Simultaneous determination of amoxicillin and clavulanic acid in pharmaceutical preparations by capillary zone electrophoresis

O ácido clavulânico acentua o espectro antibacteriano de amoxicilina, tornando a maioria dos isolados produtores de β-lactamase sensíveis ao fármaco. Desenvolveu-se um método rápido, simples e eficiente de electroforese capilar (EC) para a determinação simultânea de amoxicilina e de ácido clavulânico a partir de misturas complexas. Usando tetraborato de sódio 25 mM como electrólito em pH de 9,30, voltagem aplicada de + 25 kV, em sistema a 25 ° C e determinação por UV a 230 nm, a foi bem-sucedida a separação simultânea de amoxicilina e ácido clavulânico em, aproximadamente, 2 minutos. O desempenho analítico do método foi avaliado em termos de reprodutibilidade, precisão, exatidão e linearidade. O método analítico otimizado foi aplicado para a determinação dos dois analitos em associação, a partir de preparações farmacêuticas comerciais. Este método de EC é rápido, barato, eficiente e ecologicamente correto, quando comparado aos métodos de cromatografia líquida de alta eficiência mais frequentemente descritos na literatura.Clavulanic acid enhances the antibacterial spectrum of amoxicillin by rendering most β-lactamase producing isolates susceptible to the drug. A fast, simple and efficient capillary electrophoresis method was developed for the simultaneous determination of amoxicillin and clavulanic acid from complex mixtures. Using a 25 mM sodium tetraborate as background electrolyte at a pH of 9.30, + 25 kV applied voltage, 25 °C system temperature, UV determination at 230 nm; we succeeded in simultaneous separation of amoxicillin and clavulanic acid in approximately 2 minutes. The analytical performance of the method was evaluated in terms of reproducibility, precision, accuracy, and linearity. The optimized analytical method was applied for the determination of the two analytes from combined commercial pharmaceutical preparations. This CE method is fast, inexpensive, efficient, and environmentally friendly when compared with the more frequently used high performance liquid chromatography methods described in the literature

