The Effects of Environmental Conditions of Sudan on the Stability of Drug Products

Abstract

Drug stability is greatly affected by the environmental conditions especially temperature and humidity. WHO classified Sudan as zone III and recently in 2006 it had been classified by EMRO as zone III and zone IVA. As the climatic conditions in Sudan varies from one region to another, the study aimed at comparing these conditions with the internationally adopted conditions, to investigate the true transportation and storage conditions and their effects on the stability of justifiably selected drug products. The methodology was based on selecting six stations representing different climatic regions and six baskets of nine products together with Dataloggers were delivered to each station. Dataloggers measured and recorded temperature and humidity every 90 minutes during transportation and storage. The products had been tested initially, after transportation, after six months and lastly after 12 months using validated pharmacopoeial methods. The MKT for each station was calculated using data from Dataloggers, data from the adopted meteorological records and meteorological records for the same period of the study by the aid of stability system II, Scienteck MKT program. The resulted MKT for Sudan using the past adopted meteorological records is 31°C and 34°C when using the meteorological records for the same period of the study but the MKT of the controlled room temperature was 26°C to 29°C. The RH was higher in Portsudan, Damazin and Juba while the other parts of the country were very dry. The transportation MKTs for all stations were above 30°C. Almost all utilized products showed significant alternation in the concentrations of the active ingredients. The results had been analyzedusing SPSS, Statistica and Excel software programs to compare the MKTs and to estimate the shelf lives of the products and the following findings were concluded: 1- WHO used the mean of the past adoptedmeteorological records on calculating the MKT for Sudan and it was significantly different from the past and parallel meteorological records of four stations and it did not reflect the true picture of the actual storage conditions because of man interventions to improve the storage conditions. The mean temperature recorded by meteorological authority for the same period of the study was 3.89 °C above that recorded by Dataloggers, and the room v average RH was 6-7% lower than that of the open air. The most drastic and severe conditions for drugs were the transportation conditions which were almost above 40 C° contradicting EMRO recommendation which specified 30 C° as maximum temperature for transportation. 2- All products were labeled to be stored below 25 C°, none of the storage facilities could maintain this MKT resulting in a significant decrease in their shelf-lives. 3- With exception of metronidazole I.V in glass containers, all drug products utilized showed marked stability problems losing fraction of their shelf lives, which is attributed to the drastic transportation conditions, inappropriate storage conditions and some of them was due to quality of the products. 4- Plastic containers for parenteral aqueous fluids and tablets in hospital packs may not withstand the environmental conditions of Sudan. It was recommended that the conditions pointed out by EMRO could be acceptable as an in-house MKT and the RH could be accepted with exclusion of liquid preparation in plastic container. DRA should take immediate actions regarding transportation conditions and it should instruct the reference laboratory to perform such stability studies for all registered products on the basis of EMRO guidelines especially for calculations of the shelf lives. It was also recommended to use the Dataloggers in-house MKT as a global method to determine the storage condition all over the world and if only the meteorological records would have adopted, the MKT for Sudan might be 34 C