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Shakeeb Ahmed, Azka Gull, Mahtab Alam, Mohd Aqil, Yasmin Sultana
The objective of present study was to develop a nanoemulsion formulation of agomelatine (BCS class II drug) for the solubility enhancement. Capmul MCM, Tween 80 and PEG-400 were selected as oil, surfactant and co-surfactant respectively. The high energy ultrasonication method was used for the preparation of nanoemulsion. Three-factor three-level central composite design was employed to get the best formulation. The independent variables selected for the optimization were % oil, %Smix and sonication time (second)...
March 2018: Ultrasonics Sonochemistry
Luca Nompari, Serena Orlandini, Benedetta Pasquini, Cristiana Campa, Michele Rovini, Massimo Del Bubba, Sandra Furlanetto
Bexsero is the first approved vaccine for active immunization of individuals from 2 months of age and older to prevent invasive disease caused by Neisseria meningitidis serogroup B. The active components of the vaccine are Neisseria Heparin Binding Antigen, factor H binding protein, Neisseria adhesin A, produced in Escherichia coli cells by recombinant DNA technology, and Outer Membrane Vesicles (expressing Porin A and Porin B), produced by fermentation of Neisseria meningitidis strain NZ98/254. All the Bexsero active components are adsorbed on aluminum hydroxide and the unadsorbed antigens content is a product critical quality attribute...
February 1, 2018: Talanta
A Brunaugh, H D C Smyth
Process control and optimization is a critical aspect of process analytical technology (PAT), quality by design (QbD), and the implementation of continuous manufacturing procedures. While process control and optimization techniques have been utilized in other manufacturing industries for decades, the pharmaceutical industry has only recently begun to adopt these procedures. Micronization, particularly milling, is a generally low-yield, high-energy consumption process that is well suited for a process optimization mindset...
November 13, 2017: Drug Delivery and Translational Research
Ludivine Ferey, Adrien Raimbault, Isabelle Rivals, Karen Gaudin
An innovative Analytical Quality-by-Design (AQbD) methodology was followed to develop a specific and robust UHPLC method for the simultaneous separation of 16 active pharmaceutical ingredients (APIs). In the context of pharmaceutical repositioning, these molecules have been selected as good candidates for buccal per mucous (BPM(®)) administration route. Given the structural and physico-chemical diversity of compounds, an innovative development strategy based on QbD was applied. The main advantage of QbD is to ensure the robustness of the method...
October 16, 2017: Journal of Pharmaceutical and Biomedical Analysis
Radhakrishna K Maroju, Steve Barash, Charlene Brisbane
Formulation development includes selection of appropriate excipients to stabilize the active pharmaceutical ingredient (API) throughout its recommended shelf-life, against potential excursions in its life cycle and sometimes to aid in delivery of the therapeutic into the patient. Identity and quantity of every ingredient in a therapeutic formulation are critical to achieve their intended purpose. Deviations from a target composition can result in manufacturing, safety and efficacy challenges. It is mandatory to establish robustness of a formulation for the expected changes in its composition arising from the qualified 'process variability' of the impacting process steps during manufacture...
October 26, 2017: Journal of Pharmaceutical Sciences
Francesca Buttini, Stavroula Rozou, Alessandra Rossi, Vera Zoumpliou, Dimitrios M Rekkas
This review aims in discussing the application of the Quality by Design (QbD) approach on the development of the Dry Powders Inhalers (DPIs). It starts with a thorough presentation of the Quality's concept evolution within the pharmaceutical sector and how this slowly adopted set of quality guidelines is now a major scientific and regulatory requirement. DPIs represent a type of delivery system where the system's thinking approach integrating the device, the formulation and the patient represent a major challenge to be met...
November 2, 2017: European Journal of Pharmaceutical Sciences
Bianca Sylvester, Alina Porfire, Marcela Achim, Lucia Rus, Ioan Tomuţă
This study highlights the advantages of using a Quality by Design (QbD) approach in order to gain a more comprehensive understanding of the freeze-drying process of pravastatin-loaded long-circulating liposomes (LCL-PRAV). Within the QbD paradigm, the present study aimed to establish the design space for the optimization of freeze-dried LCL-PRAV by means of Design of Experiment (DOE). The encapsulated solute retention (ESR), the average particle size and zeta potential after freeze-drying, the residual moisture content, the macroscopic cake appearance, the glass trasition temperature (Tg) of the freeze-dried cake and the primary drying time were defined as critical quality attributes (CQAs) for the freeze-dried final product...
