Solid Oral Dosage Forms and Powders for Reconstitution

Solid Oral Dosage Forms and Powders for Reconstitution 

The most common solid oral dosage forms are capsules and tablets. For the purpose of this guidance, oral powders and granules for reconstitution are also included in this group. 

A typical container closure system is a plastic (usually HDPE) bottle with a screw-on or snap-off closure and a flexible packaging system, such as a pouch or a blister package. A typical closure consists of a cap — often with a liner — frequently with an inner seal. If used, fillers, desiccants, and other absorbent materials are considered primary packaging components. 

The most common forms of flexible packaging are the blister package and the pouch. A blister package usually consists of a lid material and a forming film. The lid material is usually a laminate, which includes a barrier layer (e.g., aluminum foil) with a print primer on one side and a sealing agent (e.g., a heat-sealing lacquer) on the other side. 

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G. Solid Oral Dosage Forms and Powders for Reconstitution... 

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