The latest trends in the taste assessment of pharmaceuticals

Anand, V. S. Prem; Kataria, M. C.; Kukkar, Vipin; Saharan, Vikas Anand; Choudhury, Pratim Kumar

doi:10.1016/j.drudis.2007.01.010

Cited by 126 publications

(66 citation statements)

References 47 publications

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“…Several in vivo and in vitro techniques such as human taste panels, e-tongue and animal preference tests are currently available to assess the taste of APIs (2). Among these approaches, the rodent BATA model has a great potential and has already shown very promising results comparable to human panel data (3,4).…”

Section: Introductionmentioning

confidence: 99%

Development of a model for robust and exploratory analysis of the rodent brief-access taste aversion data

Soto

Sheng

Standing

et al. 2015

European Journal of Pharmaceutics and Biopharmaceutics

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This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. DEVELOPMENT OF A MODEL FOR ROBUST AND EXPLORATORY ANALYSIS OF THE RODENT BRIEF-ACCESS TASTE ABSTRACTThe rodent brief-access taste aversion (BATA) model is an efficient in vivo screening tool for taste assessment. A new E max (maximum effect attributable to the drug) model was developed and further investigated in comparison to three previously published models for analysing the rodent BATA data; the robustness of all the models was discussed.The rodent BATA data were obtained from a series of experiments conducted with a bitter reference compound, quinine hydrochloride dihydrate (QHD). A new E max model that could be applied to both "lick numbers" and "lick ratios" was built and three published models that used lick ratios were employed for analysing the BATA data. IC 50 , the concentration that inhibits 50% of the maximum lick numbers, quantified the oral aversiveness of QHD. One thousand bootstrap datasets were generated from the original data. All models were applied to estimate the confidence intervals of the IC 50s without symmetric assumption.The IC 50 value obtained from the new E max model was 0.0496 mM (95% CI 0.0297-0.0857) using the lick numbers for analysis, while an IC 50 of 0.0502 mM (95% CI 0.0267-0.0859) was acquired with the lick ratios. Except from one published model, the IC 50 values have a similar range for the 95% CI.The new E max model enabled the analysis of both "lick numbers" and "lick ratios" whereas other models could only handle data presented as "lick ratios". IC 50s obtained with these two types of datasets showed similarity among all models thereby justified the robustness of the new E max model. KEY WORDSBrief-access taste aversion, lickometer, bitterness, E max model, NONMEM

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Section: Introductionmentioning

confidence: 99%

Development of a model for robust and exploratory analysis of the rodent brief-access taste aversion data

Soto

Sheng

Standing

et al. 2015

European Journal of Pharmaceutics and Biopharmaceutics

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“…6 and 7. According to FIP/AAPS (International Pharmaceutical Federation / American Association Pharmaceutical Sciences) guidelines, dissolution values of early time points (<5 min) can be used to establish the approximate base line of bitter taste (16)(17)(18). In the study of Jianchen and co-workers, taste masking of famotidine orally disintegrating tables (ODT) containing microparticles (to mask the bitterness of API) prepared by spray drying technique was evaluated by in vitro dissolution studies and in vivo human taste panel studies.…”

Section: Dissolution Studiesmentioning

confidence: 99%

Taste Masking of Griseofulvin and Caffeine Anhydrous Using Kleptose Linecaps DE17 by Hot Melt Extrusion

Juluri

Popescu²,

Zhou³

et al. 2015

AAPS PharmSciTech

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Abstract. The objective of this project was to investigate the potential of Kleptose Linecaps DE17 (KLD) in masking the unpleasant/bitter taste of therapeutic agents by hot melt extrusion (HME). Griseofulvin (GRI) and caffeine anhydrous (CA) were used as a bitter active pharmaceutical ingredient (API) model drugs. Thermogravimetric studies confirmed the stability of GRI, CA, and KLD at the employed extrusion temperatures. The differential scanning calorimetry (DSC) studies revealed a characteristic melting endotherm of GRI at 218-220°C and CA at 230-232°C in the physical mixtures as well as in all extrudates over the period of study, indicating the crystalline nature of drug. HME of KLD was achieved only in the presence of plasticizer. Among the several plasticizers investigated, xylitol showed improved processability of KLD at 15% w/w concentration. Dissolution studies of HME extrudates using simulated salivary medium exhibited ∼threefold less release compared to physical mixture at the end of 5 min (the lesser drug release, better the taste masking efficiency). Furthermore, the results from the sensory evaluation of products in human panel demonstrated strong bitter taste in the case of physical mixture compared to the HME formulation, suggesting the potential of Kleptose Linecaps DE17 as taste masking polymer in melt extruded form.

