Question
Posted on: May 19 2016Questions regarding NITROFURANTOIN suspension TMF
I read the following remark in TMF: "Due to too powerful mixing, the risk of breaking down the macrocrystalline agglomerates of Nitrofurantoin is threatened and thus the occurrence of undesirable effects is in the hand."
What undesirable effects would it go here? I myself suppose that it is about observed of a certain particle size that affects the bioavailability. Is it not better that the particles are well distributed in the suspension. This can only benefit the homogeneity and dosing correctness of the active ingredient right? Does glycerol here act as a humidifier for the particles?
Could this suspension also be made with xanthan gum instead of with avicel? Do you have a proposal? Do you find it useful to add BVB 0.5 à 1 mg/ml sucralose as sweetener?
Answer
It is known that nitrofurantoin gives gastric discomfort. Macro crystals are used to slow down the dissolving speed. An attempt is thus made to preserve the particle size of the crystals and not grind them.
Glycerin can be used to rub the Avicel RC 591 before moisten with water. The TMF has opted for the microcrystalline cellulose + CMC Because this is one of the best suspensions given the thixotrope character of the dispersion. I don't know if a sweetener is required. To my knowledge, sucralose is not a licensed raw material.