TiO2/CuO films obtained by citrate precursor method for photocatalytic application

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Dental development of children and adolescents with cleft lip and palate

Aim: To evaluate the dental development of Brazilian children and adolescents with cleft lip and palate. Methods: The sample consisted of 107 panoramic radiographs of children and adolescents with cleft lip and/or palate (cleft group) and 107 panoramic radiographs of children and adolescents without cleft lip and/or palate (control group), with chronological ages ranging from 6 to 15 years, matched in gender and chronological age within 60 days. Radiographs were digitized and masked and dental age was assessed using the method described by Demirjian et al. (1973). Three trained examiners conducted the assessments. Each examiner evaluated the radiographs three times. Data were statistically analyzed using non-parametric tests and univariate linear regression (p<0.05). Results: The dental age was overestimated in relation to the chronological age in both groups (p<0.0001). Compared to the control group, there was a delay in the dental age in the cleft group of 0.17 years (2.1 months). However, no statistically significant difference in the dental age between the cleft and the control group was found even when considering the different cleft types (p=0.152). Conclusions: There was no statistically significant difference in the dental age between the cleft and the control groups. The evaluation of dental development in individuals with cleft lip and palate should be approached in the same way as in individuals without clefts, with a focus on the individualization of diagnosis and treatment planning.

NLRP1 L155H polymorphism is a risk factor for preeclampsia development

Problem: Augmented levels of IL-1 ss have been pointed out as an important pathogenic factor for preeclampsia development. Inflammasome is the cytoplasmic complex responsible for pro-IL1 ss cleavage and IL-1 ss secretion. Aim of the study was to evaluate the association between polymorphisms in inflammasome'genes and preeclampsia. Method of study: Selected polymorphisms in inflammasome genes (NLRP1, NLRP3, CARD8, and IL1B) were analyzed in 286 Brazilian women with and 309 without preeclampsia. Results and Conlclusions: The NLRP1 variant rs12150220 (L155H) was associated with the development of preeclampsia (OR=1.58), suggesting a role of this inflammasome receptor in the pathogenesis of this multifactorial disorder.

Development of a new clean methodology with ultrasound-assisted extraction for analysis of sodium in pet foods

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Nano-displacement measurements of a new piezoelectric flextensional actuator by using a high dynamic range interferometry homodyne method

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Development and characterization of cefoxitin loaded D,L-PLA nanoparticles

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Physico-chemical characterization and analytical development for sodium azumolene, a potential drug designed to fight malignant hyperthermia

Sodium azumolene is a drug designed to fight Malignant Hyperthermia (MH), which is characterized by genetic predisposition and triggered by the use of inhalational anesthetics. This drug is shown as a water-soluble analogue of dantrolene sodium, 30-folds more water soluble, which gives advantages for its emergency use. To our knowledge there is no analytical method for sodium zaumolene raw material or dosage form published so far. The objective of the present investigation was to develop and validate analytical methods to achieve sodium azumolene chemical identification and quantification. The sodium azumolene was characterized regarding its thermal behavior, by differential thermal analysis and thermogravimetric analysis; Visible, UV and infrared absorption. To accurately assess the sodium Azumolene content three different analytical methods (visible and UV spectrophotometry and high performance liquid chromatography) were developed and validated. All methods showed to be linear, accurate, precise and reliable. Azumolene has shown to be equipotent to dantrolene in the treatment and prevention of an MH crisis and the great advantage compared to dantrolene is better water solubility. This study has characterized the sodium azumolene and presents new analytical methods which have not been reported so far.

Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for solution for injection

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Development and validation of dissolution test for fluconazole capsules by HPLC and derivative UV spectrophotometry

The purpose of this study is to develop and validate a dissolution test for fluconazole, an antifungal used for the treatment of superficial, cutaneous, and cutaneomucous infections caused by Candida species, in capsules dosage form. Techniques by HPLC and UV first derivative spectrophotometry (UV-FDS) were selected for quantitative evaluation. In the development of release profile, several conditions were evaluated. Dissolution test parameters were considered appropriate when a most discriminative release profile for fluconazole capsules was yielded. Dissolution test conditions for fluconazole capsules were 900 mL of HCl 0.1 M, 37 ± 0.5 °C using baskets with 50 rpm for 30 min of test. The developed HPLC and UV-FDS methods for the antifungal evaluation were selective and met requirements for an appropriate and validated method, according to ICH and USP requirements. Both methods can be useful in the registration process of new drugs or their renewal. For routine analysis application cost, simplicity, equipment, solvents, speed, and application to large or small workloads should be observed.

