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Desarrollo de la formulación de la suspensión oral de ibuprofeno 100 mg/5 mL para uso pediátrico Development of formulation for oral suspension Ibuprofen 100 mg/5mL for pediatric use
Nilia de la Paz Martín-Via?a,Iván Gastón Morales Lacarrere,José Manuel Gil Apán,Dunia Casanave Guanaluce
Revista Cubana de Farmacia , 2009,
Abstract: Se empleó el método de prueba y error para el desarrollo de la formulación de la suspensión oral de ibuprofeno 100 mg/5 mL para uso pediátrico; se estudió su estabilidad químico-física por el método acelerado y de vida de estante; se envasó en frasco de vidrio ámbar por 120 mL y se almacenó a temperatura ambiente. Se realizó el estudio reológico y la determinación de la viscosidad aparente, además, se efectuó el estudio microbiológico a través de la prueba de efectividad de preservativo antimicrobiano y el conteo microbiano; se comprobó la seguridad del producto mediante el estudio toxicológico. Todos los resultados cumplieron con los límites de calidad establecidos en la literatura científica, USP 30, para este tipo de forma farmacéutica. Se concluye que el medicamento desarrollado está correctamente formulado, desde el punto de vista galénico con un tiempo de vida útil de 24 meses bajo las condiciones estudiadas. Authors used the test and error method to develop the formulation of Ibuprofen oral suspension (100 mg/5 mL) for pediatric use. Its chemical-physic stability was studied through accelerated method and shelf life. It was bottled in amber glass small bottles by 120 mL, and it was stored at room temperature. A rheology study and assessment of apparent viscosity was made as well as a microbiologic one by test of effectiveness of antimicrobial preservative and the microbial count. Product safe was verified by toxicology study. All results fulfilled quality limits established in scientific literature, USP 30, for this type of pharmaceutical method. We conclude that drug developed is correctly formulated, from the doctoral point of view with a time of useful life of 24 months under study conditions.
Desarrollo de la formulación de la suspensión oral de ibuprofeno 100 mg/5 mL para uso pediátrico
de la Paz Martín-Via?a,Nilia; Gastón Morales Lacarrere,Iván; Gil Apán,José Manuel; Casanave Guanaluce,Dunia; Barzaga Fernández,Pedro; Nú?ez Gomero,Ramona;
Revista Cubana de Farmacia , 2009,
Abstract: authors used the test and error method to develop the formulation of ibuprofen oral suspension (100 mg/5 ml) for pediatric use. its chemical-physic stability was studied through accelerated method and shelf life. it was bottled in amber glass small bottles by 120 ml, and it was stored at room temperature. a rheology study and assessment of apparent viscosity was made as well as a microbiologic one by test of effectiveness of antimicrobial preservative and the microbial count. product safe was verified by toxicology study. all results fulfilled quality limits established in scientific literature, usp 30, for this type of pharmaceutical method. we conclude that drug developed is correctly formulated, from the doctoral point of view with a time of useful life of 24 months under study conditions.
Evaluación clínica de la terapia con dexametasona e ibuprofeno en la cirugía de los terceros molares retenidos
Alejandra Orellana,Esmeralda Salazar
Acta Odontológica Venezolana , 2007,
Abstract: La eliminación quirúrgica de los terceros molares ocasiona considerable dolor, edema y disfunción. Los factores que contribuyen a estas secuelas son complejos, pero muchos de ellos son relativos al proceso inflamatorio. Las estrategias farmacológicas para minimizar las manifestaciones clínicas del trauma quirúrgico son dirigidas hacia el bloqueo de la inflamación aguda. Los corticoesteroides han sido sugeridos para la reducción del edema posterior a procedimientos quirúrgicos, incluyendo la remoción de los terceros molares. Sin embargo, su uso es tema controversial debido a su potencial tóxico. Otros autores recomiendan la terapia combinada de esta droga con AINEs, como el Ibuprofeno. Objetivos:el objetivo de este estudio doble ciego fue evaluar y comparar un glucocorticoide como lo es la dexametasona en combinación con ibuprofeno y placebo para el control de la inflamación debida a la cirugía de los terceros molares. Así como también dilucidar su verdadero potencial tóxico. Métodos: se seleccionaron al azar 30 pacientes (9 de sexo masculino y 21 de sexo femenino) de 15 a 35 a os, divididos en dos grupos: el primero recibió 8 mg de Dexametasona (Decalona ) y el segundo placebo, una hora antes de la cirugía por vía intramuscular. Ambos grupos recibieron 400 mg de Ibuprofeno (Brugesic ) por vía oral cada 6 horas durante dos días y 500 mg de amoxicilina (Trimoxal ) cada 8 horas por 7 días. El efecto antiinflamatorio del