A promising alternative to medication intake
Once placed on your tongue or inside your cheek, oral (ODF) and buccal (MBF) film strips dissolve quickly and distribute the active ingredient. This offers great advantages. The patient’s fear of swallowing pills is eliminated. Also, gastro-intestinal side effects can be reduced. Finally, the drug’s effectiveness is increased. Once in contact with saliva, the active ingredient is released and transferred via the oral mucosa to the body within a very short time – entirely without chewing or the addition of water. MBF are suitable for higher doses and release of the active ingredient is time delayed.
Tablets, capsules and the like have been the established oral drug dosage forms for many years. However, the efficiency to release the active ingredient may be negatively affected. Patients may find haptics, taste or tablet size unpleasant, or have difficulty swallowing. Even fast dissolving tablets don’t completely eliminate these disadvantages, and they are difficult to handle.
A typical ODF is rectangular and between 2 and 10 square centimeters in size. If necessary, the thickness of the carrier material can be increased. MBFs normally have round shapes in order to improve comfort of the MBF within the mouth. The drug quantity for film strips is limited by its polymer matrix and the strip thickness. As a rule, the upper limit of the drug concentration typically corresponds to 30 percent of the total weight. The dimensions of the film strip can be adapted to the desired dosage.
Highly sophisticated production and packaging
The production of ODF and MBF is based on transdermal patch technology for which the typical casting production principle for films is applied. The aqueous polymer formulation is printed or sprayed onto a substrate, then dried. It is also possible to apply a taste-masking coating. The finished film polymer matrix is converted into strips and packed into individual pouches. Optional production methods are melt extrusion, extrusion of an amorphous solid dispersion, and rolling or printing methods.
During development of new products on a laboratory scale, factors such as production, conversion and packaging procedures must be considered up front to enable a smooth scale-up to production level. During high machine speeds, effects can occur which cannot be foreseen during the laboratory stage. This is why the Proof-of-Principle testing is often required in order to identify the impact of different film types and process steps. After analysis and qualification of the aqueous polymer formulation, further questions have to be clarified. For example, how surface and dissolution speed of the film strip influence release of the active ingredient, or which layer application process complies with the exact requirements for thickness, surface properties or weight of the film strip.
As with tablets and capsules, the ODF packaging must generally ensure both safe usage of the product as well as protection until consumption. Ambient environment, conversion and packaging must be controlled in one work step. Since all materials must be protected against moisture and oxygen, the integrity of the seal must be ensured. Also, package design, lengthy storage periods, good printability and economic costs must be taken into account. Opening and use of the pouches should be intuitive, and the dose itself must be clearly recognizable.