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

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 sh...

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Bibliographic Details
Published in:	International journal of pharmaceutics Vol. 441; no. 1-2; pp. 135 - 145
Main Authors:	Koide, Tatsuo, Nagato, Takuya, Kanou, Yoshiyuki, Matsui, Kou, Natsuyama, Susumu, Kawanishi, Toru, Hiyama, Yukio
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 30-01-2013
Subjects:	Chromatography, High Pressure Liquid - methods Drug Compounding - instrumentation Drug Compounding - methods Excipients - chemistry Feasibility Studies granules high performance liquid chromatography High shear granulation Image analysis ingredients lactose Lactose - chemistry Near-infrared spectroscopy Salicylamides - administration & dosage Salicylamides - chemistry Segregation Spectroscopy, Near-Infrared - methods Tablets Time Factors Image analysis High shear granulation Segregation Near-infrared spectroscopy
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Summary:	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.
Bibliography:	http://dx.doi.org/10.1016/j.ijpharm.2012.12.005 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0378-5173 1873-3476
DOI:	10.1016/j.ijpharm.2012.12.005