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“…Therefore it was difficult to adopt that mini-column method to evaluate bitter taste of ibuprofen powder-form drug because contact time of coated particles and water was different for different dosage form. Taste sensor test 19,20) was also conducted for the evaluation of bitterness of several materials including bitter taste drug. However several materials such as basic drug, antibiotic, amino acid had evaluated using this method and confirmed good correlation with sensory test, all kinds of drug had not evaluated yet.…”

Section: Investigation Of Drug Dissolution Rate From Particles By Twomentioning

confidence: 99%

“…However, a sensory test using volunteers is not the optimal method of evaluating the taste-masking level because such evaluations might differ according to the masking method, the evaluations are based on the subjective judgements and the test might be tasked volunteer's body. Therefore, several methods have been used to evaluate the taste-masking level of coated particles in vitro, including the dissolution test, 17) the simple dissolution test, 18) and the taste sensor test 19,20) ; however, evaluations performed according to these methods also differ according to the coating method that was used to coat the particles. Thus, few simple-and-easy-to-use test methods are available for evaluating and predicting the taste masking level of coated particles.…”

mentioning

confidence: 99%

Granulation of Core Particles Suitable for Film Coating by Agitation Fluidized Bed II. A Proposal of a Rapid Dissolution Test for Evaluation of Bitter Taste of Ibuprofen

Hamashita

Matsuzaki

Ono

et al. 2008

CHEMICAL & PHARMACEUTICAL BULLETIN

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883Creating drugs that are easy to ingest is an important element in promoting adequate patient compliance, thereby enabling successful medical treatment.1) The development of medicines that are easier to ingest has thus attracted special interest from the viewpoints of treatment compliance and marketability.2,3) Powdered drugs are a useful dosing form for patients who can't swallow tablets. 4) Ibuprofen [(RS)-2-(4-isobutylphenyl)propanoic acid] is a widely used over-thecounter nonsteroidal anti-inflammatory drug that is highly effective and safe for the treatment of moderate pain and fever. However, powdered ibuprofen has a strong, astringent and bitter taste that must be masked to make it easier to ingest. Powdered drugs are often coated with a film to mask their bitter taste of drugs [1][2][3][4][5][6][7] ; such films can control the dissolution rate of the drug in the mouth, and are considered suitable for masking bitter tastes. A spouted bed with draft tube [8][9][10][11] is an efficient means of coating powdered drugs with a film. First, however, core particles of the powdered drugs with properties suitable for film coating must be prepared; to accomplish this, the drugs are often manufactured using agitation fluidized beds granulation. [12][13][14] In our previous paper, 1) the formulation of core particles was optimized. Core particles were granulated using differently sized granulators and were then coated using a coater. The dissolution pattern of the coated ibuprofen particles differed when granulators of different sizes were used to prepare the granulated core particles. Therefore, the effect of the granule properties on the dissolution rate of the drug should be investigated because the dissolution rate may affect the efficacy of the drug. Although several studies have reported, the effects of particle's diameter, 15) fillers and excipients 16) on the dissolution rate of drugs. However in previous study, particle size was so large over 500 mm; not enough for good ingest ability.1) In addition, drug content ratio was not so high because of with starting large excipients seeds. Few studies have examined the detailed effects of the small core particle's structure and physical properties on the dissolution rate with high content ratio of drug. Here, we report the relationships between the major physical properties of the core particles, such as the mass median diameter, apparent density, friability and shape factor, and the dissolution rate of ibuprofen.As mentioned above, masking the taste level of the coated particles is the most important subject when producing powdered drugs. To evaluate taste-masking level, a sensory test using volunteers is usually conducted. However, a sensory test using volunteers is not the optimal method of evaluating the taste-masking level because such evaluations might differ according to the masking method, the evaluations are based on the subjective judgements and the test might be tasked volunteer's body. Therefore, several methods have been used to evaluate the taste-ma...

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The latest trends in the taste assessment of pharmaceuticals

Cited by 126 publications

References 47 publications

Development of a model for robust and exploratory analysis of the rodent brief-access taste aversion data

Development of a model for robust and exploratory analysis of the rodent brief-access taste aversion data

Taste Masking of Griseofulvin and Caffeine Anhydrous Using Kleptose Linecaps DE17 by Hot Melt Extrusion

Granulation of Core Particles Suitable for Film Coating by Agitation Fluidized Bed II. A Proposal of a Rapid Dissolution Test for Evaluation of Bitter Taste of Ibuprofen

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