Films PHARMACEUTICAL DOSAGE FORMS

〈1151〉 PHARMACEUTICAL DOSAGE FORMS

This article is based on the requirement of the United State Pharmacopoeia.

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Films

Films are thin sheets that are placed in the oral cavity. They contain one or more layers. A layer may or may not contain the drug substance. Typically, these thin sheets are formed by casting or extrusion that results in a dispersion of the components through the film. Films are classified by the site of application. “Oral 􀂦films” can be formulated to deliver medication to the mouth such as oral hygiene products or to deliver medication to the gastrointestinal tract for absorption. “Buccal 􀂦films” and “sublingual films” are formulated to facilitate absorption through the proximal mucosal membranes avoiding 􀂦first-pass metabolism or degradation in the gastrointestinal tract and providing a quick onset of action.

Films can be formulated with edible polymers such as pullulan or with water-soluble polymers such as modified cellulose, edible gums, and copolymers. The dissolution rate of the 􀂦film is controlled to facilitate incorporation of the medication into saliva or for absorption by the proximal mucosa. These films must be substantial enough to maintain their integrity during manufacture and packaging and permit handling by the patient. Because of the rapid dissolution, taste and mouthfeel are important considerations.

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