Basic principles for recommending and advising the use of cosmetics

UMF Tîrgu Mureş, Facultatea de Farmacie, Tîrgu Mureş, România, IP USMF „Nicolae Testemiţanu” din Republica MoldovaObiectivul studiului: Argumentarea necesităţii de elaborare şi publicare a unui compendiu care să ghideze farmacistul pentru realizarea consilierii profesioniste în activităţile de recomandare şi eliberare a produselor cosmetice. Iniţierea unei colaborări în acest sens între disciplinele de specialitate a Facultăţilor de Farmacie: din Tîrgu Mureş – România şi respectiv din Chişinău – Republica Moldova. Material şi metode: Studiu bibliografic. Rezultate: Atât în România cât şi în spaţiul Uniunii Europene, produsul cosmetic este delimitat legislativ de medicamente şi de alte produse pentru sănătate, fiind constituit din: „orice substanţă sau preparat care urmează să fie pus în contact cu diverse părţi externe ale corpului, cu scopul exclusiv sau principal de a le curăţa, a le parfuma, a le modifica aspectul, a le corecta mirosurile corporale, a le proteja ori a le menţine în bună stare”. Luând în considerare toate criteriile care le particularizează, legea referitoare la produsele cosmetice defineşte 20 de categorii. Având în vedere utilizarea unor categorii de cosmetice ca bunuri de larg consum, legislaţia europeană este în permanenţă armonizată cu tendinţele pieţei cosmeticelor, având ca obiective principale: asigurarea siguranţei consumatorilor, protecţia mediului şi înlocuirea studiilor pe animale cu metode in vitro. Eliberarea produselor cosmetice din farmacie implică cunoaşterea unor criterii fundamentale de diferenţiere şi de recomandare a acestora astfel încât să se realizeze şi o consiliere fundamentată pe principii ştiinţifice, nu numai intuitive. Astfel, în practica farmaceutică este necesară cunoaşterea şi aplicarea următoarelor criterii: a) Tipurile de produse cosmetice în funcţie de scopul utilizării (se diferenţiază: produse pentru igienă şi protecţie, produse de înfrumuseţare şi respectiv produse pentru îngrijire şi întreţienere); b)Regiunea corpului pe care se aplică produsele (se diferenţiază: produse pentru regiunea cutanată, produse pentru păr şi pielea capului, produse pentru unghii şi respectiv produse pentru mucoase); c) Particularităţile anatomo-fiziologice (se diferenţiază produse destinate pentru: femei, gravide, nou-născuţi, copii, bărbaţi); d) Starea regiunii corpului pe care urmează să fie aplicat produsul (se diferenţiază: produse de întreţinere – pentru regiuni cu activitate fiziologică normală şi produse reparatorii – pentru regiuni deteriorate sub acţiunea factorilor exogeni sau endogeni); e) Particularităţile tipului de ten (se diferenţiază: produse pentru ten normal, ten alipic, ten deshidratat, ten mixt, tenuri sensibile; tenurile cu particularităţi, cum sunt cele sensibile sau tenul îmbătrânit prematur, necesită produse cu efecte protective şi reparatorii); f) Selectarea formei produsului cosmetic în funcţie de tipul tenului, în corelaţie cu acţiunea excipienţilor asupra regiunii sistemului intertegumentar pe care se aplică, proprietăţile fizico-chimice ale ingredientelor active din produs şi nivelul de penetraţie necesar pentru exercitarea acţiunii (numărul ingredientelor care se asociază depinde atât de nivelul penetraţiei, cât şi de complexitatea efectelor dorite). Concluzii: Diferenţierea produselor cosmetice şi recomandarea acestora la eliberarea din farmacie necesită utilizarea unor cunoştinţe şi aplicarea unor principii bine argumentate ştiinţific. Numai în acest mod poate fi fundamentată consilierea realistă, la nivel profesional corespunzător aşteptărilor solicitanţilor şi utilizatorilor de produse cosmetice

Developing and evaluation of orodispersible tablets containing caffeine

Starting from the premise that a reduced number of active pharmaceutical ingredients (APIs) are used to treat hypotension, the aim of this study consisted of developing new formulations of caffeine-orodispersible tablets (CAFODTs). The formulation variables were the type of disintegrant and its concentration. The CAF-ODTs were prepared by direct compression, (CAF1, CAF2 and, CAF3) each of them containing 100 mg of CAF / tablet. The proposed formulations were analyzed from a pharmacotechnical point of view. For the formulations developed the tablets’ physical appearance, resistance to crushing, friability, disintegration behaviour, and the in vitro caffeine release were evaluated. White tablets, with a resistance to crushing decreasing in the following order CAF1 > CAF2 > CAF3 were obtained. The friability test showed that all the formulations are respecting the in-force European Pharmacopoeia (Ph. Eur. 10) requirements with values less than 1 %. The disintegration time for all three formulations was less than 180 seconds, the smallest time being registered in the case of CAF2 formulation, where Sodium Starch Glycolate (SSG) was used as a disintegrant (24-30 s, as a result of the different methods used. Through the in vitro releasing study, it was observed that over 99.9 % caffeine was released from all three analyzed formulations. By investigating the amount of caffeine released after 1 minute, it can be noticed that the largest amount released was recorded in CAF2 formulations, where SSG was used as a disintegrant. Compared to CAF2, the amount of CAF released was reduced to half, after the first five minutes for CAF1 formulation, where sodium croscarmellose was used, and ten times lower in the case of CAF3 where no disintegrant was used. Based on the results obtained we can conclude that all three formulations are respecting the pharmacotechnical in-force officinal requirements. The presence of SSG in the CAF2 formulation led to obtaining tablets with a reduced disintegration time in comparison to the other two formulations proposed in this study

Simultaneous determination of amoxicillin and clavulanic acid in pharmaceutical preparations by capillary zone electrophoresis

