A1 Refereed original research article in a scientific journal
Stencil Printing-A Novel Manufacturing Platform for Orodispersible Discs
Authors: Wickstrom H, Koppolu R, Makila E, Toivakka M, Sandler N
Publisher: MDPI
Publication year: 2020
Journal: Pharmaceutics
Journal name in source: PHARMACEUTICS
Journal acronym: PHARMACEUTICS
Article number: ARTN 33
Volume: 12
Issue: 1
Number of pages: 15
DOI: https://doi.org/10.3390/pharmaceutics12010033
Web address : https://doi.org/10.3390/pharmaceutics12010033
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/46672941
Stencil printing is a commonly used printing method, but it has not previously been used for production of pharmaceuticals. The aim of this study was to explore whether stencil printing of drug containing polymer inks could be used to manufacture flexible dosage forms with acceptable mass and content uniformity. Formulation development was supported by physicochemical characterization of the inks and final dosage forms. The printing of haloperidol (HAL) discs was performed using a prototype stencil printer. Ink development comprised of investigations of ink rheology in combination with printability assessment. The results show that stencil printing can be used to manufacture HAL doses in the therapeutic treatment range for 6-17 year-old children. The therapeutic HAL dose was achieved for the discs consisting of 16% of hydroxypropyl methylcellulose (HPMC) and 1% of lactic acid (LA). The formulation pH remained above pH 4 and the results imply that the drug was amorphous. Linear dose escalation was achieved by an increase in aperture area of the print pattern, while keeping the stencil thickness fixed. Disintegration times of the orodispersible discs printed with 250 and 500 mu m thick stencils were below 30 s. In conclusion, stencil printing shows potential as a manufacturing method of pharmaceuticals.
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