THE USE OF HAMSTER CHEEK POUCHES DURING PRECLINICAL STUDIES OF ORAL DISPERSIBLE DRUGS

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DOI: https://doi.org/None
Issue: 
7
Year: 
2016

A.V. Kalatanova (1); O.I. Avdeeva (1), PhD; M.N. Makarova (2), MD; A.A. Muzhikyan (1), PhD; V.V. Shedko (1); G.V. Vanatiev (1), PhD; V.G. Makarov (2), MD; M.V. Karlina (2), PhD; O.N. Pozharitskaya (2), PhD 1 -DOM FARMATSII (PHARMACY HOME) Research and Production Association; 245, Kuzmolovskoe Urban Settlement, Kuzmolovsky Urban-Type Locality, Vsevolozhsky District, Leningrad Region 188663, Russian Federation; 2 -Saint Petersburg Institute of Pharmacy; 27, Partizanskaya St., Office 424, Saint Petersburg 195248, Russian Federation

Introduction. Oral soluble or dispersible dosage forms attract the greater attention of investigators. Oral dispersible formulations and standard tablets vary substantially in pharmacokinetics. Preclinical studies require an appropriate biological model. Hamsters that have large cheek pouches are used as a model of stomatitis to evaluate the irritant action of toothpastes. Objective: to assess whether it is expedient to use hamster cheek pouches for the evaluation of the toxic effects and locally irritant action of oral dispersible dosage forms. Material and methods. The investigation used male Syrian hamsters as a test system. Model oral dispersible tables and lozenges were transbuccally administered to the animals. The locally irritant effects were evaluated by erythema severity and histological assessment of the tissues in direct contact with the objects. The histological specimens were morphologically examined using a light optical Carl Zeiss Axio Scope A1 microscope. Results. The paper gives the results of preclinical experimental studies to evaluate the effectiveness of determining the toxic effects and locally irritant action of the drugs (oral dispersible tablets and lozenges) that are orally disintegrated when administered into the hamster cheek pouches. It also shows that it is necessary to use placebo and gives recommendations on the time of assessing the negative effect on the oral mucosa. Conclusion. There is evidence that the anatomical location and histological structure of hamster cheek pouches allow the use of this model to investigate the toxicological and pharmacological properties of oral dispersible drugs and to evaluate their locally irritant action.
Keywords: 
oral dispersible drugs
pharmacokinetics
locally irritant action
hamsters
cheek pouches
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