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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
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
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
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
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
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
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
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
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
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...
September 6, 2016: Journal of Chromatographic Science
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
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
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
Róbert Lehocký, Daniel Pěček, František Štěpánek
Injectable depot formulations are aimed at providing long-term sustained release of a drug into systemic circulation, thus reducing plasma level fluctuations and improving patient compliance. The particle size distribution of the formulation in the form of suspension is a key parameter that controls the release rate. In this work, the process of wet stirred media milling (ball milling) of a poorly water-soluble substance has been investigated with two main aims: (i) to determine the parametric sensitivity of milling kinetics; and (ii) to develop scale-up methodology for process transfer from batch to flow-through arrangement...
August 25, 2016: European Journal of Pharmaceutical Sciences
Christof Finkler, Lynne Krummen
Quality by Design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11). An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody...
September 2016: Biologicals: Journal of the International Association of Biological Standardization
Rachel Specht, Meisam Bakhshayeshi
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
Francisca F Gouveia, Jesper P Rahbek, Asmus R Mortensen, Mette T Pedersen, Pedro M Felizardo, Rasmus Bro, Michael J Mealy
Significant improvements can be realized by converting conventional batch processes into continuous ones. The main drivers include reduction of cost and waste, increased safety, and simpler scale-up and tech transfer activities. Re-designing the process layout offers the opportunity to incorporate a set of process analytical technologies (PAT) embraced in the Quality-by-Design (QbD) framework. These tools are used for process state estimation, providing enhanced understanding of the underlying variability in the process impacting quality and yield...
August 11, 2016: Analytical and Bioanalytical Chemistry
Karen A Esmonde-White, Maryann Cuellar, Carsten Uerpmann, Bruno Lenain, Ian R Lewis
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing. In this review, we highlight new technology developments, data analysis models, and applications of Raman spectroscopy, which have expanded the scope of Raman spectroscopy as a process analytical technology. Emerging technologies such as transmission and enhanced reflection Raman, and new approaches to using available technologies, expand the scope of Raman spectroscopy in pharmaceutical manufacturing, and now Raman spectroscopy is successfully integrated into real-time release testing, continuous manufacturing, and statistical process control...
August 4, 2016: Analytical and Bioanalytical Chemistry
Archana Shubhakar, Radoslaw P Kozak, Karli R Reiding, Louise Royle, Daniel I R Spencer, Daryl L Fernandes, Manfred Wuhrer
Monitoring glycoprotein therapeutics for changes in glycosylation throughout the drug's life cycle is vital, as glycans significantly modulate the stability, biological activity, serum half-life, safety, and immunogenicity. Biopharma companies are increasingly adopting Quality by Design (QbD) frameworks for measuring, optimizing, and controlling drug glycosylation. Permethylation of glycans prior to analysis by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS) is a valuable tool for glycan characterization and for screening of large numbers of samples in QbD drug realization...
September 6, 2016: Analytical Chemistry
Christian Hakemeyer, Nathan McKnight, Rick St John, Steven Meier, Melody Trexler-Schmidt, Brian Kelley, Frank Zettl, Robert Puskeiler, Annika Kleinjans, Fred Lim, Christine Wurth
Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11). An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody (MAb)...
September 2016: Biologicals: Journal of the International Association of Biological Standardization
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