Małgorzata Wesoły

Influence of Experimental Conditions on Electronic Tongue Results—Case of Valsartan Minitablets Dissolution

A potentiometric electronic tongue was applied to study the release of valsartan from pharmaceutical formulations, i.e., minitablets uncoated and coated with Eudragit E. Special attention was paid to evaluate the influence of medium temperature and composition, as well as to compare the performances of the sensor arrays working in various hydrodynamic conditions. The drug dissolution profiles registered with the ion-sensitive electrodes were compared with standard dissolution tests performed with USP Apparatus 2 (paddle). Moreover, the signal changes of all sensors were processed by principal component analysis to visualize the release modifications, related to the presence of the coating agent. Finally, the importance and influence of the experimental conditions on the results obtained using potentiometric sensor arrays were discussed.

Taste-masking assessment of orally disintegrating tablets and lyophilisates with cetirizine dihydrochloride microparticles

Orally disintegrating tablets and oral lyophilisates are novel attractive dosage forms that disintegrate or dissolve in the buccal cavity within seconds without necessity of drinking. The major limitation in designing of these dosage forms is unpleasant taste of the drug substance. Cetirizine dihydrochloride is a H1-antihistamine substance indicated for the treatment of allergy. It is characterized by extremely bitter taste, therefore in order to deliver cetirizine dihydrochloride using orodispersible formulations, effective taste-masking is required. The aim of this study was to investigate whether microparticles containing cetirizine dihydrochloride could be successfully used to formulate orally disintegrating tablets by direct compression method and oral lyophilisates by freeze-drying process. Taste masking of cetirizine dihydrochloride was achieved by the spray-drying technique using Eudragit® E PO as the drug agent carrier. Based on the preliminary studies, optimal compositions of microparticles, tablets and lyophilisates were chosen. Obtained dosage forms were characterized for drug content, disintegration time and mechanical properties. In order to determine whether the microparticles subjected to direct compression and freeze-drying process effectively mask the bitter taste of cetirizine dihydrochloride, the in vivo and in vitro evaluation was performed. The results showed that designed formulates with microparticles containing cetirizine dihydrochloride were characterized by appropriate mechanical properties, uniformity of weight and thickness, short disintegration time, and the uniform content of the drug substance. Taste-masking assessment performed by three independent methods (e-tongue evaluation, human test panel and the in vitro drug release) revealed that microparticles with Eudragit® E PO are effective taste – masking carriers of cetirizine dihydrochloride and might be used to formulate orally disintegrating tablets and oral lyophilisates.

Dissolution studies of metamizole sodium and pseudoephedrine sulphate dosage forms − comparison and correlation of electronic tongue results with reference studies

Graphical abstract Figure. No caption available. HighlightsElectronic tongue (ET) for dissolution studies of modified‐release granules.Simultaneous sensing of APIs and excipients by the sensor array of ET.Evaluation of the impact of excipients on obtained dissolution profiles.Various modified‐release effect dependent on the used excipients.Comparison/correlation of electronic tongue results with pharmacopoeial studies. ABSTRACT This work reports a critical evaluation of the results of the release of active substances (APIs) from novel pharmaceutical formulations provided by an electronic tongue system (ET). Detailed dissolution studies of modified‐release granules used in pharmacotherapy containing metamizole sodium and pseudoephedrine sulphate were carried out. The impact of the dissolution‐modifying excipients (carmellose sodium and hypromellose) on the dissolution process as well as on the outcomes of the sensor array of ion‐selective electrodes was investigated. The obtained dissolution profiles were compared and correlated with those registered during the reference studies performed according to the pharmacopoeial method. It was pointed out that the proper evaluation of the efficiency of the release modification requires the examination of dosage forms as well as physical mixtures of API and excipient. Moreover, the results obtained using potentiometric ET were complementary to the classical methodology. Their partial inconsistency, remarked during several experiments, should be interpreted with caution owing to simultaneous sensing of APIs and excipients by the sensors and their various performances (i.e. selectivity and sensitivity) towards these components.

Evaluation of lyophilisates with taste-masking microshperes by electronic tongue

Novel drug delivery systems, which facilitate swallowing and improve patient adherence due to bitter taste masking of Active Pharmaceutical Ingredient (API), gain an increasing interest in recent years. Usually, studies on the taste of pharmaceutical products are conducted by human taste panel, but it concerns ethical doubts. Electronic tongue is one of the candidate tools allowing for fast, repeatable, and objective analysis of pharmaceuticals. In this work a sensor array composed of cross-selective electrodes was coupled with Principal Component Analysis in order to assess the taste-masking efficiency of the microencapsulated API (cetirizine dihydrohloride) formulated in lyophilisates. The obtained results show that presented electronic tongue can be used for the recognition of the studied pharmaceutical formulations and evaluation of the taste-masking effect.

P2.9.21 Qualitative and quantitative analysis of apple extracts based on hybrid electronic tongue

The aim of this paper is to use hybrid electronic tongue in the qualitative and quantitative analysis of extracts obtained from raw and dried apples prepared by different food processing techniques (drying techniques). The system is based on potentiometric and voltammetric sensors, moreover data recorded by spectrophotometry, amperometry and conductometry techniques were applied to enhance the classification ability of the device. The combination of the data from various measurement techniques (hybrid electronic tongue) leads to improved differentiation of the dried apple extracts samples comparing to separate techniques. Appropriate chemometric techniques were used to the recognition and classification of samples, whereas the efficiency of the qualitative and quantitative analysis was evaluated on the basis of RMSE, R, “a”, “b”, specificity and selectivity parameters.