Effects of a Low-FODMAP Diet on Irritable Bowel Syndrome in Both Children and Adults-A Narrative Review.

Irritable bowel syndrome is a typical gastrointestinal disease that causes bloating, flatulence, abdominal pain, diarrhoea, constipation, or alteration of the last two in adults and children. A diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) is one of the potential treatment strategies to reduce abdominal symptoms and increase the quality of life. The present narrative review aims to present a general overview of current studies that have evaluated the efficacy of a low-FODMAP diet against other diets in gastrointestinal symptoms, nutrient intake in adults and children, and lifestyle quality. The research was performed using seven searchable databases, which included the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), Excerpta Medica Database (EMBASE), Medline, PubMed, Scopus, and Web of Science, up to March 2023. In conclusion, there is significant evidence that the follow-up of a low-FODMAP diet might be a feasible first-line therapeutic strategy to reduce stomach discomfort, pain, bloating, and quality of life for patients with irritable bowel syndrome.

The Effects of Honey Sulfonamides on Immunological and Hematological Parameters in Wistar Rats.

Sulfonamides are among the most used drugs in beekeeping due to their effectiveness, despite their long-term persistence in tissues. Bee honey containing such residues poses numerous risks to human health. The aim of the study was to evaluate the effects on immunological and hematological parameters of Wistar rats produced by sulfonamide residues in bee honey, through the evaluation of various blood parameters such as triiodothyronine and thyroxine levels, hematocrit, hemoglobin, red blood cell count and mean corpuscular hemoglobin concentration in a given volume of erythrocytes following administration of sulfonamide-containing honey. The hematological and immunological parameters showed significant variations in the group of rats that had been fed with honey spiked with sulfonamides compared to the control group. Changes in hematological indices were demonstrated in terms of a significant reduction in the number of erythrocytes, the amount of hemoglobin, and the value of hematocrit, thus confirming the induction of anemia in the tested group. Investigation of thyroid function through the analysis of triiodothyronine (T3) and thyroxine (T4) and their ratio showed a very significant decrease in plasma thyroxine levels in laboratory rats that were fed sulfonamide-spiked honey compared to the control group. The mean T3 concentration decreased from 0.70 ± 0.14 ng/dL to 0.34 ± 0.03 ng/dL, while the mean T4 concentration was reduced from 4.50 ± 0.30 µg/dL to 3.32 ± 0.21 µg/dL, thus demonstrating toxic effects on thyroid function. In sum, the presence of sulfonamides induced significant changes in the evaluated parameters indicating that the consumption of contaminated honey samples represents a high risk factor for thyroid dysfunction with potentially serious health impacts.

In Vitro Dissolution Studies of Amiodarone Hydrochloride From Hydroxy-Propyl-ß-Cyclodextrin/Amiodarone Inclusion Complex Formulated Into Modified-Release Tablets.

Aim: Drug release from modified-release matrix tablets made of Kollidon® SR and Chitosan is dependent on its degree of solubility in the dissolution medium as well as on the matrix forming polymer. By complexing hydrochloride amiodarone with hydroxypropyl-ß-cyclodextrin, an inclusion complex was obtained, which showed an increase in solubility by more than 200%. The complex was used to obtain modified-release matrix tablets based on Kollidon® SR and Chitosan. Materials and Methods: Matrix tablets were obtained through direct compression method of non-complexed amiodarone and inclusion complex, and they were marked F1 and F10, respectively. The two formulations were studied comparatively in terms of release kinetics of the active substance through in vitro drug release tests. Those tests were conducted using a paddle apparatus II for 12 hours and two gastrointestinal simulation liquids with different pH values relevant for oral administration - 2 hours at pH 1.2 and 10 hours at pH 6.8. The release of hydrochloride amiodarone was quantified using a validated HPLC method. Two factors were calculated to assess the release profile of amiodarone: the similarity factor f1 and difference factor f2. Results: The increase in Kollidon® SR concentration resulted in a slower release of amiodarone at both pH values. The use of Chitosan resulted in a decrease of AMD release only at pH 6.8. Conclusions: The similarities between the two release profiles of AMD were confirmed by the values of the similarity factor (f1 = 43.697) and difference factor f2 (f2 = 68.263).

Fast RP-HPLC Method for the Determination of Bisoprolol.

Aim: To develop and validate a fast, robust, isocratic reversed-phase high performance liquid chromatographic method for the determination of bisoprolol in bulk and pharmaceutical formulations. Material and Method: Optimum separation of bisoprolol was achieved using as stationary phase a Zorbax SB-C18 column (100×3 mm; 5µm). The mobile phase was a mixture of phosphate buffer (pH = 3.5) and acetonitrile (70:30) with a flow rate of 1mL/min. The UV detection was performed at 225nm. The temperature of the column and autosampler was 25°C. The specificity was assessed by using metoprolol as internal standard. The method was validated in accordance with the current ICH guidelines in terms of linearity, limit of detection, limit of quantification, precision, accuracy, recovery and system suitability. Results: The retention time for bisoprolol was 1.158 minute. The calibration graph was linear in the concentration range 5-90 µg/mL. The LOD and LOQ of bisoprolol were 1.63 µg/mL and 4.94 µg/mL, respectively. The intra and interday precision of measurements were lower than the accepted criteria (RSD ≤ 2%). The recovery values of HPLC determination of bisoprolol from tablets proved that none of the excipients influenced the results of the analysis. Conclusions: The assay it was found to be accurate, reproducible, sensitive and less time consuming. The proposed method can be successfully applied to quality control studies of pharmaceutical products.

