title: A new method for evaluating the bitterness of medicines in development using a taste sensor and a disintegration testing apparatus.
abstract: The purpose of this study was to demonstrate the usefulness and wide applicability of a taste sensor and a new disintegration testing apparatus in the development and/or evaluation of orally disintegrating tablets (ODTs). In this paper, we described methods for the effective utilization of a taste sensor in the development of a new medicine. First we predicted the taste of propiverine hydrochloride, a model drug substance whose taste is unknown, using a taste sensor. Then we screened masking agents for their ability to suppress the bitterness of propiverine hydrochloride, and manufactured ODTs of propiverine hydrochloride with various masking agents. The tastes of these ODTs were then evaluated in chronological order by combining the taste sensor with the new disintegration testing apparatus, ODT-101, to resemble the oral cavity. As a result, we were able to evaluate the taste of propiverine hydrochloride and the effectiveness of various masking agents in ODTs. The result using this combination of taste sensor and ODT-101 shows good agreement with the results of human gustatory sensation testing, thus demonstrating the usefulness and applicability of the taste sensor and disintegration testing apparatus, ODT-101, in the development of new medicine.
authors.affiliation: Planning & Operations Section, Customer Joy Department, CEO Office, Eisai Co. Ltd., 5-5-5 Koishikawa, Bunkyo-ku, Tokyo, Japan. t-harada@hhc.eisai.co.jp
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Harada
authors.forename: Takahiro
authors.initials: T
authors.lastname: Uchida
authors.forename: Miyako
authors.initials: M
authors.lastname: Yoshida
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kobayashi
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Narazaki
authors.forename: Takayuki
authors.initials: T
authors.lastname: Ohwaki
mesh_terms: D000284:Administration, Oral; D001561:Benzilates / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology*; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D004339:Drug Compounding / Q000295:instrumentation* / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D009055:Mouth / Q000502:physiology; D011237:Predictive Value of Tests; D012463:Saliva / Q000737:chemistry / Q000502:physiology; D012995:Solubility; D013549:Sweetening Agents / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology; D013607:Tablets; D013649:Taste / Q000187:drug effects*
chemical_list: D001561:Benzilates; D013549:Sweetening Agents; D013607:Tablets; C015586:propiverine