Ultrasound-assisted powder-coating technique to improve content uniformity of low-dose solid dosage forms.
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Ultrasound-assisted powder-coating technique to improve content uniformity of low-dose solid dosage forms. / Genina, Natalja; Räikkönen, Heikki; Antikainen, Osmo; Heinämäki, Jyrki; Yliruusi, Jouko.
In: AAPS PharmSciTech, Vol. 11, No. 3, 2010, p. 1320-1327.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Ultrasound-assisted powder-coating technique to improve content uniformity of low-dose solid dosage forms.
AU - Genina, Natalja
AU - Räikkönen, Heikki
AU - Antikainen, Osmo
AU - Heinämäki, Jyrki
AU - Yliruusi, Jouko
PY - 2010
Y1 - 2010
N2 - An ultrasound-assisted powder-coating technique was used to produce a homogeneous powder formulation of a low-dose active pharmaceutical ingredient (API). The powdered particles of microcrystalline cellulose (MCC; Avicel® PH-200) were coated with a 4% m/V aqueous solution of riboflavin sodium phosphate, producing a uniform drug layer on the particle surfaces. It was possible to regulate the amount of API in the treated powder. The thickness of the API layer on the surface of the MCC particles increased near linearly as the number of coating cycles increased, allowing a precise control of the drug content. The tablets (n = 950) prepared from the coated powder showed significantly improved weight and content uniformity in comparison with the reference tablets compressed from a physical binary powder mixture. This was due to the coated formulation remaining uniform during the entire tabletting process, whereas the physical mixture of the powders was subject to segregation. In conclusion, the ultrasound-assisted technique presented here is an effective tool for homogeneous drug coating of powders of irregular particle shape and broad particle size distribution, improving content uniformity of low-dose API in tablets, and consequently, ensuring the safe delivery of a potent active substance to patients.
AB - An ultrasound-assisted powder-coating technique was used to produce a homogeneous powder formulation of a low-dose active pharmaceutical ingredient (API). The powdered particles of microcrystalline cellulose (MCC; Avicel® PH-200) were coated with a 4% m/V aqueous solution of riboflavin sodium phosphate, producing a uniform drug layer on the particle surfaces. It was possible to regulate the amount of API in the treated powder. The thickness of the API layer on the surface of the MCC particles increased near linearly as the number of coating cycles increased, allowing a precise control of the drug content. The tablets (n = 950) prepared from the coated powder showed significantly improved weight and content uniformity in comparison with the reference tablets compressed from a physical binary powder mixture. This was due to the coated formulation remaining uniform during the entire tabletting process, whereas the physical mixture of the powders was subject to segregation. In conclusion, the ultrasound-assisted technique presented here is an effective tool for homogeneous drug coating of powders of irregular particle shape and broad particle size distribution, improving content uniformity of low-dose API in tablets, and consequently, ensuring the safe delivery of a potent active substance to patients.
KW - content uniformity
KW - homogeneity
KW - low-dose api
KW - powder coating
KW - ultrasound
U2 - 10.1208/s12249-010-9514-9
DO - 10.1208/s12249-010-9514-9
M3 - Journal article
C2 - 20730575
VL - 11
SP - 1320
EP - 1327
JO - AAPS PharmSciTech
JF - AAPS PharmSciTech
SN - 1530-9932
IS - 3
ER -
ID: 145538684