Simultaneous Determination of Hyoscine N- Butyl Bromide and Paracetamol by RP-TLC Spectrodensitometric Method.

Aims: A simple RP-TLC Spectrodensitometric method was developed for determination of Hyoscine N-Butyl Bromide (HBB) and Paracetamol (PAR) either in bulk powder or in their pharmaceutical preparation. Study Design: Validation study. Methodology: In this method, HBB and PAR were separated on RP-18 W/ UV254 TLC plates using developing mobile phase consisting of methanol: citrate buffer (pH=1.5): triflouroacetic acid (70:30:0.1, by volume) at room temperature. Experimental conditions such as band size, slit width, different developing systems and scanning wavelength were carefully studied and the optimum conditions were selected. The obtained bands were then scanned at 210 nm. The two drugs were satisfactorily resolved with RF 0.60 ± 0.02 for HBB and 0.81 ± 0.02 for PAR. The validation of spectrodensitometric method was done regarding linearity, accuracy, precision, and specificity. Results: Linearity of the proposed methods was evaluated and it was found to lie within the concentration range of 2.0-12.0 μg.band-1 for HBB and 2.0-14.0 μg.band-1 for PAR. Conclusion: The proposed method was successfully applied for determination of HBB and PAR in pure form and in their different pharmaceutical formulations. The method proved to be specific, accurate and selective.

Interchangeability between paracetamol tablets marketed in Palestine. Is there a quality reason for a higher price?

The objective of this study was to evaluate the quality of 10 commercial paracetamol products available on the Palestinian market. We carried out a survey on the price of all paracetamol tablet products and assessed their quality. To assess quality, all products were examined visually for their organoleptic properties, tested for weight uniformity, friability, disintegration, and dissolution profile, and assayed for paracetamol content. All imported products were 2 to 3 times more expensive than the locally produced generic products. Based on our testing procedure, all paracetamol products were equivalent to the innovator product except for 1 imported product which fell below the approved specifications developed for the innovator product. Although the majority of generic products met the dissolution specification requirement that 80% of the drug must dissolve in 30 minutes, 1 generic product failed. These results demonstrate that generic paracetamol tablets produced by local manufacturers are often comparable in vitroto the innovator product and have lower costs

Evaluation of two bioadsorbents for removing paracetamol from aqueous media

The frequent contamination of water resources with drugs comprises one the most important environmental problems. In order to avoid serious disturbances for aquatic life, efficient and economically viable procedures should be developed for removing common pollutants, as paracetamol. From these considerations, the present work evaluated the efficiency of sugar cane bagasse (SCB) and vegetable sponge (VS), two natural adsorbents commonly found in Brazil, for retaining paracetamol molecules dispersed in aqueous solutions. Thus, systems composed of glass columns and peristaltic pumps were optimized and, for pH, the best value was 7.0. After optimisation, adsorption isotherms were built and it was possible to calculate the MAC F values for SCB (120.5 ug/g) and VS (37.5 ug/g). Additionally, real matrices of pretreated water, from a municipal plant for water catchment, were enriched with paracetamol at 5 uM and passed through glass columns packed with SCB, VS and activated carbon (AC). The results showed that SCB was more attractive than AC in terms of price and efficiency (60 percent against 45 percent adsorption, respectively), while VS was responsible for removing 40 percent of paracetamol dissolved in the enriched water samples. Thus, the proposed natural adsorbents can be classified as viable materials to remove paracetamol from water used for human consumption.

