Drug products liquid-based oral

F. Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems... 

If the dosage form contains cosolvents (or if, for any reason, it may be expected to extract greater amounts of substances from plastic packaging components than water), then additional extractable information may be needed to address safety issues. Performance is typically not a factor for liquid-based oral drug products. 

Liquid-based oral drug products are usually dispensed in glass bottles (sometimes in plastic), often with a screw cap with a liner, and possibly with a tamper-resistant seal or an overcap that is welded onto the bottle. The same cap liners and inner seals are sometimes used with solid oral dosage forms. A laminated material can be used to overwrap glass bottles for extra safety. 

Liquid-Based Oral Drug Products Typical liquid-based oral dosage forms are elixirs, emulsions, extracts, fluid extracts, solutions, gels, syrups, spirits, tinctures, aromatic waters, and suspensions. These products are usually nonsterile but may be monitored for changes in bioburden or for the presence of specific microbes. 

A liquid-based oral drug product typically needs to be protected from solvent loss, microbial contamination, and sometimes exposure to light or reactive gases (e.g., oxygen). For glass components, data showing that a component meets the requirements of USP Containers Glass containers are accepted as sufficient evidence of safety and compatibility. For LDPE components, data from USP container tests are typically considered sufficient evidence of compatibility. 

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