Famotidine Orally Disintegrating Tablets: Bitterness Comparison of Original and Generic Products
The purpose of the present study was to compare the palatability of the original and eight generic versions of famotidine orally disintegrating tablets by means of human gustatory sensation tests, a comparison of the release profiles, and using an automated taste sensor, the α-Astree Electronic Tong...
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Veröffentlicht in: | Chemical & Pharmaceutical Bulletin 2009/04/01, Vol.57(4), pp.382-387 |
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creator | Tokuyama, Emi Matsunaga, Chiharu Yoshida, Koichi Mifsud, Jean-Christophe Irie, Tetsumi Yoshida, Miyako Uchida, Takahiro |
description | The purpose of the present study was to compare the palatability of the original and eight generic versions of famotidine orally disintegrating tablets by means of human gustatory sensation tests, a comparison of the release profiles, and using an automated taste sensor, the α-Astree Electronic Tongue. In the gustatory sensation test, the original product (Gaster®D, 10 mg) showed the lowest bitterness intensity. Among the eight generic products tested, the variance in the sweetness intensity was not great, but there were large variances in the intensity of bitterness, some of the generic products being significantly more bitter than that of the original product. On the other hand, some generic products show similar bitterness level as the original product. In a study of release profiles, the original product had the lowest release rates of both famotidine and aspartame; in comparison, some of the generic products had high release rates of famotidine and aspartame, even in the initial stages. Whereas some generic products had low release rates of famotidine and aspartame. Finally, sample solutions were analysed using the taste sensor. There was a good correlation between the taste predicted by principal component analysis and the Euclidean distance obtained by the taste sensor, and bitterness intensities obtained in the human gustatory tests. |
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In the gustatory sensation test, the original product (Gaster®D, 10 mg) showed the lowest bitterness intensity. Among the eight generic products tested, the variance in the sweetness intensity was not great, but there were large variances in the intensity of bitterness, some of the generic products being significantly more bitter than that of the original product. On the other hand, some generic products show similar bitterness level as the original product. In a study of release profiles, the original product had the lowest release rates of both famotidine and aspartame; in comparison, some of the generic products had high release rates of famotidine and aspartame, even in the initial stages. Whereas some generic products had low release rates of famotidine and aspartame. Finally, sample solutions were analysed using the taste sensor. There was a good correlation between the taste predicted by principal component analysis and the Euclidean distance obtained by the taste sensor, and bitterness intensities obtained in the human gustatory tests.</description><identifier>ISSN: 0009-2363</identifier><identifier>EISSN: 1347-5223</identifier><identifier>DOI: 10.1248/cpb.57.382</identifier><identifier>PMID: 19336932</identifier><language>eng</language><publisher>Japan: The Pharmaceutical Society of Japan</publisher><subject>Administration, Oral ; Aspartame - chemistry ; bitterness ; Drugs, Generic ; Euclidean distance ; Famotidine - administration & dosage ; Famotidine - chemistry ; famotidine orally disintegrating tablet ; generic product ; Histamine H2 Antagonists - administration & dosage ; Histamine H2 Antagonists - chemistry ; Humans ; Principal Component Analysis ; Quinine - chemistry ; Solubility ; Sweetening Agents - chemistry ; Taste ; taste sensor</subject><ispartof>Chemical and Pharmaceutical Bulletin, 2009/04/01, Vol.57(4), pp.382-387</ispartof><rights>2009 The Pharmaceutical Society of