Evaluation of physicochemical and microbiological stability of liquid preparation from tizanidine hydrochloride tablets - a Hospital concern

Tizanidine hydrochloride is a centrally acting skeletal muscle relaxant, used in the management of spasticity. This drug is commercially available only as tablets, which highlights the need to develop oral liquid formulations. In the hospital environment, this aspect is circumvented by the preparation of suspensions, to allow administration to children and adults with impaired swallowing, but there are no data regarding their stability. The purpose of this study was to evaluate the physicochemical andmicrobiological stability of liquid dosage forms prepared in the hospital environment from tizanidine hydrochloride tablets, applying high performance liquid chromatography (HPLC) and microbiological analysis. A simple and stability-indicating HPLC method was developed and validated for specificity, linearity, limits of detection and quantification, precision, accuracy and robustness. The liquid formulations were placed in amber PET and glass bottles, which were stored under three different conditions: at room temperature, under refrigeration and at 40 ºC. The liquid formulations were analyzed and demonstrated chemical stability for 56 days, allowing their use for long periods. However, the determination of microbiological stability showed that these formulations are prone to microbial contamination, which has dramatically reduced its stability to 7 days, in both bottles and at all evaluated temperatures

Pterodon pubescens oil nanoemulsions: physiochemical and microbiological characterization and in vivo anti-inflammatory efficacy studies

Abstract Pterodon pubescens (Benth.) Benth., Fabaceae, fruits have been investigated for their anti-inflammatory and antinociceptive activities, and have demonstrated effectiveness in inflammatory conditions. A physiochemical and microbiological stability study was conducted to investigate two nanoemulsion-based delivery systems of two different hydrophilic surfactants (polyethylene glycol-40H castor oil or polyethylene glycol-40 castor oil). The nanoemulsions, containing P. pubescens oil, lecithin, hydrophilic surfactant and water, were analyzed for droplet size distribution, polydispersity index, pH, consistency index, stability against centrifugal force, and active content/vouacapan derivatives. The physicochemical characteristics were followed for 365 days. The nanoemulsion system was evaluated for anti-inflammatory activity by using with a peritonitis model, immediately after preparation and after 365 days of storage at 25 °C. The stability study demonstrated that proper storage (25 °C) preserved the characteristics of the nanoemulsion containing 7.5% polyethylene glycol-40H castor oil, 5% lecithin, and 5% P. pubescens oil. Further, it ensured a shelf life of 365 days as a phytotherapeutic formulation. In the peritonitis assay induced by carrageenan, nanoemulsion prepared with polyethylene glycol-40H castor oil (125 mg/kg) reduced leukocyte migration, even after 365 days of storage (25 °C), highlighting its potential for the treatment of inflammatory diseases. However, further studies are needed to confirm its clinical effectiveness.

Microbiological Contamination and Anti-bacterial Traits of Common Oral Herbal Medicinal Products within Dhaka Metropolis.

Aims: Present study endeavored to examine the growth and survival of microorganisms within 6 categories of oral herbal medicines commonly used by the community within Dhaka metropolis. Methodology: Samples were analyzed for the presence of bacteria and fungi up to 14 days. The microbial analysis was conducted by conventional cultural and biochemical methods. The in vitro anti-bacterial activity of the medicines was also detected employing agar well diffusion method. Results: Initially all samples were found to be contaminated with total viable bacteria (102-104cfu/ml); however, the fungal and pathogenic growth was not observed. In course of time, the bacterial and fungal load increased up to 106cfu/ml and 103cfu/ml, respectively in most of the samples up to 14 days. The staphylococcal growth commenced after 48 hours in all samples and vigorously increased in two samples up to 105cfu/ml. Two categories of samples were found to be populated with Klebsiella spp. (102cfu/ ml); while other pathogenic bacteria were completely absent. Out of 6 categories of samples tested, 4 were found to exhibit the anti-bacterial trait against a few bacteria examined. Significant activity was found for sample 1 against E. coli, and sample 3 against E. coli and Staphylococcus spp. Sample 2 exhibited moderate activity against 4 test bacteria; while sample 4 was also noticed to be moderately active against 2 test bacteria. Conclusion: Overall, together with the trivial anti-bacterial features, the appearance of massive bacteria and fungi after 14 days in most of the samples with an excessive staphylococcal load may pose the probable health risks to the medicine users.

