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210303_HCQ_Tablets_chemRxiv[1].pdf (1.57 MB)

Hydroxychloroquine Immediate Release Tablets: Formulation and Evaluation of a Solid Dosage Form

preprint
submitted on 08.03.2021, 08:52 and posted on 11.03.2021, 05:23 by Tomaz Einfalt, Pascal Detampel, Daniel Häussinger, Jens Casper, Christoph R. Meier, Maxim Puchkov, Jörg Huwyler
Hydroxychloroquine (HCQ) is a quinoline derivate used for the treatment of malaria and rheumatoid disorders. During early phases of the SARS-CoV2 (COVID-19) pandemic, preliminary and later not substantiated reports suggested that HCQ might benefit COVID-19 patients. This had sparked a worldwide and rapidly rising demand for HCQ drug products. Consequently, patients with pre-existing rheumatic diseases in Switzerland were confronted with an acute drug shortage.

We have therefore designed, produced and characterized a generic HCQ drug formulation. The proposed HCQ formulation can be manufactured by using a minimal number of operation steps (mixing, wet granulation, sieving, blending, compression) and readily available pharmaceutical excipients.

HCQ tablets were manufactured by granulation of the active pharmaceutical ingredient (API), blending with the external phase and compaction using a non instrumented single punch tablet press. Analytics and identification of the API was performed by a combination of NMR, ESI-MS, FTIR and HPLC. HCQ tablets met the quality criteria for an immediate release HCQ dosage form.

We hope that free access to non-proprietary protocols covering analytical procedures, formulation design, and manufacturing instructions for HCQ tablets will help to bridge existing and future supply chain gaps.


Funding

None

History

Email Address of Submitting Author

joerg.huwyler@unibas.ch

Institution

University of Basel

Country

Switzerland

ORCID For Submitting Author

0000-0003-1748-5676

Declaration of Conflict of Interest

None

Version Notes

v1.0 - 8.3.2021

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ChemRxiv

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