tratamiento fue evaluado por tres métodos: subjetivo, medición de referencias anatómicas y por un método computarizado de fotografías digitales. Mientras que el dolor fue evaluado mediante la Escala Visual Análoga. Resultados: los resultados obtenidos demostraron la superioridad de la terapia con dexametasona e ibuprofeno para el control del edema postoperatorio sobre la terapia con ibuprofeno exclusivamente. No se encontraron diferencias estadísticamente significativas en cuanto al dolor. También se demostró la ausencia de complicaciones postoperatorias y reacciones adversas al administrar dexametasona con la posología indicada. The surgical removal of impacted third molar teeth can result in considerable pain, swelling and dysfunction. The factors contributed to postoperative pain, edema and trismus are complex, but many of the contributors factors are related to the inflammatory process. Pharmacologic strategies for minimizing the clinical manifestation of surgical trauma are often directed toward blocking the acute inflammation. Corticosteroids have been suggested for the reduction of inflammatory sequel of surgical procedures, including
Actividad analgésica y antipirética de un extracto fluido de Pimenta dioica L. y evaluación de su toxicidad aguda oral  [cached]
Ania Benítez López,Juana Tillán Capó,Yolanda Cabrera González
Revista Cubana de Farmacia , 1998,
Abstract: Se estudió la actividad analgésica y antipirética del extracto fluido de Pimenta dioica L. en animales de experimentación, así como su toxicidad aguda oral. Se evaluó el efecto analgésico a las dosis 825, 1 320 y 1 650 mg/kg mediante la técnica de contorsiones inducidas por agentes químicos (Witkin y col, 1961), y la antipiresia fue testada en conejos a las dosis 206 y 406 mg/kg, frente a una endotoxina de E. coli. Se compararon los resultados obtenidos en ambos estudios con ibuprofeno 200 mg/kg, y se demostró que el extracto administrado por vía oral, a las dosis de 1 650 mg/kg -analgesia- y 406 mg/kg -antipiresia- posee una efectividad similar al ibuprofeno. Se realizó el estudio toxicológico en ratones, y se obtuvo una DL50 de 2,56 g/kg, lo que permite clasificar al extracto como no tóxico. The analgesic and antipyretic activity of the Pimenta dioica L. fluid extract was studied in experimental animals, as well as its acute oral toxicity. The analgesic effect was evaluated at doses of 825, 1 320 and 1 650 mg/kg by the technique of contorsions induced by chemical agents (Witkin et. al., 1961), whereas antipyresis was tested in rabbits at doses of 206 and 406 mg/kg against an endotoxin of E. coli. The results obtained in both studies were compared with ibuprofen 200 mg/kg, and it was proved that the oral administration of the extract at doses of 1 650 mg/kg -analgesia- and 406 mg/kg -antipyresis- has an efectivity similar to that of ibuprofen. The toxicological study was conducted in mice and it was obtained a DL50 of 2.56 g/kg, which allows to classify the extract as non toxic.
The Effect of Preemptive Intraveneous Dexketoprofen Trometamol on Analgesia Quality Created
Canan Atalay,Naz?m Do?an,mehmet K?z?lkaya,,Hüsnü Kür?ad
Journal of Clinical and Analytical Medicine , 2012, DOI: 10.4328
Abstract: Aim: We investigated the fentanyl dose used in patient-controlled analgesia (PCA) of preemptive intravenous (IV) dexketoprofen trometamol (DKP) after abdominal hysterectomy. Material and Method: Following approval by the local ethics committee, 40 patients scheduled for ASA I-II abdominal hysterectomy were randomly divided into two groups. The anesthetic techniques were standardized. Group F (n=20): Placebo administered 30 minutes prior to operation and after 8 hours; Group D (n=20): 50mg IV dexketoprofen trometamol administered 30 minutes prior to operation and after 8 hours. When VAS>3, 1.5 %u03BCg/kg fentanyl was administered to both groups in the recovery room. At intervals and afterwards, analgesia was provided through PCA (bolus dose: 25 %u03BCg fentanyl; lock out period: 10 min.; 4-hr limit: 400 %u03BCg). VAS score, sedation score, fentanyl consumption, postoperative nausea and vomiting (PONV), and side-effects were recorded. Results: Demographic data and duration of surgery in the two groups were similar. Respiratory depression was not seen in either group. There was no significant difference based on the VAS score (p= 0.07). Nausea and vomiting were significantly higher in the Group F compared to Group D (p=0.03). Compared to Group F, PONV were less in Group D, at 12hr and 24hr postoperatively (p=0.03). Fentanyl consumption at 12 and 24 hours was lower in Group D than Group F (p=0.001). Discussion: In cases where 50 mg of intravenous dexketoprofen trometamol was administered, we observed that the fentanyl consumption decreased by 40%, analgesia quality increased and the incidence of sideeffects decreased.
