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Volume of dissolution media changed.
The considered factors mainly influencing the dissolution test results were pH and volume of dissolution medium, and paddle stirring speed.
Where M 0 is the dose, V 0 is the volume of dissolution fluid, and C s is the drug solubility.
Paddle speed changed Volume of dissolution media changed Additional topics/clarification on FDCs (Fixed Dose Combinations), ODTs (Orally Disintegrating Tablets), products Update to the list of model drugs Strengthen GI stability requirement.
Optimum conditions to carry out the dissolution test were: 900 ml volume of dissolution medium and 70 rpm paddle stirring speed for both environments and pH 1 and 5.5, for the gastric and intestinal environment, respectively.
A 32 full factorial design was used to study the effect of two factors (at three levels), namely volume of dissolution medium (150, 200, 250 ml) and reciprocation rate (5, 15, 25 dips per min).
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where dC/dt is the dissolution rate, D is the solute diffusion coefficient, V is the volume of the dissolution medium, h d is the diffusion boundary thickness, S is the surface area of the solute, C s is the saturation solubility of the solute, and C t (t) is the bulk solute concentration.
A 10-mL volume of fresh dissolution medium (PBS solution) was added to make up the volume after withdrawal of sample.
Aliquots of 5-mL samples were withdrawn from the medium and replaced with the same volume of fresh dissolution medium every time.
The withdrawn volume was replaced by the same volume of fresh dissolution media.
After regular time intervals, samples were withdrawn from the receptor compartment and exact volume of a dissolution medium was added to the same compartment to maintain the constant volume throughout the study.
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