Processing method for raw drug particles of non-uniform particle size

Abstract

The present invention relates to a pre-processing method for the purpose of formulating a raw drug of unsorted particle sizes into a drug through a production method having excellent production performance. According to the pre-processing method of the present invention, a raw drug having a specific particle size distribution and an additive including at least a dispersant are mixed, cracked and sized, thereby dispersing and adhering the additive to the surface of the raw drug particles to yield a powder having a specific particle size distribution. This allows a pharmaceutical formulation tobe produced via a direct tableting method, continuous wet granulation system, or the like, with excellent production performance, production efficiency, and production cost. Thus, the invention is extremely useful.

Description

technical field [0001] The present invention relates to a pretreatment method such as a tableting step or a granulation step in the manufacture of pharmaceutical preparations using raw materials with inconsistent powder physical properties (particle diameter, particle shape, density, etc.). Background technique [0002] In the manufacture of pharmaceutical preparations, as a method of manufacturing tablets in solid preparations, for example, there is a dry direct tableting method (also called "dry tableting method") in which a mixture of a drug substance and additives is compressed without preparing granules. Type direct compression method", or simply referred to as "direct compression method".); through dry granulation method (roller compactor method, roll granulator method) or wet granulation Method (stirring granulation method, extrusion granulation method, spray granulation method, fluidized bed granulation method) and other methods to prepare granules and then compress ...

AI Technical Summary

Problems solved by technology

However, in scale-up, for example, in batch fluidized bed granulation, there is the following problem: the larger the equipment, the higher the amount of feed per unit area (kg / m 2 : charging density) becomes larger and the charging thickness increases, so the thickness density of the particles applied to the granulation becomes larger

These bulk drug particles with a lot of static electricity are extremely difficult to flow back to the spray area even if they are shaken off by shaking off, which is likely to become a factor that damages the uniformity of content

In addition, even when stirring and mixing with a batch-type stirring granulator (vertical granulator: manufactured by Powrex, etc.), although the whole is uniform, there may be small lumps formed by secondary aggregation locally

The small pieces formed by the secondary aggregation are extremely difficult to disperse, so granulation is carried out in the state of small pieces formed by the secondary aggregation, and as a result, there may be problems in content uniformity such as stains and spots.

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