Impact of downstream processing on crystal quality during the precipitation of a pharmaceutical product
In pharmaceutical industries, active pharmaceutical ingredients (API) are made of crystals whose properties must be controlled because they influence the end-use properties of the drug. Even if crystal quality is mainly determined during the precipitation step, downstream processing also has an infl...
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Published in | Powder technology Vol. 208; no. 2; pp. 337 - 342 |
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Main Authors | , , , |
Format | Journal Article Conference Proceeding |
Language | English |
Published |
Amsterdam
Elsevier B.V
25.03.2011
Elsevier |
Subjects | |
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Abstract | In pharmaceutical industries, active pharmaceutical ingredients (API) are made of crystals whose properties must be controlled because they influence the end-use properties of the drug. Even if crystal quality is mainly determined during the precipitation step, downstream processing also has an influence. In this study, the influence of washing on the crystal size and shape was analyzed. For the API being considered, different impurities have to be removed from the final suspension by filter cake washing. The efficiency of the washing steps was measured by different types of characterization on the solid phase (differential scanning calorimetry, scanning electron microscopy, and size distribution) and on the remaining filtrate (concentration of impurities). A second component also coprecipitates with the API. A specific study has been carried out on the withdrawal of this by-product and on its impact on the evolution of the crystalline form during washing steps. It was found that three filter cake washings allow us to remove all the impurities and to obtain a pure crystalline form.
The efficiency of the washing steps of API crystals was measured by different types of characterization on the solid phase (differential scanning calorimetry, scanning electron microscopy, and size distribution) and on the remaining filtrate (concentration of impurities by ICP). These methods permitted also to determine the mechanisms of washing and to put into light the coprecipitation of API with a by-product.
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AbstractList | In pharmaceutical industries, active pharmaceutical ingredients (API) are made of crystals whose properties must be controlled because they influence the end-use properties of the drug. Even if crystal quality is mainly determined during the precipitation step, downstream processing also has an influence. In this study, the influence of washing on the crystal size and shape was analyzed. For the API being considered, different impurities have to be removed from the final suspension by filter cake washing. The efficiency of the washing steps was measured by different types of characterization on the solid phase (differential scanning calorimetry, scanning electron microscopy, and size distribution) and on the remaining filtrate (concentration of impurities). A second component also coprecipitates with the API. A specific study has been carried out on the withdrawal of this by-product and on its impact on the evolution of the crystalline form during washing steps. It was found that three filter cake washings allow us to remove all the impurities and to obtain a pure crystalline form. In pharmaceutical industries, active pharmaceutical ingredients (API) are made of crystals whose properties must be controlled because they influence the end-use properties of the drug. Even if crystal quality is mainly determined during the precipitation step, downstream processing also has an influence. In this study, the influence of washing on the crystal size and shape was analyzed. For the API being considered, different impurities have to be removed from the final suspension by filter cake washing. The efficiency of the washing steps was measured by different types of characterization on the solid phase (differential scanning calorimetry, scanning electron microscopy, and size distribution) and on the remaining filtrate (concentration of impurities). A second component also coprecipitates with the API. A specific study has been carried out on the withdrawal of this by-product and on its impact on the evolution of the crystalline form during washing steps. It was found that three filter cake washings allow us to remove all the impurities and to obtain a pure crystalline form. The efficiency of the washing steps of API crystals was measured by different types of characterization on the solid phase (differential scanning calorimetry, scanning electron microscopy, and size distribution) and on the remaining filtrate (concentration of impurities by ICP). These methods permitted also to determine the mechanisms of washing and to put into light the coprecipitation of API with a by-product. [Display omitted] |
Author | Estime, N. Teychené, S. Biscans, B. Autret, J.M. |
