Abstract
In contact-less printing, such as piezo-electric drop on demand printing used in the study, the drop formation process is independent of the substrate. This means that having developed a printable formulation, printed pharmaceutical dosage forms can be obtained on any pharmaceutical grade substrate, such as polymer-based films. In this work we evaluated eight different oral films based on their suitability as printing substrates for sodium picosulfate. The different polymer films were compared regarding printed spot morphology, chemical stability and dissolution profile. The morphology of printed sodium picosulfate was investigated with scanning electron microscopy and optical coherence tomography. The spreading of the deposited drops was found to be governed by the contact angle of the ink with the substrate. The form of the sodium picosulfate drops changed on microcrystalline cellulose films at ambient conditions over 8 weeks and stayed unchanged on other tested substrates. Sodium picosulfate remained amorphous on all substrates according to small and wide angle X-ray scattering, differential scanning calorimetry and polarized light microscopy measurements. The absence of chemical interactions between the drug and substrates, as indicated by infrared spectroscopy, makes all tested substrates suitable for printing sodium picosulfate onto them.
| Original language | English |
|---|---|
| Pages (from-to) | 169-180 |
| Number of pages | 12 |
| Journal | International Journal of Pharmaceutics |
| Volume | 547 |
| Issue number | 1-2 |
| Early online date | 18 May 2018 |
| DOIs | |
| Publication status | Published - 25 Aug 2018 |
Funding
This work has been funded within the Austrian COMET Program under the auspices of the Austrian Federal Ministry of Transport, Innovation and Technology (BMVIT), the Austrian Federal Ministry of Economy, Family and Youth (BMWFJ) and by the State of Styria (Styrian Funding Agency SFG). COMET is managed by the Austrian Research Promotion Agency FFG. Bruker-AXS (Karlsruhe, Germany) is acknowledged for providing the Bruker-AXS Microcalix system in this study. We thank our colleagues at the Research Center Pharmaceutical Engineering for technical support. Appendix A
Keywords
- dissolution
- ink jet printing
- orodispersible film
- sodium picosulfate