Baškytė, Ieva

Oral route is still widely accepted route but have a common drawback of difficulty in swallowing. Therefore, there is a growing interest in new orodispersible formulations, such as orally disintegrating granules, in the scientific literature. It is an innovative and user-friendly dosage form that fast disintegrate in the mouth without water. The active substance is quick absorbed in the oral cavity, pharynx or esophagus and also enters the stomach together with saliva, hence orodispersible granules are used when a rapid therapeutic effect is required, such as during allergic reactions. Besides, dosage forms is easy and convenient to use for pediatrics, geriatrics, mentally disabled, bed-ridden patients who have difficulty in swallowing or for patients who are travelling and do not have access to water. Orally disintegrating granules produced by simple and innovative moisture-activated dry granulation method using different amount of microcrystalline cellulose and polyvinylpyrrolidone. The technological properties of the produced granules are evaluated and the quality is determined with the tests specified in European pharmacopoeia: uniformity of content, disintegration time. The best technological properties were in orodispersible granules consisting of 17.5% microcrystalline cellulose and 17.5% polyvinylpyrrolidone: flowability 6.89±0.41 g/s., angle of repose 25.67±0.7º, Carrʾs index 9.09±0.677 %, Hausner coefficient 1.100±0.06 – these granules corresponded to excellent flowability. The flowability of the other granules was good. Based on the results, the highest percentage of particles obtained corresponded to a particle size of 450-560 μm. The content uniformity test showed that the amount of active substance in all granules complied with the permissible limits 85-115%. Disintegration test showed that using moisture-activated dry granulation method all granules dissintegrates in 1 min: preparation [...].