Packaging multidose

Multidose Packaging of Unpreserved Topical Drops. In some cases it may be desirable to provide a product without an antimicrobial preservative for patients who exhibit sensitivity to various preservatives. This can be accomplished with the use of unit dose containers, but these usually contain more than that... 

FDA regulations for ophthalmic liquids allow the use of unpreserved multidose packaging if the product is packaged and labeled in such a manner as to afford adequate protection and minimize the hazards resulting from contamination during use (21 CFR 200.50). Thus, the same unit-dose containers can be modified to use a resealable cap and the labehng modified to limit the usage to a minimum number of doses such as to discard after 12 hours from initial use and limit the content volume to the expected number of doses with only a small overfill if necessary. It may be necessary to use a secondary... 

The first example of novel packaging design approaches is a multidose eye-drop pack containing an aqueous solution of a drug used for the treatment of allergic conjunctivitis. The drug is a polar, ionic compound, available as the sodium salt, which is highly water-soluble and has a low lipophilicity. Formulation details are as follows ... 

The preparation of the powder mixture is analogous to the preparation of single-dose powders (see Sect. 4.5), but the flow properties are less critical, because the powder mixture does not have to be distributed evenly over dose units. A diluent is generally not necessary, but in case it is required, lactose is often used. Bulk or multidose powders can be packaged in glass, plastic, metal or other containers that have a wide mouth to allow the handling of the powdermeasuring device. 

However also in many non-sterile medicines discrimination between stability in the intact package and after opening is necessary, because by opening the package, in particular a multidose package, certain conditions will undergo great... 

Maximum usage periods for patients after opening the package, for medicines in multidose containers, with a standardised formula, are given in Table 22.15. These maximum usage periods are only valid within the shelf life of the preparation. 

Be reliably reclosable in case of multidose containers, or in case of single-dose packaging, the closure cannot be reclosed... 

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