Pharmaceutical development of an adhesive gel based on a biodegradable natural complex

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Introduction. One of the most important issues in the development and improvement of pharmacy is the creation of original and increasing the effectiveness of existing dosage forms. At the same time, there is justifiable interest in the group of application dosage forms (ADF), which have many advantages, both biopharmaceutical and technological and economic in nature. At the same time, the most significant and promising within this group are dosage forms such as gels and films.

Purpose of the study – development of optimal composition, adhesive gel technology, pharmacological confirmation of effectiveness on a model of intestinal anastomosis.

Material and methods. To obtain an adhesive gel, compositions based on Na-CMC (0.5–1.5%), Na-alginate (0.5–1.5%) and chitosan (1–3%) were prepared. The osmotic capacity of the gels was studied using a model of dialysis through a semipermeable membrane. The adhesive properties of the gel were determined on an experimental model of intestinal anastomosis by the time of localization of the film-gel complex at the site of application. The biodegradation properties of the film-gel complex were also studied in in vitro and in vivo experiments.

Results. A 1.5% gel based on Na-CMC has a greater capacity compared to other prototypes, capable of absorbing up to 12.56% of moisture from its own weight. Gel based on Na-alginate (1.5%) absorbs up to 10.20%, and chitosan (3.0%) – up to 11.05% moisture. The “film-gel” complex based on chitosan gel (3.0%) did not migrate from the site of application within 128 hours, which indicates its satisfactory adhesive properties, since the time during which the complex was at the site of localization corresponds to the critical time the period during which coronary artery failure most often occurs. The film-gel complex biodegraded in the blood plasma of rats within 136 hours, and remained in the abdominal cavity of rats at the site of application for up to 7 days.

Conclusions. Comparative studies of various models of adhesive gels obtained on different bases were carried out: Na-CMC (1.5%), Na-alginate (1.5%) and chitosan (3.0%) and showed the advantages of a gel based on chitosan in relation to its ability to ensure film fixation at the application site.

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作者简介

S. Rytchenkov

Volgograd State Medical University of the Ministry of Health of the Russian Federation

编辑信件的主要联系方式.
Email: rytchenkovs@gmail.com
ORCID iD: 0009-0005-7597-4138

Lecturer, Department of Disaster Medicine, Institute of Public Health named after. N.P. Grigorenko

俄罗斯联邦, Volgograd

S. Poroisky

Volgograd State Medical University of the Ministry of Health of the Russian Federation

Email: poroyskiy@mail.ru
ORCID iD: 0000-0001-6990-6482

Dr.Sc. (Med.), Associate Professor, Head Department of Disaster Medicine, Institute of Public Health named after. N.P. Grigorenko

俄罗斯联邦, Volgograd

E. Stepanova

Pyatigorsk Medical-Pharmaceutical Institute – branch of the Volga State Medical University of the Ministry of Health of the Russian Federation

Email: e.f.stepanova@mail.ru
ORCID iD: 0000-0002-4082-3330

Dr.Sc. (Pharm.), Professor, Professor of the Department of Pharmaceutical Technology with a Course in Medical Biotechnology

俄罗斯联邦, Pyatigorsk

Т. Tatarenko-Kozmina

Scientific Research Institute "Clinical Medicine named after. N. A. Semashko"; Moscow State Medical and Dental University named after A.I. Evdokimov Ministry of Health of the Russian Federation

Email: kosmtina025@gmail.com

Dr.Sc. (Biol.), Head of Department of Medical Biology with the Fundamentals of Cellular and Molecular Biotechnology

俄罗斯联邦, Moscow; Moscow

А. Pleten

Moscow State Medical and Dental University named after A.I. Evdokimov Ministry of Health of the Russian Federation

Email: pleatol@mail.ru
ORCID iD: 0000-0003-4991-2150

Dr.Sc. (Biol.), Professor of the Department of Biological Chemistry

俄罗斯联邦, Moscow

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2. Fig.1. An experimental model of applying an applicative dosage form to the intestinal anastomosis of the pig intestine in order to study the adhesive properties of the gel: a – a film-gel complex superimposed on the formed intestinal anastomosis of the pig intestine fixed on a hollow glass tube; b – a film-gel complex superimposed on the formed intestinal anastomosis of the pig intestine fixed on a hollow glass tube placed in an experimental medium of a sodium phosphate buffer solution

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3. Fig. 2. A film-gel complex superimposed on pig intestines, fixed on a hollow rubber tube, placed in rat blood plasma in order to study biodegradation

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4. Fig. 3. Rat blood plasma with fragments of the film-gel complex decomposed by plasma enzymes after the study

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5. Fig. 4. Application dosage form covering the injured area of the intestine for 3 days in the abdominal cavity of rats

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6. Fig. 5. Absence of an application dosage form on the injured part of the intestine of the abdominal cavity of a rat on the 7th day of the experiment

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