Orally dispersible tablets (ODT) are important for their fast disintegration in mouth as well as for their fast action and high biological availability of the drug. This dosage form is suitable in cases when the tablet swallowing is difficult, either for children or patients with dysphagia or for those who have no access to water. Development of ODT is complicated mainly by masking the unpleasant taste of the drug. It is necessary to keep the critical para¬meters of the tablets such as their hardness and fast disintegration. There are many methods of taste masking, but their application is very individual. In some cases the taste correction by with sweeteners and flavors can be sufficient, sometimes it is necessary to choose more sophisticated methods such as tablet coating or chemical modification of the active substance. In recent years, the taste masking using cyclodextrins and ion exchangers has been widely used. However, their use is limited to active substances capable of forming stable complexes with the taste-masking agents. The agents can negatively affect the dissolution profile of the active substance as well as slow down tablet disintegration. In a number of ODT efficient taste masking is achieved by a combination of appropriate physicochemical methods and technologies.
The work was aimed at the evaluation of a cleanliness of pharmaceutical equipments after the end of the production and subsequent cleaning process. The influence of a dirty-hold time, a time interval between the end of the production period and the beginning of the cleaning process on its efficiency and the cleanliness of the equipment has been studied. The evaluation was performed for commercial tablet antihypertensive formulation with API losartan potassium. Sampling was carried out by a wet-swabbing method from the equipments and consequently obtained samples were analytically evaluated using HPLC. In the production of the concerned pharmaceutical, it has been found that the cleaning process is properly designed and validated. Despite the concentration of losartan in swabs from the equipment was in all cases within the limits of acceptance criteria, the effect of the dirty-hold time was proved. In the equipments with long hold-time period, the monitored substance was found in substantially higher concentrations.
- MeSH
- antihypertenziva chemie MeSH
- časové faktory MeSH
- farmaceutický průmysl přístrojové vybavení normy MeSH
- kontaminace zdravotnického vybavení prevence a kontrola MeSH
- losartan chemie MeSH
- příprava léků přístrojové vybavení normy MeSH
- tablety MeSH
- vysokoúčinná kapalinová chromatografie MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- validační studie MeSH
The article presents a review of current situation in the the production of vegetable oils (triacylglycerols) and their use for food products and as a raw material in chemical industry. Most vegetable oils are used as edible oil and margarine) and only a small part (ca. 14 %) are used in the chemical industry (e.g. for production methyl esters), surfactants and a very small part in cosmetics and pharmaceuticals. Other possibilities of using vegetable oils are their hydrogenation and hydrogenolysis to alkanes or pyrolysis to low alkenes (ethylene) and aromatics.
A fuzzy model has been developed for the optimization of high-shear wet granulation wetting on a plant scale depending on the characteristics of pharmaceutical active substance particles. The model optimized on the basis of experimental data involves a set of rules obtained from expert knowledge and full-scale process data. The skewness coefficient of particle size distribution and the tapped density of the granulated mixture were chosen as the model input variables. The output of the fuzzy ruled system is the optimal quantity of wetting liquid. In comparison to manufacturing practice, a very strong sensitivity of the optimal quantity of the added wetting liquid to the size and shape of the active substance particles has been identified by fuzzy modeling.
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