Comparing Early Postoperative Period Analgesic Effect of Dexketoprofene Trometamol and Lornoxicam in Mediastinoscopy Cases  [cached]
Gonul Sagiroglu
Eurasian Journal of Medicine , 2011,
Abstract: Objective: In this study, we aimed comparing early postoperative period analgesic effectiveness and the effects on opioid consumption of intravenous dexketoprofen and lornoxicam that are given preemptively. Materials and Methods: Forty patients, planned elective mediastinoscopy, were included in this prospective randomized study. These patients were classified in two groups, group D for dexketoprofene trometamol and group L for lornoxicam, randomly. 20 minutes before the operation 50 mg dexketoprofene trometamol and 8 mg lornoxicam were injected intravenously for group D and group L respectively. In postoperative intensive care unit, pain scores, mean arterial pressures, heart rates and peripheric O2 saturations of patients were recorded at 0, 10, 20, 60, 90 and 120th minutes. Results: When we evaluate the VAS score of the groups, there was a significant decrease in group D in all measured timesstatistically compairing to group L (p<0.001). When both group were evaluated in itself according to 0 minute time, in group L there was a significant decrease at 10 minutes time (p<0.0001) but in group D there was not a significant decrease (p>0.05). Conclusion: Since intravenous dexketoprofen, applied preemptively, has more potent analgesic effect and causing less opioid consumption in early postoperative period, is better than intravenous lornoxicam.
Spectrophotometric methods for simultaneous estimation of Thiocolchicoside and Dexketoprofen Trometamol in pharmaceutical dosage form
Trivedi JB,Chaudhari BG
International Journal For Pharmaceutical Research Scholars , 2012,
Abstract: Two simple spectrophotometric methods have been developed for simultaneous estimation ofThiocolchicoside and Dexketoprofen trometemol from pharmaceutical dosage form. Method-I involvedsimultaneous equation method and Method-II is the Q-absorbance method. For simultaneous equationmethod, the absorbances of the standard solutions were taken at two wavelengths 368 nm (λ-max ofThiocolchicoside) and 258 nm (λ-max of dexketoprofen trometamol). For Q-absorbance method, theabsorbances of the standard solutions were taken at two wavelengths 258 nm (λ-max of dexketoprofentrometamol) and 281 nm (Isoabsorptive point), in methanol. Linearity range was found to be 2-24 μg/mlfor dexketoprofen trometamol and Thiocolchicoside in both methods based on the ratio of the two drugsin combined dosage form. The accuracy and precision of the methods were determined and validatedstatistically. Both methods showed good reproducibility and recovery with RSD less than 2. Proposedmethods were found to be rapid, specific, precise and accurate and can be successfully applied for theroutine analysis of dexketoprofen trometamol and Thiocolchicoside in pharmaceutical dosage form.
