Drug Stability

Published: 01st October 2010
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Drug stability means the capability of a drug or a drug substance to remain within an established condition of characteristics, quality of strength and purity within a particular time period. The basic factors that affect the stability of a drug are light, moisture, microbes, and in some case the temperature. The degradation process of a drug increases with the increase of the temperature level. This way, a dangerous bi-product can be formed which can have serious effects on your health. Other things that affect drug stability are the packaging materials, the active ingredients and the components of the drug, and the transportation system.

The drug stability can be of various types. The important types include:

Chemical stability

Microbiological stability

Physical stability

The Process of Drug Stabilization:

Drug stabilization basically means working against all the factors that can cause the decomposition of the drugs. The World Health Organization has some guidelines for the drug stability process to help prevent decomposition of drugs. These include:

Temperature - All the drugs are needed to be stored in a suitable temperature to avoid decomposition. In case of general medicines the temperature should be around 25 degree C and should never be stored above 30 degree C or below 15 degree C. Generally three types of temperatures are mentioned in the labels of the drugs. They are: cold storage, cool storage and room storage.

Humidity - The humidity of the place where the drugs are stored should be around 40-60%. The packing materials of the drug products are also chosen in a manner to help prevent the exposure of the medicines to high humidity.

Light - Drugs that are sensitive to the light are stored usually in the yellowish-brown colored bottles and the tablets are stored in the aluminum foils.

Oxygen - The paper packing of the drugs helps to fight against the oxidation, leaving the minimum oxygen content in the packing. Antioxidants are used in the formulations to achieve this. To select the best suited antioxidant for a medicine, the drug is first placed together with an antioxidant and then its oxidative condition is checked.

Solvents - The hydrolysis rate of a drug can be decreased with the addition of a suitable solvent. Salts and esters can also be used as solvents to prevent in the decomposition of the drugs.

Chelating Agents - Oxidative decomposition can be prevented with the use of the chelating agents. Agents like citric acid, dihydroxyethyl glycine form complexes with metal ions.

In addition to these a stabilization formula is used to induce drug stability and extend the shelf life of most drugs.

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