OPTIMIZATION OF THE PREPARATION OF KOLLIDON SR-BASED AMIODARONE HYDROCHLORIDE TABLETS WITH SUSTAINED RELEASE.

AIM: The formulation of sustained release tablets of AMD-HCl using KOLLIDON SR as matrix-forming agent. Chitosan, a natural polysaccharide with superior hydrating and absorbing properties was used in the formulation stage to optimize the release characteristics of those matrix tablets. MATERIAL AND METHODS: Nine formulations of sustained release matrix tablets of AMD x HCl (200 mg/tablet) were prepared through direct compression. The concentrations of matrix forming agents were included as independent variables of a type 2(3) mixed factorial plan in order to develop formulations of AMD-HCl with optimal release characteristics. The dependent variables of that plan were the amount of AMD released from the tablets studied by using in vitro dissolution testing. The test was carried out in the paddle apparatus II for 12 hours in two pH media that were relevant to oral delivery: 2 hours at pH 1.2 and 10 hours at pH 6.8. The released AMD-HCl was quantitatively determined through a validated HPLC method. RESULTS: The increase in KOL concentration leads to a decrease in AMD release rate at both pH values. The use of CHT resulted in a decrease of AMD release only at pH 6.8 in formulations with the lowest concentration of KOL. CONCLUSIONS: The retarding effect on the release of AMD-HCl in the tablets developed in this study was directly proportional to the KOL concentration in the formulation.

A NEW SPECTROPHOTOMETRIC METHOD FOR THE ASSAY OF LISINOPRIL.

AIM: A new spectrophotometric method for the assay of lisinopril using 2,4-dinitrophenol as reagent is described. MATERIAL AND METHODS: The method involved the addition of 2,4-dinitrophenol to lisinopril in methanol followed by absorbance measurement at 400 nm. Experimental conditions that provide wide linear range, maximum sensitivity, selectivity, accuracy and precisions were optimized. RESULTS AND DISCUSSIONS: Beer's law was obeyed in the concentration range 2.0-14.0 µg/mL. Linear regression equation of calibration graph was A = 0.005 + 0.045 x concentration, with a regression coefficient (r) of 0.9995 (n = 8). The limits of detection (LOD) and quantification (LOQ) calculated according to the ICH guidelines were 0.42 and 1.42 µg/mL, respectively. Accuracy and precision of the assays were determined by computing the intra-day and inter-day variations at three different lisinopril concentrations; the intra-day and inter-day RSD was < 1.43% and accuracy was better than 1.72%. CONCLUSIONS: The proposed method is simple, easy to perform, sensitive, linear, precise, accurate and robust.

ANTINFLAMMATORY ACTIVITY OF AN N, N'-DISALICYLIDENEMETHYLENDIAMINE-DERIVED SCHIFF BIS BASE AND ITS COPPER(II) COMPLEX.

AIM: The cooper(II) complex combination of N, N'-disalicylidenemethylenediamine and the Schiff bis base were investigated for anti-inflammatory activity. MATERIAL AND METHODS: In vivo, the anti-inflammatory activity of the metallic complex in comparison with the activity of the Schiff bis base was tested by the method of Winter and co-workers using the Levy technique. RESULTS AND DISCUSSIONS: Our study on the anti-inflammatory activity of a new Schiff bis base and its complex cooper(II) combination showed that the Schiff bis bases exhibited significant anti-inflammatory action in acute experimental inflammation when compared to the control group. The copper cation from the complex combination enhanced the anti-inflammatory effect of the Schiff bis base, the effect being stronger at doses of 10 mg/kg cooper(II) complex. CONCLUSIONS: The Schiff bis base and its cooper(II) complex had an anti-inflammatory effect comparable to that of indomethacin.

Spectrophotometric method for estimation of bisoprolol fumarate in tablets.

UNLABELLED: Bisoprolol fumarate is prescribed for the treatment of hypertension and angina pectoris. AIM: The purpose of this study was to develop a simple, sensitive, accurate, and reproducible method for estimation of bisoprolol fumarate in tablets. MATERIAL AND METHODS: The proposed method was based on a yellow colored complex formed with tropaeolin 00, extractable in dichloromethane with maximum absorbance at 412 nm. The method was validated statistically. RESULTS: The linearity domain was observed in the concentration of 5-30 microg/ml. The recovery studies confirmed the accuracy of the proposed method. CONCLUSIONS: The proposed method can be applied for the routine analysis of bisoprolol from formulations.

Validation of spectrophotometric method for Se(IV) determination: analytical applications.

