Kaassis, Abdessamad YA;
Williams, Gareth R;
(2023)
Biocompatible hydroxy double salt tablet formulations.
Journal of Drug Delivery Science and Technology
, Article 104989. 10.1016/j.jddst.2023.104989.
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Abstract
Generally, commercial extended release tablets are core-based, which can cause problems for certain patients if they split them prior to ingestion. There is a need to develop non-core-based extended release tablets. We have previously reported the synthesis of two new biocompatible hydroxy double salts (HDSs), [Mg2Zn3(OH)8]Cl2⋅3.4H2O (MgZn–Cl) and [Fe2.4Zn2.6(OH)8]Cl2⋅2H2O (FeZn–Cl) (J. Mater. Chem. B 2016, 4, 5789), and found them to be good candidates for the extended release of diclofenac (Dic), ibuprofen (SI) and valproate (Val) (Appl. Clay. Sci. 2022, 221, 106456). Here we build on these previous results and report scale-up synthesis of MgZn–Cl and FeZn–Cl loaded with Dic, SI, and Val. The scaled-up products were blended with excipients and formulated into non-core based tablets. The post-compression parameters of the HDS-based tablets were assessed against the pharmacopeia requirements (friability, weight, and dose uniformity) and all passed the tests. Drug release studies were carried out using the paddle method (USPII) in conditions representative of the gastrointestinal tract. The HDS tablets were found to meet the pharmacopeia requirements for modified release dosage forms and showed similar release profiles to current commercial formulations. It is thus possible to develop modified release non-core based tablets using HDSs. These have additional benefits over standard commercial tablets, because the presence of the essential elements Zn, Fe and/or Mg in the layers can compensate for deficiencies induced over long-term treatment, and enhance therapeutic efficacy in some cases. Furthermore, the buffering effect of the HDS layers has the potential to prevent the gastric irritation often associated with the use of non-steroidal anti-inflammatory drugs.
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