Rapidfilm ®: An innovative pharmaceutical form designed to improve patient compliance
The aim of the research was to assess the bioequivalence between Rapidfilm ®, a new patented delivery system, versus the traditional orodispersible tablet (ODT). A randomized, two-way, single dose, crossover, bioequivalence study was conducted in 24 fasting, healthy volunteers with two formulations...
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| Veröffentlicht in: | International journal of pharmaceutics 2010-06, Vol.393 (1), p.55-60 |
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| container_title | International journal of pharmaceutics |
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| creator | Reiner, Valentina Giarratana, Nadia Monti, Nunzia Ceppi Breitenbach, Armin Klaffenbach, Peter |
| description | The aim of the research was to assess the bioequivalence between Rapidfilm
®, a new patented delivery system, versus the traditional orodispersible tablet (ODT).
A randomized, two-way, single dose, crossover, bioequivalence study was conducted in 24 fasting, healthy volunteers with two formulations of ondansetron (Ondansetron Rapidfilm
® vs. Zofran
® Zydis
® Lingual ODT by GlaxoSmithKline GmbH & Co. KG).
Plasma samples were analysed by a validated LC–MS/MS method during a collection period of 24
h post-dosing. The analysis of variance (ANOVA) on the targeted pharmacokinetic parameters did not show any significant difference between the two formulations and 90% confidence intervals (CIs) fell within the common acceptance range of 80–125%, satisfying the bioequivalence criteria. These results allow Rapidfilm
® to claim the same panel of indications of the conventional immediate release oral solid dosage forms, but offering several advantages also over the ODT: it can result in higher patient convenience for several applications. |
| doi_str_mv | 10.1016/j.ijpharm.2010.03.055 |
| format | Article |
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®, a new patented delivery system, versus the traditional orodispersible tablet (ODT).
A randomized, two-way, single dose, crossover, bioequivalence study was conducted in 24 fasting, healthy volunteers with two formulations of ondansetron (Ondansetron Rapidfilm
® vs. Zofran
® Zydis
® Lingual ODT by GlaxoSmithKline GmbH & Co. KG).
Plasma samples were analysed by a validated LC–MS/MS method during a collection period of 24
h post-dosing. The analysis of variance (ANOVA) on the targeted pharmacokinetic parameters did not show any significant difference between the two formulations and 90% confidence intervals (CIs) fell within the common acceptance range of 80–125%, satisfying the bioequivalence criteria. These results allow Rapidfilm
® to claim the same panel of indications of the conventional immediate release oral solid dosage forms, but offering several advantages also over the ODT: it can result in higher patient convenience for several applications.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2010.03.055</identifier><identifier>PMID: 20363308</identifier><identifier>CODEN: IJPHDE</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Administration, Oral ; Adult ; Analysis of Variance ; Antiemetics - administration & dosage ; Antiemetics - adverse effects ; Antiemetics - blood ; Antiemetics - chemistry ; Antiemetics - pharmacokinetics ; Bioequivalence ; Biological and medical sciences ; Chemistry, Pharmaceutical ; Chromatography, Liquid ; Cross-Over Studies ; Delivery system ; Dosage Forms ; Drug Carriers ; Drug Compounding ; Female ; General pharmacology ; Humans ; Male ; Medical sciences ; Ondansetron ; Ondansetron - administration & dosage ; Ondansetron - adverse effects ; Ondansetron - blood ; Ondansetron - chemistry ; Ondansetron - pharmacokinetics ; Orally disintegrating tablet (ODT) ; Orodispersible film ; Orodispersible tablet ; Patient Compliance ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Serotonin Antagonists - administration & dosage ; Serotonin Antagonists - adverse effects ; Serotonin Antagonists - blood ; Serotonin Antagonists - chemistry ; Serotonin Antagonists - pharmacokinetics ; Tandem Mass Spectrometry ; Therapeutic Equivalency</subject><ispartof>International journal of pharmaceutics, 2010-06, Vol.393 (1), p.55-60</ispartof><rights>2010 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>2010 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c394t-563a34b9c0cae6e9302fc1274e15523b1e1fcc283a6284e8524ab56d0b02184e3</citedby><cites>FETCH-LOGICAL-c394t-563a34b9c0cae6e9302fc1274e15523b1e1fcc283a6284e8524ab56d0b02184e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ijpharm.2010.03.055$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3548,27922,27923,45993</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22901496$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20363308$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Reiner, Valentina</creatorcontrib><creatorcontrib>Giarratana, Nadia</creatorcontrib><creatorcontrib>Monti, Nunzia Ceppi</creatorcontrib><creatorcontrib>Breitenbach, Armin</creatorcontrib><creatorcontrib>Klaffenbach, Peter</creatorcontrib><title>Rapidfilm ®: An innovative pharmaceutical form designed to improve patient compliance</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>The aim of the research was to assess the bioequivalence between Rapidfilm
®, a new patented delivery system, versus the traditional orodispersible tablet (ODT).
