Preclinical Validation of MIN-T: A Novel Controlled-Released Formulation for the Adjunctive Local Application of Minocycline in Periodontitis

Małgorzata Benedyk-Machaczka; Piotr Mydel; Karsten Mäder; Marta Kaminska; Nadine Taudte; Marcel Naumann; Martin Kleinschmidt; Sandra Sarembe; Andreas Kiesow; Sigrun Eick; Mirko Buchholz

doi:10.20944/preprints202409.0433.v1

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preprints.org > medicine and pharmacology > dentistry and oral surgery > doi: 10.20944/preprints202409.0433.v1

Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Preclinical Validation of MIN-T: A Novel Controlled-Released Formulation for the Adjunctive Local Application of Minocycline in Periodontitis

Małgorzata Benedyk-Machaczka

Version 1 : Received: 4 September 2024 / Approved: 5 September 2024 / Online: 5 September 2024 (12:28:41 CEST)

How to cite: Benedyk-Machaczka, M.; Mydel, P.; Mäder, K.; Kaminska, M.; Taudte, N.; Naumann, M.; Kleinschmidt, M.; Sarembe, S.; Kiesow, A.; Eick, S.; Buchholz, M. Preclinical Validation of MIN-T: A Novel Controlled-Released Formulation for the Adjunctive Local Application of Minocycline in Periodontitis. Preprints 2024, 2024090433. https://doi.org/10.20944/preprints202409.0433.v1 Benedyk-Machaczka, M.; Mydel, P.; Mäder, K.; Kaminska, M.; Taudte, N.; Naumann, M.; Kleinschmidt, M.; Sarembe, S.; Kiesow, A.; Eick, S.; Buchholz, M. Preclinical Validation of MIN-T: A Novel Controlled-Released Formulation for the Adjunctive Local Application of Minocycline in Periodontitis. Preprints 2024, 2024090433. https://doi.org/10.20944/preprints202409.0433.v1

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MDPI and ACS Style

Benedyk-Machaczka, M.; Mydel, P.; Mäder, K.; Kaminska, M.; Taudte, N.; Naumann, M.; Kleinschmidt, M.; Sarembe, S.; Kiesow, A.; Eick, S.; Buchholz, M. Preclinical Validation of MIN-T: A Novel Controlled-Released Formulation for the Adjunctive Local Application of Minocycline in Periodontitis. Preprints 2024, 2024090433. https://doi.org/10.20944/preprints202409.0433.v1

APA Style

Benedyk-Machaczka, M., Mydel, P., Mäder, K., Kaminska, M., Taudte, N., Naumann, M., Kleinschmidt, M., Sarembe, S., Kiesow, A., Eick, S., & Buchholz, M. (2024). Preclinical Validation of MIN-T: A Novel Controlled-Released Formulation for the Adjunctive Local Application of Minocycline in Periodontitis. Preprints. https://doi.org/10.20944/preprints202409.0433.v1

Chicago/Turabian Style

Benedyk-Machaczka, M., Sigrun Eick and Mirko Buchholz. 2024 "Preclinical Validation of MIN-T: A Novel Controlled-Released Formulation for the Adjunctive Local Application of Minocycline in Periodontitis" Preprints. https://doi.org/10.20944/preprints202409.0433.v1

Abstract

Adjunctive treatment of periodontitis lacks solutions allowing enough time for wound healing in the periodontal pockets by avoiding a fast re-colonization. Such a solution might be an antibiotic containing formulation with a controlled release over weeks. Here, a recently described minocycline containing approach is qualified for further clinical development by focusing on proof-of-concept, systemic burden, resistance development and degradation studies. Animal studies were done in two different (mouse-chamber, rat Porphyromonas gingivalis challenging) models, including effects on inflammation markers, bone loss and bone structure. Also, serum concentrations of minocycline after local application were determined by HPLC-MS/MS. The resistance status of bacterial clinical isolates against minocycline was investigated and the degradation of the formulation was characterized by laser scanning- and scanning electron microscopy. Animal studies clearly demonstrated the applicability of the new formulation in the investigated models. Inflammation markers decreased dosage dependent and reduced bone loss compared to non-treated group was observed. Thereby, the systemic burden of the antibiotic was neglectable. Minocycline is still effective against oral pathogens; resistance development was not seen. The biodegradable thread was first swollen and subsequently degraded over weeks. The results support the continued clinical development of this new formulation. A phase I clinical trial is planned to further evaluate its safety and efficacy.

Keywords

periodontitis; proof-of-concept; adjunctive therapy; minocycline; local application; controlled release; non-clinical; resistance; biodegradation

Subject

Medicine and Pharmacology, Dentistry and Oral Surgery

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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