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Chandra Bhushan Tripathi, Poonam Parashar, Malti Arya, Mahendra Singh, Jovita Kanoujia, Gaurav Kaithwas, Shubhini A Saraf
Breast cancer is the most common cancer of occurrence in women and has the highest mortality incidence rate therein. The present study envisaged to develop doxorubicin (Dox) loaded folate functionalized nanoemulsion (NE) for profound therapeutic activity against mammary gland cancer. NE was prepared using pseudo-ternary phase diagrams utilizing α-linolenic acid (ALA) as lipid phase, to further enhance the anticancer potential of Dox. Box-Behnken design was employed to systematically develop the NE. Optimized NE (f-Dox-NE) was evaluated for in vitro and in vivo performance...
May 10, 2018: Drug Delivery and Translational Research
Himanshu Bhatt, Sri Vishnu Kiran Rompicharla, Neeraja Komanduri, Aashma Shah, Sateja Paradkar, Balaram Ghosh, Swati Biswas
BACKGROUND: Solid lipid nanoparticles (SLNs) represent an affordable, easily scalable, stable and biocompatible drug delivery system with a high drug to lipid ratio which also improves solubility of poorly soluble drugs. OBJECTIVE: SLNs were developed by using glyceryl monostearate as the single lipid in presence of surfactant Poloxamer 188 and evaluated the efficiency of the SLNs to load the therapeutic cargo, curcumin (CUR). METHOD: The nano-formulation was optimized by Quality by Design approach to understand the effect of various process parameters on various quality attributes, including drug loadability, particle size and polydispersity...
May 3, 2018: Current Drug Delivery
Lei Nie, Mingming Hu, Xu Yan, Tingting Guo, Haibin Wang, Sheng Zhang, Haibin Qu
This case study described a successful application of the quality by design (QbD) principles to a coupling process development of insulin degludec. Failure mode effects analysis (FMEA) risk analysis was first used to recognize critical process parameters (CPPs). Five CPPs, including coupling temperature (Temp), pH of desB30 solution (pH), reaction time (Time), desB30 concentration (Conc), and molar equivalent of ester per mole of desB30 insulin (MolE), were then investigated using a fractional factorial design...
May 3, 2018: AAPS PharmSciTech
Mansi Upadhyay, Sandeep Kumar Reddy Adena, Harsh Vardhan, Sarita K Yadav, Brahmeshwar Mishra
The research aims the development and optimization of capecitabine loaded interpenetrating polymeric network by ionotropic gelation method using polymers locust bean gum and sodium alginate by QbD approach. FMEA was performed to recognize the risks influencing CQAs. BBD was applied to study the effect of factors (polymer ratio, amount of cross-linker and curing time) on responses (particle size, % drug entrapment and % drug release). Polynomial equations and 3-D graphs were plotted to relate between factors and responses...
April 27, 2018: International Journal of Biological Macromolecules
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 drug product quality attributes and process performance of a continuous twin screw wet granulation process. The knowledge gained in this study is intended to be used for Quality by Design (QbD)-based formulation design and formulation optimization. Three principal components which represent the overarching properties of 8 selected pharmaceutical fillers were used as factors, whereas factors 4 and 5 represented binder type and binder concentration in a design of experiments (DoE)...
April 20, 2018: International Journal of Pharmaceutics
Orsolya Gyulai, Anita Kovács, Tamás Sovány, Ildikó Csóka, Zoltán Aigner
This research work presents the use of the Quality by Design (QbD) concept for optimization of the spherical agglomeration crystallization method in the case of the active agent, ambroxol hydrochloride (AMB HCl). AMB HCl spherical crystals were formulated by the spherical agglomeration method, which was applied as an antisolvent technique. Spherical crystals have good flowing properties, which makes the direct compression tableting method applicable. This means that the amount of additives used can be reduced and smaller tablets can be formed...
April 20, 2018: Materials
Chun-Hui Zhai, Jian-Bang Xuan, Hai-Liu Fan, Teng-Fei Zhao, Jian-Lan Jiang
In order to make a further optimization of process design via increasing the stability of design space, we brought in the model of Support Vector Regression (SVR). In this work, the extraction of podophyllotoxin was researched as a case study based on QbD. We compared the fitting effect of SVR and the most used quadratic polynomial model (QPM) in QbD, and an analysis was made between the two design spaces obtained by SVR and QPM. As a result, the SVR stayed ahead of QPM in prediction accuracy, the stability of model and the generalization ability...
April 20, 2018: Drug Development and Industrial Pharmacy
Meriem Fizir, Liu Wei, Niu Muchuan, Asma Itatahine, Yamina Ait Mehdi, Hua He, Pierre Dramou
This article describes the development, optimization, and evaluation of a novel composite imprinted polymer, on the basis of magnetic halloysite nanotubes (MHNTs-MIPs) using "Quality by Design (QbD)" approach combining computer simulation and response surface methodology. Norfloxacin, methacrylic acid, and ethylene glycol dimethacrylate were used as template, functional monomer and cross-linker, respectively. As a comparison, two MHNTs-MIPs have been prepared with the most suitable functional monomer methacrylic acid (MAA) along with acrylamide (AM)...
July 1, 2018: Talanta
Jens Wesholowski, Andreas Berghaus, Markus Thommes
In the framework of Quality-by-Design (QbD), the inline determination of process parameters or quality attributes of a product using sufficient process analytical technology (PAT) is a center piece for the establishment of continuous processes as a standard pharmaceutical technology. In this context, Twin-Screw-Extrusion (TSE) processes, such as Hot-Melt-Extrusion (HME), are one key aspect of current research. The main benefit of this process technology is the combination of different unit operations. Several of these sub-processes are linked to the Residence Time Distribution (RTD) of the material within the apparatus...
