Influence and optimisation of operating parameters with a new binder in wet granulation. I: use in powder form.

ABSTRACT

It is very important to know the properties of a new binder in wet granulation because it involves the good or poor quality of the grain and the tablets. To estimate the effects of various procedural parameters on the tablet properties, to evaluate the optimal quantity of binder and solvent, the consequences of excess solvent or time mixing and to limit the number of experiments, the authors use the method of design of experiments. The experiments were carried out on a classical blend of lactose and maize starch and the binder was LYCATAB DSH, a maltodextrin. In this first part the binder was used in powder form and three process factors were retained and controlled, the binder quantity, the quantity of wetting liquid and the mixing time after granulation. Different outcomes were measured and mathematical relationships between responses and operating factors were performed and discussed. A 4% binder concentration with 14-16% of solvent gives good results and an increase in mixing time improves the tablet hardness without increasing the disintegration time (the wetting liquid was water and the blender a LOEDIGE).