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Browsing by Subject "kapselit"

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  • Kovanen, Satu (2016)
    Nowadays, there is still lack of commercially produced drugs for children. Extemporaneous compounding is needed widespread. Oral powders, capsules and oral suspensions are the most typical extemporaneous dosage forms. In Finland, oral powders have traditionally been the most used. Major concern relating to the extemporaneous products is that they are not authorized. That means that their safety and effectiveness have not been established. Compounding oral powders is time consuming and their overall mass is much higher compared to capsules with same strength. That increases the amount of foreign matter in child patients, which is highly not recommended. The aim of this study was to examine, whether the extemporaneous sotalolhydrochloride capsules meet European Pharmacopoeia standards of content uniformity. Additionally, because the feeding tubes are widely used in neonatal patients, it was also reasoned to examine the content uniformity of capsules lead through the feeding tube. A significant part of this study was to develop an accurate and effective HPLC -method for analyzing sotalolhydrochloride, which, in the end, turned out well. With its seven minute driving time per sample, it is suitable even in routine analysis. Two of three capsule batches, as well as the oral powders, met the European Pharmacopoeia standards of content uniformity. Also, leading the capsule contents through the feeding tubes met the standards, but the amount of drug substance was significantly lower compared to capsules and oral powders. With lower overall mass and being quicker to prepare, capsules are recommendable option for traditional oral powders in extemporaneous children's medication. Still, according to this study, it is important to take into consideration the possibility of excessive variation in content uniformity. Thus, in the future, it is necessary to develop the quality control systems in hospital pharmacies.
  • Siirola, Outi (2013)
    There aren't always available suitable authorized drug products for different age and different weight pediatric patients. Hospital pharmacies have to prepare suitable doses and dosage form for these very young patients extemporaneously. In Finland oral powders are usually used in pediatric medication. In previous studies it has been found that part of drug dose sticks to paper of oral powder and the patient doesn't get the entire intended dose. It is suggested that hard capsules may be better dosage form than oral powders, because capsules have smaller area than oral powders, where the powder can stick. The aim of this study was to examine, whether warfarin- and spironolactone capsules prepared by hospital pharmacy meet European Pharmacopeia standards of uniformity of content. Capsules were compounded from commercial tablets and capsulated by Feton-capsulating device. In this study capsules manufactured with automatic capsule filling device attached to analytical balance, oral powders and capsules prepared from pure drug substance were also compared to capsules compounded from tablets. The three month stability of compounded capsules was also examined. In hospital pharmacy many different strengths are compounded from same drug substance, ordered by physician. Ordered strengths can be nearly identical, but whether the small differences in concentration can possibly be prepared in hospital pharmacy is unknown. From both drug substances two strengths with small difference in concentration were prepared and it was studied if statistically significant difference exists. The drug concentrations of preparations were measured by high performance chromatography (HPLC). Aqualab-water activity meter was used to study water activity of samples during the stability testing. Content uniformities of all capsule batches complied with test specified in the European Pharmacopeia.The drug concentrations of capsules were significantly lower than target concentrations. With these drug substances no difference, between the drug concentration of oral powder and capsules, was found. According to this study oral powders can be replaced by capsules. Warfarin and spironolactone capsules remain at least three months, when storaged in room temperature. Warfarin capsules can be prepared accuracy of 0,1 mg and spironolactone capsules accuracy of 0,5 mg.