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
Hauptverfasser: Tokuyama, Emi, Matsunaga, Chiharu, Yoshida, Koichi, Mifsud, Jean-Christophe, Irie, Tetsumi, Yoshida, Miyako, Uchida, Takahiro
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container_end_page 387
container_issue 4
container_start_page 382
container_title Chemical & Pharmaceutical Bulletin
container_volume 57
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.
doi_str_mv 10.1248/cpb.57.382
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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. 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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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