Development and validation of a stability-indicative turbidimetric assay to determine the potency of doxycycline hyclate in tablets

The doxycycline (DOX) is a broad-spectrum antibiotic used in several countries. This drug is part of the list of medicines to the SUS (Unified Health System), a model of health care in Brazil. This study describes the development and validation of a microbiological assay, applying the turbidimetric method for the determination of DOX, as well as the evaluation of the ability of the method in determining the stability of DOX in tablets against acidic and basic hydrolysis, photolytic and oxidative degradations, using Escherichia coli ATCC 10536 as micro-organism test and 3×3 parallel line assay design, with nine tubes for each assay, as recommended by the Brazilian Pharmacopoeia. The developed and validated method showed excellent results of linearity, selectivity, precision, accuracy and robustness. The assay is based on the inhibitory effect of DOX using Escherichia coli ATCC 10536. The results of the assay were treated by analysis of variance and were found to be linear (r= 0.9986) in the range from 4.0 to 9.0μg/mL, precise (repeatability R.S.D.= 0.99 and intermediate precision was confirmed by statistical analysis the mean values obtained from analysis by different analysts) and exact (97.73%). DOX solution exposed to direct UV light, alkaline and acid hydrolysis and hydrogen peroxide causing oxidation were used to evaluate the specificity of the bioassay. Comparison of bioassay and liquid chromatography showed differences in results between methodologies. The results showed that the bioassay is valid, simple and useful alternative methodology for DOX determination in routine quality control.

Validation of a stability indicating capillary electrophoresis method for the determination of darunavir in tablets and comparison with the of infrared absorption spectroscopic method

Darunavir (DRV) is a protease inhibitor used in the treatment of HIV infection, which constitutes a keystone in the therapy of patients infected with this virus. There is no monograph described in official compendia. The literature provides few methods of analysis for the determination of DRV in pharmaceuticals which include TLC, IR, UPLC, HPLC, HPLC-MS, HPLC-MS/MS, but there are no reports of the use of capillary electrophoresis (CE) for the determination of this drug. Thus, this research proposed the development and validation of a CE method for the determination of DRV in tablets. The method was completely validated according to the International Conference on Harmonization guidelines, showing linearity, selectivity, precision, accuracy and robustness. The migration was achieved in less than 1 minute using fused-silica uncoated capillary with an id of 50 μm and total length of 21 cm and voltage of +20 kV. The sample injection was performed in the hydrodynamic mode. The method was linear over the concentration range of 50-200 μg mL-1 with correlation coefficient 0.9998 and limits of detection and quantification of 7.29 and 22.09 μg mL-1, respectively. The drug was subjected to acid, base, oxidation and photolysis degradation. Degradation products were found interfering with the assay of DRV, therefore the method can be regarded as stability indicating. The validated method is useful and appropriate for the routine quality control of DRV in tablets.

Development and validation of the quantitative analysis of cefuroxime sodium in powder for injection by infrared spectroscopy

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Development and validation of a stability-indicative agar diffusion assay to determine the potency of flucloxacillin sodium in capsules

Flucloxacillin sodium (FLU) is a semi-synthetic penicillin active against many gram-positive bacteria such as streptococci and penicilinase-producing staphylococci, including methicillin-susceptible S. aureus. This study describes the development and validation of a microbiological assay, applying the diffusion agar method for the determination of FLU, as well as the evaluation of the ability of the method in determining the stability of FLU in capsules against acidic and basic hydrolysis, photolytic and oxidative degradations, using S. aureus ATCC 25923 as micro-organism test and 3 x 3 parallel line assay design (three doses of the standard and three doses of the sample in each plate), with six plates for each assay, according to the Brazilian Pharmacopoeia. The validation method showed good results including linearity, precision, accuracy, robustness and selectivity. The assay is based on the inhibitory effect of FLU using Staphylococcus aureus ATCC 25923. The results of the assay were treated by analysis of variance (ANOVA) and were found to be linear (r = 0.9997) in the range from 1.5 to 6.0 μg/mL, precise (repeatability: R.S.D. = 1.63 and intermediate precision: R.S.D. = 1.64) and accurate (98.96%). FLU solution (from the capsules) exposed to direct UVC light (254 nm), alkaline and acid hydrolysis and hydrogen peroxide causing oxidation were used to evaluate the specificity of the bioassay. Comparison of bioassay and liquid chromatography by ANOVA showed no difference between methodologies. The results demonstrated the validity of the proposed bioassay, which is a simple and useful alternative methodology for FLU determination in routine quality control.