Evaluation of different substrates for inkjet printing of rasagiline mesylate.
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Evaluation of different substrates for inkjet printing of rasagiline mesylate. / Genina, Natalja; Janßen, Eva Maria; Breitenbach, Armin; Breitkreutz, Jörg; Sandler, Niklas.
In: European Journal of Pharmaceutics and Biopharmaceutics, Vol. 85, No. 3 Pt B, 11.2013, p. 1075-83.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Evaluation of different substrates for inkjet printing of rasagiline mesylate.
AU - Genina, Natalja
AU - Janßen, Eva Maria
AU - Breitenbach, Armin
AU - Breitkreutz, Jörg
AU - Sandler, Niklas
PY - 2013/11
Y1 - 2013/11
N2 - The main goal of the present study was to evaluate applicability of the different model substrates, namely orodispersible films (ODFs), porous copy paper sheets, and water impermeable transparency films (TFs) in preparation of the inkjet-printed drug-delivery systems. Rasagiline mesylate (RM) was used as a low-dose active pharmaceutical ingredient (API). Flexible doses of the drug in a single unit were obtained by printing several subsequent layers on top of the already printed ones, using an off-the-shelf consumer thermal inkjet (TIJ) printer. The produced drug-delivery systems were subjected to microscopic and chemical analysis together with solid-state characterization and content uniformity studies. The results revealed that RM recrystallized on the surface of ODFs and TFs, and the printed crystals were arranged in lines. No drug crystals were detected after printing on the surface of the copy paper due to absorption of the ink into the matrix of the substrate. The best linear correlation between the dose of the drug and the number of the printing layers was obtained for the porous copy paper. The other two substrates showed poor linearity and unacceptable standard deviations of the printed drug substance due to limited absorption of the API ink into the carrier. The shear stress between the substrate, the print head, and the paper feeding rollers caused smearing of the drug that had been surface-deposited during the earlier printing cycles. In conclusion, this study indicates that the edible substrates with absorption properties similar to copy paper are favorable for successful preparation of drug-delivery systems by TIJ printers.
AB - The main goal of the present study was to evaluate applicability of the different model substrates, namely orodispersible films (ODFs), porous copy paper sheets, and water impermeable transparency films (TFs) in preparation of the inkjet-printed drug-delivery systems. Rasagiline mesylate (RM) was used as a low-dose active pharmaceutical ingredient (API). Flexible doses of the drug in a single unit were obtained by printing several subsequent layers on top of the already printed ones, using an off-the-shelf consumer thermal inkjet (TIJ) printer. The produced drug-delivery systems were subjected to microscopic and chemical analysis together with solid-state characterization and content uniformity studies. The results revealed that RM recrystallized on the surface of ODFs and TFs, and the printed crystals were arranged in lines. No drug crystals were detected after printing on the surface of the copy paper due to absorption of the ink into the matrix of the substrate. The best linear correlation between the dose of the drug and the number of the printing layers was obtained for the porous copy paper. The other two substrates showed poor linearity and unacceptable standard deviations of the printed drug substance due to limited absorption of the API ink into the carrier. The shear stress between the substrate, the print head, and the paper feeding rollers caused smearing of the drug that had been surface-deposited during the earlier printing cycles. In conclusion, this study indicates that the edible substrates with absorption properties similar to copy paper are favorable for successful preparation of drug-delivery systems by TIJ printers.
KW - Absorption
KW - Administration, Oral
KW - Antiparkinson Agents
KW - Antiparkinson Agents: chemistry
KW - Chemistry, Pharmaceutical
KW - Chemistry, Pharmaceutical: methods
KW - Drug Delivery Systems
KW - Indans
KW - Indans: chemistry
KW - Ink
KW - Mesylates
KW - Mesylates: chemistry
KW - Microscopy, Electron, Scanning
KW - Pharmaceutical Preparations
KW - Pharmaceutical Preparations: chemistry
KW - Porosity
KW - Printing
KW - Printing: methods
KW - Stress, Mechanical
KW - Surface Properties
KW - Viscosity
KW - X-Ray Diffraction
U2 - 10.1016/j.ejpb.2013.03.017
DO - 10.1016/j.ejpb.2013.03.017
M3 - Journal article
C2 - 23563101
VL - 85
SP - 1075
EP - 1083
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
SN - 0939-6411
IS - 3 Pt B
ER -
ID: 145539071