In Situ Gelling Dexamethasone Oromucosal Formulation: Physical Characteristics Influencing Drug Delivery

The study focuses on the development of an in situ gelling dexamethasone (DEX) oromucosal formulation designed for the treatment of aphthous stomatitis. Three series of formulations were prepared; a first series containing DEX suspended, a second series containing DEX and, in addition, mint essentia...

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Main Authors: Daniel Krchňák, Ľudmila Balážová, Michal Hanko, Dominika Žigrayová, Miroslava Špaglová
Format: Article
Language:English
Published: MDPI AG 2025-01-01
Series:Gels
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Online Access:https://www.mdpi.com/2310-2861/11/1/26
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author Daniel Krchňák
Ľudmila Balážová
Michal Hanko
Dominika Žigrayová
Miroslava Špaglová
author_facet Daniel Krchňák
Ľudmila Balážová
Michal Hanko
Dominika Žigrayová
Miroslava Špaglová
author_sort Daniel Krchňák
collection DOAJ
description The study focuses on the development of an in situ gelling dexamethasone (DEX) oromucosal formulation designed for the treatment of aphthous stomatitis. Three series of formulations were prepared; a first series containing DEX suspended, a second series containing DEX and, in addition, mint essential oil (EO), and a third series containing EO and DEX solubilized in propylene glycol (PG). In the composition, polymers in the role of mucoadhesive agent were interchanged (hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), methyl cellulose (MC), carboxymethyl cellulose (CMC), and sodium carboxymethyl cellulose (NaCMC). Specifically, DEX was incorporated at a concentration of 0.1% (<i>w</i>/<i>w</i>) in each formulation. The influence of mint EO and DEX solubilization on the physical properties (pH measurements, rheological analysis, swelling ability, and texture analysis) and in vitro drug release was studied. Key findings revealed that HPMC-based formulation containing mint EO and PG exhibited best swelling properties (700 ± 46% after 5 h), adequate adhesiveness and in vitro drug release (34.7 ± 5.9%). Furthermore, the irritation potential assessed via the hen’s egg test on the chorioallantoic membrane (HET-CAM) demonstrated low irritancy risk. Finally, Fourier-transform infrared spectroscopy (FT-IR) showed no incompatibility between DEX and excipients. Overall, the research highlights the potential of mucoadhesive systems in improving the therapeutic efficacy of oromucosal drug delivery for managing painful oral lesions.
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spelling doaj-art-b688881ffcda4793a369cb6835ab55a42025-01-24T13:33:49ZengMDPI AGGels2310-28612025-01-011112610.3390/gels11010026In Situ Gelling Dexamethasone Oromucosal Formulation: Physical Characteristics Influencing Drug DeliveryDaniel Krchňák0Ľudmila Balážová1Michal Hanko2Dominika Žigrayová3Miroslava Špaglová4Department of Galenic Pharmacy, Faculty of Pharmacy, Comenius University Bratislava, Odbojárov 10, SK-832 32 Bratislava, SlovakiaDepartment of Pharmaceutical Technology, Pharmacognosy and Botany, University of Veterinary Medicine and Pharmacy in Košice, Komenského 73, SK-041 81 Kosice, SlovakiaDepartment of Pharmaceutical Analysis and Nuclear Pharmacy, Faculty of Pharmacy, Comenius University Bratislava, Odbojárov 10, SK-832 32 Bratislava, SlovakiaDepartment of Galenic Pharmacy, Faculty of Pharmacy, Comenius University Bratislava, Odbojárov 10, SK-832 32 Bratislava, SlovakiaDepartment of Galenic Pharmacy, Faculty of Pharmacy, Comenius University Bratislava, Odbojárov 10, SK-832 32 Bratislava, SlovakiaThe study focuses on the development of an in situ gelling dexamethasone (DEX) oromucosal formulation designed for the treatment of aphthous stomatitis. Three series of formulations were prepared; a first series containing DEX suspended, a second series containing DEX and, in addition, mint essential oil (EO), and a third series containing EO and DEX solubilized in propylene glycol (PG). In the composition, polymers in the role of mucoadhesive agent were interchanged (hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), methyl cellulose (MC), carboxymethyl cellulose (CMC), and sodium carboxymethyl cellulose (NaCMC). Specifically, DEX was incorporated at a concentration of 0.1% (<i>w</i>/<i>w</i>) in each formulation. The influence of mint EO and DEX solubilization on the physical properties (pH measurements, rheological analysis, swelling ability, and texture analysis) and in vitro drug release was studied. Key findings revealed that HPMC-based formulation containing mint EO and PG exhibited best swelling properties (700 ± 46% after 5 h), adequate adhesiveness and in vitro drug release (34.7 ± 5.9%). Furthermore, the irritation potential assessed via the hen’s egg test on the chorioallantoic membrane (HET-CAM) demonstrated low irritancy risk. Finally, Fourier-transform infrared spectroscopy (FT-IR) showed no incompatibility between DEX and excipients. Overall, the research highlights the potential of mucoadhesive systems in improving the therapeutic efficacy of oromucosal drug delivery for managing painful oral lesions.https://www.mdpi.com/2310-2861/11/1/26dexamethasoneaphthous stomatitismucoadhesionmint essential oilcellulose derivatives
spellingShingle Daniel Krchňák
Ľudmila Balážová
Michal Hanko
Dominika Žigrayová
Miroslava Špaglová
In Situ Gelling Dexamethasone Oromucosal Formulation: Physical Characteristics Influencing Drug Delivery
Gels
dexamethasone
aphthous stomatitis
mucoadhesion
mint essential oil
cellulose derivatives
title In Situ Gelling Dexamethasone Oromucosal Formulation: Physical Characteristics Influencing Drug Delivery
title_full In Situ Gelling Dexamethasone Oromucosal Formulation: Physical Characteristics Influencing Drug Delivery
title_fullStr In Situ Gelling Dexamethasone Oromucosal Formulation: Physical Characteristics Influencing Drug Delivery
title_full_unstemmed In Situ Gelling Dexamethasone Oromucosal Formulation: Physical Characteristics Influencing Drug Delivery
title_short In Situ Gelling Dexamethasone Oromucosal Formulation: Physical Characteristics Influencing Drug Delivery
title_sort in situ gelling dexamethasone oromucosal formulation physical characteristics influencing drug delivery
topic dexamethasone
aphthous stomatitis
mucoadhesion
mint essential oil
cellulose derivatives
url https://www.mdpi.com/2310-2861/11/1/26
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AT michalhanko insitugellingdexamethasoneoromucosalformulationphysicalcharacteristicsinfluencingdrugdelivery
AT dominikazigrayova insitugellingdexamethasoneoromucosalformulationphysicalcharacteristicsinfluencingdrugdelivery
AT miroslavaspaglova insitugellingdexamethasoneoromucosalformulationphysicalcharacteristicsinfluencingdrugdelivery