| Manufacture of fine spherical granules by an extrusion/spheronization method. | |
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MedLine Citation:
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PMID: 17257789 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Fine spherical granules of uniform particle size less than 500 microm are desired for easy handling in dispensing pharmacy. These fine particles have been produced by layering an active ingredient and excipients on a core; however, several technical problems have been difficult to overcome, e.g., the amount of layered ingredients is limited and often granules themselves agglomerate during the layering process and affect the quality of the finished product. Here, we studied the feasibility of the manufacture of fine spherical granules by an extrusion/spheronization method. A screen with a pore size of 0.4mm or smaller was used for extrusion, and reduction of the extrusion pressure at the screen was necessary to prevent the screen from breaking. In light of the reduction of the screen pressure, we found low substituted hydroxypropylcellulose (L-HPC), croscarmellose sodium (Ac-Di-Sol) and carmellose calcium (ECG-505), markedly decreased the screen pressure. It is suggested that the high swelling property of these excipients is closely related to screen pressure reduction. In the spheronization process, it was found that L-HPC gave the highest sphericity, while Ac-Di-Sol and ECG-505 were unsatisfactory. It is concluded that L-HPC is the most appropriate excipient for the manufacture of fine spherical granules of less than 500 microm diameter by the extrusion/spheronization method. |
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Authors:
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Hideyoshi Kanbe; Tetsuo Hayashi; Yoichi Onuki; Takashi Sonobe |
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Publication Detail:
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Type: Evaluation Studies; Journal Article Date: 2006-12-23 |
Journal Detail:
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Title: International journal of pharmaceutics Volume: 337 ISSN: 0378-5173 ISO Abbreviation: Int J Pharm Publication Date: 2007 Jun |
Date Detail:
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Created Date: 2007-05-22 Completed Date: 2007-08-02 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7804127 Medline TA: Int J Pharm Country: Netherlands |
Other Details:
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Languages: eng Pagination: 56-62 Citation Subset: IM |
Affiliation:
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Central Research Laboratories, SSP Co., Ltd., Nanpeidai 1143, Narita-shi, Chiba 286-1511, Japan. hideyoshi.kanbe@ssp.co.jp |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Carboxymethylcellulose
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chemistry Cellulose / analogs & derivatives*, chemistry Diphenhydramine / chemistry* Drug Compounding Excipients / chemistry* Feasibility Studies Particle Size Powders Pressure Surface Properties Technology, Pharmaceutical / methods* Water / chemistry |
| Chemical | |
Reg. No./Substance:
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0/Excipients; 0/Powders; 58-73-1/Diphenhydramine; 7732-18-5/Water; 9004-32-4/Carboxymethylcellulose; 9004-34-6/Cellulose; 9004-64-2/hydroxypropylcellulose |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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