April 15, 2018: Pharmaceutics
Daniel Martinez-Marquez, Ali Mirnajafizadeh, Christopher P Carty, Rodney A Stewart
3D printing is an emergent manufacturing technology recently being applied in the medical field for the development of custom bone prostheses and scaffolds. However, successful industry transformation to this new design and manufacturing approach requires technology integration, concurrent multi-disciplinary collaboration, and a robust quality management framework. This latter change enabler is the focus of this study. While a number of comprehensive quality frameworks have been developed in recent decades to ensure that the manufacturing of medical devices produces reliable products, they are centred on the traditional context of standardised manufacturing techniques...
2018: PloS One
Stefano Colombo, Moritz Beck-Broichsitter, Johan Peter Bøtker, Martin Malmsten, Jukka Rantanen, Adam Bohr
Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals...
April 4, 2018: Advanced Drug Delivery Reviews
Nathalie R Wingert, Jéssica B Ellwanger, Lívia M Bueno, Caren Gobetti, Cássia V Garcia, Martin Steppe, Elfrides E S Schapoval
Simultaneous analysis of drug compounds and their impurities of degradation and synthesis became constant in the modern pharmaceutical analysis. Likewise, analytical techniques must improve sensitivity and selectivity for the monitoring of pharmaceutical products, allowing a full assessment of impurities in drug products and, therefore, ensure safety and efficacy of pharmacological treatments. The application of Quality by Design (QbD) principles has proved to be feasible on the elaboration of analytical methods, allowing the comprehensive evaluation and measurement of different analytical parameters and their effects on critical properties of the methodology in development...
April 3, 2018: European Journal of Pharmaceutical Sciences
Lindsay A Wegiel, Steven J Ferris, Steven L Nail
One of the current methods for cycle optimization in primary drying to is develop a graphical design space based on quality by design (QbD). In order to construct the design space, the vial heat transfer coefficient (Kv ) is needed. This paper investigated experimental factors that can affect the Kv result, examined the relationship between the batch average Kv and Kv values for individual vials, and recommended best practices for measuring Kv . Factors investigated included the technique for measuring ice temperature, shelf temperature, the use of a radiation shield on the door of the freeze-dry chamber, and shelf spacing...
April 3, 2018: AAPS PharmSciTech
Lalit Kumar Khurana, Romi Singh, Harinder Singh, Manju Sharma
BACKGROUND: The objective of this study was to apply Quality by Design (QbD) principles on process parameter optimization for development of hybrid delivery system (combination of (SLNs) and In-situ gelling system) for hydrophilic drug Moxifloxacin Hydrochloride (MOX) to achieve its controlled delivery, which otherwise may not be possible through single type of technology. METHODS: Risk assessment studies were carried out to identify probable risks influencing CQAs on the product...
April 2, 2018: Current Pharmaceutical Design
Ildikó Csóka, E Pallagi, T L Paál
The pharmaceutical 'QbD for R&D' needs extension of the established QbD model with elements such as unmet therapeutic need, stakeholder satisfaction, modern quality management tools, and reconsideration of design space after industrial scale-up.
March 27, 2018: Drug Discovery Today
Ya-Qi Wang, Jiao-Jiao Jiao, Zhen-Feng Wu, Qin Zheng, Ming Yang
"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized...
January 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Stanley Chung, Jun Tian, Zhijun Tan, Jie Chen, Jongchan Lee, Michael Borys, Zheng Jian Li
Controlling the charge profile of therapeutic protein is a critical challenge in the current quality-by-design (QbD) paradigm, throughout all phases of biologics process development (PD): cell line development, upstream cell culture, recovery process, downstream purification, and analytical characterization. Charge variant profiles may influence efficacy and/or lead to unintended side-effects. Thus, maintaining a consistent charge profile is of tremendous importance, and increasingly, researchers have focused efforts toward developing strategies to mitigate variability during cell culture and to improve separation and detection of charge variants...
March 13, 2018: Biotechnology and Bioengineering
Suryakanta Swain, Rabinarayan Padhy, Bikash Ranjan Jena, Sitty Manohar Babu
BACKGROUND: Quality by Design is associated to the modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also leads to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify desire and required product performance report such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality attributes (CQA)...
March 8, 2018: Current Drug Discovery Technologies
Micael Karlberg, Moritz von Stosch, Jarka Glassey
In today's biopharmaceutical industries, the lead time to develop and produce a new monoclonal antibody takes years before it can be launched commercially. The reasons lie in the complexity of the monoclonal antibodies and the need for high product quality to ensure clinical safety which has a significant impact on the process development time. Frameworks such as quality by design are becoming widely used by the pharmaceutical industries as they introduce a systematic approach for building quality into the product...
March 7, 2018: Critical Reviews in Biotechnology
Ana L Quiroga-Campano, Nicki Panoskaltsis, Athanasios Mantalaris
Demand for high-value biologics, a rapidly growing pipeline, and pressure from competition, time-to-market and regulators, necessitate novel biomanufacturing approaches, including Quality by Design (QbD) principles and Process Analytical Technologies (PAT), to facilitate accelerated, efficient and effective process development platforms that ensure consistent product quality and reduced lot-to-lot variability. Herein, QbD and PAT principles were incorporated within an innovative in vitro-in silico integrated framework for upstream process development (UPD)...
March 2, 2018: Metabolic Engineering
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