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Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description
Contributor(s):: Popkin, ME, Omer, BASeibert, KD, Luciani, CV, Srivastava, S, Hobson, L, Lepore, JV
A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API...
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Optimization of critical quality attributes in continuous twin-screw wet granulation via design space validated with pilot scale experimental data
Contributor(s):: Liu, Huolong, Galbraith, S. C., Ricart, Brendon, Stanton, Courtney, Smith-Goettler, Brandye, Verdi, Luke, O'Connor, Thomas, Lee, Sau, Yoon, Seongkyu
In this study, the influence of key process variables (screw speed, throughput and liquid to solid (L/S) ratio) of a continuous twin screw wet granulation (TSWG) was investigated using a central composite face-centered (CCF) experimental design method. Regression models were developed to predict...
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Influence of material properties and equipment configuration on loss-in-weight feeder performance for drug product continuous manufacture
Contributor(s):: Yadav, IK, Holman, JMeehan, E, Tahir, F, Khoo, J, Taylor, J, Benedetti, A, Aderinto, O, Bajwa, G
A programme of work on continuous tablet manufacturing was completed as part of a UK based collaborative Research Article project (REMEDIES: RE-configuring MEDIcines End-to-end Supply) to evaluate the operating space of the continuous platform with respect to material properties. Loss-in-weight...
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Enhancing the Poor Flow and Tableting Problems of High Drug-Loading Formulation of Canagliflozin Using Continuous Green Granulation Process and Design-of-Experiment Approach
Contributor(s):: Almutairy, Bjad K., Khafagy, El-Sayed, Alalaiwe, Ahmed, Aldawsari, Mohammed F., Alshahrani, Saad M., Alsulays, Bader B., Alshetaili, Abdullah S., Alshehri, Sultan M, Fayed, Mohamed H.
Maximization of drug-loading can significantly reduce the size of dosage form and consequently decrease the cost of manufacture. In this Research Article, two challenges were addressed: poor flow and tableting problems of high-drug loading (>70%) formulation of canagliflozin (CNG), by adopting...