Photocatalytic degradation of acetaminophen

The photocatalytic degradation of a common analgesic [acetarninophen] with titanium dioxide irradiated with low energy ultraviolet light [365 nm] was studied in order to determine the effect of several parameters such as catalyst's weight, photochemical effect, and initial concentration. The results indicate that acetaminophen is degraded in the order of 4% by the photochemical effect. The presence of titanium dioxide in optimal amounts increases the rate of reaction and the overall conversion. The kinetic study demonstrated that photocatalytic degradation of acetaminophen follows a pseudo first order reaction rate which could be represented by a model similar to Langmuir-Hinshelwood equation. Accordingly, the results confirmed that the degradation of acetaminophen proceeds even while other intermediate organic products [IOP] are being formed; some of these organic products were identified by High Performance Liquid Chromatography [HPLC]. These products [OIP] remain in the solution for a while before being degraded to CO[2]. Furthermore, the experimental results indicate that the mineralization of acetaminophen can be described by an overall kinetic rate equation obtained from the experimental values of total organic carbon [TOC]

A quantitative study of the influence of coprocessing of binders on the mechanical properties of paracetamol tablets

A 2³ factorial experimental design has been used to quantitatively study individual and interaction effects of the nature of binder (N), concentration of binder (C) and the applied pressure (P) on two mechanical properties, namely, tensile strength (TS) and brittle fracture index (BFI), of paracetamol tablets. The factorial design was also used to study the quantitative effects of coprocessing of binders on the mechanical properties. The results obtained from this study suggest that the nature (i.e. plastic/elastic) and ratio of binders coprocessed together alter the influence of C and P on TS and BFI.

Utilizou-se planejamento experimental fatorial 2³ para estudar, quantitativamente, os efeitos individuais e de interação da natureza do ligante (N), concentração do ligante (C) e a pressão aplicada (P) em duas propriedades mecânicas, como forças de ruptura (TS) e índice de fragilidade (BFI) de comprimidos de paracetamol. O planejamento fatorial foi, também, empregado para estudar os efeitos quantitativos do coprocessamento de ligantes nas propriedades mecânicas. Os resultados obtidos desse trabalho sugerem que a natureza (plástica/elástica) e a proporção de ligantes coprocessados, juntas, alteram a influência de C e P em TS e em BFI.

Polimorfismo farmacéutico / Pharmaceutical polymorphism

Se explica lo que es un sólido cristalino y el polimorfismo en general. Se muestra la relación estructura cristalina/propiedades físicas y químicas a partir del átomo de carbono. Se entrega la definición de polimorfismo de la FDA. Se muestra el polimorfismo del paracetamol y se dan algunas cifras relativas a la existencia del polimorfismo en principios activos de medicamentos. Se explica que la consecuencia más importante para los polimorfos farmacéuticos es la diferencia de solubilidad y cómo eso afecta propiedades como la biodisponibilidad y la bioequivalencia, entre otras. Se muestra la dificultad de elaboración de formas farmacéuticas a partir de polimorfos específicos a través del caso emblemático del medicamento Ritonavir. Se muestran las consecuencias económicas y de salud pública en América Latina a partir de una experiencia en países vecinos como Brasil y Argentina y se informa de una Resolución del ISP en Chile que reconoce la existencia de los polimorfos y su importancia en la estabilidad y Bio-Disponibilidad de los productos farmacéuticos.

An explanation is given of crystalline solids and polymorphism in general. The crystal structure/chemical and physical properties relation is illustrated for the element carbon. The FDA's definition of polymorphism is given. The polymorphism of phenacetin (para-acetylaminophenol) is shown and some figures are given for the existence of polymorphism in medicinal active principles. The fact that solubility difference is the most important consequence of pharmaceutical polymorphs is stated, and how it affects properties like bioavailability and bioactivity, among others, is explained. The difficulty of making pharmaceutical preparations from specific polymorphs is illustrated by means of the emblematic case of the drug Ritonavir. The economic and public health consequences in Latin America are shown using the experience of neighboring countries like Brazil and Argentina, and a Resolution of the Public Health Institute (ISP) of Chile in relation to the polymorphism is reported.

Physicochemical characterization of acetaminophen-ethylcellulose solid dispersion

In this study, ethylcellulose was evaluated as a carrier for the preparation of sustained release of acetaminophen via solid dispersion technique. Physical mixture at the same level of acetaminophen and ethylcellulose was prepared. Differential scanning calorimetry and scanning electron microscope were used to characterize the physical properties of the various systems and to determine if there is possible interaction between acetaminophen and ethylcellulose