Method for drug formulation and a pharmaceutical composition

A melt granulating method for producing pellets which contain a therapeutically active substance, comprising, in an intensive mixer,

• (i) mechanically working a mixture which contains (a) the active substance in cohesive form and (b) a binder having a melting point between 40.degree. C. and 100.degree. C. while supplying energy in an amount such that the binder will melt and the mixture will granulate to form pellets, wherein the quantity ratio between active substance and binder is selected so that the pellets formed will be overmoist so as to become tacky;
• (ii) adding further cohesive substance, either in one or more batches, while supplying energy during the mechanical working process so that the melting temperature of the binder is exceeded;
• (iii) interrupting the mechanical working involving the supply of energy and the supply of the cohesive substance and the binder when the desired mean particle size of dry pellets has been achieved, and
• (iv) removing particles which are larger or smaller than a predetermined maximum and minimum size respectively.