Browsing by Subject "moisture sensitiveness"

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  • Palttala, Iida (Helsingfors universitet, 2010)
    Automated dose dispensing is an increasing field in which medicines are packaged mechanically into small one-dose pouches in portions of two weeks. Suitability of tablets for automated dose dispensing has not been researched systematically earlier. The study was made in collaboration with the dose dispensing unit of Espoonlahti pharmacy. The aim of the study was to define optimal characteristics for an automatically dispensed tablet from a viewpoint of the dose dispensing process to reduce breakings and transitions. Breaking means that tablet crumbles, splits up or breaks up otherwise during mechanical dose dispensing process. Transition means that tablet is dispensed in a wrong dose pouch. Percentually breakings and transitions occur very little, but quantitatively plenty and increasingly when automated dose dispensing is becoming more common. Breakings and transitions cause plenty extra work because of correcting pouches, so their amount should be aimed to reduce. In addition, the aim is to find out matters to enquire from the manufacturers of medicines that would help concluding whether a product is suitable for automated dose dispensing based on written information. Results of the study indicate that to reduce breakings and transitions, an optimal tablet product for dose dispensing is rather small or middle sized, coated, strong and without a breakline and the optimal relative humidity of air in the product room of dose dispensing unit would be around 30 - 40 %. Matters to enquire from the manufacturers of medicines besides size, coating, breaking strength and breakline are stability of the product outside of its original package and light, heat and moisture sensitiveness of the product. Besides breakings and transitions, also stability of a moisture sensitive acetylsalicylic acid product (Disperin 100 mg) was investigated in 25 °C/60 % RH because air humidity in the product room is not adjustable. Duration of the test was four weeks. It is enough since it is the maximum time that tablets are outside their original packages during drug dispensing process before use. Tablets were kept in opened original container (bottle), in closed original container, in cassette of dispensing machine and in two different dose pouches (new material and the one in use). According to the results, cassettes are protecting tablets from moisture as poorly as an opened bottle. Instead, new pouch material protects tablets better than the material in use. Results of Raman spectroscopy measurements indicate no change in acetylsalicylic acid to salicylic acid during four weeks test. Moisture affects to tablets by decreasing breaking strength, which may cause more breakings. Air humidity should be adjusted in product rooms or tablets should be unpacked into cassettes as near operating the machine as possible to prevent breakings. Especially when air humidity is high. Among others, a heat sensitive drug product was researched because of the seaming unit of dose dispensing machine which is radiating heat of about 75 °C to pouches if machine is pulled over in the middle of work. Study was performed with variable temperature XRPD. Results of the study of heat sensitiveness indicate that 75 °C for 60 minutes doesn't induce changes in carbamazepine tablet (Neurotol 200 mg). However, results of the study reveal that researched product did not contain the most heat sensitive form of carbamazepine, so other heat sensitive drug products should be examined to get more information about effects of heat.