Development of Composition and Technologies of Dental Gel of Meloxicam

Maria N. Anurova; Elena O. Bakhrushina; Natalya B. Demina; Alena Sergeevna Kashperko; Ekaterina D. Shevchenko; Elizaveta V. Leshcheva; Ivan I. Krasnyuk; Alaxander I. Bardakov

doi:10.3889/oamjms.2020.4541

Authors

Maria N. Anurova Sechenov First Moscow State University, Moscow, Russia
Elena O. Bakhrushina Sechenov First Moscow State University, Moscow, Russia https://orcid.org/0000-0001-8695-0346
Natalya B. Demina Sechenov First Moscow State University, Moscow, Russia
Alena Sergeevna Kashperko Sechenov First Moscow State University, Moscow, Russia https://orcid.org/0000-0002-9917-6772
Ekaterina D. Shevchenko Eberhard Karls Universität Tübingen, Tübingen, Germany
Elizaveta V. Leshcheva Sechenov First Moscow State University, Moscow, Russia
Ivan I. Krasnyuk Sechenov First Moscow State University, Moscow, Russia
Alaxander I. Bardakov Sechenov First Moscow State University, Moscow, Russia

DOI:

https://doi.org/10.3889/oamjms.2020.4541

Keywords:

meloxicam, dental gel, bioadhesion, mucin, rheology, local irritant effect

Abstract

BACKGROUND: Dental gels have several advantages over other oral dosage forms. Being a viscoplastic dosage form, the gel, when applied to the damaged area of the gum or mucous membrane, creates a protective film, preventing mechanical irritation, and providing a localized effect of the drug components.

AIM: The aim of this work was to develop the composition and technology of the dental gel of meloxicam, the study of the main technological and consumer characteristics, as well as the local irritating effect of the dosage form.

METHODS: Dental gels were prepared using purified water, alcohol, glycerol, and buckthorn oil as solvents, gelling agents used were: Hydroxyethylcellulose Natrosol® 250 HHX Pharm, Carbopol® 974P NF Polymer, and solubilizer Poloxamer 407 (Lutrol® F 127). The bioadhesive component and Noveon® Polycarbophil component were used for dental gel preparation. Aspartame was used as sweetener. Menthol and ascorbic acid were used to correct the organoleptic properties of the pharmaceutical composition. The formulated dental gel of meloxicam at a concentration of 7.5% was evaluated for organoleptic properties, pH, rheological characteristics, bioadhesive properties, and stability under the accelerated aging period. The in vivo local irritant effect was evaluated using ten rabbits by cutaneous, subcutaneous, subconjunctival administration, as well as application to the upper palate.

RESULTS: Based on the results of studying technological and organoleptic properties, the optimal composition based on the Natrosol® 250 HHX hydroxyethylcellulose gelling agent, glycerol solvent, and purified water in the ratio 1/5 was selected, the composition contains Noveon® bioadhesive in an amount of 2%. The composition has good taste, pH close to pH of saliva has high bioadhesive properties, satisfactory rheological characteristics. The shelf life of the experimental series by accelerated aging was 2 years. The selected composition does not have a local irritant effect.

CONCLUSION: A new dosage form of meloxicam was developed – a gel for use in dental practice.

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