As selenium is an important part of the antioxidant enzymes and also because there are several studies suggesting a possible link between cancer and selenium deficiency, this paper presents a spectrophotometric method for the assay of Se(IV), using N,N-diethyl-p-phenylenediamine monohydrochloride as reagent. The proposed method is based on the reaction between the selenium and potassium iodide in low acidic medium, when iodine is released. This last product will further oxidise the new reagent. The final obtained product is strongly coloured in red and has an absorption maximum at 552 nm and molar extinction coefficient (ε) of 6.1 × 10(4) L mol(-1) cm(-1). The optimum working conditions were established, and the developed method was validated, being characterised by a good linearity (in the range of 0.5-3.0 µg/mL), a limit of detection (0.0573 µg/mL) and a limit of quantification (0.1737 µg/mL). At the same time, the repeatability, the precision of the method and the accuracy were established. The proposed and validated method was applied with good results for the determination of Se(IV) in spring and bottled water from Iasi and also in pharmaceutical and cosmetic products.

Validation of a spectrophotometric assay method for bisoprolol using picric acid.

UNLABELLED: Bisoprolol is a drug belonging to beta blockers drugs used primarily for the treatment of cardiovascular diseases. AIM: A spectrophotometric method for quantitative determination of bisoprolol was developed based on the formation of a complex combination between bisoprolol and picric acid. MATERIAL AND METHODS: The complex combination of bisoprolol and picric acid has a maximum absorbance peak at 420 nm. Optimum working conditions were established and the method was validated. RESULTS: The method presented a good linearity in the concentration range 5-120 microg/ml (regression coefficient r2 = 0.9992). The RSD for the precision of the method was 1.74 and for the intermediate precision 1.43, and recovery values ranged between 98.25-101.48%. CONCLUSIONS: The proposed and validated spectrophotometric method for the determination of bisoprolol is simple and cost effective.

Spectrometric method for the assay of ramipril using molybdophosphoric acid.

UNLABELLED: Ramipril is a drug of the angiotensin converting enzyme inhibitor class. AIM: A new molecular absorbance spectrometric method was developed for the assay of ramipril using molybdophosphoric acid in acidic medium. MATERIAL AND METHODS: The reaction product showed a maximum absorbance at 361 nm. The optimum conditions of the reaction were established. The developed method was validated. RESULTS: The method showed a good linearity in the range of 8 - 36 microg/ml (correlation coefficient r = 0.9996). The detection limit (LD) was 0.86microg/ml and the quantification limit (LQ) 2.88 pg/ml. Precision and accuracy were determined (RSD = 1.15%); mean recovery was 98.90% in the 97.13-101.03% concentration range. CONCLUSIONS: The proposed method is simple, easy to perform, sensitive, linear, precise, accurate and robust.

Evaluation of some pharmaceutical formulations of lisinopril through dissolution testing.

AIM: Lisinopril is a drug of the angiotensin converting enzyme (ACE) inhibitor class that is primarily used in treatment of hypertension, congestive heart failure, heart attacks and also in preventing renal and retinal complications of diabetes. We compared the dissolution profiles of Lisinopril 20 mg tablets (Antibiotice S.A. lasi) and Zestril 20 mg tablets (Astra Zeneca). MATERIAL AND METHOD: Because lisinopril is a third class active substance, we performed dissolution tests in standard media at three pH values: 1.2, 4.5 and 6.8 using the paddle apparatus at 75 rpm. RESULTS: Both pharmaceutical formulations present a dissolution percentage more than 85% (Q) of the labeled amount. CONCLUSION: Both pharmaceutical formulations present similar dissolution profile. Key words:

[Construction and characterisation of a selective membrane electrode for the assay of lisinopril]. / Constructia si caracterizarea unui electrod membrana selectiv pentru determinarea lisinoprilului.

UNLABELLED: In order to analyze lisinopril using a selective membrane electrode, the electro-active compound was obtained and included in the selective membrane. The new analysis method was developed and validated. MATERIAL AND METHOD: The electro-active compound was obtained through the precipitation of lisinopril in acidic media using silicowolframic acid solution. The membrane was obtained by mixing the electro-active compound with polyvinylchloride using tetrahydrofurane as solvent. The solution was evaporated in order to obtain a thick membrane, which was then attached at one end of a polyvinylchloride tube. The internal Ag/AgCl reference electrode was inserted in that tube. The assembly was filled with a lisinopril internal solution. The electrode was characterized by establishing the following characteristics: electrode slope, selectivity, optimal pH range, response time and life-time period. The developed method was validated. RESULTS: The method showed a good linearity in the range of 10(-7) and 10(-2)M (the correlation coefficient r = 0.9991). The detection limit (LD) was 8,66 x 10(-8)M and the quantification limit (LQ) was 7,8 x 10(-7)M. There were established the precision (RSD = 1.73%) and the accuracy (mean recovery was 99.92%) CONCLUSIONS: The experimental results demonstrated a good sensibility.

[Turbidimetric assay of famotidine]. / Determinarea cantitativa turbidimetrica a famotidinei sub forma de fosfomolibdat.

This paper proposes a new method for the quantitative determination of famotidine, based on its reaction with phosphomolybdic acid. The measurements were carried out at wavelength of 400 nm. This method has been validated and it has been applied to the determination of famotidine in pharmaceutical products.