Development, physicochemical evaluation, and in vivo permeation studies of topical formulations containing 0.1% tacrolimus

Abstract The objective of this paper was to develop and evaluate two semi-solid pharmaceutical forms containing 0.1% tacrolimus: cream (CRT01) and gel (GLT01). For the evaluation of physicochemical stability, at times 0, 30, 60 and 90 days, at 23°C and at 40°C, High Performance Liquid Chromatography coupled with a Diode Array Detector (HPLC-DAD) was employed. This method was developed and validated for tacrolimus quantification. The occlusivity test and skin permeation assay were also performed, using an animal model (Wistar rats), and the CRT01 and GLT01 were compared to the 0.1% tacrolimus ointment (PFU01) obtained from the University Pharmacy, Federal University of Rio de Janeiro, Brazil. CRT01 and GLT01 presented a homogeneous aspect and consistency adequate for topical products, along with sensory characteristics above PFU01. They also presented adequate physicochemical stability for 90 days and a lower occlusive effect than PFU01 (p<0.05). CRT01 showed greater affinity for the skin when compared to PFU01 and GLT01, with low systemic absorption. The CRT01 semi-solid formulation was considered the most adequate one to treat patients with atopic dermatitis or other dermatologic inflammatory diseases, promoting rational use of tacrolimus

Literature review of domestic and international research on patient satisfaction / 中国卫生政策研究

This paper elaborates on the connotation and development path of patient satisfaction theory, organi-zes and concisely reviews the status quo and progress of domestic and international research on patient satisfaction, and clarifies the three aspects of research on patient satisfaction:research into instruments of measurement, research into evaluation models, and research into analytical methodology. The problems and deficiency of existing research are also analyzed, specifically: first, the long-term reliance on the customer paradigm in the field of marketing re-search;and secondly, the lack of a unified, standardized patient satisfaction assessment system. Based on introspec-tion, some suggestions are put forward:first, the next step should be to focus on the innovation of patient satisfaction analysis theories and methods using comprehensive multidisciplinary perspectives;and secondly, methods for researc-hing how patient satisfaction data acquisition channels affect the results should be actively explored and an optimal method should be sought.

In vitro-in vivo studies of the quantitative effect of calcium, multivitamins and milk on single dose ciprofloxacin bioavailability / 药物分析学报

Ciprofloxacin, commonly used in India as an anti-microbial for prolonged use in chronic and non-specific indications, may affect the bioavailability of the drug. The drug prescribed is commonly taken with multivitamins, calcium and milk. A simple and reliable analytical methodology obtaining a correlation with in vivo urinary excretion studies using UV and HPLC and in vitro dissolution studies (IVIVC) has shown a significant increase in elimination rate of ciprofloxacin co-administered with multivitamins, calcium and milk. Appreciable IVIVC results proved that dissolution studies could serve as an alternative to in vivo bioavailability and also support bio-waivers.

Evaluation and comparison of automated analysers on hepatic enzymes.

Background: Clinical Biochemistry tests comprise over one third of all hospital laboratory investigation. The laboratory accreditation requirement has become an important aspect in selecting the analysers for analysing and evaluating the samples. Recently accrediting bodies are focusing on the importance of total quality management and assessment of trueness of laboratory measurements. The present study aimed to evaluate the hepatic enzymes using a single analytical methodology in 2 different automated analysers (semi autoanalyser and fully automated analyser) to understand the reliability of instrumentation on analytical methodology that would fit the laboratory performance standard. Methods: A total number of 50 serum samples from adult patients requested for liver function tests at Shri Sathya Sai medical college and research institute were analysed. The samples were evaluated for hepatic enzymes on (Cobasmira) Autoanalyser and (Biosystems) Semi Autoanalyser using the same analytical methodology and the values were compared between the 2 automated analysers. Data analysis was done by appropriate statistical methods. Results: No large differences were obtained in the values between the 2 automated analysers. Mean ± SD of each of the hepatic enzyme analysed by automated analysers were very close to each other indicating a minimum bias. Pearson’s correlation and scattered diagram showed significant positive correlation at 95% confidence interval between 2 automated analysers. Conclusion: The findings of this study confirm that both the automated analysers were reliable for evaluation of hepatic enzymes.

