Oral thin films (OTF) are a promising novel drug delivery system intended to deliver active therapeutic moieties locally or systemically in the oral cavity under the tongue, on the roof of the mouth, in the intestines, or while held in the mouth.
OTF technologies enable fast or sustained release of the active substance which ensures the ideal dosage to the target location in the body. This method may not be conventional and widely used yet but, it has many benefits for both the patient and the manufacturer and its usage may become even more common shortly.
Types of Oral Thin Films
There are two main types of oral films:
- Oromucosal films; and
- Orodispersible films
Oromucosal films are mucoadhesive and are designed to deliver components either locally or systemically. Oromucucosal films have a sub-category that includes buccal films, sublingual films and palatal films. These films vary depending on the site of application and/or way of absorption.
The second type of oral films, orodispersible films, are mainly non-mucoadhesive and disintegrate in the mouth with saliva. Water and chewing are not necessary for orodispersible films. Orodispersible films are either orally disintegrating or orally dissolving depending on their ability to disintegrate and dissolve in the mouth.
What Makes Up an Oral Thin Film?
Oral film formulations may include, but are not limited to:
- Viscosity Enhancers
- Other Additives like sweetening agents, saliva stimulants, coloring agents, etc.
The two key components are polymers and plasticizers. Choosing the wrong components could alter the hardness, disintegration and dissolution and overall performance of the film. At the end of the day, what matters in a formulation is the success of the product and acceptance by the patient. The OTF must work properly, not threaten patient acceptability and the mechanical properties must make for easy manufacturing.
There are no perfect drug delivery methods on the market and there probably never will be. OTFs have many positives, which will be mentioned soon, but a few improvements are needed as well. One of the areas improvement is needed is in packaging and dosing limitations. Because of this OTFs are more ideal for small dose drugs. Other improvements needed include more research and optimization to allow a wider range of drugs and additional guidance on how to develop and test OTFs.
Advantages of OTFs
There are many advantages to using this novel drug delivery system. OTFs can be a lifesaver for pediatric patients, geriatric patients and patients that have trouble swallowing solids or liquids, contain more accurate dosing, easy to transport and the possibility to reproduce quickly. OTFs are also easily accessible and can be made available for larger surface areas with faster wetting, disintegration and dissolution.
In comparison to tablets and capsules, manufacturing OTFs is much easier, simpler and faster as there are fewer steps. There have also been studies and talks addressing the possibility of incorporating poorly water-soluble films into oral films. Soon the oral film platform technology will be the delivery system of choice – particularly in geriatric and pediatric populations.
Avomeen’s Drug Formulation and Development Services
Avomeen knows manufacturers will face difficult challenges when developing a novel drug delivery system. We have helped clients develop a diverse selection of NDDS, including oral films, and we’re here to help. Contact us to schedule a drug formulation consultation with our expert scientists.
Interested in learning more about formulating an NDDS? Check out our whitepaper that discusses drug formulation including novel drug delivery systems, the pros and cons of certain drug forms and unique challenges in developing an NDDS.
The first step in establishing a good formulation is good pre-formulation services. Get more information on the chemistry behind it all in our blog, Respect the Chemistry, which details API and physicochemical considerations.
In Part 1 of our pharma formulation services blog series, Solving a Problem, we discuss suitable dosage forms, the importance of the goals in development and how formulation is not only an art, but a science.