Japan</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c688t-93e021dad867a42f3ba3dbb2ca0a7d9eb11c3bd8ee4c1d874a9d0bfc968ef7843</citedby><cites>FETCH-LOGICAL-c688t-93e021dad867a42f3ba3dbb2ca0a7d9eb11c3bd8ee4c1d874a9d0bfc968ef7843</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1883,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19336932$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tokuyama, Emi</creatorcontrib><creatorcontrib>Matsunaga, Chiharu</creatorcontrib><creatorcontrib>Yoshida, Koichi</creatorcontrib><creatorcontrib>Mifsud, Jean-Christophe</creatorcontrib><creatorcontrib>Irie, Tetsumi</creatorcontrib><creatorcontrib>Yoshida, Miyako</creatorcontrib><creatorcontrib>Uchida, Takahiro</creatorcontrib><creatorcontrib>dSchool of Pharmaceutical Science</creatorcontrib><creatorcontrib>aSchool of Pharmaceutical Science</creatorcontrib><creatorcontrib>Kumamoto University</creatorcontrib><creatorcontrib>Mukogawa Women's University</creatorcontrib><creatorcontrib>cAlpha MOS</creatorcontrib><creatorcontrib>bPRIMETECH CORP</creatorcontrib><title>Famotidine Orally Disintegrating Tablets: Bitterness Comparison of Original and Generic Products</title><title>Chemical & Pharmaceutical Bulletin</title><addtitle>Chem. Pharm. Bull.</addtitle><description>The purpose of the present study was to compare the palatability of the original and eight generic versions of famotidine orally disintegrating tablets by means of human gustatory sensation tests, a comparison of the release profiles, and using an automated taste sensor, the α-Astree Electronic Tongue. In the gustatory sensation test, the original product (Gaster®D, 10 mg) showed the lowest bitterness intensity. Among the eight generic products tested, the variance in the sweetness intensity was not great, but there were large variances in the intensity of bitterness, some of the generic products being significantly more bitter than that of the original product. On the other hand, some generic products show similar bitterness level as the original product. In a study of release profiles, the original product had the lowest release rates of both famotidine and aspartame; in comparison, some of the generic products had high release rates of famotidine and aspartame, even in the initial stages. Whereas some generic products had low release rates of famotidine and aspartame. Finally, sample solutions were analysed using the taste sensor. There was a good correlation between the taste predicted by principal component analysis and the Euclidean distance obtained by the taste sensor, and bitterness intensities obtained in the human gustatory tests.</description><subject>Administration, Oral</subject><subject>Aspartame - chemistry</subject><subject>bitterness</subject><subject>Drugs, Generic</subject><subject>Euclidean distance</subject><subject>Famotidine - administration & dosage</subject><subject>Famotidine - chemistry</subject><subject>famotidine orally disintegrating tablet</subject><subject>generic product</subject><subject>Histamine H2 Antagonists - administration & dosage</subject><subject>Histamine H2 Antagonists - chemistry</subject><subject>Humans</subject><subject>Principal Component Analysis</subject><subject>Quinine - chemistry</subject><subject>Solubility</subject><subject>Sweetening Agents - chemistry</subject><subject>Taste</subject><subject>taste sensor</subject><issn>0009-2363</issn><issn>1347-5223</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkE1v1DAQhiMEokvhwg9AOXFAyuKPxB9cECzdglSpHMrZOPZk65XjLLZz6L_HUbblyGXmMM-8M3qq6i1GW0xa8dGc-m3Ht1SQZ9UG05Y3HSH0ebVBCMmGUEYvqlcpHREiHeL0ZXWBJaVMUrKpfu_1OGVnXYD6NmrvH-pvLrmQ4RB1duFQ3-neQ06f6q8uZ4gBUqp303jS0aUp1NNQ9tzBBe1rHWx9DQGiM_XPONnZ5PS6ejFon-DNuV9Wv_ZXd7vvzc3t9Y_dl5vGMCFyIykggq22gnHdkoH2mtq-J0Yjza2EHmNDeysAWoOt4K2WFvWDkUzAwEVLL6v3a-4pTn9mSFmNLhnwXgeY5qQYR5J1mP0XJIgJxsiS-GEFTZxSijCoU3Sjjg8KI7WIV0W86rgq4gv87pw69yPYf-jZdAH2K1Cmzmg_BV-cq-M0x6IuKZO4uYfRlftIKoQ6jtrShEIlfikcS9S1S9DnNeiYsj7A0yUdszMeHp9q17IsP03udVQQ6F98dq09</recordid><startdate>20090401</startdate><enddate>20090401</enddate><creator>Tokuyama, Emi</creator><creator>Matsunaga, Chiharu</creator><creator>Yoshida, Koichi</creator><creator>Mifsud, Jean-Christophe</creator><creator>Irie, Tetsumi</creator><creator>Yoshida, Miyako</creator><creator>Uchida, Takahiro</creator><general>The Pharmaceutical Society of Japan</general><general>Pharmaceutical Society of Japan</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>7QR</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20090401</creationdate><title>Famotidine