A randomized, two-way, single dose, crossover, bioequivalence study was conducted in 24 fasting, healthy volunteers with two formulations of ondansetron (Ondansetron Rapidfilm
® vs. Zofran
® Zydis
® Lingual ODT by GlaxoSmithKline GmbH & Co. KG).
Plasma samples were analysed by a validated LC–MS/MS method during a collection period of 24
h post-dosing. The analysis of variance (ANOVA) on the targeted pharmacokinetic parameters did not show any significant difference between the two formulations and 90% confidence intervals (CIs) fell within the common acceptance range of 80–125%, satisfying the bioequivalence criteria. These results allow Rapidfilm
® to claim the same panel of indications of the conventional immediate release oral solid dosage forms, but offering several advantages also over the ODT: it can result in higher patient convenience for several applications.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Analysis of Variance</subject><subject>Antiemetics - administration & dosage</subject><subject>Antiemetics - adverse effects</subject><subject>Antiemetics - blood</subject><subject>Antiemetics - chemistry</subject><subject>Antiemetics - pharmacokinetics</subject><subject>Bioequivalence</subject><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical</subject><subject>Chromatography, Liquid</subject><subject>Cross-Over Studies</subject><subject>Delivery system</subject><subject>Dosage Forms</subject><subject>Drug Carriers</subject><subject>Drug Compounding</subject><subject>Female</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Ondansetron</subject><subject>Ondansetron - administration & dosage</subject><subject>Ondansetron - adverse effects</subject><subject>Ondansetron - blood</subject><subject>Ondansetron - chemistry</subject><subject>Ondansetron - pharmacokinetics</subject><subject>Orally disintegrating tablet (ODT)</subject><subject>Orodispersible film</subject><subject>Orodispersible tablet</subject><subject>Patient Compliance</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Serotonin Antagonists - administration & dosage</subject><subject>Serotonin Antagonists - adverse effects</subject><subject>Serotonin Antagonists - blood</subject><subject>Serotonin Antagonists - chemistry</subject><subject>Serotonin Antagonists - pharmacokinetics</subject><subject>Tandem Mass Spectrometry</subject><subject>Therapeutic Equivalency</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkMuKFDEUhsOgOD2jjzBDNuKq2pOcJFXlRobBucCAIOo2pFKnNE3dTKobfCkfwiczbfc4S1cHfr5z-xi7ELAWIMzbzTps5u8uDmsJOQNcg9YnbCWqEgtUpXnGVoBlVWhR4ik7S2kDAEYKfMFOJaBBhGrFvn5yc2i70A_89693_GrkYRynnVvCjvjf-c7Tdgne9byb4sBbSuHbSC1fJh6GOU57LuM0LtxPw9wHN3p6yZ53rk_06ljP2ZebD5-v74qHj7f311cPhcdaLYU26FA1tQfvyFCNIDsvZKlIaC2xESQ672WFzshKUaWlco02LTQgRQ7wnL05zM2H_NhSWuwQkqe-dyNN22RLRIFKGZFJfSB9nFKK1Nk5hsHFn1aA3Ru1G3s0avdGLaDNRnPf5XHDthmo_df1qDADr4-AS9lSF_P_IT1xsgahapO59weOso9doGiTz9Y8tSGSX2w7hf-c8gfJNpeT</recordid><startdate>20100630</startdate><enddate>20100630</enddate><creator>Reiner, Valentina</creator><creator>Giarratana, Nadia</creator><creator>Monti, Nunzia Ceppi</creator><creator>Breitenbach, Armin</creator><creator>Klaffenbach, Peter</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><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>7X8</scope></search><sort><creationdate>20100630</creationdate><title>Rapidfilm ®: An innovative pharmaceutical form designed to improve patient compliance</title><author>Reiner, Valentina ; Giarratana, Nadia ; Monti, Nunzia Ceppi ; Breitenbach, Armin ; Klaffenbach, Peter</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c394t-563a34b9c0cae6e9302fc1274e15523b1e1fcc283a6284e8524ab56d0b02184e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Analysis of Variance</topic><topic>Antiemetics - administration & dosage</topic><topic>Antiemetics - adverse effects</topic><topic>Antiemetics - blood</topic><topic>Antiemetics - chemistry</topic><topic>Antiemetics - pharmacokinetics</topic><topic>Bioequivalence</topic><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical</topic><topic>Chromatography, Liquid</topic><topic>Cross-Over Studies</topic><topic>Delivery system</topic><topic>Dosage Forms</topic><topic>Drug Carriers</topic><topic>Drug