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  • Author: Nicoleta Todoran x
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Open access

Paula Antonoaea, Nicoleta Todoran, Emőke Rédai, Adriana Ciurba, Cătălina Bogdan, Mirela Moldovan and Daniela Lucia Muntean

Abstract

Objective: Transdermal therapeutic systems (TTSs) represent an intensely studied alternative to oral delivery of non-steroid anti-inflammatory drugs (NSAIDs) in the treatment of rheumatic diseases due to its ability of avoiding the side effects of the oral route. This study aims to present the evaluation of the mechanical properties of three NSAIDs (meloxicam, tenoxicam and indomethacin) individually included in four type of polymeric matrixes, as part of new formulations development process. Methods: 12 products in form of TTS matrixes were prepared by solvent casting evaporation technique, using hydroxypropyl methylcellulose (HPMC 15000, HPMC E5) and/or ethylcellulose as matrix-forming polymers. Each of the resulted products was evaluated by determining the water vapor absorption, desorption or transmission in controlled atmosphere humidity (evaluation of porosity); the elongation capacity, tensile strength and bioadhesiveness (evaluation of mechanical properties). Results: The analysis of three groups of the experimental data expressed as averages on each group was necessary, in order to identify the parameters which statistically are critically influenced by the ingredients associated in the TTSs matrix compositions. Analysis by normality tests, variance and correlation tests (Anova, Pearson) enabled evaluation of the effect of NSAID type vs. the effect of polymer matrix type on the parameters of the NSAID TTS matrix. Conclusions: Meloxicam incorporated in the structure of HPMC 15000 polymeric matrix favors its viscoelastic structure. Ethylcellulose functions as plasticizer and supports the matrix bioadhesiveness. HPMC E5 does not meet the requirements for TTS preparation in the used experimental conditions.

Open access

Aura Rusu, Maria-Alexandra Sbanca, Nicoleta Todoran and Camil-Eugen Vari

Abstract

Objective: Letrozole is a highly potent oral nonsteroidal aromatase inhibitor triazole derivative. The aim of this study was to quantify letrozole from bulk, pharmaceutical formulation, and spiked urine samples by developing a simple, rapid and cost effective capillary electrophoresis method. Methods: A capillary zone electrophoresis method was optimized and validated. Additionally, an UV spectrophotometry method was used for comparing results. Results:The capillary zone electrophoresis method using a 90 mM sodium tetraborate background electrolyte proved to be an efficient method for determination of letrozole in a very short time, less than 2 minutes, using 20 kV voltage, 50 mbar/2 seconds pressure and 50°C temperature as optimum parameters. Additionally, the UV spectrophotometry method proved to be simple and efficient to quantify letrozole from bulk material and pharmaceutical formulation with linearity of response between 5 to 20 μg·mL-1 concentrations. For both methods, validation parameters, including linearity, detection and quantification limits were determined. Also we proved that our electrophoretic method has potential in analyzing letrozole from biological samples, obtaining encouraging results on estimation of letrozole from spiked urine samples without any special treatment. Conclusions: To quantify letrozole from bulk material, pharmaceutical preparations, and spiked urine samples the capillary zone electrophoresis method using a tetraborate sodium background electrolyte has proven to be simple and appropriate. Also a simple UV spectrophotometric method has been developed and validated for the same purposes.

Open access

Adriana Ciurba, Emőke Rédai, Ioana Pop, Paula Antonoaea and Nicoleta Todoran

Abstract

Objective: The aim of this study is to develop lactose-free orodispersible tablets with loratadine for patients with lactose intolerance. Materials and methods: Seven compositions (F1-F7) of 10 mg loratadine were prepared in form of orally disintegrating tablets, by direct compression, using croscarmellose sodium and pre-gelatinized starch in various concentrations as superdisintegrants, diluted with microcrystalline cellulose and combined with mannitol and maltodextrin as binder agents. The tablets had been studied in terms of their pharmacotechnical characteristics, by determining: the weight uniformity of the tablets, their friability, breaking strength and disintegration time, drug content and the dissolution profile of loratadine. The statistical analyses were performed with GraphPad Prism Software Inc. As dependent variables, both the hardness of the tablets and their disintegration ability differ between batches due to their compositional differences (as independent variables). DDSolver were used for modeling the kinetic of the dissolution processes by fitting the dissolution profiles with time-dependent equations (Zero-order, First-order, Higuchi, Korsmeyer-Peppas, Peppas-Sahlin). Results: All proposed formulas shows rapid disintegration, in less than 15 seconds, and the dissolution loratadine spans a period of about 10 minutes. Akaike index as well as R2 adjusted parameter have demonstrated that the studied dissolution profiles are the best fitted by Zero-order kinetic. Conclusion: In conclusion, association of croscarmellose sodium (7.5%) with pre-gelatinized starch (6%) as superdisintegrants and mannitol as the binder agent (35%), positively influences the dissolution properties of loratadine from orally fast dispersible tablets.

