Orodispersible Films
Orodispersible films (ODFs) offer another option for rapid drug delivery. These thin films or strips are often more acceptable to patients with dysphagia or a fear of choking than solid dosage forms or ODTs. Films consist of hydrophilic polymers that dissolve in the mouth within seconds. They may be placed on the tongue for oral absorption, under the tongue for sublingual absorption, or along the buccal surface for transmucosal absorption directly into the systemic circulation. The latter route bypasses gut absorption and delivery into the hepatic portal system, thus avoiding first pass metabolism and increasing drug bioavailability.
The ODF formulation has already proven to be a popular means of delivering over-the-counter products such as breath fresheners (Listerine Pocketpaks® Breath Strips), simethicone (Gas-X Thin Strips®), and multivitamins. Several of the first ODFs to reach the market (Benadryl®, Children's Triaminic®, and TheraFlu® thin strips), however, have been subsequently discontinued. The reasons for the removal appear to include production issues as well as poor sales. The latter may reflect the declining use of cough and cold products in children over the past several years. The first prescription ODF, a new formulation of ondansetron (Zuplenz®), was approved by the FDA on July 2, 2010. It is available in both 4 mg and 8 mg strengths and is approved for use in children 4 years of age and older. A month after the release of this product, a buprenorphine ODF (Suboxone® sublingual film) was approved for the treatment of opioid dependence in adults. Several ODFs are currently in development, including films for levocetirizine, rizatriptan, and rotavirus vaccine.