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https://www.readbyqxmd.com/read/28943207/supramolecular-nano-engineered-lipidic-carriers-based-on-diflunisal-phospholipid-complex-for-transdermal-delivery-qbd-based-optimization-characterization-and-preclinical-investigations-for-management-of-rheumatoid-arthritis
#1
Amanpreet Kaur, Bhupinder Singh Bhoop, Sanjay Chhibber, Gajanand Sharma, Vijay Singh Gondil, Om Prakash Katare
Diflunisal (DIF) is used for treatment of rheumatoid arthritis, osteoarthritis etc. DIF-phospholipid complex (DIF-PL complex) was prepared by solvent-evaporation method and characterized by molecular docking studies, SEM, FTIR, DSC, PXRD studies. Further, the DIF-PL complex was incorporated into supramolecular nano-engineered lipidic carriers (SNLCs) for transdermal delivery. The optimization exercise was done using Face centered cubic design (FCCD) after screening of variables by L8 Taguchi orthogonal array design...
September 21, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28917923/effect-of-carboxymethylation-on-rheological-and-drug-release-characteristics-of-terminalia-catappa-gum
#2
Radhika Sharma, Vikas Rana
The carboxymethylation of galactomannans, arabinogalactans, arbinoxylan, etc is known to modify solubility, swelling index, rheological behaviour, powder characteristics, etc. Therefore, an attempt had been made to study the effect of carboxymethylation on Terminalia catappa (TC) gum. For this, modified Williamson synthesis reaction was utilized employing Quality by Design (QbD) approach. Grafting of carboxymethyl group on Terminalia catappa was confirmed by ATR-FTIR, H(1)NMR and DSC analyses. The rheological attributes revealed that the carboxymethylation of TC lowers the viscosity, enhance thermal stability (high activation energy), disentanglement was near to re-entanglement, and weak gelling characteristic...
November 1, 2017: Carbohydrate Polymers
https://www.readbyqxmd.com/read/28916394/a-useful-strategy-based-on-chromatographic-data-combined-with-quality-by-design-approach-for-food-analysis-applications-the-case-study-of-furanic-derivatives-in-sugarcane-honey
#3
Pedro Silva, Catarina L Silva, Rosa Perestrelo, Fernando M Nunes, José S Câmara
Sugarcane honey (SCH) is one of the Madeira Island products par excellence and it is now popular worldwide. Its sui generis and peculiar sensory properties, explained by a variety of volatile compounds including furanic derivatives (FDs), arise mainly from manufacturing and storage conditions. A simple high-throughput approach based on semi-automatic microextraction by packed sorbent (MEPS) combined with ultra-high performance liquid chromatography (UHPLC) was developed and validated for identification and quantification of target FDs in sugarcane honey...
September 8, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28892871/formulation-by-design-approach-for-development-of-ultrafine-self-nanoemulsifying-systems-of-rosuvastatin-calcium-containing-long-chain-lipophiles-for-hyperlipidemia-management
#4
Sarwar Beg, O P Katare, Bhupinder Singh
The present work entails systematic development of liquid self-nanoemulsifying drug delivery systems (L-SNEDDS) of rosuvastatin calcium containing long-chain lipophiles using QbD-driven Formulation by Design (FbD) approach. Elements of quality target product profile (QTPP) were defined and critical material attributes (CQAs) earmarked. Excipient screening was performed for selecting a suitable long-chain lipophile along with a surfactant and a cosolvent. Maximal drug solubility was observed in Peceol (i.e., lipid), Tween 80 (i...
August 31, 2017: Colloids and Surfaces. B, Biointerfaces
https://www.readbyqxmd.com/read/28875358/determination-of-critical-quality-attributes-for-a-biotherapeutic-in-the-qbd-paradigm-gcsf-as-a-case-study
#5
Sumit K Singh, Deepak Kumar, Anurag S Rathore
Estimating impact of the various product-related variants and impurities on a biotherapeutic's safety and efficacy is an essential requirement in the quality by design paradigm. In view of the limited role that clinical studies offer in this regard, we demonstrate a preclinical approach to achieve this for granulocyte colony-stimulating factor (GCSF). While our repeated-dose toxicity data suggest that these variants do not elicit any adverse effects or histopathological changes, aggregated GCSF impurity caused sluggishness in animal behavior manifested by a possible muscular injury...
