Packaging topical drug products

Topical dosage forms such as unpressurized sprays, lotions, ointments, solutions, and suspensions may be considered for marketing in glass bottles with appropriate dispenser. Some topical drug products, especially ophthalmic, are sterile or may be subject to microbial limits. In these cases, packaging material and handling should be done as those for injectables. 

Containers used for topical administration include plastics, glass, and metals. Most topical preparations are packaged in plastic jars, metal tubes, glass jars or, in some cases, a combination of these materials. Suitable tests are performed to ensure that drug products do not leach or react with the proposed containers. The various types of topical formulations are discussed in Pharmaceutical Dosage Forms (1151) of the USP/NFP ... 

Accelerated stability tests provide a means of comparing alternative formulations, packaging materials, and/or manufacturing processes in short-term experiments. As soon as the final formulation and manufacturing process have been established, the manufacturer carries out a series of accelerated stability tests which will enable the stability of the drug product to be predicted and its shelf-life and storage conditions determined. Real-time studies must be started at the same time for confirmation purposes. Suitable measures should be taken to establish the utilization period for preparations in muitidose containers, especially for topical use. 

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