Influence of the aqueous film coating process on the properties and stability of tablets containing a moisture-labile drug.
The effects of an aqueous film coating process on the morphology and storage stability of hydroxypropyl methylcellulose-coated tablets containing a moisture-labile model drug (acetylsalicylic acid, ASA) were evaluated using an instrumented side-vented tablet pan coater. Coating parameters studied were inlet air absolute humidity 5 g/m3 and 12 g/m3, spraying air pressure 100 kPa and 500 kPa, pan air temperature 35 degrees C and 55 degrees C, and coating solution flow rate 2.2 g/min and 7.8 g/min. The surface roughness of the coatings was measured with a laser profilometer and the chemical hydrolysis of the model drug ASA with an UV-spectrophotometer. The film-coated tablets were stored at 25 degrees C/60% RH and 40 degrees C/75% RH for three months. The high absolute humidity of the inlet air increased the residual water content and surface roughness of the coated tablets. Using a lower coating solution flow rate, higher spraying air pressure and pan temperature the coatings were smooth and homogeneous. In both ambient and accelerated storage conditions, the roughness of the coatings and the hydrolysis of ASA increased, but this was independent of the film coating process. Uniform and smooth hydroxypropyl methylcellulose coatings can be achieved by improved control of process parameters related to the application of the coating solution and water evaporation of the tablet surface.
Pharmaceutical Technology Division, Department of Pharmacy, University of Helsinki, Finland. mirja.ruotsalainen@helsinki.fi
Mirja
M
Ruotsalainen
Jyrki
J
Heinämäki
Krista
K
Taipale
Jouko
J
Yliruusi
D000392:Air Movements; D001241:Aspirin / Q000032:analysis / Q000493:pharmacokinetics; D002626:Chemistry, Pharmaceutical; D020099:Coated Materials, Biocompatible / Q000032:analysis / Q000493:pharmacokinetics; D004355:Drug Stability; D004356:Drug Storage; D006813:Humidity / Q000009:adverse effects; D008747:Methylcellulose / Q000737:chemistry / Q000493:pharmacokinetics; D004364:Pharmaceutical Preparations; D013608:Tablets, Enteric-Coated / Q000032:analysis / Q000493:pharmacokinetics; D014867:Water
D020099:Coated Materials, Biocompatible; D004364:Pharmaceutical Preparations; D013608:Tablets, Enteric-Coated; D014867:Water; D008747:Methylcellulose; D001241:Aspirin