Effect of powder processing on performance of fenofibrate formulations
In this study, the effect of the order in which powder blending and jet-milling were performed for the production of the bulk powders on the performance of 200-mg dose orally disintegrating tablets (ODTs) of fenofibrate was evaluated. Bulk powders composed of fenofibrate, mannitol, copovidone S630,...
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Published in | European journal of pharmaceutics and biopharmaceutics Vol. 69; no. 2; pp. 727 - 734 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
Amsterdam
Elsevier B.V
01.06.2008
Elsevier Science |
Subjects | |
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Abstract | In this study, the effect of the order in which powder blending and jet-milling were performed for the production of the bulk powders on the performance of 200-mg dose orally disintegrating tablets (ODTs) of fenofibrate was evaluated. Bulk powders composed of fenofibrate, mannitol, copovidone S630, and docusate sodium in a 10:10:2:1.2 ratio were prepared by the following three processes:
process A: fenofibrate
+
excipients
→
blending;
process B: fenofibrate
→
jet-milling
→
blending with excipients;
process C: fenofibrate
+
excipients
→
blending
→
jet-milling. The bulk powders were granulated followed by blending and tableting. The materials were tested for Differential Scanning Calorimetry (DSC), drug particle sizing post-reconstitution, dissolution, optical micrography, Scanning Electron Microscopy (SEM), Energy Dispersive X-ray Spectroscopy (EDS) and disintegration of the ODTs. It was found that the crystallinity of fenofibrate was not impacted by the blending and jet-milling processes. Process A produced materials having poorer fenofibrate reconstitution as compared to processes involving jet-milling. It was discovered that milling a blend of fenofibrate/excipient (process C) was advantageous over milling the raw drug alone (process B). Process C yielded bulk powder that showed rapid dissolution and ODTs which exhibited rapid disintegration. |
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AbstractList | In this study, the effect of the order in which powder blending and jet-milling were performed for the production of the bulk powders on the performance of 200-mg dose orally disintegrating tablets (ODTs) of fenofibrate was evaluated. Bulk powders composed of fenofibrate, mannitol, copovidone S630, and docusate sodium in a 10:10:2:1.2 ratio were prepared by the following three processes: process A: fenofibrate+excipients-->blending; process B: fenofibrate-->jet-milling-->blending with excipients; process C: fenofibrate+excipients-->blending-->jet-milling. The bulk powders were granulated followed by blending and tableting. The materials were tested for Differential Scanning Calorimetry (DSC), drug particle sizing post-reconstitution, dissolution, optical micrography, Scanning Electron Microscopy (SEM), Energy Dispersive X-ray Spectroscopy (EDS) and disintegration of the ODTs. It was found that the crystallinity of fenofibrate was not impacted by the blending and jet-milling processes. Process A produced materials having poorer fenofibrate reconstitution as compared to processes involving jet-milling. It was discovered that milling a blend of fenofibrate/excipient (process C) was advantageous over milling the raw drug alone (process B). Process C yielded bulk powder that showed rapid dissolution and ODTs which exhibited rapid disintegration. In this study, the effect of the order in which powder blending and jet-milling were performed for the production of the bulk powders on the performance of 200-mg dose orally disintegrating tablets (ODTs) of fenofibrate was evaluated. Bulk powders composed of fenofibrate, mannitol, copovidone S630, and docusate sodium in a 10:10:2:1.2 ratio were prepared by the following three processes: process A: fenofibrate+excipients-->blending; process B: fenofibrate-->jet-milling-->blending with excipients; process C: fenofibrate+excipients-->blending-->jet-milling. The bulk powders were granulated followed by blending and tableting. The materials were tested for Differential Scanning Calorimetry (DSC), drug particle sizing post-reconstitution, dissolution, optical micrography, Scanning Electron Microscopy (SEM), Energy Dispersive X-ray Spectroscopy (EDS) and disintegration of the ODTs. It was found that the crystallinity of fenofibrate was not impacted by the blending and jet-milling processes. Process A produced materials having poorer fenofibrate reconstitution as compared to processes involving jet-milling. It was discovered that milling a blend of fenofibrate/excipient (process C) was advantageous over milling the raw drug alone (process B). Process C yielded bulk powder that showed rapid dissolution and ODTs which exhibited rapid disintegration. In this study, the effect of the order in which powder blending and jet-milling were performed for the production of the bulk powders on the performance of 200-mg dose orally disintegrating tablets (ODTs) of fenofibrate was evaluated. Bulk powders composed of fenofibrate, mannitol, copovidone S630, and docusate sodium in a 10:10:2:1.2 ratio were prepared by the following three processes: process A: fenofibrate + excipients → blending; process B: fenofibrate → jet-milling → blending with excipients; process C: fenofibrate + excipients → blending → jet-milling. The bulk powders were granulated followed by blending and tableting. The materials were tested for Differential Scanning Calorimetry (DSC), drug particle sizing post-reconstitution, dissolution, optical micrography, Scanning Electron Microscopy (SEM), Energy Dispersive X-ray Spectroscopy (EDS) and disintegration of the ODTs. It was found that the crystallinity of fenofibrate was not impacted by the blending and jet-milling processes. Process A produced materials having poorer fenofibrate reconstitution as compared to processes involving jet-milling. It was discovered that milling a blend of fenofibrate/excipient (process C) was advantageous over milling the raw drug alone (process B). Process C yielded bulk powder that showed rapid dissolution and ODTs which exhibited rapid disintegration. |
Author | Tessier, Todd Bernstein, Howard Jain, Rajeev A. Straub, Julie A. Brito, Luis |
Author_xml | – sequence: 1 givenname: Rajeev A. surname: Jain fullname: Jain, Rajeev A. email: jain@acusphere.com – sequence: 2 givenname: Luis surname: Brito fullname: Brito, Luis – sequence: 3 givenname: Julie A. surname: Straub fullname: Straub, Julie A. – sequence: 4 givenname: Todd surname: Tessier fullname: Tessier, Todd – sequence: 5 givenname: Howard surname: Bernstein fullname: Bernstein, Howard |
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Cites_doi | 10.1081/PDT-120027417 10.1016/0378-5173(94)00132-4 10.1111/j.2042-7158.1976.tb02817.x 10.3109/03639049809082719 10.1016/S0378-5173(99)00347-6 10.1016/j.jconrel.2004.03.026 10.1016/0378-5173(94)90094-9 10.1016/S0378-5173(98)00247-6 10.1016/S0378-5173(99)00063-0 10.1016/0731-7085(95)01274-O 10.1016/j.jconrel.2005.02.010 10.1081/DDC-120030422 10.1023/A:1016232230638 10.1016/S0142-9612(00)00115-0 10.1016/0378-5173(94)90219-4 |
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Keywords | ODTs Fenofibrate Poorly soluble Jet-milling Performance evaluation Pharmaceutical technology Fibrate derivatives Formulation Performance Powder Antilipemic agent |
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Snippet | In this study, the effect of the order in which powder blending and jet-milling were performed for the production of the bulk powders on the performance of... |
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SubjectTerms | Biological and medical sciences Calorimetry, Differential Scanning Chemistry, Pharmaceutical Drug Compounding - instrumentation Fenofibrate Fenofibrate - administration & dosage Fenofibrate - chemistry General pharmacology Hypolipidemic Agents - administration & dosage Hypolipidemic Agents - chemistry Jet-milling Kinetics Medical sciences Microscopy, Electron, Scanning ODTs Particle Size Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Poorly soluble Powders Solubility Tablets |
Title | Effect of powder processing on performance of fenofibrate formulations |
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