Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications
The aim of this study was to evaluate two important aspects of patent applications of crystalline forms of drugs: (i) the physicochemical characterization of the crystalline forms; and (ii) the procedure for preparing crystals of the blockbuster drug clopidogrel. To this end, searches were conducted...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Universidade de São Paulo
2014-04-01
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200229&lng=en&tlng=en |
| _version_ | 1828950302938628096 |
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| author | Luiz Marcelo Lira Alexandre Lopes Lourenço Guilherme Ferreira Neves Valéria Pereira de Sousa Carlos Rangel Rodrigues Lúcio Mendes Cabral |
| author_facet | Luiz Marcelo Lira Alexandre Lopes Lourenço Guilherme Ferreira Neves Valéria Pereira de Sousa Carlos Rangel Rodrigues Lúcio Mendes Cabral |
| author_sort | Luiz Marcelo Lira |
| collection | DOAJ |
| description | The aim of this study was to evaluate two important aspects of patent applications of crystalline forms of drugs: (i) the physicochemical characterization of the crystalline forms; and (ii) the procedure for preparing crystals of the blockbuster drug clopidogrel. To this end, searches were conducted using online patent databases. The results showed that: (i) the majority of patent applications for clopidogrel crystalline forms failed to comply with proposed Brazilian Patent Office guidelines. This was primarily due to insufficient number of analytical techniques evaluating the crystalline phase. In addition, some patent applications lacked assessment of chemical/crystallography purity; (ii) use of more than two analytical techniques is important; and (iii) the crystallization procedure for clopidogrel bisulfate form II were irreproducible based on the procedure given in the patent application. |
| first_indexed | 2024-12-14T06:21:33Z |
| format | Article |
| id | doaj.art-2f9703d148d942f6ad27b33d75fef037 |
| institution | Directory Open Access Journal |
| issn | 2175-9790 |
| language | English |
| last_indexed | 2024-12-14T06:21:33Z |
| publishDate | 2014-04-01 |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-2f9703d148d942f6ad27b33d75fef0372022-12-21T23:13:48ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-97902014-04-0150222924210.1590/S1984-82502014000200001S1984-82502014000200229Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applicationsLuiz Marcelo LiraAlexandre Lopes LourençoGuilherme Ferreira NevesValéria Pereira de SousaCarlos Rangel RodriguesLúcio Mendes CabralThe aim of this study was to evaluate two important aspects of patent applications of crystalline forms of drugs: (i) the physicochemical characterization of the crystalline forms; and (ii) the procedure for preparing crystals of the blockbuster drug clopidogrel. To this end, searches were conducted using online patent databases. The results showed that: (i) the majority of patent applications for clopidogrel crystalline forms failed to comply with proposed Brazilian Patent Office guidelines. This was primarily due to insufficient number of analytical techniques evaluating the crystalline phase. In addition, some patent applications lacked assessment of chemical/crystallography purity; (ii) use of more than two analytical techniques is important; and (iii) the crystallization procedure for clopidogrel bisulfate form II were irreproducible based on the procedure given in the patent application.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200229&lng=en&tlng=enClopidogrel/forma cristalina/caracterização físico-químicaClopidogrel/forma cristalina/patentesPolimorfismo |
| spellingShingle | Luiz Marcelo Lira Alexandre Lopes Lourenço Guilherme Ferreira Neves Valéria Pereira de Sousa Carlos Rangel Rodrigues Lúcio Mendes Cabral Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications Brazilian Journal of Pharmaceutical Sciences Clopidogrel/forma cristalina/caracterização físico-química Clopidogrel/forma cristalina/patentes Polimorfismo |
| title | Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications |
| title_full | Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications |
| title_fullStr | Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications |
| title_full_unstemmed | Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications |
| title_short | Assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications |
| title_sort | assessment of analytical techniques for characterization of crystalline clopidogrel forms in patent applications |
| topic | Clopidogrel/forma cristalina/caracterização físico-química Clopidogrel/forma cristalina/patentes Polimorfismo |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200229&lng=en&tlng=en |
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