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On the matter of division of powder-granule combination preparations into a prescribed dosage unit, the Guideline for Dispensing by the Japan Pharmaceutical Association recommends separate division of powder and granule (two-step dividing method) rather than the division of the 2 components at the same time (one-step dividing method). As discussed in the previous paper, however, the two-step dividing method is not adequate when the combination preparations are divided by machine, not by hands.In this study, the one-step and two-step dividing methods were compared in terms of the content uniformity of the powder component in the sample after division by machine. The machine used was the modified type (L-2) of Konishi KC-787-K15. The samples used were the powder-granule combination preparations in 5 grades of powder/granule ratio ranging from 1/8 to 8/ 1, containing 1 powder and 1 of 4 granules of different physical properties as component.As a result, the two-step dividing method did not show smaller variation of powder content than one-step dividing method, and it is complicated and requires much time. It is, therefore, concluded that the one-step dividing method is more adequate for division of powder-granule combination preparations so far as the automatic dividing and packing machine, such as L-2, equipped with the feeder that has the function of alternating motion, is used.

Comparison of One-Step and Two-Step Dividing Methods for Powder-Granule Combination Preparations by Automatic Dividing and Packing Machine