Effects of Transportation Conditions Across Sudan on The Stability of Medicines

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Gamil, Abd Al-Rhman Mahmoud
El-Nima, El-Amin Ibrahim
El-Tiab, Kamal El-Din
M. Nour, Abu Buker Osman
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The stability of pharmaceuticals mainly influenced by the rate of degradation reaction which in turn greatly affected by temperature variation. According to Arhenius Theory the rate of reaction is exponentially proportional to rise in temperature, and according to Q10 Theory, the rate of reaction increase 2 to 4 folds every 10°C rise in temperature. So, the concept of the Mean Kinetic Temperature was adopted as an expression for the fluctuating temperature. EMRO of WHO specifies 30°C as the maximum transportation temperature for Sudan. Five drug products of different varieties and packaging were transported with electronic temperature and humidity recording devices to six Sudanese cities of different climates. The samples were tested before and after transportation using pharmacopoeial methods. The recorded temperatures were electronically treated by Stability System II software to calculate the Mean Kinetic Temperature. The resulted transportation MKT to all cities, including Khartoum and those using air flight vehicles, exceeded the specified limits. The MKT of Khartoum streets and traffics reached 48.3 °C during summer seasons. The active pharmaceutical ingredients of most drug products utilized were greatly affected and consequently the expiration date will be earlier than that specified in the labels. The average change in Artemether products was 9.7% for tablets and 3.13% for injection. Metronidazole IV fluid lost water resulting in significant increase in concentration of the solute. Amoxicillin trihydrate powder for suspension and Rifampicin tablets lost 6.9% and 6.16% from their potency respectively. It is potentially recommended that transportation and distribution of medicines should be in a controlled specifically licensed conditioned vehicle, datalogger should be attached and the temperature should not exceed the specified limit. Special care should be given to Artemeter products for both quality and handling. Large volume parentrals in plastic container should be avoided whenever it is possible. DRA reference laboratory should be rehabilitated and perfectly equipped and staffed to achieve all stability studies required.
Effects , Transportation ,Conditions ,Sudan,Stability , Medicines