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Keywords | API Efficiency Wash Coprecipitation Differential scanning calorimetry Scanning electron microscopy Impurity Reaction product Washing Particle size distribution Morphology Pharmaceutical industry Filter cake |
Language | English |
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References | Hoffner, Fuchs, Heuser (bb0010) 2004; 27 Ruslim, Hoffner (bb0005) 2007; 62 Ruslim (bb0025) 2007; 30 Wakeman (bb0015) March 1998 Srividya (bb0030) Oct 24-26 2007 Vemavarapu (bb0035) 2009; 189 Ruslim (bb0020) 2009; 87 Hoffner (10.1016/j.powtec.2010.08.026_bb0010) 2004; 27 Ruslim (10.1016/j.powtec.2010.08.026_bb0020) 2009; 87 Ruslim (10.1016/j.powtec.2010.08.026_bb0025) 2007; 30 Srividya (10.1016/j.powtec.2010.08.026_bb0030) 2007 Vemavarapu (10.1016/j.powtec.2010.08.026_bb0035) 2009; 189 Ruslim (10.1016/j.powtec.2010.08.026_bb0005) 2007; 62 Wakeman (10.1016/j.powtec.2010.08.026_bb0015) 1998 |
References_xml | – start-page: 185 year: March 1998 end-page: 190 ident: bb0015 article-title: Washing thin and nonuniform filter cakes: effects of wash liquor maldistribution publication-title: Filtration and Separation contributor: fullname: Wakeman – year: Oct 24-26 2007 ident: bb0030 article-title: Studies on the crystallization and characterization of pure and publication-title: International Conference on Advanced Materials and Composites contributor: fullname: Srividya – volume: 189 start-page: 444 year: 2009 end-page: 453 ident: bb0035 article-title: Coprecipitation of pharmaceutical actives and their structurally related additives by the RESS process publication-title: Powder Technology contributor: fullname: Vemavarapu – volume: 87 start-page: 1075 year: 2009 end-page: 1084 ident: bb0020 article-title: Evaluation of pathways for washing soluble solids publication-title: Chemical Engineering Research and Design contributor: fullname: Ruslim – volume: 62 start-page: 3951 year: 2007 end-page: 3961 ident: bb0005 article-title: Optimization of the wash liquor flow rate to improve washing of pre-deliquored filter cakes publication-title: Chemical Engineering Science contributor: fullname: Hoffner – volume: 30 start-page: 1055 year: 2007 end-page: 1061 ident: bb0025 article-title: Calcium-ion removal from peat by a mechanical filter cake washing process publication-title: Chemical Engineering and Technology contributor: fullname: Ruslim – volume: 27 start-page: 1065 year: 2004 end-page: 1071 ident: bb0010 article-title: Washing processes for disperse particulate systems—process spectrum and aspects for the process choice publication-title: Chemical Engineering and Technology contributor: fullname: Heuser – volume: 27 start-page: 1065 year: 2004 ident: 10.1016/j.powtec.2010.08.026_bb0010 article-title: Washing processes for disperse particulate systems—process spectrum and aspects for the process choice publication-title: Chemical Engineering and Technology doi: 10.1002/ceat.200406142 contributor: fullname: Hoffner – volume: 62 start-page: 3951 year: 2007 ident: 10.1016/j.powtec.2010.08.026_bb0005 article-title: Optimization of the wash liquor flow rate to improve washing of pre-deliquored filter cakes publication-title: Chemical Engineering Science doi: 10.1016/j.ces.2007.04.022 contributor: fullname: Ruslim – year: 2007 ident: 10.1016/j.powtec.2010.08.026_bb0030 article-title: Studies on the crystallization and characterization of pure and l-leucine doped potassium dihydrogen phosphate single crystals contributor: fullname: Srividya – volume: 189 start-page: 444 year: 2009 ident: 10.1016/j.powtec.2010.08.026_bb0035 article-title: Coprecipitation of pharmaceutical actives and their structurally related additives by the RESS process publication-title: Powder Technology doi: 10.1016/j.powtec.2008.07.005 contributor: fullname: Vemavarapu – start-page: 185 year: 1998 ident: 10.1016/j.powtec.2010.08.026_bb0015 article-title: Washing thin and nonuniform filter cakes: effects of wash liquor maldistribution publication-title: Filtration and Separation doi: 10.1016/S0015-1882(98)91368-4 contributor: fullname: Wakeman – volume: 87 start-page: 1075 year: 2009 ident: 10.1016/j.powtec.2010.08.026_bb0020 article-title: Evaluation of pathways for washing soluble solids publication-title: Chemical Engineering Research and Design doi: 10.1016/j.cherd.2009.01.007 contributor: fullname: Ruslim – volume: 30 start-page: 1055 year: 2007 ident: 10.1016/j.powtec.2010.08.026_bb0025 article-title: Calcium-ion removal from peat by a mechanical filter cake washing process publication-title: Chemical Engineering and Technology doi: 10.1002/ceat.200700142 contributor: fullname: Ruslim |
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SubjectTerms | API Applied sciences Chemical engineering Chemical Sciences Coprecipitation crystals differential scanning calorimetry drugs Efficiency Exact sciences and technology filter cake filtrates Fluid Dynamics ingredients Life Sciences Miscellaneous pharmaceutical industry Pharmaceutical sciences Physics scanning electron microscopy Solid-solid systems Wash washing |
Title | Impact of downstream processing on crystal quality during the precipitation of a pharmaceutical product |
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