Stability, Dose Uniformity, and Palatability of Three Counterterrorism Drugs—Human Subject and Electronic Tongue Studies

Sadrieh, Nakissa; Brower, James; Yu, Lawrence X.; Doub, William H.; Straughn, Arthur B.; Machado, Stella G.; Pelsor, Francis R.; Martin, Emmanuelle Saint; Moore, Terry W.; Reepmeyer, John C.; Toler, Duckhee Y.; NguyenPho, Agnes; Roberts, Rosemary; Schuirmann, Donald J.; Nasr, Moheb; Buhse, Lucinda F.

doi:10.1007/s11095-005-6387-x

Cited by 45 publications

(20 citation statements)

References 12 publications

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“…Most of these reports are focused on the development of new drug formulations by choosing appropriate taste masking strategies. Besides, original and generic products were compared [12,13], products modified with commercially available beverages or jellies characterized [14,15], the effect of micro encapsula-tion [16] or oral film formulations [17] on taste-masking efficacy assessed and stability and dose uniformity studies [18] presented. In a recent study, the capability of HPLC and e-tongue analysis was compared with human taste panels regarding taste assessment and the applied e-tongue was proven to be even more sensitive than the human taste panels [19].…”

Section: Introductionmentioning

confidence: 99%

Independent comparison study of six different electronic tongues applied for pharmaceutical analysis

Pein

Kirsanov

Ciosek

et al. 2015

Journal of Pharmaceutical and Biomedical Analysis

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a b s t r a c tElectronic tongue technology based on arrays of cross-sensitive chemical sensors and chemometric data processing has attracted a lot of researchers' attention through the last years. Several so far reported applications dealing with pharmaceutical related tasks employed different e-tongue systems to address different objectives. In this situation, it is hard to judge on the benefits and drawbacks of particular e-tongue implementations for R&D in pharmaceutics. The objective of this study was to compare the performance of six different e-tongues applied to the same set of pharmaceutical samples. For this purpose, two commercially available systems (from Insent and AlphaMOS) and four laboratory prototype systems (two potentiometric systems from Warsaw operating in flow and static modes, one potentiometric system from St. Petersburg, one voltammetric system from Barcelona) were employed. The sample set addressed in the study comprised nine different formulations based on caffeine citrate, lactose monohydrate, maltodextrine, saccharin sodium and citric acid in various combinations. To provide for the fair and unbiased comparison, samples were evaluated under blind conditions and data processing from all the systems was performed in a uniform way. Different mathematical methods were applied to judge on similarity of the e-tongues response from the samples. These were principal component analysis (PCA), RV matrix correlation coefficients and Tuckerís congruency coefficients.

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Section: Introductionmentioning

confidence: 99%

Independent comparison study of six different electronic tongues applied for pharmaceutical analysis

Pein

Kirsanov

Ciosek

et al. 2015

Journal of Pharmaceutical and Biomedical Analysis

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“…A number of pharmaceutical laboratories around the world are using this instrument to assess the bitterness of NCEs/APIs and the masking efficiency of NMIs. In addition, it is used in placebo development, in taste matching of formulations, and in unknown-to-reference comparisons (9)(10)(11)(12)(13)(14)(15). The e-Tongue consists of an array of liquid electrochemical sensors coated with an organic mem-brane that governs the sensitivity and selectivity of each individual sensor.…”

Section: Introductionmentioning

confidence: 99%

An Electronic Tongue: Evaluation of the Masking Efficacy of Sweetening and/or Flavoring Agents on the Bitter Taste of Epinephrine

et al. 2010

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Abstract. An epinephrine (E) tablet is under development for sublingual (SL) administration for the first-aid treatment of anaphylaxis; however, the inherent bitterness of E may hinder acceptability by patients, especially children. To assess the degree of E bitterness and to predict the masking effects of sweetening and/or flavoring non-medicinal ingredients (NMIs), the potential usefulness of an electronic tongue (e-Tongue) was evaluated. The e-Tongue sensors were conditioned, calibrated, and tested for taste discrimination. Six standard active pharmaceutical ingredients were used to build and validate a bitterness model which was then used to assess E bitartrate (EB) solutions from 0.3-9 mM. Tastemasking efficiency of aspartame (ASP), acesulfame potassium (ASK), and citric acid (CA) each at 0.5 mM was evaluated. Using EB 9 mM, the bitterness score was 20 on a scale of 20 (unacceptable) down to 1 (not detected). When NMIs 0.5 mM were added, neither ASK (17.2, unacceptable) nor was ASP (14.0, limit acceptable) effective in masking the bitter taste. When the combination of ASK and ASP was used, the bitterness score was reduced to 9.2 (acceptable). However, the addition of CA alone resulted in the best reduction of the bitterness score to 3.3 (not detected). Using the e-Tongue, the incorporation of a variety of sweetening and/or flavoring NMIs into a SL tablet of E could be shown to mask its bitter taste by up to 80%. These results should be confirmed by in vivo studies.

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“…Multiple other variables, such as characterization of the dissolved drug, stability, dose-uniformity, and palatability or the absence of chemical irritants, are also important 13. …”

Section: Discussionmentioning

confidence: 99%

Oseltamivir compounding in the hospital pharmacy during the (H1N1) influenza pandemic

Marin¹,

Oliveira²,

Cipriano³

et al. 2010

Clinics

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AIMS:Pandemics impose large demands on the health care system. The supply of appropriate chemotherapeutic agents, namely oseltamivir solution, presented a serious challenge in the recent influenza pandemic. This study reports on the rational series of pharmacotechnical steps that were followed to appropriately handle bulk oseltamivir powder to meet the increased demand.METHODS:During a six-week period in August and September of 2009, a task force was created in the Central Pharmacy of Hospital das Clínicas to convert imported oseltamivir phosphate into ready-to-use solution for utilization by physicians and public health authorities. The protocol included dissolution, physico-chemical tests and the bottling of a liquid microdose formulation for emergency room and outpatient dispensing with adequate quality control during all phases.RESULTS:The successful production routine was based on a specially designed flowchart according to which a batch of 33210 g of oseltamivir powder was converted into 32175 solution units during the aforementioned period with a net loss of only 2.6%. The end products were bottles containing 50 ml of 15 mg/mL oseltamivir solution. The measured concentration was stable and accurate (97.5% - 102.0% of the nominal value). The drug was prescribed as both a prophylactic and therapeutic agent.DISCUSSION:Hospital pharmacies are conventionally engaged in the manipulation of medical prescriptions and specialty drugs. They are generally responsible for only small-scale equipment used for manufacturing and quality-control procedures. The compounding of oseltamivir was a unique effort dictated by exceptional circumstances.CONCLUSION:The shortage of oseltamivir solution for clinical use was solved by emergency operationalization of a semi-industrial process in which bulk powder was converted into practical vials for prompt delivery.

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Stability, Dose Uniformity, and Palatability of Three Counterterrorism Drugs—Human Subject and Electronic Tongue Studies

Abstract: Doxycycline, potassium iodide, and ciprofloxacin, which are stockpiled in solid tablet form, can conveniently be prepared into more palatable formulations, using common household foods and drinks. The electronic tongue can be used to perform an initial screening for palatability.

Cited by 45 publications

References 12 publications

Independent comparison study of six different electronic tongues applied for pharmaceutical analysis

Independent comparison study of six different electronic tongues applied for pharmaceutical analysis

An Electronic Tongue: Evaluation of the Masking Efficacy of Sweetening and/or Flavoring Agents on the Bitter Taste of Epinephrine

Oseltamivir compounding in the hospital pharmacy during the (H1N1) influenza pandemic

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