Factors Affecting Drug Stability
1. Introduction
A drug stability test is conducted to ascertain a re-test timeframe for any given drug material or shelf life and suggested storage conditions. An increase in the number of products available in the market, globalization of the pharmaceutical industry and customers’ demand for sophisticated products have necessitated more stringent quality control measures. As a result, the focus on stability testing of finished products has increased manifold (Eli Lilly and Company, 2005). Stability tests are conducted to establish and validate the shelf life of a drug product, i
2. Definition of terms
The term ‘shelf life’ refers to the time during which a product retains its original properties when stored under specified conditions (USP ). The term ‘retest period’ refers to the time during which a product that has failed a stability test can be expected to remain within specifications if it is retested (USP ). The term ‘storage conditions’ refer to the temperature, humidity and other factors that need to be controlled during storage of a product in order to ensure its stability (USP ).
3. Objectives
The objective of this study was to review the literature on factors affecting drug stability and to identify possible trends in stability testing.
4. Scope
This review covers publications on drug stability from 2005 to 2015. The scope of this review is limited to publications that discuss factors affecting drug stability, including chemical, physical and biological factors.
5. Significance of study
Stability testing is an important part of quality control for finished pharmaceutical products. It is conducted to ensure that the product meets its quality specifications throughout its shelf life. Stability testing is also important in order to determine the retest period for a product that has failed a stability test. This information is essential for ensuring patient safety and for maintaining the quality of pharmaceutical products in the market.
6. Review of related literature
6.1 Chemical factors affecting drug stability
Chemical instability is one of the most common causes of degradation of pharmaceutical products (Eli Lilly and Company, 2005). Chemical reactions can occur between the active ingredient and excipients, or between different excipients in a formulation. Reactions can also occur between the active ingredient and packaging materials, or between different packaging materials. These reactions can lead to changes in the chemical composition of the product, which may in turn result in changes in physical or biological properties.
There are several factors that can affect the rate of chemical reactions, including temperature, humidity, light exposure and oxygen concentration (Eli Lilly and Company, 2005). In general, reactions occur more rapidly at higher temperatures and higher humidities. Light exposure can also accelerate reactions by providing energy for reaction initiation or by promoting decomposition through photochemical reactions. Oxygen concentration can also affect reaction rates by promoting oxidation reactions.
6. 2 Physical factors affecting drug stability
Physical instabilities are another common cause of degradation of pharmaceutical products (Eli Lilly and Company, 2005). Physical instabilities can be caused by changes in temperature, humidity, light exposure or mechanical stress. These instabilities can lead to changes in physical properties such as color, shape or texture. They can also cause changes in chemical composition or result in changes in biological activity.
Temperature is one of the most important physical variables that can affect drug stability (Eli Lilly and Company, 2005). Most reactions are accelerated at higher temperatures. In general, products should be stored at the lowest possible temperature that is compatible with their intended use.
Humidity can also affect drug stability, particularly for products that are hygroscopic or that contain moisture-sensitive components (Eli Lilly and Company, 2005). In general, it is advisable to store hygroscopic products in a dry environment and to protect them from moisture.
Light exposure can also affect drug stability by causing physical or chemical changes (Eli Lilly and Company, 2005). Light can cause physical changes such as fading of color or degradation of flavor. It can also cause chemical changes such as oxidation or hydrolysis. Products that are light-sensitive should be protected from light by packaging them in opaque containers.
Mechanical stress can also affect drug stability by causing physical or chemical changes (Eli Lilly and Company, 2005). Mechanical stress can cause physical changes such as breakage or deformation. It can also cause chemical changes such as oxidation or hydrolysis. Products that are susceptible to mechanical stress should be handled carefully to avoid damage.
7. Methodology
This study was a review of the literature on factors affecting drug stability. The following databases were searched for relevant publications: PubMed, Web of Science and Google Scholar. The search terms used were “drug stability”, “factors affecting drug stability” and “trends in drug stability testing”. The search was limited to publications in English from 2005 to 2015.
8. Results and discussion
8.1 Chemical factors affecting drug stability
8.1. Temperature
Temperature is one of the most important variables that can affect drug stability (Eli Lilly and Company, 2005). Most reactions are accelerated at higher temperatures. In general, drugs should be stored at the lowest possible temperature that is compatible with their intended use. Storage at higher temperatures can lead to increased rates of chemical reactions, which may result in changes in the chemical composition of the product (Eli Lilly and Company, 2005). These changes may in turn result in changes in physical or biological properties.
8. 1.2 Humidity
Humidity can also affect drug stability, particularly for products that are hygroscopic or that contain moisture-sensitive components (Eli Lilly and Company, 2005). In general, it is advisable to store hygroscopic products in a dry environment and to protect them from moisture. Excessive humidity can lead to increased rates of chemical reactions, which may result in changes in the chemical composition of the product (Eli Lilly and Company, 2005). These changes may in turn result in changes in physical or biological properties.
8. 1.3 Light exposure
Light exposure can also affect drug stability by causing physical or chemical changes (Eli Lilly and Company, 2005). Light can cause physical changes such as fading of color or degradation of flavor. It can also cause chemical changes such as oxidation or hydrolysis. Products that are light-sensitive should be protected from light by packaging them in opaque containers.
8. 1.4 Oxygen concentration
Oxygen concentration can also affect drug stability by promoting oxidation reactions (Eli Lilly and Company, 2005). Oxidation reactions can lead to changes in the chemical composition of the product, which may in turn result in changes in physical or biological properties.
8. 2 Physical factors affecting drug stability
8.2.1 Temperature
Temperature is one of the most important physical variables that can affect drug stability (Eli Lilly and Company, 2005). Most reactions are accelerated at higher temperatures. In general, products should be stored at the lowest possible temperature that is compatible with their intended use. Storage at higher temperatures can lead to increased rates of physical and chemical reactions, which may result in changes in the physical or chemical composition of the product (Eli Lilly and Company, 2005). These changes may in turn result in changes in biological activity.
8. 2.2 Humidity
Humidity can also affect drug stability, particularly for products that are hygroscopic or that contain moisture-sensitive components (Eli Lilly and Company, 2005). In general, it is advisable to store hygroscopic products in a dry environment and to protect them from moisture. Excessive humidity can lead to increased rates of physical and chemical reactions, which may result in changes in the physical or chemical composition of the product (Eli Lilly and Company, 2005). These changes may in turn result in changes in biological activity.
8. 2.3 Light exposure
Light exposure can also affect drug stability by causing physical or chemical changes (Eli Lilly and Company, 2005). Light can cause physical changes such as fading of color or degradation of flavor. It can also cause chemical changes such as oxidation or hydrolysis. Products that are light-sensitive should be protected from light by packaging them in opaque containers.
8. 2.4 Mechanical stress
Mechanical stress can also affect drug stability by causing physical or chemical changes (Eli Lilly and Company, 2005). Mechanical stress can cause physical changes such as breakage or deformation. It can also cause chemical changes such as oxidation or hydrolysis. Products that are susceptible to mechanical stress should be handled carefully to avoid damage.
9. Conclusion
The literature review showed that there are several factors that can affect drug stability, including chemical, physical and biological factors. Among the chemical factors, temperature is the most important variable that can affect drug stability. Most reactions are accelerated at higher temperatures. In general, drugs should be stored at the lowest possible temperature that is compatible with their intended use. Storage at higher temperatures can lead to increased rates of chemical reactions, which may result in changes in the chemical composition of the product. These changes may in turn result in changes in physical or biological properties.
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