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Quality by Design (QbD)
Implementation of Quality by Design (QbD) for Development of Bilayer Tablets
Bilayer tablets offer various drug release profiles for individual drugs incorporated in each layer of a bilayer tablet, which is rarely achievable by conventional tablets. These tablets also help avoid physicochemical incompatibilities between drugs and excipients. Successful manufacturing of such…
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The Significance of Tablet Internal Structure on Disintegration and Dissolution of Immediate-Release…
The internal microstructure of a tablet, such as pore geometry and pore volume, impacts the tablet’s disintegration kinetics. Ideally, one could design the microstructure to control dissolution onset and therapeutical performance of immediate-release formulas; however, manufacturing tablets with a…
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Interpretable artificial neural networks for retrospective QbD of pharmaceutical tablet…
As the pharmaceutical industry increasingly adopts the Pharma 4.0. concept, there is a growing need to effectively predict the product quality based on manufacturing or in-process data. Although artificial neural networks (ANNs) have emerged as powerful tools in data-rich environments, their…
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Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for…
Abstract
One of the main challenges to paediatric drug administration is swallowing difficulties, hindering the acceptability of the medicine and hence clinical outcomes. This study aims at developing a child-appropriate dosage form, the orodispersible mini-tablet (ODMT), using the model drug…
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Quality by design approach with multivariate analysis and artificial neural network models to…
Purpose
Although understanding the variability in the physicochemical properties of an excipient in a drug formulation is becoming an important aspect of the quality by design approach, few studies have reported the effect of excipient variability on design space. This study aimed to understand how…
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Optimized L-SNEDDS and Spray-Dried S-SNEDDS Using a Linked QbD-DM3 Rational Design for Model…
A QbD-DM3 strategy was used to design ketoprofen (KTF) optimized liquid (L-SNEDDS) and solid self-nanoemulsifying drug delivery systems (S-SNEDDS). Principal component analysis was used to identify the optimized L-SNEDDS containing Capmul® MCM NF, 10% w/w; Kolliphor® ELP, 60% w/w; and propylene…
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Exposing Profound Screening Potential of Ethanol-Based Dissolution Media in the Development of…
Characterization of drug release from modified-release products in the presence of alcohol is required to evaluate the possibility of dose dumping due to safety assurance reasons. A generic product containing BCS IV drug and HPMCAS polymer was formulated as amorphous solid dispersion with hot-melt…
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Pharmaceutical Hot Melt Extrusion Process Development Using QbD and Digital Twins
Pharmaceutical product development guided by Quality by Design (QbD) is based on a complete understanding of the critical process parameters (CPPs) that are important for achieving the desired product critical quality attributes (CQAs). The effect of process settings, such as the screw speed, the…
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Design and Optimization of Lornoxicam Dispersible Tablets Using Quality by Design (QbD) Approach
The present study aims to design and optimize the lornoxicam dispersible tablet (LXDT) formulation using the Quality by design (QbD) approach. A randomized Box–Behnken experimental design was used to characterize the effect of the critical factors, such as filler (MCC/Mannitol) ratio, mixing time,…
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Development, Quality by Design-Based Optimization, and Stability Assessment of Oral Liquid…
The absence of oral liquid pharmaceutical forms appropriate for use in pediatric and adult patients with difficulty swallowing is a public health problem, especially in the hospital context. Baclofen is a muscle relaxant of choice for treating spasticity, generally marketed only in tablet form,…
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