| Current status of amorphous formulation and other special dosage forms as formulations for early clinical phases. | |
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MedLine Citation:
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PMID: 19610076 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Although most chemists in the pharmaceutical industry have a good understanding on favorable physicochemical properties for drug candidates, formulators must still deal with many challenging candidates. On the other hand, formulators are not allowed to spend much time on formulation development for early phases of the clinical studies. Thus, it is basically difficult to apply special dosage form technologies to the candidates for the first-in-human formulations. Despite the availability of numerous reviews on oral special dosage forms, information on their applicability as the early phase formulation has been limited. This article describes quick review on the oral special dosage forms that may be applied to the early clinical formulations, followed by discussion focused on the amorphous formulations, which still has relatively many issues to be proved for the general use. The major problems that inhibit the use of the amorphous formulation are difficulty in the manufacturing and the poor chemical/physical stability. Notably, the poor physical stability can be critical, because of not the poor stability itself but the difficulty in the timely evaluation in the preclinical developmental timeframes. Research directions of the amorphous formulations are suggested to utilize this promising technology without disturbing the preclinical developmental timelines. |
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Authors:
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Kohsaku Kawakami |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: Journal of pharmaceutical sciences Volume: 98 ISSN: 1520-6017 ISO Abbreviation: J Pharm Sci Publication Date: 2009 Sep |
Date Detail:
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Created Date: 2009-08-04 Completed Date: 2009-10-12 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 2985195R Medline TA: J Pharm Sci Country: United States |
Other Details:
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Languages: eng Pagination: 2875-85 Citation Subset: IM |
Affiliation:
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National Institute for Materials Science, Biomaterials Center, 1-1 Namiki, Tsukuba, Ibaraki 305-0044, Japan. kawakami.kohsaku@nims.go.jp |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Animals Chemistry, Pharmaceutical* / trends Crystallization Dosage Forms* Drug Evaluation, Preclinical Humans Technology, Pharmaceutical* / trends |
| Chemical | |
Reg. No./Substance:
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0/Dosage Forms |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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