Navegando por Autor "Solon, Lílian Grace da Silva"
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Artigo Comparative Bioavailability of a Generic and Two Compounded Naproxen Sodium Suspensions Administered to Rats(J Bioanal Biomed, 2010-04-23) Araujo, Aurigena Antunes de; Solon, Lílian Grace da Silva; Guerra, Gerlane Bernardo Coelho; Barichello, José Mário; Pérez-Urizar, José; Soares, Luiz Alberto LiraThe purpose of this study was to determine naproxen concentrations in rat plasma samples by HPLC and to compare the bioavailability of a generic and two compounded naproxen sodium suspensions (test 1 and test 2). Analysis was run at a fl ow rate of 1.2 mL.min -1 with a mobile phase of acetonitrile: NaH 2 PO 4 0.01 M pH 4.00 (50:50, v/v) at 280 nm, using a C 18 column (150 mm x 4.6 mm, 5 μ m). The calibration curve was linear (R 2 = 0.9987) over the range of 0.25 - 200 μ g.mL -1 . The precision for inter and intra-day analysis ranged from 2.46% to 12.39%. C max , T max and AUC t were 191.25 ± 11.17 μ g.mL -1 , 1.00 ± 0.106 h and 2438.16 ± 291.34 μ g.h.mL -1 for the reference drug, 188.22 ± 24.78 μ g.mL -1 , 1.06 ± 0.092 h and 1755.02 ± 228.90 μ g.h.mL -1 for test 1, and 160.50 ± 10.58 μ g.mL -1 , 0.66 ± 0.102 h and 1955.28 ± 142.80 μ g.h.mL -1 for test 2. No signi fi cant differences were found based on analysis of variance, with mean values and 90% CI of test2/reference ratio (C max 83.92% and AUC t 80.19%). For test1/reference ratio, the result was C max 98.41% and AUC t 71.98%. Based on these results, it can be concluded that the validated method was successfully applied to this study; the test 1 formulation failed to demonstrate a bioequivalence to the reference drug; however, the test 2 and reference naproxen sodium suspension were bioequivalent in terms of the rate and extent of absorption under these conditions.Artigo Comparative Bioavailability of Two Extemporaneous Solid Formulations of Carbamazepine against the Innovator in Mexican Healthy Subjects(OMICS International, 2014-03-04) Araujo, Aurigena Antunes de; Guerra, Gerlane Bernardo Coelho; Solon, Lílian Grace da Silva; Dibildox, Estela; Perez-Urizar, Jose; Escobedo-Moratilla, Abraham; Torres-Roque, Irma; Martinez-Delgado, Maricela; Zapata-Morales, Juan Ramon; Soares, Luiz Alberto Lira; Covarrubias-Pinedo, AmadorExtemporaneous or off-label prescribing is not illegal and may sometimes be clinically and economically appropriate. However it is associated with a number of clinical, safety and ethical issues. Bioequivalence of these products must be proven before they are used in place of patent medicines. In the present study, a single-center, open, randomized, single-dose, 2-period crossover, 2-sequences pilot assay (two subgroups with n=6) was carried out to evaluate the bioavailability of two extemporaneous capsule of carbamazepine (200 mg): A-Formula® (A); and Formule® (B) in comparison to a tablet of the innovator product Tegretol® (C). Twelve healthy volunteers were randomly assigned to one of two arms to receive one test/reference formulation and following a two week wash-out period they received the other compound. Blood sampling was performed over 72 hours after dosing and levels of carbamazepine were determined by HPLC. Main findings of the study include that peak of plasma carbamazepine was faster following the extemporaneous capsules as compared to reference (Tmax: A: 6.58 h; B: 4.83 h vs 8.25-10.00 h, respectively), although no changes was observed in Cmax (A: 3.32 μg/mL; B: 3.10 μg/mL vs C: 3.14-2.85 μg/mL) neither in AUC0-t (A: 116.34 μg*h/mL; B: 145.66 μg*h/mL vs C: 123.18-138.37 μg*h/mL). The elimination half-life that ranged between 38.64-61.29 h but not difference were observed between all formulations. By using bioequivalence statistics it appears that A-Formula® or Formule® is bioequivalent to Tegretol® in terms of AUC0-t but not regarding Cmax. In conclusion, we demonstrated that two extemporaneous capsules of carbamazepine, A-Formula® and Formule® show similar concentration-time profiles to the reference tablet of immediate Tegretol®, however further studies with longer sample size are needed to confirm its bioequivalence and interchangeability.Artigo Determination of carbamazepine in pharmaceutical formulations(Universidade de São Paulo, USP, 2010) Araujo, Aurigena Antunes de; Solon, Lílian Grace da Silva; Oliveira, Ana Isabel Maia de; Guerra, Gerlane Coelho Bernardo; Soares, Luiz Alberto LiraThe aim of this study was to evaluate the quality of five different solid formulations of carbamazepine. The reference formulation was Tegretol® 200.00 mg (Novartis) and the others were: generic formulation of carbamazepine 200.00 mg (National Industry), similar formulation of carbamazepine 200.00 mg (National Industry), and two formulations of carbamazepine 200.00 mg acquired from two different compounding pharmacies. The latter consisted of capsules obtained in Natal, the capital city of the Brazilian State of Rio Grande do Norte. The quality of samples was evaluated through physical and physical-chemical tests, including: weight, diameter, thickness, content, dissolution, disintegration, hardness, friability and moisture. The results of friability analysis showed that all formulations met Brazilian and United States Pharmacopeia (USP) specifications. In spite of having a higher hardness compared to the reference, the generic formulation had a lower disintegration time. This could be associated to the presence of crospovidone in its formulation. Results of this study showed that all formulations had dissolutions which were in accordance with Brazilian Pharmacopoeia specifications, and quality control tests. An exception was found for the similar formulation, which had a hardness parameter that exceeded the USP standard. However, this difference was not significant given the similar formulation's satisfactory disintegration time.Artigo Estudo de controle de qualidade físico-químico de suspensões orais manipuladas de naproxeno sódico(Pontifícia Universidade Católica de Campinas/ PUC-Campinas, 2012) Araújo, Aurigena Antunes de; Solon, Lílian Grace da Silva; Oliveira, Ana Isabel Maia de; Souza, Graziene Lopes de; Soares, Luiz Alberto LiraObjetivo Este trabalho objetivou realizar um estudo comparativo de controle de qualidade entre a suspensão de referência de naproxeno sódico, Flanax®, denominada R, e suspensões obtidas de seis farmácias de manipulação na cidade de Natal, Rio Grande do Norte, denominadas A, B, C, D, E e F, com concentrações de 25mg/mL. Realizaram-se ensaios para determinação do teor, pH, homogeneidade, identificação, volume e características organolépticas. Métodos O método utilizado para o doseamento mostrou precisão, exatidão, linearidade e especificidade. Resultados As formulações obtidas nas farmácias B, C e E apresentaram teor abaixo das especificações farmacopeicas, enquanto a formulação F apresentou um teor acima do recomendado. Em relação ao pH, as suspensões C, E e F apresentaram valores fora das especificações. Quanto à homogeneidade, as amostras obtidas das farmácias C e E foram reprovadas. Observou-se que a maioria das amostras apresentou volume compatível ao rotulado, exceto a amostra C. Conclusão Os resultados indicaram a necessidade de uma maior fiscalização pelos órgãos competentes, de forma a garantir a segurança do paciente e a qualidade dos medicamentos produzidos pelas farmácias de manipulação.