BIOEQUIVALENCE STUDY OF TWO ORAL FORMULATIONS OF METAMIZOLE 500 MG IN HEALTHY VOLUNTEERS  [PDF]
Dhaneshwar Shep *, Rakesh Ojha , Rajeshwari Rathod , Sweta Patel , Manish Nivsarkar , Sanjay Maroo and Harish Padh
International Journal of Pharmaceutical Sciences and Research , 2012,
Abstract: Background: Metamizole (Dipyrone) is widely used and has effective analgesic, antipyretic, and antispasmodic properties. After oral or intravenous administration, dipyrone is rapidly hydrolyzed to the active moiety 4-methylaminoantipyrine. Aim: The aim of this study was to assess the bioequivalence of 2 oral formulations of Metamizole 500 mg. Methods: This double blind, randomized, single-dose, 2-period crossover study in healthy Indian adult volunteers was conducted at PERD Centre, Ahmedabad. Subjects received Metamizole 500 mg of either test or reference formulation with a washout period of 7 days. After study drug administration, serial blood samples were collected over a period of 24 hours. Plasma concentration of 4-methylaminoantipyrine was measured by pre-validated LC-MS method. Pharmacokinetic (PK) parameters Cmax, Tmax, t1/2, AUC0-t, AUC0-∞, and kel, were determined for test and reference formulations. The formulations were to be considered bioequivalent if the log-transformed ratios of Cmax, AUC0-t, and AUC0-∞ were within the predetermined bioequivalence range of 80% to 125%. Results: A total of 14 subjects were enrolled. No significant differences were found based on analysis of variance, with mean values and 90% confidence intervals of test/reference ratios for these parameters as follows: Cmax, 18.24 versus 18.44 μg/mL (92.68 - 106.61); AUC0-t, 92.97 Versus 91.37 μg.hr/mL (89.49 - 113.09); and AUC0-∞, 96.64 Versus 94.65 μg.hr/mL (92.31 - 111.63). Conclusion: Since the 90% confidence intervals for Cmax, AUC0-t, and AUC0 ∞ were within the interval of 80-125%, it was concluded that both formulations were bioequivalent, according to both the rate and extent of absorption.
Incidence and anatomic localization of oral candidiasis in patients with AIDS hospitalized in a public hospital in Belo Horizonte, MG, Brazil
Gableri, Ilanna G.;Barbosa, Anne C.;Velela, Raquel R.;Lyon, Sandra;Rosa, Carlos A.;
Journal of Applied Oral Science , 2008, DOI: 10.1590/S1678-77572008000400004
Abstract: the objective of this study was to evaluate the incidence, anatomic localization and yeast species isolated from each clinical type of oral candidiasis. the clinical samples were obtained from 67 patients with aids with cd4 cell counts below 200 cells/mm3 and hospitalized in a public hospital (eduardo de menezes hospital) in the city of belo horizonte, mg, brazil. yeasts were isolated using chromagar? candida. the results show that 50.7% of these patients had oral candidiasis. the pseudomembranous form was the most frequent clinical manifestation of oral candidiasis, followed by the erythematous and angular cheilite forms. the most common site of these clinical forms of oral candidiasis was the tongue. candida albicans was the most common yeast species isolated from the lesions. however, other species were also found to be associated with these forms of oral candidiasis.
Comparison Effectiveness of Fosfomysin Trometamol and Ciprofloxacin in Treating Uncomplicated Urinary Tract Infections  [PDF]
Levent ?ZCAN,Serkan YILMAZ,Murat PEKDEM?R,Elif YAKA
Turkish Journal of Emergency Medicine , 2011,
Abstract: Objectives: Acute urinary tract infection (UTI) is one of the most common infections requiring empirical antibiotic therapy. Selection of efficient and safe antimicrobial agent is important in the emergency department (ED). The aim of this study is to compare the microbiological and clinical efficiency of single-dose fosfomycin trometamol (FT) therapy with a 3-day course of ciprofloxacin (CP) for the treatment of uncomplicated UTI. Methods: This randomized, prospective, single-blind study evaluated women aged between 18 and 65 years and complaining of dysuria, frequency and urgency in the ED. The onset of symptoms were less than 72 hours before admission to the ED. Patients received either a single-dose FT or 3-day course of CP. Those with positive cultures of mid-stream urine samples constituted study patients. Microbiological and clinical cure were assessed at the test-of-cure visit (7-10 days after completion of therapy). Chi-square tests were used to compare efficiencies of regimens. Results: Mean age of 81 women included the study was 30±12. There were 40 patients in the FT group and 41 patients in the CP group. The most common uropathogen isolated was E. Coli in 50 subjects (61.3%). Clinical cure was demonstrated in 38 patients (96%) in the FT group and 38 patients (93%) in the CP group (χ2: 0,347, df: 1, p=0.275). Bacteriologic eradication was achieved in 30 patients (80%) in the FT treated group and 27 patients (65.8%) in the CP treated group (χ2: 0,1591, df: 1, p=0.207). 3 patients (7.5%) in the FT and 4 patients (10%) in the CP group experienced pyrosis, while nausea was seen in 5 patients (12%) in the CP group as adverse events. Conclusions: Fosfomycin trometamol therapy was found to be as safe and effective as ciprofloxacin as a first line treatment of acute uncomplicated UTI.
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