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Article

Anionic Methacrylate Copolymer Microparticles for the Delivery of Myo-Inositol Produced by Spray-Drying: In Vitro and In Vivo Bioavailability

by
Roberto Caruana
1,
Maria Grazia Zizzo
2,
Gaetano Felice Caldara
3,
Francesco Montalbano
1,
Silvia Fasciano
4,
Dora Arena
4,
Marida Salamone
4,
Gaetano Di Fazio
4,
Alessandro Bottino
4 and
Mariano Licciardi
2,*
1
Technology Scientific S.r.l., Via del Quarnaro 14, 90144 Palermo, PA, Italy
2
Dipartimento di Scienze e Tecnologie Biologiche Chimiche e Farmaceutiche (STEBICEF), Università degli Studi di Palermo, 90123 Palermo, PA, Italy
3
Dipartimento di Promozione della Salute, Materno-Infantile, di Medicina Interna e Specialistica di Eccellenza “G. D’Alessandro”, Università degli Studi di Palermo, 90123 Palermo, PA, Italy
4
IDI Integratori Dietetici Italiani S.r.l., Via G. Mameli 12, 95020 Aci Bonaccorsi, CT, Italy
*
Author to whom correspondence should be addressed.
Int. J. Mol. Sci. 2024, 25(7), 3852; https://doi.org/10.3390/ijms25073852
Submission received: 30 January 2024 / Revised: 21 March 2024 / Accepted: 28 March 2024 / Published: 29 March 2024
(This article belongs to the Special Issue Novel Biopolymeric Materials Incorporating Bioactive Ingredients and Their Applications)
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Abstract

In this study, a new micro delivery system based on an anionic methacrylate copolymer, able to improve the biological response of myo-inositol by daily oral administration, was manufactured by spray-drying. It has an ideal dose form for oral administration, with an experimental drug loading (DL)% of 14% and a regulated particle size of less than 15 µm. The new formulation features an improvement on traditional formulations used as a chronic therapy for the treatment of polycystic ovary syndrome. The microparticles’ release profile was studied and ex vivo porcine intestinal mucosa permeation experiments were performed to predict potential improvements in oral absorption. Batch n. 3, with the higher Eudragit/MI weight ratio (ratio = 6), showed the best-modified release profiles of the active ingredient, ensuring the lowest myo-inositol loss in an acidic environment. The in vivo evaluation of the myo-inositol micro delivery system was carried out in a rat animal model to demonstrate that the bioavailability of myo-inositol was increased when compared to the administration of the same dosage of the pure active ingredient. The AUC and Cmax of the loaded active molecule in the micro delivery system was improved by a minimum of 1.5 times when compared with the pure substance, administered with same dosage and route. Finally, the increase of myo-inositol levels in the ovary follicles was assessed to confirm that a daily administration of the new formulation improves myo-inositol concentration at the site of action, resulting in an improvement of about 1.25 times for the single administration and 1.66 times after 7 days of repeated administration when compared to pure MI.
Keywords: myo-inositol; spray-drying; controlled release; microparticles; polycystic ovary syndrome (PCOS); anionic methacrylate copolymer myo-inositol; spray-drying; controlled release; microparticles; polycystic ovary syndrome (PCOS); anionic methacrylate copolymer

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MDPI and ACS Style

Caruana, R.; Zizzo, M.G.; Caldara, G.F.; Montalbano, F.; Fasciano, S.; Arena, D.; Salamone, M.; Di Fazio, G.; Bottino, A.; Licciardi, M. Anionic Methacrylate Copolymer Microparticles for the Delivery of Myo-Inositol Produced by Spray-Drying: In Vitro and In Vivo Bioavailability. Int. J. Mol. Sci. 2024, 25, 3852. https://doi.org/10.3390/ijms25073852

AMA Style

Caruana R, Zizzo MG, Caldara GF, Montalbano F, Fasciano S, Arena D, Salamone M, Di Fazio G, Bottino A, Licciardi M. Anionic Methacrylate Copolymer Microparticles for the Delivery of Myo-Inositol Produced by Spray-Drying: In Vitro and In Vivo Bioavailability. International Journal of Molecular Sciences. 2024; 25(7):3852. https://doi.org/10.3390/ijms25073852

Chicago/Turabian Style

Caruana, Roberto, Maria Grazia Zizzo, Gaetano Felice Caldara, Francesco Montalbano, Silvia Fasciano, Dora Arena, Marida Salamone, Gaetano Di Fazio, Alessandro Bottino, and Mariano Licciardi. 2024. "Anionic Methacrylate Copolymer Microparticles for the Delivery of Myo-Inositol Produced by Spray-Drying: In Vitro and In Vivo Bioavailability" International Journal of Molecular Sciences 25, no. 7: 3852. https://doi.org/10.3390/ijms25073852

APA Style

Caruana, R., Zizzo, M. G., Caldara, G. F., Montalbano, F., Fasciano, S., Arena, D., Salamone, M., Di Fazio, G., Bottino, A., & Licciardi, M. (2024). Anionic Methacrylate Copolymer Microparticles for the Delivery of Myo-Inositol Produced by Spray-Drying: In Vitro and In Vivo Bioavailability. International Journal of Molecular Sciences, 25(7), 3852. https://doi.org/10.3390/ijms25073852

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