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Nanosuspensions after downstream processing into drug products have successfully shown its impact on formulation design, the augmentation of product life cycle, patent life, and therapeutic efficacy.
The use of in vitro methods including dispersion tests and more complex models of in vitro lipolysis as indicators of potential in vivo performace are subsequently described, with particular focus on recent data which suggests that the digestion of surfactants present in lipid-based formulations may impact on formulation performance.
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Fig. 7 Amorphous solubility determination (reproduced with permission from Capsugel) Fig. 8 Determining the impact of formulation on the "parachute" effect (reproduced with permission from Capsugel).
23 factorial design was employed to assess the impact of formulation attributes on tablets' characteristics.
The present study investigated the impact of formulation variables on the aerodynamic particle diameter (da) when nebulized by vibrating-membrane technology.
Here, we present a series of investigations that were carried out to understand the impact of formulation variables on the nebulization performance of novel biodegradable sildenafil-loaded nanoparticles designed for targeted aerosol therapy of life-threatening pulmonary arterial hypertension.
The purpose of this work was to develop multi unit particulate formulation using fluid bed processor for the controlled release of Metoprolol succinate and to understand the impact of formulation parameters on the critical quality attributes using a quality-by-design approach.
Understanding of the impact of formulation composition and process on clinical performance is a centerpiece of QbD.
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.
The purpose of this work was to develop and characterize chitosan alginate beads for the extended delivery of cefpodoxime proxetil (CFP), to understand the impact of formulation and process parameters on the critical quality attributes (CQAs) using a quality-by-design approach.
The aims of this study were to develop and characterize paclitaxel nanoparticles, to identify and control critical sources of variability in the process, and to understand the impact of formulation and process parameters on the critical quality attributes (CQAs) using a quality-by-design (QbD) approach.
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