Manufacture of Tablets with Structurally-Controlled Drug Release using Rapid Tooling Injection Moulding

With advancements in the pharmaceutical industry pushing more towards tailored medicines, novel approaches to tablet manufacture are in high demand. One of the main drivers towards micro-scale batch production is the ability to fine-tune drug release. This study demonstrates the use of rapid tooling injection moulding (RTIM) for tablet manufacture. Tablets were manufactured with varying structural features to alter the surface area whilst maintaining the same volume, resulting in differing specific surface area (SSA).

The precision of this technique is evaluated based on eleven polymer formulations, with the tablets displaying < 2% variability in mass. Further tablets were produced containing paracetamol in three different polymer-based formulations to investigate the impact of SSA on the drug release. Significant differences were observed between the formulations based on the polymers polyvinyl alcohol (PVA) and Klucel ELF. The polymer base of the formulation was found to be critical to the sensitivity of the drug release profile to SSA modification. The drug release profile within each formulation was modified by the addition of structural features to increase the SSA.

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List of raw materials, their supplier details and their acronyms as used in this study

MaterialSupplierAcronym
Affinisol HPMC HME 15LVThe Dow Chemical Company, USAAFF
Eudragit E POEvonik, GermanyEPO
Klucel EFAshland, USAKEF
Klucel ELFAshland, USAKELF
Klucel LFAshland, USAKLF
Low-density PolyethyleneSigma Aldrich, USALDPE
PolyethyleneSigma Aldrich, USAPE
Polyethylene Glycol 4000Sigma Aldrich, USAPEG
Polyvinyl alcoholSigma Aldrich, USAPVA
Soluplus®BASF, GermanySOL
Sorbitol Emprove Parteck SI 150Merck, USASOR
Stearic AcidSigma Aldrich, USASA
ParacetamolMallinckrodt, UKPCM

Erin Walsh, Natalie Maclean, Alice Turner, Moulham Alsuleman, Elke Prasad, Gavin Halbert, Joop H. ter Horst, Daniel Markl,
Manufacture of Tablets with Structurally-Controlled Drug Release using Rapid Tooling Injection Moulding,
International Journal of Pharmaceutics,2022, 121956, ISSN 0378-5173,
https://doi.org/10.1016/j.ijpharm.2022.121956.

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