| 摘要 |
PCT No. PCT/SE91/00690 Sec. 371 Date Apr. 16, 1993 Sec. 102(e) Date Apr. 16, 1993 PCT Filed Oct. 15, 1991 PCT Pub. No. WO92/06679 PCT Pub. Date Apr. 30, 1992.A melt granulating method for the production of pellets (spheres) which contain a therapeutically active substance of high-dosage type. The method is characterized by: (i) mechanically working a mixture which contains (a) the active substance in cohesive form and (b) a binder (melting point 40 DEG C.-100 DEG C.) while supplying sufficient energy for the binder to melt and to form spherical overwetted pellets; (ii) adding further cohesive substance, while maintaining the mechanical working; (iii) interrupting the mechanical working and supply of energy and cohesive substance when the desired mean particle size of dry pellets (spheres) has been achieved; and (iv) removing the smallest and largest particles and dividing the remaining pellets into dosage batches. A novel pharmaceutical composition containing a dosage of 300-500 mg of pellets is obtainable from this process. |
