Assessing the homogeneity of Actimask® acetaminophen and N-acetyl glucosamine mixture to predict further steps in the development of orodispersible tablets

One of the main problems in production tablets, which has significant negative consequences, is segregation tablet mixture leading to inhomogeneity dosage units, material losses manufacturing process and improperness specified pharmaceutical technical characteristics mixture.
 The aim research. This work aims at study substances N-acetyl-D-glucosamine Actimask® Acetaminophen determination uniformity powder active ingredients (APIs) predict optimal technology for obtaining a formulation with acceptable properties.
 Materials methods. (Zhejiang Candorly Pharmaceutical, China) (SpiPharma, USA) were used.
 Scanning probe microscope Solver P47N-PRO ("NT-MDT", Russia), optical microscope, flowability tester VP-12A, laser diffraction particle size analyzer SALD-2201 ("Shimadzu", Japan), liquid chromatograph Agilent 1260 Infinity II Diode Array Detector (Agilent Technologies, USA), spectrophotometers Shimadzu UV-1800 Japan) API properties (microscopic characteristics, moisture absorption capacity, flowability, bulk volume tapped volume, distribution by sieve analysis diffraction), as well vibration simulation following chromatographic carried out this work.
 Results discussion. shape particles Acetaminophen, was determined microscopic analysis, demonstrated possibility stick ones. experimental allowed reveal hygroscopicity both APIs; poor unsatisfactory Hausner ratio, Carr index N-acetyl-D-glucosamine; excellent Actimask®. Vibration caused mixture. It found that all layers do not meet requirements an excessive content registered, indicates stratification Conclusions. physical have differences their distribution. Segregation after confirmed assay analysis. In order solve problem, granulation may be proposed.