September 5, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28874884/quality-by-design-applied-liquid-chromatography-tandem-mass-spectrometry-determination-of-enzalutamide-anti-prostate-cancer-therapy-drug-in-spiked-plasma-samples
#6
Ask Sankar, Shanmugasundaram Palani, Ravichandiran Velayudham
This research article presents the Quality by Design (QbD)-finalised conditions for a method that uses liquid chromatography-tandem mass spectrometry for the determination of concentration of enzalutamide (ENZ), an atypical anticancer drug, in a drug formulation and in spiked plasma samples. Critical process attributes (CPA) considered to be the influential parameters in separation, identification, and quantification processes by ultrahigh-performance liquid chromatography-electrospray ionisation-tandem mass spectrometry (UHPLC-ESI-MS/MS) were organic content, buffer strength, pH modifier, flow rate, spray voltage, sheath gas, and auxiliary gas that alter critical analytical attributes, such as retention time (R1) and area (R2)...
2017: Analytical Chemistry Insights
https://www.readbyqxmd.com/read/28805469/long-chain-triglycerides-based-self-nanoemulsifying-oily-formulations-sneofs-of-darunavir-with-improved-lymphatic-targeting-potential
#7
Babita Garg, Sarwar Beg, Ranjot Kaur, Rajendra Kumar, Om Prakash Katare, Bhupinder Singh
The current studies entail systematic development of SNEOFs containing long-chain triglycerides for improving lymphatic targeting of darunavir for complete inhibition of HIV progression. As per QbD-oriented approach for formulation development, the QTPP was defined and CQAs were earmarked. Preformulation equilibrium solubility and phase diagram studies, and risk assessment through FMEA studies identified Lauroglycol 90, Tween 80 and Transcutol HP as the lipid, emulgent and cosolvent, respectively, for formulating SNEOFs of darunavir...
August 14, 2017: Journal of Drug Targeting
https://www.readbyqxmd.com/read/28794904/qbd-based-approach-for-optimization-of-tenofovir-disoproxil-fumarate-loaded-liquid-crystal-precursor-with-improved-permeability
#8
Sharvil Patil, Chandrashekhar Kadam, Varsha Pokharkar
BCS class III drugs suffer from a drawback of low permeability even though they have high aqueous solubility. The objective of current work was to screen the suitability of glyceryl monooleate (GMO)/Pluronic F127 cubic phase liquid crystals precursors for permeation enhancement and in turn the bioavailability of tenofovir disoproxil fumarate (TDF), a BCS class III drug. Spray-drying method was used for preparation of TDF loaded liquid crystal precursors (LCP) consisting of GMO/Pluronic F127 and lactose monohydrate with an ability to in situ transform into stable cubic phases upon hydration...
November 2017: Journal of Advanced Research
https://www.readbyqxmd.com/read/28776065/trends-in-process-analytical-technology-present-state-in-bioprocessing
#9
Marco Jenzsch, Christian Bell, Stefan Buziol, Felix Kepert, Harald Wegele, Christian Hakemeyer
Process analytical technology (PAT), the regulatory initiative for incorporating quality in pharmaceutical manufacturing, is an area of intense research and interest. If PAT is effectively applied to bioprocesses, this can increase process understanding and control, and mitigate the risk from substandard drug products to both manufacturer and patient. To optimize the benefits of PAT, the entire PAT framework must be considered and each elements of PAT must be carefully selected, including sensor and analytical technology, data analysis techniques, control strategies and algorithms, and process optimization routines...