November 3, 2017: Drug Development and Industrial Pharmacy
Ketsia Yekpe, Nicolas Abatzoglou, Bernard Bataille, Ryan Gosselin, Tahmer Sharkawi, Jean-Sébastien Simard, Antoine Cournoyer
This study applied the concept of Quality by Design (QbD) to tablet dissolution. Its goal was to propose a quality control strategy to model dissolution testing of solid oral dose products according to International Conference on Harmonization guidelines. The methodology involved the following three steps: (1) a risk analysis to identify the material- and process-related parameters impacting the critical quality attributes of dissolution testing, (2) an experimental design to evaluate the influence of design factors (attributes and parameters selected by risk analysis) on dissolution testing, and (3) an investigation of the relationship between design factors and dissolution profiles...
November 2, 2017: Pharmaceutical Development and Technology
Shahab Mohtashamian, Soheil Boddohi, Saman Hosseinkhani
Self-assembled nanogel was prepared by electrostatic complexation of two oppositely charged biological macromolecules, which were cationic nisin and anionic chondroitin sulfate (ChS). The critical factors affected the physical properties of ChS-nisin nanogel was screened and optimized by Plackett-Burman design (PB) and central composite design (CCD). The independent factors selected were: concentration ratio of nisin to ChS, injection rate of nisin solution, buffer solvent type, magnetic stirring rate, pH of initial buffer solution, centrifuge-cooling temperature, and centrifuge rotation speed...
October 25, 2017: International Journal of Biological Macromolecules
Heidi Fisk, Yun Xu, Chloe Westley, Nicholas J Turner, Jason Micklefield, Royston Goodacre
Process Analytical Technologies (PAT) are used within industry to give real-time measurements of critical quality parameters, ultimately improving the quality by design (QbD) of the final product and reducing manufacturing costs. Spectroscopic and spectrophotometric methods are readily employed within PAT due to their ease of use, compatibility towards a range of sample types, robustness and their multiplexing capabilities. We have developed a UV resonance Raman (UVRR) spectroscopy approach to quantify industrially-relevant biotransformations accurately, focusing on nitrile metabolising enzymes: nitrile hydratase (NHase) and amidase versus nitrilase activity...
October 27, 2017: Analytical Chemistry
Sorina Morar-Mitrica, Monica L Adams, George Crotts, Christine Wurth, Peter M Ihnat, Tanvir Tabish, Valentyn Antochshuk, Willow DiLuzio, Daniel Dix, Jason Fernandez, Kapil Gupta, Michael S Fleming, Bing He, James K Kranz, Dingjiang Liu, Chakravarthy Narasimhan, Eric Routhier, Kathy Taylor, Nobel Truong, Elaine Stokes
The BioPhorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share (FPS) group conducted an inter-company collaboration exercise, which included a bench-marking survey and extensive group discussions around the scope, design, and execution of robustness studies...
October 23, 2017: Journal of Pharmaceutical Sciences
Sarwar Beg, Sumant Saini, Shantanu Bandopadhyay, O P Katare, Bhupinder Singh
PURPOSE: The current research work entails Quality by Design (QbD)-based systematic development of nanostructured lipid carriers (NLCs) of olmesartan medoxomil (OLM) with improved biopharmaceutical attributes. METHODS: Quality target product profile (QTPP) was defined and critical quality attributes (CQAs) were earmarked. Solubility of drug was performed in various lipids for screening of them. NLCs were prepared by hot-microemulsion method using solid lipids, liquid lipids and surfactants with maximal solubility...
October 19, 2017: Drug Development and Industrial Pharmacy
Ah Ram Lee, Seok Young Kwon, Du Hyung Choi, Eun Seok Park
A bilayer tablet, which consisted of telmisartan and amlodipine besylate, was formulated based on a Quality by Design (QbD) approach. The control and response factors were determined based on primary knowledge and the target values of the control tablet (Twynsta(®)). A D-optimal mixture design was used to obtain the optimal formulations in terms of D-mannitol, crospovidone, and MCC for the telmisartan layer, and CCM-Na, PVP K25, and Prosolv for the amlodipine layer. The quantitative effects of the different formulation factors on the response factors were accurately predicted using the equations of best fit and a strong linearity was observed between the predicted and actual values of the response factors...
