Quality by Design Coupled with Near Infrared in Formulation of Transdermal Glimepiride Liposomal Films
This study is aimed at developing glimepiride (GMD) liposomal films using quality by design (QbD) and process analytical technology (PAT) principles. Risk analysis and Plackett–Burman design were utilized to evaluate formulation variables in two paths. Internal path included liposomal parameters (ph...
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Veröffentlicht in: | Journal of pharmaceutical sciences 2015-06, Vol.104 (6), p.2062-2075 |
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creator | Ahmed, Osama Abdelhakim Aly Kurakula, Mallesh Banjar, Zainy Mohamed Afouna, Mohsen Ibrahim Zidan, Ahmed Samir |
description | This study is aimed at developing glimepiride (GMD) liposomal films using quality by design (QbD) and process analytical technology (PAT) principles. Risk analysis and Plackett–Burman design were utilized to evaluate formulation variables in two paths. Internal path included liposomal parameters (phosphatidylserine, cholesterol and drug concentrations, and pH of hydration medium). External path constituted films parameters, namely, polymer, plasticizer, and permeation enhancer percentages. As a PAT tool, near infrared (NIR)-based chemometric analysis was used in quantifying GMD contents. Liposomal formulations showed maximum GMD entrapment capacity of 41.9% with vesicular size of 0.51μm at phospholipid to cholesterol to drug weight ratio of 2:1:0.8. Its transdermal films showed elongation ratio of 75%, folding endurance of 700-fold, 16.6% and 26.8% drug release after 1 and 12h, respectively. Moreover, 3D response spaces for GMD entrapment and release characteristics were established. Regarding NIR analysis, partial-least-square regression model was accurate in quantifying drug content as indicated by the low root-mean-squared error of calibrations and prediction of 0.031 and 0.032, and bias values of 0.0015 and 0.0021, respectively. In conclusion, this study highlights the level of understanding that can be accomplished through a well-designed research based on QbD and PAT paradigms. |
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Risk analysis and Plackett–Burman design were utilized to evaluate formulation variables in two paths. Internal path included liposomal parameters (phosphatidylserine, cholesterol and drug concentrations, and pH of hydration medium). External path constituted films parameters, namely, polymer, plasticizer, and permeation enhancer percentages. As a PAT tool, near infrared (NIR)-based chemometric analysis was used in quantifying GMD contents. Liposomal formulations showed maximum GMD entrapment capacity of 41.9% with vesicular size of 0.51μm at phospholipid to cholesterol to drug weight ratio of 2:1:0.8. Its transdermal films showed elongation ratio of 75%, folding endurance of 700-fold, 16.6% and 26.8% drug release after 1 and 12h, respectively. Moreover, 3D response spaces for GMD entrapment and release characteristics were established. Regarding NIR analysis, partial-least-square regression model was accurate in quantifying drug content as indicated by the low root-mean-squared error of calibrations and prediction of 0.031 and 0.032, and bias values of 0.0015 and 0.0021, respectively. In conclusion, this study highlights the level of understanding that can be accomplished through a well-designed research based on QbD and PAT paradigms.</description><identifier>ISSN: 0022-3549</identifier><identifier>EISSN: 1520-6017</identifier><identifier>DOI: 10.1002/jps.24448</identifier><identifier>PMID: 25873019</identifier><identifier>CODEN: JPMSAE</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Administration, Cutaneous ; Cholesterol - chemistry ; Drug Delivery Systems ; Formulation ; glimepiride ; Humans ; Hypoglycemic Agents - administration & dosage ; Infrared spectroscopy ; liposomes ; Liposomes - chemistry ; NIR ; Percutaneous ; Phosphatidylserines - chemistry ; Placket–Burmann design ; Skin - metabolism ; Spectrophotometry, Infrared ; Sulfonylurea Compounds - administration & dosage ; Transdermal drug delivery ; transdermal film ; Transdermal Patch</subject><ispartof>Journal of pharmaceutical sciences, 2015-06, Vol.104 (6), p.2062-2075</ispartof><rights>2015 Wiley Periodicals, Inc. and the American Pharmacists Association</rights><rights>2015 Wiley Periodicals, Inc. and the American Pharmacists Association.