Uso delle ciclodestrine per la solubilizzazione e la stabilizzazione di farmaci in film sottili polimerici (Oral Thin Films) ad uso farmaceutico. Cyclodextrines for solubilization and stabilization of drugs in Oral Thin Films (OTFS)
The design of efficient films as carriers for drug delivery requires a proper selection of the polymer and excipients used for their fabrication because they affect the ability of the films to swell, degrade and modulate the release of the therapeutic molecule.
The reduced size and thickness as well as the large number of excipients used in the film formulation can severely limit the loading levels capacity of the dosage form. Similarly, uncontrolled crystallization of drug upon fabrication or storage is frequently evidenced in this type of delivery systems, especially when a high dose of the active molecule is included. High concentration of a drug can promote the formation of fractal-shaped aggregates . The presence of these aggregates, commonly observed with lipophilic molecules, can adversely affect the uniformity of the resulting film as well as drug release kinetics and the physical stability during storage.
From a pharmaceutical perspective, the investigation of strategies aimed to avoid drug nucleation and crystal growth as well as the inhomogeneous distribution of the therapeutic molecule deserve special attention as these aspects are of critical importance for the development of commercially viable formulations.
An interesting strategy may be represented by the use of a functional excipient, such as cyclodextrins, which should help maintaining low amount of plasticizer avoiding problems related to drug solubility and crystallization. In particular, the hydroxypropyl-beta-cyclodextrin (HPbCD) may be extremely useful due to its high solubility, good complexing properties and absence of irritant or toxic effects
This project is aimed at developing a mucoadhesive film formulation for topical buccal administration of therapeutic drugs (characterized by low solubility and poor wettability) by investigating the influence of drug complexation with HPbetaCD on mechanical properties as well as dissolution properties and release rate from the buccal film.