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Outline
The 2025 edition of the Chinese Pharmacopoeia defines films as film-like preparations made by processing active pharmaceutical ingredients with suitable polymers, intended for oral or mucosal use. Among these, orodispersible films (ODFs) are specifically defined as films that rapidly dissolve in the oral cavity to exert systemic or local effects. ODFs circumvent the drawbacks associated with orally disintegrating tablets, such as fragility and the potential risk of choking. This dosage form has aroused significant interest among both academic world and the pharmaceutical industry due to its accurate dosing, portability, and suitability for elderly and pediatric patients or those with swallowing difficulties. This review summarizes the advantages and limitations of ODFs, their listing status, suitable active pharmaceutical ingredients, commonly used excipients, preparation techniques, and emerging nanoparticle technologies. Additionally, it emphasizes quality evaluation requirements—such as dissolution, disintegration time, and mechanical properties—tailored to the characteristics of this dosage form. The aim is to provide readers and researchers with a comprehensive understanding of the development and evaluation of ODFs.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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