keyword
MENU ▼
Read by QxMD icon Read
search

QbD

keyword
https://www.readbyqxmd.com/read/28231048/original-research-paper-formulation-and-pharmaceutical-development-of-quetiapine-fumarate-sustained-release-matrix-tablets-using-a-qbd-approach
#1
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
#2
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
#3
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
#4
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
#5
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...
8, 2017: Iranian Biomedical Journal
https://www.readbyqxmd.com/read/28166428/design-of-experiments-doe-in-pharmaceutical-development
#6
Stavros N Politis, Paolo Colombo, Gaia Colombo, Dimitrios M Rekkas
At the beginning of the 20(th) 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...
February 6, 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
#7
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
#8
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
#9
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
#10
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
https://www.readbyqxmd.com/read/28039572/formulation-and-optimization-of-multiparticulate-drug-delivery-system-approach-for-high-drug-loading
#11
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
#12
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...
April 2017: 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
#13
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...
March 1, 2017: 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
#14
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
#15
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
#16
REVIEW
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
#17
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
#18
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
#19
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
#20
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
keyword
keyword
93458
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"