ABSTRACT Clavulanic acid enhances the antibacterial spectrum of amoxicillin by rendering most β-lactamase producing isolates susceptible to the drug. A fast, simple and efficient capillary electrophoresis method was developed for the simultaneous determination of amoxicillin and clavulanic acid from complex mixtures. Using a 25 mM sodium tetraborate as background electrolyte at a pH of 9.30, + 25 kV applied voltage, 25 °C system temperature, UV determination at 230 nm; we succeeded in simultaneous separation of amoxicillin and clavulanic acid in approximately 2 minutes. The analytical performance of the method was evaluated in terms of reproducibility, precision, accuracy, and linearity. The optimized analytical method was applied for the determination of the two analytes from combined commercial pharmaceutical preparations. This CE method is fast, inexpensive, efficient, and environmentally friendly when compared with the more frequently used high performance liquid chromatography methods described in the literature

The influence of hydrogen peroxide on the rheological behaviour of Ultrez-21 gels

Objectives. The aim of this study was to analyse the influence of hydrogen peroxide (H2 O2) and its concentrations on the rheological characteristics of Ultrez-21 1% gel, in order to develop and optimize formulations easy to prepare in the pharmacy, for various pharmaceutical or cosmetic applications. Material and methods. A series of gels containing 5-29.5% H2O2 were analysed and compared to the gel base in terms of rheological properties induced by the action of forces applied either with constant intensity (adhesiveness, consistency, extensibility, viscosity) or with variable intensity (viscous structural flow, thixotropy). Perhydrol has been selected as a source of H2O2, as it is a product commonly used in pharmacy, and which, being a concentrated solution (30% m/mH2O2), can be very easily diluted by mixing with water to obtain the desired concentration in gels. Outcomes. Even if the presence of H2O2 causes changes in adhesiveness, consistency, extensibility and viscosity of gels, they do not correlate with the H2O2 contents, each gel having its own specific behaviour. The gels have a lower flow threshold when are sheared at D = 0.33 s-1 than the gel base. Differences between shear flows are statistically significant both in terms of the deviation from linearity (Runs test) and the deviation from zero value (F test). The slopes of the regression lines have positive values in all cases, but statistically different (p 15% H2O2 decrease the thixotropic capacity of the Ultrez-21 gel with comparable values (32, 38, 35 and 28%). Conclusions. All the studied gels have a plastic-thixotropic behaviour which changes both with the presence and the concentration of hydrogen peroxide. The differences in consistency, adhesion and extensibility between the gels cannot be attributed to the viscosity, but rather to the degree of homogeneity and / or strength of the dispersed system formed by hydrogen peroxide in the Ultrez-21 gel. The flow behaviour of the gels correlates with the variation of pH, consistency and adhesiveness, and less with the spreading properties

Development of Co-Amorphous Loratadine–Citric Acid Orodispersible Drug Formulations

This study aimed at the preparation and characterization of co-amorphous loratadine–citric acid orally disintegrating dosage forms (ODx). A co-amorphous loratadine–citric acid was prepared by solvent evaporation method in three different molecular ratios. DSC, FTIR, and dissolution studies have been conducted for the binary system. The co-amorphous system was used to obtain oral lyophilizates and orally disintegrating tablets by direct compression. Diameter, thickness, hardness, disintegration time, uniformity of mass, and dissolution was determined for the dosage forms. DSC curves showed a lack of sharp endothermic peaks for the binary systems. FTIR spectra presented a hypsochromic modification of the characteristic peaks. Dissolution studies indicated a five-fold increase in the dissolved amount compared to pure loratadine in water. Disintegration times of direct compression ODx varied in the range of 34–41 s and for freeze-dried ODx in the range of 8–9 s. Friability was under 1% in all cases. The dissolution of loratadine in buffer solution at pH = 1 was almost complete. In conclusion binary systems of loratadine and citric acid enhance solubility and combined with the orally disintegrating pharmaceutical form also increase patient compliance