Assessment of swallowability and palatability of oral dosage forms in children: Report from an M-CERSI pediatric formulation workshop
[Display omitted] The acceptability of pediatric pharmaceutical products to patients and their caregivers can have a profound impact on the resulting therapeutic outcome. However, existing methodology and approaches used for acceptability assessments for pediatric products is fragmented, making robu...
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| Veröffentlicht in: | International journal of pharmaceutics 2018-02, Vol.536 (2), p.570-581 |
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| container_title | International journal of pharmaceutics |
| container_volume | 536 |
| creator | Ternik, Robert Liu, Fang Bartlett, Jeremy A. Khong, Yuet Mei Thiam Tan, David Cheng Dixit, Trupti Wang, Siri Galella, Elizabeth A. Gao, Zhihui Klein, Sandra |
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The acceptability of pediatric pharmaceutical products to patients and their caregivers can have a profound impact on the resulting therapeutic outcome. However, existing methodology and approaches used for acceptability assessments for pediatric products is fragmented, making robust and consistent product evaluations difficult. A pediatric formulation development workshop took place in Washington, DC in June 2016 through the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI). A session at the workshop was dedicated to acceptability assessments and focused on two major elements that affect the overall acceptability of oral medicines, namely swallowability and palatability. The session started with presentations to provide an overview of literature, background and current state on swallowability and palatability assessments. Five parallel breakout discussions followed the presentations on each element, focusing on three overarching themes, risk-based approaches, methodology and product factors. This article reports the key outcomes of the workshop related to swallowability and palatability assessments. |
| doi_str_mv | 10.1016/j.ijpharm.2017.08.088 |
| format | Article |
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The acceptability of pediatric pharmaceutical products to patients and their caregivers can have a profound impact on the resulting therapeutic outcome. However, existing methodology and approaches used for acceptability assessments for pediatric products is fragmented, making robust and consistent product evaluations difficult. A pediatric formulation development workshop took place in Washington, DC in June 2016 through the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI). A session at the workshop was dedicated to acceptability assessments and focused on two major elements that affect the overall acceptability of oral medicines, namely swallowability and palatability. The session started with presentations to provide an overview of literature, background and current state on swallowability and palatability assessments. Five parallel breakout discussions followed the presentations on each element, focusing on three overarching themes, risk-based approaches, methodology and product factors. This article reports the key outcomes of the workshop related to swallowability and palatability assessments.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2017.08.088</identifier><identifier>PMID: 28844897</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Acceptability ; Adherence ; Administration, Oral ; Child ; Children ; Compliance ; Deglutition ; Dosage Forms ; Humans ; Patient Satisfaction ; Pediatric formulations ; Taste</subject><ispartof>International journal of pharmaceutics, 2018-02, Vol.536 (2), p.570-581</ispartof><rights>2017 Elsevier B.V.</rights><rights>Copyright © 2017 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c412t-57bceda52f4d40c046b0b151f6af8b107c33fbe3c413d2cf47529d6770f613fd3</citedby><cites>FETCH-LOGICAL-c412t-57bceda52f4d40c046b0b151f6af8b107c33fbe3c413d2cf47529d6770f613fd3</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.2017.08.088$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>309,310,314,780,784,789,790,3550,23930,23931,25140,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28844897$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ternik, Robert</creatorcontrib><creatorcontrib>Liu, Fang</creatorcontrib><creatorcontrib>Bartlett, Jeremy A.</creatorcontrib><creatorcontrib>Khong, Yuet Mei</creatorcontrib><creatorcontrib>Thiam Tan, David Cheng</creatorcontrib><creatorcontrib>Dixit, Trupti</creatorcontrib><creatorcontrib>Wang, Siri</creatorcontrib><creatorcontrib>Galella, Elizabeth A.</creatorcontrib><creatorcontrib>Gao, Zhihui</creatorcontrib><creatorcontrib>Klein, Sandra</creatorcontrib><title>Assessment of swallowability and palatability of oral dosage forms in children: Report from an M-CERSI pediatric formulation workshop</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>[Display omitted]
