Laminated Film Bag for Single Dose Oral Solution

Oral liquid dose includes oral solution, oral suspension, oral emulsion, syrup, mixture. Liquor etc. The common packaging format for oral liquid dose includes glass bottle, plastic bottle, laminated sheet and laminated film/bag. Oral liquid dose packaging can be classified as multiple-dose packaging or single- dose packaging due to packaging formats. Laminated film/bag usually applies to single- dose packaging of oral liquid dose. Generally, the volume of single-dose packaging is no more than 30ml.

Laminated film/bag with different structure/component or other packaging format is allowed according to the specification and requirements of oral liquid dose. This guideline suggests that the administration route of oral liquid dose has low risk, but the possibility of interacting between oral liquid dose and packaging is significant.

Single-dose laminated film/bag provides some benefits of accurate dosage, non-antibacterial agent added formula, lower contamination risks for oral liquid dose. It also contains some convenient performances such as storage, transportation, and easy open. Generally laminated film/bag packaging can do prior printing so as to reduce the migration risk in using adhesive sticker from external labels. Laminated film/bag of single-dose oral liquid should be selected based on well scientific principle. Necessary research content, test method and quality acceptance criteria should be determined based on the laminated film/bag with different structures and compositions, and the content of to-be-packaged oral liquid dose.

The stability and uniformity during different batches of laminated film/bag should be guaranteed. Specific test method or quality acceptance criteria (except for the quoted methods in China Pharmacopeia) or testing list is not provided in this guideline. These details should be determined according to the specific pharmaceutic dose form and administration route of specific container/packaging system. Meanwhile, the quality acceptance criteria should be formulated according to the specific component of package and container packaging system.

This guideline may not cover all kinds of oral liquid dose, interested parties should conduct analysis as well as verification and research work in actual condition. This guideline is complied with existing regulations, standard system and current cognitive level. Relevant content will be adjusted appropriately while regulations and standards are improved continuously along with the development of science and technology. It is not including the administration matter of registration and approval, so it must not be referred as a regulation and should be used on the premise of relevant regulations
（from CNPPA）