Orally Disintegrating Tablets: Bitterness Comparison of Original and Generic Products</title><author>Tokuyama, Emi ; Matsunaga, Chiharu ; Yoshida, Koichi ; Mifsud, Jean-Christophe ; Irie, Tetsumi ; Yoshida, Miyako ; Uchida, Takahiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c688t-93e021dad867a42f3ba3dbb2ca0a7d9eb11c3bd8ee4c1d874a9d0bfc968ef7843</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Administration, Oral</topic><topic>Aspartame - chemistry</topic><topic>bitterness</topic><topic>Drugs, Generic</topic><topic>Euclidean distance</topic><topic>Famotidine - administration & dosage</topic><topic>Famotidine - chemistry</topic><topic>famotidine orally disintegrating tablet</topic><topic>generic product</topic><topic>Histamine H2 Antagonists - administration & dosage</topic><topic>Histamine H2 Antagonists - chemistry</topic><topic>Humans</topic><topic>Principal Component Analysis</topic><topic>Quinine - chemistry</topic><topic>Solubility</topic><topic>Sweetening Agents - chemistry</topic><topic>Taste</topic><topic>taste sensor</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tokuyama, Emi</creatorcontrib><creatorcontrib>Matsunaga, Chiharu</creatorcontrib><creatorcontrib>Yoshida, Koichi</creatorcontrib><creatorcontrib>Mifsud, Jean-Christophe</creatorcontrib><creatorcontrib>Irie, Tetsumi</creatorcontrib><creatorcontrib>Yoshida, Miyako</creatorcontrib><creatorcontrib>Uchida, Takahiro</creatorcontrib><creatorcontrib>dSchool of Pharmaceutical Science</creatorcontrib><creatorcontrib>aSchool of Pharmaceutical Science</creatorcontrib><creatorcontrib>Kumamoto University</creatorcontrib><creatorcontrib>Mukogawa Women's University</creatorcontrib><creatorcontrib>cAlpha MOS</creatorcontrib><creatorcontrib>bPRIMETECH CORP</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Chemoreception Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Chemical & Pharmaceutical Bulletin</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tokuyama, Emi</au><au>Matsunaga, Chiharu</au><au>Yoshida, Koichi</au><au>Mifsud, Jean-Christophe</au><au>Irie, Tetsumi</au><au>Yoshida, Miyako</au><au>Uchida, Takahiro</au><aucorp>dSchool of Pharmaceutical Science</aucorp><aucorp>aSchool of Pharmaceutical Science</aucorp><aucorp>Kumamoto University</aucorp><aucorp>Mukogawa Women's University</aucorp><aucorp>cAlpha MOS</aucorp><aucorp>bPRIMETECH CORP</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Famotidine Orally Disintegrating Tablets: Bitterness Comparison of Original and Generic Products</atitle><jtitle>Chemical & Pharmaceutical Bulletin</jtitle><addtitle>Chem. Pharm. Bull.</addtitle><date>2009-04-01</date><risdate>2009</risdate><volume>57</volume><issue>4</issue><spage>382</spage><epage>387</epage><pages>382-387</pages><issn>0009-2363</issn><eissn>1347-5223</eissn><abstract>The purpose of the present study was to compare the palatability of the original and eight generic versions of famotidine orally disintegrating tablets by means of human gustatory sensation tests, a comparison of the release profiles, and using an automated taste sensor, the α-Astree Electronic Tongue. In the gustatory sensation test, the original product (Gaster®D, 10 mg) showed the lowest bitterness intensity. Among the eight generic products tested, the variance in the sweetness intensity was not great, but there were large variances in the intensity of bitterness, some of the generic products being significantly more bitter than that of the original product. On the other hand, some generic products show similar bitterness level as the original product. 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subjects | Administration, Oral Aspartame - chemistry bitterness Drugs, Generic Euclidean distance Famotidine - administration & dosage Famotidine - chemistry famotidine orally disintegrating tablet generic product Histamine H2 Antagonists - administration & dosage Histamine H2 Antagonists - chemistry Humans Principal Component Analysis Quinine - chemistry Solubility Sweetening Agents - chemistry Taste taste sensor |
title | Famotidine Orally Disintegrating Tablets: Bitterness Comparison of Original and Generic Products |
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