Development Process for Oral Soluble Film

Oral soluble film is a film preparation that can be dissolved in water quickly after a certain dose of drug is loaded into the film material. It has the advantages of rapid disintegration in the oral cavity, thin thickness, light weight, folding and tensile strength, easy to carry, accurate dosage and so on. In addition, it can improve the compliance of the elderly, children and psychiatric patients, and reduce the pain of swallowing.

Oral soluble film preparation methods include solvent casting, hot melt extrusion (HME), semi-solid casting, solid dispersion extrusion and milling. The solvent casting, also known as the coating method, is currently the most used. Solvent casting has the advantage of simple process and low cost, is by far the most practical method of oral film for clinical use, but also one of the most widely used preparation technology. Oral soluble film agent generally consists of the main drug, film-forming materials, plasticizers, corrective agents, coloring agents, buffers (such as sodium citrate, citric acid, etc.), stabilizers (eg, 2,6-di-tert-butyl-4-methylphenol) and solvents components. The oral film may also add disintegrants, wetting agents, surfactants, stabilizers, fillers, etc., depending on the specific situation.

Figure 1. Schematic diagram of oral soluble film process development.

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