STUDY OF STABILITY AND DEFINITIONS OF EXPIRATION DATE FOR SUPPOSITORY «DIAFENAT»

Abstract

STUDY OF STABILITY AND DEFINITIONS OF EXPIRATION DATE FOR SUPPOSITORY «DIAFENAT»

N. A. Herbina

National University of Pharmacy, Kharkiv

In the last decade marked a significant tendency to spread destructive inflammatory diseases of the rectum, which are the ten most common diseases among the population ofUkraineand the world. The new combined medicine in the form of suppositories codenamed "Diafenat" was developed under direction of Prof. Dmitrievskiy D.I.  at the Department of Industrial Technology Drug. To the medicine were included, according to symptoms of diseases, original domestic substances: hemostatics – succiphenatum, substance with reparative and anti-inflammatory activity – (±)-cys-3- (2´-bеnzoimidazolyl)-1,2,2-trimethyl-cyclopentancarboxylic acid (diacamph) and a local anesthetic – benzocaine. As a base were chosen proksanol-268 with polyethylenoxide 400 and propylene glycol. Pharmacological studies have shown that combined suppositories "Diafenat" exhibit pronounced reparative, inflammatory, hemostatic and anesthetic effect. Developed medicine was not inferior to comparator (suppository "Olestezyn", JSC "Altayvitaminy»Russia), and in some aspects exceeded its activities.

The complex physical, chemical and microbiological testing of suppositories key indicators  were carried out: description, identification and quantitative analysis of active substances, uniformity, disintegration time, pH, average weight, microbiological purity. Based on the obtained dates indicators methods of quality control for suppositories "Diaphenat" were developed. Stability of suppositories during storage was studied and their  shelf life (2 years at 8,0-15,0 °C) was defined. 

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