</rights><rights>Copyright © 2015 Wiley Periodicals, Inc., A Wiley Company</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4678-10eaaf30e168fe60a4703553d1d5a30dc0f942d1d8f778d328d8211ca2c5b8793</citedby><cites>FETCH-LOGICAL-c4678-10eaaf30e168fe60a4703553d1d5a30dc0f942d1d8f778d328d8211ca2c5b8793</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjps.24448$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjps.24448$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25873019$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ahmed, Osama Abdelhakim Aly</creatorcontrib><creatorcontrib>Kurakula, Mallesh</creatorcontrib><creatorcontrib>Banjar, Zainy Mohamed</creatorcontrib><creatorcontrib>Afouna, Mohsen Ibrahim</creatorcontrib><creatorcontrib>Zidan, Ahmed Samir</creatorcontrib><title>Quality by Design Coupled with Near Infrared in Formulation of Transdermal Glimepiride Liposomal Films</title><title>Journal of pharmaceutical sciences</title><addtitle>J Pharm Sci</addtitle><description>This study is aimed at developing glimepiride (GMD) liposomal films using quality by design (QbD) and process analytical technology (PAT) principles. Risk analysis and Plackett–Burman design were utilized to evaluate formulation variables in two paths. Internal path included liposomal parameters (phosphatidylserine, cholesterol and drug concentrations, and pH of hydration medium). External path constituted films parameters, namely, polymer, plasticizer, and permeation enhancer percentages. As a PAT tool, near infrared (NIR)-based chemometric analysis was used in quantifying GMD contents. Liposomal formulations showed maximum GMD entrapment capacity of 41.9% with vesicular size of 0.51μm at phospholipid to cholesterol to drug weight ratio of 2:1:0.8. Its transdermal films showed elongation ratio of 75%, folding endurance of 700-fold, 16.6% and 26.8% drug release after 1 and 12h, respectively. Moreover, 3D response spaces for GMD entrapment and release characteristics were established. Regarding NIR analysis, partial-least-square regression model was accurate in quantifying drug content as indicated by the low root-mean-squared error of calibrations and prediction of 0.031 and 0.032, and bias values of 0.0015 and 0.0021, respectively. In conclusion, this study highlights the level of understanding that can be accomplished through a well-designed research based on QbD and PAT paradigms.</description><subject>Administration, Cutaneous</subject><subject>Cholesterol - chemistry</subject><subject>Drug Delivery Systems</subject><subject>Formulation</subject><subject>glimepiride</subject><subject>Humans</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Infrared spectroscopy</subject><subject>liposomes</subject><subject>Liposomes - chemistry</subject><subject>NIR</subject><subject>Percutaneous</subject><subject>Phosphatidylserines - chemistry</subject><subject>Placket–Burmann design</subject><subject>Skin - metabolism</subject><subject>Spectrophotometry, Infrared</subject><subject>Sulfonylurea Compounds - administration & dosage</subject><subject>Transdermal drug delivery</subject><subject>transdermal film</subject><subject>Transdermal Patch</subject><issn>0022-3549</issn><issn>1520-6017</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kF1vFCEUQInR2LX64B8wJL7ow7QXGObj0axurdn4EeszYeGibJhhhBmb_ffSbuuD0SfC5XBycwh5zuCMAfDz_ZTPeF3X3QOyYpJD1QBrH5JVeeOVkHV_Qp7kvAeABqR8TE647FoBrF8R92XRwc8HujvQt5j995Gu4zIFtPTazz_oR9SJXo4u6VRGfqSbmIYl6NnHkUZHr5Ies8U06EAvgh9w8slbpFs_xRxvphsfhvyUPHI6ZHx2d56Sb5t3V-v31fbTxeX6zbYyddN2FQPU2glA1nQOG9B1C0JKYZmVWoA14Pqal1vn2razgne244wZzY3cdW0vTsmro3dK8eeCeVaDzwZD0CPGJavihV62dQMFffkXuo9LGst2txQXrG9koV4fKZNizgmdmpIfdDooBuomvirx1W38wr64My67Ae0f8r52Ac6PwLUPePi_SX34_PVeKY4_sET75TGpbDyOBq1PaGZlo__HIr8BmYKfFw</recordid><startdate>201506</startdate><enddate>201506</enddate><creator>Ahmed, Osama Abdelhakim Aly</creator><creator>Kurakula, Mallesh</creator><creator>Banjar, Zainy Mohamed</creator><creator>Afouna, Mohsen Ibrahim</creator><creator>Zidan, Ahmed Samir</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7QP</scope><scope>7QR</scope><scope>7TK</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>201506</creationdate><title>Quality