August 4, 2017: Advances in Biochemical Engineering/biotechnology
https://www.readbyqxmd.com/read/28748713/qbd-for-pediatric-oral-lyophilisates-development-risk-assessment-followed-by-screening-and-optimization
#10
Tibor Casian, Sonia Iurian, Catalina Bogdan, Lucia Rus, Mirela Moldovan, Ioan Tomuta
OBJECTIVE: This study proposed the development of oral lyophilisates with respect to pediatric medicine development guidelines, by applying risk management strategies and DoE as an integrated QbD approach. METHODS: Product critical quality attributes were overviewed by generating Ishikawa diagrams for risk assessment purposes, considering process, formulation and methodology related parameters. Failure Mode Effect Analysis was applied to highlight critical formulation and process parameters with an increased probability of occurrence and with a high impact on the product performance...
August 16, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28681334/enhanced-ungual-permeation-of-terbinafine-hcl-delivered-through-liposome-loaded-nail-lacquer-formulation-optimized-by-qbd-approach
#11
Viral H Shah, Amee Jobanputra
The present investigation focused on developing, optimizing, and evaluating a novel liposome-loaded nail lacquer formulation for increasing the transungual permeation flux of terbinafine HCl for efficient treatment of onychomycosis. A three-factor, three-level, Box-Behnken design was employed for optimizing process and formulation parameters of liposomal formulation. Liposomes were formulated by thin film hydration technique followed by sonication. Drug to lipid ratio, sonication amplitude, and sonication time were screened as independent variables while particle size, PDI, entrapment efficiency, and zeta potential were selected as quality attributes for liposomal formulation...
July 5, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28681160/biopharmaceutical-evaluation-and-cmc-aspects-of-oral-modified-release-formulations
#12
Rong-Kun Chang, Neil Mathias, Munir A Hussain
This article discusses the range of outcomes from biopharmaceutical studies of specific modified release (MR) product examples in preclinical models and humans. It touches upon five major biopharmaceutical areas for MR drug products: (1) evidence for regional permeability throughout the GI tract, (2) susceptibility to food-effect, (3) susceptibility to pH-effect, (4) impact of chronopharmacology in designing MR products, and (5) implications to narrow therapeutic index products. Robust bioperformance requires that product quality is met through a thorough understanding of the appropriate critical quality attributes that ensure reliable and robust manufacture of a MR dosage form...
July 5, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28650901/application-of-quality-by-design-approach-to-bioanalysis-development-of-a-method-for-elvitegravir-quantification-in-human-plasma
#13
Sara Baldelli, Giorgio Marrubini, Dario Cattaneo, Emilio Clementi, Matteo Cerea
BACKGROUND: The application of Quality by Design (QbD) principles in clinical laboratories can help to develop an analytical method through a systematic approach, providing a significant advance over the traditional heuristic and empirical methodology. In this work, we applied for the first time the QbD concept in the development of a method for drug quantification in human plasma using elvitegravir as the test molecule. METHODS: The goal of the study was to develop a fast and inexpensive quantification method, with precision and accuracy as requested by the European Medicines Agency guidelines on bioanalytical method validation...
October 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28629981/retrospective-quality-by-design-rqbd-applied-to-the-optimization-of-orodispersible-films
#14
Branca M A Silva, Sílvia Vicente, Sofia Cunha, Jorge F J Coelho, Cláudia Silva, Marco Seabra Reis, Sérgio Simões
The study demonstrates the application of QbD based on historical data for a product at a later development stage - retrospective QbD (rQbD). More specifically, it is investigated the root-cause for the observed slower drug release in Orodispersible Films (ODFs) during storage. Risk assessment tools were used to identify parameters affecting ODFs critical quality attributes, namely percent drug release and residual water content. The parameters room temperature, room relative humidity, drying temperature and mixing equipment were used in the statistical modeling of the available data...
