Pharmaceutical packaging is considered an integral part of the formulation development in the industry and exerts profound impact on the stability of drug product throughout product shelf life. Selection of packaging material is based upon the type of dosage form, route of administration, chemical nature of the active pharmaceutical ingredients and excipient used in the formulations. among the liquid dosage forms, Non injectable liquid formulations such as elixirs, suspensions, syrups etc are less susceptible to interaction with packaging material as compared to the injectable formulations due to significant difference in the preparation techniques. In the present review, we focus on the packaging aspects of non-injectable liquid formulations. Different packaging materials, which can be used for the packaging of non-injectable liquid formulation are discussed. Regulatory aspects of Unlisted State Food and Drug Administration [USFDA] and European Medicines Agency [EMA] are also highlighted. Additionally, packaging of non-injectable liquid formulation for pediatric use is discussed.
Key words: Non-injectable liquids, USFDA, EMA, Packaging material
|
