Der Pharmacia Lettre
Abstract
Author(s): P.Yadav, J.S.Chauhan, P.Kannojia, N. K Jain, V.Tomar
Today the production of Pharmaceutical granules is still based on the batch concept. In the early
stage of the development of a solid dosage form the batch size is small. In later stage the size of
the batch produced in the pharmaceutical production may be up to 100 times larger. Thus scaleup
process is an extremely important one. Unfortunately in many cases the variety of the
equipment involved does not facilitate the task of scale-up. During the scale-up process the
quantity of the granules may change. A change in granule size distribution, final moisture
content, friability, compressibility and compactibility of the granules may strongly influence the
properties of the final tablet, such as tablet hardness, tablet friability, disintegration time,
dissolution rate of the active substance, and aging of the tablet. In the following sections, the
scale up process is analyzed taking into mathematical considerations of scale up theory, the
search for scale up invariants, the establishment of in-process control methods. This paper
describes an overview of granulation, rapid mixer granulator, Scale up in the field of
granulation, various approaches used for scale up determination of Rapid Mixer Granulator,
process variables, methods for end point determination & analysis of granulation process.
