Detection of component segregation in granules manufactured by high shear granulation with over-granulation conditions using near-infrared chemical imaging

被引：24

作者：

Koide, Tatsuo ^{[1
]}

Nagato, Takuya ^{[2
]}

Kanou, Yoshiyuki ^{[2
]}

Matsui, Kou ^{[2
]}

Natsuyama, Susumu ^{[2
]}

Kawanishi, Toru ^{[1
]}

Hiyama, Yukio ^{[1
]}

机构：

[1] Natl Inst Hlth Sci, Div Drugs, Setagaya Ku, Tokyo 1588501, Japan

[2] Powrex Corp, Osaka Powder Technol Ctr, Itami, Hyogo 6640831, Japan

来源：

INTERNATIONAL JOURNAL OF PHARMACEUTICS | 2013年 / 441卷 / 1-2期

关键词：

Image analysis; Near-infrared spectroscopy; High shear granulation; Segregation; HIGH-SPEED MIXER; PHYSICAL-PROPERTIES; WET GRANULATION; SPECTROSCOPY; SUBSTANCE; GROWTH; RAMAN; DRUG; NIR;

D O I：

10.1016/j.ijpharm.2012.12.005

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The objective of this study was to evaluate the high shear granulation process using near-infrared (NIR) chemical imaging technique and to make the findings available for pharmaceutical development. We prepared granules and tablets made under appropriate-and over-granulation conditions with high shear granulation and observed these granules and tablets using NIR chemical imaging system. We found an interesting phenomenon: lactose agglomeration and segregation of ingredients occurred in experimental tablets when over-granulation conditions, including greater impeller rotation speeds and longer granulation times, were employed. Granules prepared using over-granulation conditions were larger and had progressed to the consolidation stage; segregation between ethenzamide and lactose occurred within larger granules. The segregation observed here is not detectable using conventional analytical technologies such as high pressure liquid chromatography (HPLC) because the content of the granules remained uniform despite the segregation. Therefore, granule visualization using NIR chemical imaging is an effective method for investigating and evaluating the granulation process. (C) 2012 Elsevier B. V. All rights reserved.

引用

页码：135 / 145

页数：11

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