensure better skin protection from harm caused by ultraviolet radiation (UV). Despite the advantages of Quality by Design and Process Analytical Technology approaches to the development and optimization of new products, we found in the literature only a few studies concerning their applications in cosmetic product industry. Thus, in this research work, we applied the QbD and PAT approaches to the development of multifunctional sunscreens containing bemotrizinol, ethylhexyl triazone, and ferulic acid...
October 13, 2016: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/27625003/development-of-rapidly-dissolving-pellets-within-the-quality-by-design-approach
#14
A A Karatzas, S N Politis, D M Rekkas
The purpose of this study was the development of novel, fast disintegrating, effervescent pellets by employing the direct pelletization technique as a single step process. In line with the Quality by Design (QbD) regulatory framework, statistical experimental design was extensively applied to correlate significant formulation and process variables with the critical quality attributes of the product. Pellets were studied with regards to sphericity, size and size distribution. In contrast to the existing multiparticulate platforms, this development integrated only water-soluble excipients to facilitate the multifunctional use of the final dosage form...
September 13, 2016: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/27616074/quality-by-design-qbd-approach-for-design-and-development-of-drug-device-combination-products-a-case-study-on-flunisolide-nasal-spray
#15
Swapnil Sharadkumar Chudiwal, Mohamed Hassan G Dehghan
The objective of the present study was to design and develop drug-device combination product in particular flunisolide nasal spray using quality by design (QbD) approach. Quality target product profile (QTPP) of flunisolide nasal spray was defined and critical quality attributes (CQAs) i.e. viscosity (cp) (Y1) and D50 DSD (µm) (Y2) were identified. Potential risk factors were identified using a fish bone diagram and failure mode effect analysis (FMEA) tools. Plackett Burman and Box Behnken design were used for screening the significant factors and optimizing the variables range respectively...
September 10, 2016: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/27606256/pharmaceutical-product-development-a-quality-by-design-approach
#16
REVIEW
Kannissery Pramod, M Abu Tahir, Naseem A Charoo, Shahid H Ansari, Javed Ali
The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications...
July 2016: International Journal of Pharmaceutical Investigation
https://www.readbyqxmd.com/read/27601040/development-and-validation-of-a-stability-indicating-liquid-chromatographic-method-for-estimating-vilazodone-hydrochloride-in-pharmaceutical-dosage-form-using-quality-by-design
#17
Sagar Suman Panda, Venkata Varaha Bera Ravi Kumar, Sarwar Beg, Sunil Kumar Sahu, Swayamprabha Muni
A stability-indicating liquid chromatographic method was developed employing the principles of quality by design (QbD) to quantify vilazodone hydrochloride (VLN) in pharmaceutical dosage form. A Box-Behnken experimental design was employed to establish optimum conditions including method robustness by selecting organic phase proportion (%), mobile phase flow rate (mL/min) and pH of buffer as the factors, to study their effect on plate number as the response variable. Chromatography was performed on a C-18 column using methanol:phosphate buffer of pH 7...
November 2016: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/27586019/qbd-based-development-of-proliposome-of-lopinavir-for-improved-oral-bioavailability
#18
Grishma M Patel, Pragna K Shelat, Anita N Lalwani
Aim of present work was to apply Quality by Design (QbD) principles for the development of proliposome of poorly soluble lopinavir (LPV). The patient-centric quality target product profile (QTPP) was defined and critical quality attributes (CQAs) earmarked. Risk assessment studies were carried out to identify the probable risks affecting the CQAs of the product. On the basis of preliminary study, lipid: drug ratio and amount of carrier were selected as critical material attributes (CMAs) and were optimized by face centered central composite design...
August 29, 2016: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27575919/water-on-hydrophobic-surfaces-mechanistic-modeling-of-hydrophobic-interaction-chromatography
#19
Gang Wang, Tobias Hahn, Jürgen Hubbuch
Mechanistic models are successfully used for protein purification process development as shown for ion-exchange column chromatography (IEX). Modeling and simulation of hydrophobic interaction chromatography (HIC) in the column mode has been seldom reported. As a combination of these two techniques is often encountered in biopharmaceutical purification steps, accurate modeling of protein adsorption in HIC is a core issue for applying holistic model-based process development, especially in the light of the Quality by Design (QbD) approach...
September 23, 2016: Journal of Chromatography. A
https://www.readbyqxmd.com/read/27575657/a-design-space-exploration-for-control-of-critical-quality-attributes-of-mab
#20
Hemlata Bhatia, Erik Read, Cyrus Agarabi, Kurt Brorson, Scott Lute, Seongkyu Yoon
A unique "design space (DSp) exploration strategy," defined as a function of four key scenarios, was successfully integrated and validated to enhance the DSp building exercise, by increasing the accuracy of analyses and interpretation of processed data. The four key scenarios, defining the strategy, were based on cumulative analyses of individual models developed for the Critical Quality Attributes (23 Glycan Profiles) considered for the study. The analyses of the CQA estimates and model performances were interpreted as (1) Inside Specification/Significant Model (2) Inside Specification/Non-significant Model (3) Outside Specification/Significant Model (4) Outside Specification/Non-significant Model...
October 15, 2016: International Journal of Pharmaceutics
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