THE DEFINITION OF GEL “ALGOZAN” STABILITY IN THE PROCESS OF STORAGE

Authors

  • D. S. Pulyaev National Pharmaceutical University, Kharkiv, Department of factory medicine technology,

DOI:

https://doi.org/10.14739/2409-2932.2014.1.24656

Keywords:

stability, qualitative indices, gel, Diclofenac Diethylamine, dry extract of horse chestnut seeds

Abstract

Introduction. Stability is the main qualitative index of any medicine as it secures the storage of medicine therapeutic features during several years in the process of usage and keeping, so special attention has to be paid on the stage of working out and technology.

The investigations of the stability research should have the definitions of those soft medical form indices which can influence its quality, safety, efficiency and include physical, chemical, microbiological gel parameters and the stabilizers contents.

The aim of the work. The main aim of the work is the definition of gel “Algozan” stability which is intended to be used for locomotorium and phlebitis treatment.

The object of the research is gel “Algozan” on the basis of carbomer which includes Diclofenac Diethylamine, dry extract of horse chestnut seeds. To establish the term of validity the classical method of the stability determination with the periodical analysis of medical forms patterns in35 gmaluminium tubes with varnish inner covering has been used (TY Y25463020-01-98). The research has been carried out using five gel series at two temperature conditions – 8-15º C and 15-25º C. The control has been done in terms which corresponded to every 6 months period within two years.

Results and discussions.

On the basis of organoleptic (form, colour, smell) and physical-chemical (colloid and termostability; pH) research it has been established that the medicine is not susceptible to external factors affect in the process of storage. The index “Particle Size” has been proposed for homogeneity control in the process of gel manufacturing and storage. According to microscopic analysis data all gel patterns are monodispersive systems with the dispersive phase particles from 1 to 2 mkm. The research of the mass tube loss within the period of storage has defined that the mass of the tube contents is stable within the term and is in the limits from 33,6 to36,4 gm.

Anti-microbe agents tests have shown that nipagin, nipasol quantity contests vibration didn’t exceed the average mistake limits of the liquid chromatography method and it is not more than 1,65 mg and 0,55 mg. Received microbiological research data indicates that bacteria of  Enterobacteriaceae, Staphylococcus aureus, Pseudomonas aeruginosa family have not been found in the medical form within the period of observation.

Reograme of this worked out medical form indicates the thixotropic features and characterizes its ability for structure restoration after the destruction, satisfactory appliance, faculty for extrusion from the tube, good tube pre-packing after 2 years storage.

Conclusion. The results allow to predict the storage term of the medicine within 2 years at the temperature 8-25º C and can be taken into account while working out the quality control method project for gel “Algozan”.    

References

Гладышева С.А. Изучение консистентных свойств геля для профилактики и терапии алопецій / С.А. Гладышева, Е.В. Гладух, И.А. Пухальская и др. // Актуальні питання фармацевтичної і медичної науки та практики. – 2010. – № 1. – С. 32.

Державна фармакопея України / Державне п-во «Науково-експертний фармакопейний центр». – 1-е вид. – Доповнення 2. – Х. : РІРЕГ, 2008. – 620 с.

Михайленко В.В. Розробка методик аналізу та вивчення стабільності гелю «Апіарт» / В.В. Михайленко, О.І. Тихонов, В.П. Черненко // Вісник фармації. – 2011. – № 4 (68). – С. 28–30.

Фармацевтичні та медико-біологічні аспекти ліків : навч. посіб. / [І.М. Перцев, О.Х. Пімінов, М.М. Слободянюк та ін.] ; за ред. І.М. Перцева. – Вінниця : НОВА КНИГА, 2007. – 728 с.

Fairweather W.R. Regulatory, Design and Analysis Aspects of Complex Stability Studies / W.R. Fairweather // J. Pharm. Sci. – 1995. – V. 84. – P. 1322–1326.

Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2013 Generics.

Sumie Yo. Stability of Drugs and Dosage Forms/ Yo. Sumie, J.S. Valentino // Kluwer Academic Publishers. – New York, 2002. – 268 р.

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How to Cite

1.
Pulyaev DS. THE DEFINITION OF GEL “ALGOZAN” STABILITY IN THE PROCESS OF STORAGE. Current issues in pharmacy and medicine: science and practice [Internet]. 2014May23 [cited 2024Apr.26];(1). Available from: http://pharmed.zsmu.edu.ua/article/view/24656

Issue

No. 1 (2014)

Section

Pharmaceutical manufacturing

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