Open access

Nicoleta Todoran, Adriana Ciurba, Emőke Rédai, V. Ion, Luminița Lazăr and Emese Sipos

Abstract

Chloramphenicol eye drops are commonly prescribed in concentrations of 0.5-1% in the treatment of infectious conjunctivitis. In terms of ophthalmic solution preparation, the major disadvantage of chloramphenicol consists in its low solubility in water. The solubility is increased by substances that form chloramphenicol-complexes, for example: boric acid/borax or cyclodextrins. Objective: Experimental studies aimed to evaluate the potential advantages of enhancing the solubility and stability of chloramphenicol (API) by molecular encapsulation in b-cyclodextrin (CD), in formulation of ophthalmic solutions buffered with boric acid/borax system. Methods and Results: We prepared four APIb- CD complexes, using two methods (kneading and co-precipitation) and two molar ratio of API/b-cyclodextrin (1:1 and 1:2). The formation of complexes was proved by differential scanning calorimetry (DSC) and the in vitro dissolution tests. Using these compounds, we prepared eight ophthalmic solutions, formulated in two variants of chloramphenicol concentrations (0.4% and 0.5%). Each solution was analyzed, by the official methods, at preparation and periodically during three months of storing in different temperature conditions (4°C, 20°C and 30°C). Conclusions: Inclusion of chloramphenicol in b-cyclodextrin only partially solves the difficulties due to the low solubility of chloramphenicol. The protection of chloramphenicol molecules is not completely ensured when the ophthalmic solutions are buffered with the boric acid/borax system.

Open access

Saracut Claudiu, Molnar Calin, L Farczádi, L Vlase, Tero-Vescan Amelia, Todoran Nicoleta and Copotoiu Constantin

Abstract

Objectives: The aim of the study was to determine the level of secondary bile acids (SBA) in the diets and feces of mice and the variation of amount ingested/excreted if these SBA are administered as monotherapy or in 1:1 dose.

Methods: The mice were divided into 4 groups and fed for 140 days with different diets. The control lot received a normal diet and the others received diets supplemented with 0.25% deoxycholic acid (DCA), 0.25% lithocholic acid (LCA) and 0.125% DCA+0.125% LCA. After 140 days, the mice feces were collected and homogenized to obtain a mixture for each lot from which the determinations of the studied SBA were performed. For the mice food evaluation, portions of 10 g from each of the 4 diets were subjected to the SBA determination.

Results: The daily ingestion over more than 4 months of DCA or LCA added to the diet and administered as monotherapy determine a significantly increase of the SBA eliminated into the feces (the DCA level was 11x higher, and of the LCA 233x higher). If half of the LCA dose is replaced with DCA, the level of LCA in the feces gets comparable with that of the DCA (their combined amounts represents only 13x higher increase of these two bile acids in feces).

Conclusions: The simultaneous ingestion and excretion of DCA and LCA can be considered as a particular situation ruled by endogenous mechanisms. This behavior represents an important observation, knowing that the bile acids effects in the colorectal cancer are dose dependent.

Open access

Paula Antonoaea, Anca Gabriela Cârje, Adriana Ciurba, Nicoleta Todoran, Alexandru Robert Vlad and Daniela Lucia Muntean

Abstract

Objective: The aim of this study was to develop and validate two HPLC methods for the quantification of meloxicam and tenoxicam from transdermal therapeutic systems.

Methods: Based on 1.0% hydroxypropyl methylcellulose 15000, transdermal patches containing meloxicam or tenoxicam were prepared by solvent evaporation technique. Analytical performances of the HPLC methods for the quantification of meloxicam and tenoxicam from such systems were assessed in terms of specificity, linearity, detection limit, quantification limit, recovery and precision.

Results and discussion: The linearity of the method was assessed through a calibration curve in the 1.0 - 75.0 μg∙mL−1 concentration range, with a regression coefficient higher than 0.999. The detection limit and the quantification limit were found to be 0.46 μg∙mL−1 and 1.39 μg∙mL−1, for meloxicam; and 0.88 μg∙mL−1, respectively 2.64 μg∙mL−1 for tenoxicam. According to the European Pharmacopeia 5.0 the mean recovery was found to be between 75% and 125%. As performance criteria for precision was used the RSD% which were lower than 2.0% for both methods.

Conclusions: The proposed liquid chromatography methods provide selective, linear and precise results for the quantification of meloxicam and tenoxicam from transdermal therapeutic systems. The presence of a single peak in the chromatograms of the analyzed transdermal patches with meloxicam or tenoxicam, certify the successful determination of the active pharmaceutical ingredient in the prepared patches.

Open access

Stela Mariana Al Hussein, Hussam Al Hussein, Camil Eugen Vari, Nicoleta Todoran, Hamida Al Hussein, Adriana Ciurba and Maria Titica Dogaru

Abstract

Objective. This study aimed to evaluate the effects of practices and attitudes towards lifestyle in adolescence as risk or protective factors, for both the acne occurrence and lesions’ severity.

Methods. A cross-sectional study based on a self-reported questionnaire was conducted during 4 months on 148 high school students, aged 16-20 years, in a high school community of Tîrgu Mureș. Acne prevalence and severity, demographic and anthropometric characteristics, the family history of acne vulgaris, smoking behavior and the weekly intake of certain food categories supposed to increase the risk of acne vulgaris were evaluated. Statistical analysis was performed in terms of Odds ratio, Confidence Interval and Chi-square (p<0.05) methods.

Results. In the investigated community, acne prevalence was found of 47.30%, while 78 subjects (control group) had no facial acne lesions. In acne group: 57.1% had family history of acne, 62.9% were smokers, 22.9% were overweight or obese and 84.3% did not receive any dietary information from specialists. 41.4% were not fish consumers, while 74.3% rarely or never were eating fruits and vegetables. Statistically significant differences between the two analyzed groups were found in terms of sweets, carbonated drinks, dietary fat, white bread, fish, fruits and vegetables weekly intake.

Conclusions. Family history, smoking behavior, excessive dietary fat, sweets, carbonated drinks and white bread could be considered as risk factors in acne vulgaris. An increased weekly intake of fish, vegetables and fruits, may have a protective effect in acne development or severity.