October 12, 2017: International Journal of Pharmaceutics
Sheng-Yun Dai, Bing Xu, Xin-Yuan Shi, Xiang Xu, Ying-Qiang Sun, Yan-Jiang Qiao
This study is aimed to propose a continual improvement strategy based on quality by design (QbD). An ultra high performance liquid chromatography (UPLC) method was developed to accomplish the method transformation from HPLC to UPLC of Panax notogineng saponins (PNS) and achieve the continual improvement of PNS based on QbD, for example. Plackett-Burman screening design and Box-Behnken optimization design were employed to further understand the relationship between the critical method parameters (CMPs) and critical method attributes (CMAs)...
March 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Xiao-Na Liu, Qiu-Sheng Zheng, Xiao-Qing Che, Zhi-Sheng Wu, Yan-Jiang Qiao
The blending end-point determination of Angong Niuhuang Wan (AGNH) is a key technology problem. The control strategy based on quality by design (QbD) concept proposes a whole blending end-point determination method, and provides a methodology for blending the Chinese materia medica containing mineral substances. Based on QbD concept, the laser induced breakdown spectroscopy (LIBS) was used to assess the cinnabar, realgar and pearl powder blending of AGNH in a pilot-scale experiment, especially the whole blending end-point in this study...
March 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Xiang-Long Cui, Bing Xu, Fei Sun, Sheng-Yun Dai, Xin-Yuan Shi, Yan-Jiang Qiao
In this paper, under the guidance of quality by design (QbD) concept, the control strategy of the high shear wet granulation process of the ginkgo leaf tablet based on the design space was established to improve the process controllability and product quality consistency. The median granule size (D50) and bulk density (Da) of granules were identified as critical quality attributes (CQAs) and potential critical process parameters (pCPPs) were determined by the failure modes and effect analysis (FMEA). The Plackeet-Burmann experimental design was used to screen pCPPs and the results demonstrated that the binder amount, the wet massing time and the wet mixing impeller speed were critical process parameters (CPPs)...
March 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Bing Xu, Xiang-Long Cui, Chan Yang, Xin Wang, Xin-Yuan Shi, Yan-Jiang Qiao
Quality by design (QbD) highlights the concept of "begin with the end", which means to thoroughly understand the target product quality first, and then guide pharmaceutical process development and quality control throughout the whole manufacturing process. In this paper, the Ginkgo biloba granules intermediates were taken as the research object, and the requirements of the tensile strength of tablets were treated as the goals to establish the methods for identification of granules' critical quality attributes (CQAs) and establishment of CQAs' limits...
March 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Xing-Chu Gong, Teng Chen, Hai-Bin Qu
Quality by design (QbD) concept is an advanced pharmaceutical quality control concept. The application of QbD concept in the research and development of pharmaceutical processes of traditional Chinese medicines (TCM) mainly contains five parts, including the definition of critical processes and their evaluation criteria, the determination of critical process parameters and critical material attributes, the establishment of quantitative models, the development of design space, as well as the application and continuous improvement of control strategy...
March 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Bing Xu, Xin-Yuan Shi, Zhi-Sheng Wu, Yan-Ling Zhang, Yun Wang, Yan-Jiang Qiao
The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory...
March 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Sanjida Mahjabeen, Manolya K Hatipoglu, Vishal Chandra, Doris M Benbrook, Lucila Garcia-Contreras
Cervical dysplasia induced by the human papilloma virus (HPV) unpredictably progresses to cervical cancer. Therapeutic options are invasive and affect the patient's quality of life. SHetA2 has demonstrated therapeutic efficacy against human and murine HPV- induced tumors, but its oral bioavailability is <1%. An optimized vaginal suppository formulation can deliver SHetA2 in sufficient doses to prevent cervical dysplasia. The quality by design (QbD) approach was employed to optimize the suppository formulation consisting of cocoa butter as base with 5% Kolliphor and 40% SHetA2...
October 5, 2017: Journal of Pharmaceutical Sciences
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