Validação de método analítico para doseamento de flavonoides totais em cápsulas contendo extrato seco de Passiflora incarnata L / Validation of analytical method for assay of total flavonoids in capsules containing dry extract of Passiflora incarnata L

Este trabalho teve como objetivo desenvolver e validar metodologia analítica por espectrofotometria no UV para a quantificação de flavonóides totais, expressos em vitexina, em cápsulas contendo extrato seco de Passiflora incarnata L. O método foi desenvolvido a partir da metodologia de doseamento de flavonóides totais descrita na monografia do extrato seco de P. incarnata L, disponível na Farmacopeia Britânica (2010). A validação da metodologia analítica de doseamento foi realizada de acordo com a Anvisa RE N° 899/2003 e diretrizes da International Conference on Harmonization. O método mostrou-se seletivo, pois não houve interferência dos adjuvantes na leitura das absorbâncias nas soluções analisadas. Apresentou coeficiente de correlação linear (r) de 0,9999, confirmando a linearidade do método. Os valores de desvio padrão relativo, obtidos tanto para precisão, nos níveis de repetibilidade e precisão intermediária, quanto para exatidão não excederam o máximo de 15% determinado nos critérios de aceitação para métodos bioanalíticos, considerando a complexidade da matéria-prima vegetal.

The aim of this study was to develop and validate an analytical method using UV spectrophotometry to determine total flavonoids, expressed in vitexin, in capsules containing a dry extract of Passiflora incarnata L. The analytical method was based on the spectrophotometric assay described in the British Pharmacopoeia (2010), for the dry extract of P. incarnata L. The validation of this method of quantitation was done in accordance with ANVISA resolution 899/2003 and the International Conference on Harmonization guidelines. The method was selective, because there was no interference from additives in the reading of the absorbance of solutions analyzed. It showed a linear regression correlation coefficient (r) of 0.9999, confirming the linearity of the method. The values of relative standard deviation calculated for precision (both repeatability and intermediate precision) and for accuracy did not exceed the maximum of 15% allowed in the acceptance criteria for bioanalytical methods, considering the complexity of the plant raw material.

Validação de metodologia analítica para a determinação de derivados do ácido o-hidroxicinâmico de Echinodorus grandiflorus / Validation of analytical methodology for the determination of derivatives of o-hydroxycinnamic acid from Echinodorus grandiflorus

Este artigo descreve o desenvolvimento e a validação de método espectrofotométrico UV-Visível para quantificação de derivados do ácido o-hidroxicinâmico em folhas de Echinodorus grandiflorus. O método demonstrou ser linear (r² = 0,9974), preciso (DPR < 15%) na análise de matriz complexa e exata (recuperação = 107,56%).

This paper describes the development and the validation of an UV-Vis spectrophotometric method for the quantification of derivatives of o-hydroxycinnamic acid in leaves of Echinodorus grandiflorus. The method showed to be linear (r² = 0.9974), precise (RSD < 15%) in the analysis of complex matrix and accurate (recovery = 107.56%).

Desarrollo y optimización de una metodología analítica para la determinación de sedimento en bebida de mesa derivada del cacao / Development and optimization of an analytical methodology for sediment determination in a drink derived from the cacao

Se realizó un estudio encaminado a desarrollar y optimizar una metodología analítica que permita determinar la cantidad de sedimento que presenta una bebida derivada del cacao (chocolate de mesa), para ser aplicada como prueba rutinaria de control de calidad indicadora del proceso, con base en los principios de la sedimentación. Para la caracterización del sedimento, se hizo la distribución de tamaños de partícula, porcentaje de grasa y peso del sedimento en seco. El desarrollo de la metodología y su optimización se llevó a cabo con una muestra patrón (licor de cacao), y posteriormente con el producto en proceso (licor de cacao con lecitina) y con el producto terminado (chocolate con azúcar), provenientes de dos procesos diferentes. Los resultados muestran que la metodología permite diferenciar las muestras durante el proceso, con el producto terminado y con productos obtenidos mediante diferentes procesos.

A directed study was realized to develop and optimize an analytical methodology that allowed to determine the amount of sediment presents in a drink derived from the cacao (dinking chocolate), to be applied as routine test of indicating quality control of the process, support in the sedimentation principles. For the characterization of sediment, were realized the distribution particle size, fat percentage and dry weight of sediment. The development of the methodology and its optimization were realized with a sample patron (cacao liquor), then the methodology was defied with product in process (cacao liquor with lecithin) and finished product (chocolate with sugar), of the same process and a different process. The results show that the methodology allows differentiation the samples during the process, finished product and products obtained by different processes.