Batch versus continuous blending of binary and ternary pharmaceutical powder mixtures

被引：14

作者：

Jaspers, Maarten ^{[1
]}

Kulkarni, Sri Sharath ^{[1
]}

Tegel, Florian ^{[2
]}

Roelofs, Timo P. ^{[1
]}

de Wit, Myrthe T. W. ^{[1
]}

Janssen, Pauline H. M. ^{[1
]}

Meir, Bernhard ^{[2
]}

Weinekoetter, Ralf ^{[2
]}

Dickhoff, Bastiaan H. J. ^{[1
]}

机构：

[1] DFE Pharma, Klever Str 187, D-47568 Goch, Germany

[2] Gericke AG, Althardstr 120, CH-8105 Regensdorf, Switzerland

来源：

INTERNATIONAL JOURNAL OF PHARMACEUTICS-X | 2022年 / 4卷

关键词：

Excipients; Active pharmaceutical ingredients; Powder blending; Continuous manufacturing; Blend uniformity; Continuous blending; PARTICLE-SIZE; SEGREGATION; PERFORMANCE; SHAPE; DENSITY;

D O I：

10.1016/j.ijpx.2021.100111

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The material properties of excipients and active pharmaceutical ingredients (API's) are important parameters that affect blend uniformity of pharmaceutical powder formulations. With the current shift from batch to continuous manufacturing in the pharmaceutical industry, blending of excipients and API is converted to a continuous process. The relation between material properties and blend homogeneity, however, is generally based on batch-wise blending trials. Limited information is available on how material properties affect blending performance in a continuous process. Here, blending of API and excipients is studied in both a batch and a continuous process. Homogeneity of the resulting mixtures is analyzed, which reveals that the impact of material properties is very different in a continuous process. Where parameters such as particle size, density and flow ability have significant impact on blending performance in a traditional batch process, continuous blending is more robust resulting in uniform blends for a large variety of blend compositions.

引用

页数：13

共 35 条

[1] Deformation and Mechanical Characteristics of Compacted Binary Mixtures of Plastic (Microcrystalline Cellulose), Elastic (Sodium Starch Glycolate), and Brittle (Lactose Monohydrate) Pharmaceutical Excipients [J].