August 7, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28593514/influence-of-formulation-factors-on-the-aerosol-performance-of-suspension-and-solution-metered-dose-inhalers-a-systematic-approach
#15
Poonam Sheth, Dennis Sandell, Denise S Conti, Jay T Holt, Anthony J Hickey, Bhawana Saluja
Metered dose inhalers (MDIs) are complex drug-device combination products widely used to treat pulmonary disorders. The efficacy, driven by aerosol performance of the products, depends on a multitude of factors including, but not limited to, the physicochemical properties of drug and nature and amount of excipient(s). Under the quality by design (QbD) paradigm, systematic investigations are necessary to understand how changes in critical quality attributes (CQAs) of formulation, device, and manufacturing process influence key product performance parameters, such as delivered dose (DD) and fine particle dose (FPD)...
June 7, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28579758/development-of-antiproliferative-long-circulating-liposomes-co-encapsulating-doxorubicin-and-curcumin-through-the-use-of-a-quality-by-design-approach
#16
Lucia Ruxandra Tefas, Bianca Sylvester, Ioan Tomuta, Alina Sesarman, Emilia Licarete, Manuela Banciu, Alina Porfire
The aim of this work was to use the quality-by-design (QbD) approach in the development of long-circulating liposomes co-loaded with curcumin (CUR) and doxorubicin (DOX) and to evaluate the cytotoxic potential of these liposomes in vitro using C26 murine colon carcinoma cell line. Based on a risk assessment, six parameters, namely the phospholipid, CUR and DOX concentrations, the phospholipid:cholesterol molar ratio, the temperature during the evaporation and hydration steps and the pH of the phosphate buffer, were identified as potential risk factors for the quality of the final product...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28579542/modeling-in-the-quality-by-design-environment-regulatory-requirements-and-recommendations-for-design-space-and-control-strategy-appointment
#17
Jelena Djuris, Zorica Djuric
Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies...
June 1, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28579437/quality-by-design-of-nanopharmaceuticals-a-state-of-the-art
#18
REVIEW
Thierry Bastogne
Pharmaceutical Quality-by-Design is a risk-based approach of drug development relying on the understanding of both the product and the process. This state of the art analyzes 24 studies published during the last ten years. A risk modeling of the nanomaterial formulation and manufacturing is firstly presented. After a brief history of the QbD approach, its basic components are recalled in a second part. The most critical material attributes, process parameters, quality variables and measurement technologies are reviewed...
June 1, 2017: Nanomedicine: Nanotechnology, Biology, and Medicine
https://www.readbyqxmd.com/read/28549972/quality-by-design-approach-for-studying-the-impact-of-formulation-and-process-variables-on-product-quality-of-oral-disintegrating-films
#19
Sonal Mazumder, Naresh Pavurala, Prashanth Manda, Xiaoming Xu, Celia N Cruz, Yellela S R Krishnaiah
The present investigation was carried out to understand the impact of formulation and process variables on the quality of oral disintegrating films (ODF) using Quality by Design (QbD) approach. Lamotrigine (LMT) was used as a model drug. Formulation variable was plasticizer to film former ratio and process variables were drying temperature, air flow rate in the drying chamber, drying time and wet coat thickness of the film. A Definitive Screening Design of Experiments (DoE) was used to identify and classify the critical formulation and process variables impacting critical quality attributes (CQA)...
May 23, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28532031/screening-of-process-variables-to-enhance-the-solubility-of-famotidine-with-2-hydroxypropyl-%C3%AE-cyclodextrin-pvp-k-30-by-using-plackett-burman-design-approach
#20
Umakant Verma, Jitendra B Naik, Jayesh S Patil, Sunil K Yadava
In the present work, inclusion complex of famotidine (FMT) was prepared with (2-HydroxyPropyl)-β-Cyclodextrin (HP-β-CyD) and polyvinylpyrrolidone K-30 (PVP K-30) by spray drying technique to enhance the solubility of famotidine. FMT is a potent histamine H2-receptor antagonist having low solubility as well as oral bioavailability. In order to enhance the solubility of FMT, a quality by design (QbD) approach has been used by employing Plackett-Burman design (PBD). With the application of PBD, seven independent process variables were investigated and optimized for maximum solubility...
August 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
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