Compounding</topic><topic>Female</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Ondansetron</topic><topic>Ondansetron - administration & dosage</topic><topic>Ondansetron - adverse effects</topic><topic>Ondansetron - blood</topic><topic>Ondansetron - chemistry</topic><topic>Ondansetron - pharmacokinetics</topic><topic>Orally disintegrating tablet (ODT)</topic><topic>Orodispersible film</topic><topic>Orodispersible tablet</topic><topic>Patient Compliance</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Serotonin Antagonists - administration & dosage</topic><topic>Serotonin Antagonists - adverse effects</topic><topic>Serotonin Antagonists - blood</topic><topic>Serotonin Antagonists - chemistry</topic><topic>Serotonin Antagonists - pharmacokinetics</topic><topic>Tandem Mass Spectrometry</topic><topic>Therapeutic Equivalency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Reiner, Valentina</creatorcontrib><creatorcontrib>Giarratana, Nadia</creatorcontrib><creatorcontrib>Monti, Nunzia Ceppi</creatorcontrib><creatorcontrib>Breitenbach, Armin</creatorcontrib><creatorcontrib>Klaffenbach, Peter</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of pharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Reiner, Valentina</au><au>Giarratana, Nadia</au><au>Monti, Nunzia Ceppi</au><au>Breitenbach, Armin</au><au>Klaffenbach, Peter</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rapidfilm ®: An innovative pharmaceutical form designed to improve patient compliance</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2010-06-30</date><risdate>2010</risdate><volume>393</volume><issue>1</issue><spage>55</spage><epage>60</epage><pages>55-60</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><coden>IJPHDE</coden><abstract>The aim of the research was to assess the bioequivalence between Rapidfilm
®, a new patented delivery system, versus the traditional orodispersible tablet (ODT).
A randomized, two-way, single dose, crossover, bioequivalence study was conducted in 24 fasting, healthy volunteers with two formulations of ondansetron (Ondansetron Rapidfilm
® vs. Zofran
® Zydis
® Lingual ODT by GlaxoSmithKline GmbH & Co. KG).
Plasma samples were analysed by a validated LC–MS/MS method during a collection period of 24
h post-dosing. The analysis of variance (ANOVA) on the targeted pharmacokinetic parameters did not show any significant difference between the two formulations and 90% confidence intervals (CIs) fell within the common acceptance range of 80–125%, satisfying the bioequivalence criteria. These results allow Rapidfilm
® to claim the same panel of indications of the conventional immediate release oral solid dosage forms, but offering several advantages also over the ODT: it can result in higher patient convenience for several applications.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>20363308</pmid><doi>10.1016/j.ijpharm.2010.03.055</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0378-5173 |
| ispartof | International journal of pharmaceutics, 2010-06, Vol.393 (1), p.55-60 |
| issn | 0378-5173 1873-3476 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_733134461 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Administration, Oral Adult Analysis of Variance Antiemetics - administration & dosage Antiemetics - adverse effects Antiemetics - blood Antiemetics - chemistry Antiemetics - pharmacokinetics Bioequivalence Biological and medical sciences Chemistry, Pharmaceutical Chromatography, Liquid Cross-Over Studies Delivery system Dosage Forms Drug Carriers Drug Compounding Female General pharmacology Humans Male Medical sciences Ondansetron Ondansetron - administration & dosage Ondansetron - adverse effects Ondansetron - blood Ondansetron - chemistry Ondansetron - pharmacokinetics Orally disintegrating tablet (ODT) Orodispersible film Orodispersible tablet Patient Compliance Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Serotonin Antagonists - administration & dosage Serotonin Antagonists - adverse effects Serotonin Antagonists - blood Serotonin Antagonists - chemistry Serotonin Antagonists - pharmacokinetics Tandem Mass Spectrometry Therapeutic Equivalency |
| title | Rapidfilm ®: An innovative pharmaceutical form designed to improve patient compliance |
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