Stability studying of antral film-coated tablets
Journal Title: Фармацевтичний журнал - Year 2016, Vol 2, Issue 2
Abstract
Stability studying is very important in process of development of finished drug products. Stability of drugs provides saving of theirs therapeutical properties during several years of shelf life. Stability should be under close attention of the developer, as this parameter is not checked by state control and only is on responsibility of the manufacturer. The aim of the article is a scientific justification of Antral film-coated tablet’s stability during storage and setting the expiration date of the drug. The object of the study was Antral, film-coated tablets 0,2 g. For this research there were used such methods: UV spectrophotometry, TLC and HPTLC. The preparation was evaluated in accordance with the methods of quality control procedures and specifications of the intermediate and finished products, as well as the State Pharmacopoeia of Ukraine. The results of the drug stability studies during stress tests, accelerated and long-term storage tests, were performed. The study was carried out at two temperature conditions: 25 °C and 60% relative humidity and 40 °C and 75% relative humidity and also stress studies to examine the effect of oxidizing agents, acids, alkalis, metals on the impurities formation process in active substance and drug . Based on the forecast by extrapolation of experimental data and long-term stability studies of the drug of pilot scale batches has been established for 2 years, and then the registration expiration date has been confirmed on the basis of long-term stability studies of pilot scale batches. The results of long-term stability studies of production batches allowed to establish the shelf life of the drug for 3 years.
Authors and Affiliations
S. N. Gureyeva, I. А. Kondratova
Keywords
Related Articles
- EP ID EP563134
- DOI -
- Views 49
- Downloads 0
The analysis modern trends of social and effective organization of pharmaceutical provision to rural population in Ukraine
In Ukraine, the pharmaceutical provision of the rural population, which is about 31% in the total population of the country, requires a qualitatively new approaches taking into account the social orientation of the pharm...
Analysis of dynamics of the drug list in the аffordable medicines program for treatment of cardiovascular diseases
The implementation of the government program on reimbursement in Ukraine meets the requirements of WHO to ensure access to drugs, especially in the treatment of cardiovascular diseases (CVD). The list of TN drugs includ...
Evaluation of pharmacotherapy of patients with measles in the hospital by ABC-, VEN- and frequency analysis
The use of a routine vaccination to prevent infectious diseases have proved to be effective for many years. However, to date, due to lack of government funding for the timely ensuring by the necessary vaccines of polycli...
Laboratory preparation and quality control of medicinal composition based on nanosilica and polymethylsiloxane
The prepared ex tempore adsorption composition which consists of nanosilica, polymethylsiloxane, metronidazole and decamethoxin serves as an effective mean for the topical treatment of wounds. The aim of the study was t...
Dynamics of accessibility of medicines for type 2 diabetes monotherapy in Ukraine
Diabetes mellitus is recognized as noninfectious epidemic in the world. Antidiabetic medications for the patients are taking continually and they are expensive. So, the actual question is the evaluation of the economic a...