The acceptability of pediatric pharmaceutical products to patients and their caregivers can have a profound impact on the resulting therapeutic outcome. However, existing methodology and approaches used for acceptability assessments for pediatric products is fragmented, making robust and consistent product evaluations difficult. A pediatric formulation development workshop took place in Washington, DC in June 2016 through the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI). A session at the workshop was dedicated to acceptability assessments and focused on two major elements that affect the overall acceptability of oral medicines, namely swallowability and palatability. The session started with presentations to provide an overview of literature, background and current state on swallowability and palatability assessments. Five parallel breakout discussions followed the presentations on each element, focusing on three overarching themes, risk-based approaches, methodology and product factors. This article reports the key outcomes of the workshop related to swallowability and palatability assessments.</description><subject>Acceptability</subject><subject>Adherence</subject><subject>Administration, Oral</subject><subject>Child</subject><subject>Children</subject><subject>Compliance</subject><subject>Deglutition</subject><subject>Dosage Forms</subject><subject>Humans</subject><subject>Patient Satisfaction</subject><subject>Pediatric formulations</subject><subject>Taste</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcFu1DAQhi1ERbeFRwD5yCWLHSexlwuqVqWtVFSpwNly7DHrxYmDJ8uqD8B712W3XJFGGmn0_TP65yfkLWdLznj3YbsM22lj8rCsGZdLpkqpF2TBlRSVaGT3kiyYkKpquRSn5Axxyxjrai5ekdNaqaZRK7kgfy4QAXGAcabJU9ybGNPe9CGG-YGa0dHJRDM_DwqSsonUJTQ_gPqUB6RhpHYTosswfqT3MKU8U5_TUOT0S7W-vP96Qydwwcw52L-aXVkZ0kj3Kf_ETZpekxNvIsKbYz8n3z9ffltfV7d3Vzfri9vKNryeq1b2Fpxpa9-4hlnWdD3rect9Z7zqOZNWCN-DKLRwtfWNbOuV66RkvuPCO3FO3h_2Tjn92gHOeghoIUYzQtqh5ishatEy3ha0PaA2J8QMXk85DCY_aM70UwJ6q48J6KcENFOlVNG9O57Y9QO4f6rnlxfg0wGAYvR3gKzRBhiLsZDBztql8J8Tj7bhnM0</recordid><startdate>20180205</startdate><enddate>20180205</enddate><creator>Ternik, Robert</creator><creator>Liu, Fang</creator><creator>Bartlett, Jeremy A.</creator><creator>Khong, Yuet Mei</creator><creator>Thiam Tan, David Cheng</creator><creator>Dixit, Trupti</creator><creator>Wang, Siri</creator><creator>Galella, Elizabeth A.</creator><creator>Gao, Zhihui</creator><creator>Klein, Sandra</creator><general>Elsevier B.V</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>7X8</scope></search><sort><creationdate>20180205</creationdate><title>Assessment of swallowability and palatability of oral dosage forms in children: Report from an M-CERSI pediatric formulation workshop</title><author>Ternik, Robert ; Liu, Fang ; Bartlett, Jeremy A. ; Khong, Yuet Mei ; Thiam Tan, David Cheng ; Dixit, Trupti ; Wang, Siri ; Galella, Elizabeth A. ; Gao, Zhihui ; Klein, Sandra</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c412t-57bceda52f4d40c046b0b151f6af8b107c33fbe3c413d2cf47529d6770f613fd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Acceptability</topic><topic>Adherence</topic><topic>Administration, Oral</topic><topic>Child</topic><topic>Children</topic><topic>Compliance</topic><topic>Deglutition</topic><topic>Dosage Forms</topic><topic>Humans</topic><topic>Patient Satisfaction</topic><topic>Pediatric formulations</topic><topic>Taste</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ternik, Robert</creatorcontrib><creatorcontrib>Liu, Fang</creatorcontrib><creatorcontrib>Bartlett, Jeremy A.</creatorcontrib><creatorcontrib>Khong, Yuet Mei</creatorcontrib><creatorcontrib>Thiam Tan, David Cheng</creatorcontrib><creatorcontrib>Dixit, Trupti</creatorcontrib><creatorcontrib>Wang, Siri</creatorcontrib><creatorcontrib>Galella, Elizabeth A.</creatorcontrib><creatorcontrib>Gao, Zhihui</creatorcontrib><creatorcontrib>Klein, Sandra</creatorcontrib><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>Ternik, Robert</au><au>Liu, Fang</au><au>Bartlett, Jeremy A.</au><au>Khong, Yuet Mei</au><au>Thiam Tan, David Cheng</au><au>Dixit, Trupti</au><au>Wang, Siri</au><au>Galella, Elizabeth A.</au><au>Gao, Zhihui</au><au>Klein, Sandra</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessment of swallowability and palatability of oral dosage forms in children: Report from an M-CERSI pediatric formulation workshop</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2018-02-05</date><risdate>2018</risdate><volume>536</volume><issue>2</issue><spage>570</spage><epage>581</epage><pages>570-581</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><abstract>[Display omitted]
The acceptability of pediatric pharmaceutical products to patients and their caregivers can have a profound impact on the resulting therapeutic outcome. However, existing methodology and approaches used for acceptability assessments for pediatric products is fragmented, making robust and consistent product evaluations difficult. A pediatric formulation development workshop took place in Washington, DC in June 2016 through the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI). A session at the workshop was dedicated to acceptability assessments and focused on two major elements that affect the overall acceptability of oral medicines, namely swallowability and palatability. The session started with presentations to provide an overview of literature, background and current state on swallowability and palatability assessments. Five parallel breakout discussions followed the presentations on each element, focusing on three overarching themes, risk-based approaches, methodology and product factors. This article reports the key outcomes of the workshop related to swallowability and palatability assessments.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>28844897</pmid><doi>10.1016/j.ijpharm.2017.08.088</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Acceptability Adherence Administration, Oral Child Children Compliance Deglutition Dosage Forms Humans Patient Satisfaction Pediatric formulations Taste |
| title | Assessment of swallowability and palatability of oral dosage forms in children: Report from an M-CERSI pediatric formulation workshop |
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