Development and stability assessment of liquid paediatric formulations containing sildenafil citrate

The purpose of this study is to develop and improve oral liquids formulations of sildenafil citrate for paediatric use. Four different formulations were developed, which are as follows: two aqueous solutions of sildenafil citrate (2.5 mg/mL), with or without preservatives, and two other solutions of sildenafil in simple syrup (1.25 mg/mL), with or without preservatives. All of the formulations were physically, chemically and microbiologically stable for three months. The results of the stability studies allowed for the optimisation of formulations without preservatives due to their simplicity and their similar stable conditions when compared to the formulations containing antimicrobials. The shelf life of both formulations was three months; however, upon opening, aqueous solutions should be used within 10 days and kept refrigerated, and syrup solutions should be used within 14 days in a hospital setting.

O objetivo deste trabalho é desenvolver e otimizar formulações líquidas orais de citrato de sildenafil adequadas ao uso pediátrico. Foram desenvolvidas quatro formulações diferentes: duas soluções aquosas de citrato de sildenafila (2,5 mg/mL) com ou sem conservantes e duas soluções de citrato de sildenafil em xarope simples (1,25 mg/mL) com ou sem conservantes. Todas as formulações desenvolvidas apresentaram estabilidade quer físico-química quer microbiológica durante 3 meses. Os resultados dos estudos de estabilidade permitiram otimizar as formulações isentas de conservantes, uma vez que estas eram mais simples e apresentavam do mesmo modo uma boa estabilidade, comparando com as formulações que continham conservantes. O período de utilização de ambas as formulações é de três meses, no entanto, após abertura do frasco, a solução aquosa deve ser utilizada durante 10 dias, acondicionada no refrigerador e o xarope deve ser utilizado durante 14 dias, mesmo em ambiente hospitalar.

Estudio de la estabilidad microbiológica de la barracuda a través del tiempo de almacenaje en Costa Rica / Microbiological stability through storage period of Sphyraena ensis in Costa Rica

En el presente estudio se evaluaron algunos de los cambios microbiológicos y bioquímicos producidos en una especie de pez de consumo frecuente en Costa Rica, como lo es la barracuda Sphyraena ensis. Se evaluaron muestras de barracuda obtenidas durante la estación lluviosa y durante la estación seca. A cada una de éstas se le realizó un recuento aerobio psicrófilo, recuento e identificación de Vibrio, Enterococcus y Pseudomonas durante 6 días de almacenaje a dos temperaturas, 2 y 7ºC. Así también, se le realizó a cada una, la evaluación de la concentración de histamina producida mediante un inmunoensayo enzimático comercial. Los resultados obtenidos ponen de manifiesto que se da un incremento en los recuentos obtenidos a través del tiempo de almacenaje, dicho crecimiento es mayor al aumentar la temperatura de refrigeración. La mayoría de muestras mantenidas a 7ºC presentan recuentos superiores a 106 UFC/g luego de tres días de almacenaje, situación que no se presenta en las muestras mantenidas a 2ºC. No obstante, luego de 6 días de almacenaje, todas las muestras, independientemente de la temperatura de almacenaje, sobrepasan este valor. De la misma manera, se da un incremento en la concentración de histamina producida a través del tiempo de almacenaje, especialmente al conservar el producto a mayor temperatura debido al aumento de bacterias capaces de descarboxilar la histidina. No existe una diferencia estadísticamente significativa entre los recuentos obtenidos en estación lluviosa con respecto a la estación seca, no obstante, sí existe una diferencia con respecto a los géneros bacterianos aislados.

At the present study some of the microbiological and biochemical changes that occur through storage period in Sphyraena ensis, a fish specie of frequent consumption in Costa Rica were studied. Samples of S. ensis obtained during rainy and dry season were evaluated. Analysis included aerobic psychrotrophic count, identification and count of Vibrio, Enterococcus and Pseudomonas through a six day storage period at two different refrigeration temperatures, 2 and 7ºC. Same time, a commercial enzymatic immunoassay was used for the evaluation of the variation on the concentration of histamine produced in the different samples. Results obtained show that there is an increase on the bacteriological counts through the storage period, this increase is bigger as refrigeration temperature increases. Most of the samples maintained at 7ºC showed counts above 106 CFU/g after three days of storage, those stored at 2ºC did not present such high population levels. Nevertheless, after 6 days of storage, all samples, despite the storage temperature used, presented levels above the described one. Also, an histamine concentration increased through storage time, especially when the product was conserved at the higher temperature due to an increase in the number of histidine descarboxilating bacteria. There is no statistical difference between the counts obtained during rainy or dry season; nevertheless, there is a difference assicieated to the bacterial genera isolated.