A1 Vertaisarvioitu alkuperäisartikkeli tieteellisessä lehdessä
Stencil Printing-A Novel Manufacturing Platform for Orodispersible Discs
Tekijät: Wickstrom H, Koppolu R, Makila E, Toivakka M, Sandler N
Kustantaja: MDPI
Julkaisuvuosi: 2020
Journal: Pharmaceutics
Tietokannassa oleva lehden nimi: PHARMACEUTICS
Lehden akronyymi: PHARMACEUTICS
Artikkelin numero: ARTN 33
Vuosikerta: 12
Numero: 1
Sivujen määrä: 15
DOI: https://doi.org/10.3390/pharmaceutics12010033
Verkko-osoite: https://doi.org/10.3390/pharmaceutics12010033
Rinnakkaistallenteen osoite: 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.
Ladattava julkaisu This is an electronic reprint of the original article. |