Pharmaceutical product shelf-life physical stability

Topical preparations, like all other dosage forms, must be formulated, manufactured, and packaged in a manner that assures that they meet general standards of bioavailability, physical (physical system) stability, chemical (ingredient) stability, freedom from contamination, and elegance. Like all other pharmaceuticals, these factors must remain essentially invariant over the stated shelf life of the product and they must be reproducible from batch to batch. 

Stability of Liposomes A shelf life of at least two years is requested for pharmaceutical products. Therefore, chemical stability and physical stability are important parameters for the overall performance of liposomal formulations. Additionaly, another very important factor is the retention of encapsulated drug. 

Knowledge of the physical stability of a formulation is very important for two reasons. First, a pharmaceutical product must look fresh and elegant as long as it remains on the shelf. Second, the active ingredient must be available to the patient throughout the expected shelf life of the product. The causes of deterioration in quality of active ingredient could be due to incompatibility with excipients, oxidation, reduction, hydrolysis, and racemization to name a few. 

Emulsions are used extensively in the food, pharmaceutical, and cosmetics industries, where their most important properties include stability (both physical and qualitative), rheology, reactivity, shelf life, texture, appearance, and flavor. All of these properties are affected by droplet size and/or size distribution [107,108], which in turn are functions of the method of production. Because emulsions are thermodynamically unstable, they require energy input for production and usually rely on a stabilizing agent (emulsifier, surfactant) to remain stable over long periods [109]. 

Stability The ability of a pharmaceutical product to retain its chemical, physical, microbiological and biopharmaceutical properties within specified limits throughout its shelf-life. 

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