by Design Coupled with Near Infrared in Formulation of Transdermal Glimepiride Liposomal Films</title><author>Ahmed, Osama Abdelhakim Aly ; Kurakula, Mallesh ; Banjar, Zainy Mohamed ; Afouna, Mohsen Ibrahim ; Zidan, Ahmed Samir</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4678-10eaaf30e168fe60a4703553d1d5a30dc0f942d1d8f778d328d8211ca2c5b8793</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Administration, Cutaneous</topic><topic>Cholesterol - chemistry</topic><topic>Drug Delivery Systems</topic><topic>Formulation</topic><topic>glimepiride</topic><topic>Humans</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Infrared spectroscopy</topic><topic>liposomes</topic><topic>Liposomes - chemistry</topic><topic>NIR</topic><topic>Percutaneous</topic><topic>Phosphatidylserines - chemistry</topic><topic>Placket–Burmann design</topic><topic>Skin - metabolism</topic><topic>Spectrophotometry, Infrared</topic><topic>Sulfonylurea Compounds - administration & dosage</topic><topic>Transdermal drug delivery</topic><topic>transdermal film</topic><topic>Transdermal Patch</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ahmed, Osama Abdelhakim Aly</creatorcontrib><creatorcontrib>Kurakula, Mallesh</creatorcontrib><creatorcontrib>Banjar, Zainy Mohamed</creatorcontrib><creatorcontrib>Afouna, Mohsen Ibrahim</creatorcontrib><creatorcontrib>Zidan, Ahmed Samir</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of pharmaceutical sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ahmed, Osama Abdelhakim Aly</au><au>Kurakula, Mallesh</au><au>Banjar, Zainy Mohamed</au><au>Afouna, Mohsen Ibrahim</au><au>Zidan, Ahmed Samir</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quality by Design Coupled with Near Infrared in Formulation of Transdermal Glimepiride Liposomal Films</atitle><jtitle>Journal of pharmaceutical sciences</jtitle><addtitle>J Pharm Sci</addtitle><date>2015-06</date><risdate>2015</risdate><volume>104</volume><issue>6</issue><spage>2062</spage><epage>2075</epage><pages>2062-2075</pages><issn>0022-3549</issn><eissn>1520-6017</eissn><coden>JPMSAE</coden><abstract>This study is aimed at developing glimepiride (GMD) liposomal films using quality by design (QbD) and process analytical technology (PAT) principles. Risk analysis and Plackett–Burman design were utilized to evaluate formulation variables in two paths. Internal path included liposomal parameters (phosphatidylserine, cholesterol and drug concentrations, and pH of hydration medium). External path constituted films parameters, namely, polymer, plasticizer, and permeation enhancer percentages. As a PAT tool, near infrared (NIR)-based chemometric analysis was used in quantifying GMD contents. Liposomal formulations showed maximum GMD entrapment capacity of 41.9% with vesicular size of 0.51μm at phospholipid to cholesterol to drug weight ratio of 2:1:0.8. Its transdermal films showed elongation ratio of 75%, folding endurance of 700-fold, 16.6% and 26.8% drug release after 1 and 12h, respectively. Moreover, 3D response spaces for GMD entrapment and release characteristics were established. Regarding NIR analysis, partial-least-square regression model was accurate in quantifying drug content as indicated by the low root-mean-squared error of calibrations and prediction of 0.031 and 0.032, and bias values of 0.0015 and 0.0021, respectively. In conclusion, this study highlights the level of understanding that can be accomplished through a well-designed research based on QbD and PAT paradigms.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25873019</pmid><doi>10.1002/jps.24448</doi><tpages>14</tpages></addata></record> |
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subjects | Administration, Cutaneous Cholesterol - chemistry Drug Delivery Systems Formulation glimepiride Humans Hypoglycemic Agents - administration & dosage Infrared spectroscopy liposomes Liposomes - chemistry NIR Percutaneous Phosphatidylserines - chemistry Placket–Burmann design Skin - metabolism Spectrophotometry, Infrared Sulfonylurea Compounds - administration & dosage Transdermal drug delivery transdermal film Transdermal Patch |
title | Quality by Design Coupled with Near Infrared in Formulation of Transdermal Glimepiride Liposomal Films |
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