When it comes to administering drugs, the oral route has always been a popular one. How does the saying go? Over the lips, past the gums, look out stomach here it comes! Although it bears mentioning that all drugs that go over the lips are not destined for the stomach. Yes, there are medicines in pill form that are meant to be swallowed outright — or chewed first and swallowed after — but there are also drugs absorbed sublingually (underneath the tongue) and buccally (through the lining of the cheek). These methods of drug delivery have seen a surge in popularity over recent years, and for good reason. They provide a whole host of benefits to patients, drug administrators, and drug companies.
Relative to other drug delivery systems, oral thin films (OTFs) are a newer concept in medicine. Which drugs can and cannot be formulated for this method of delivery remains to be seen and largely depends on invention. At Tapemark, we are one of the industry’s foremost leaders in the development and manufacturing of OTF drugs. If you have a drug you’d like to develop for OTF delivery, let’s talk.
Now, for a little background information on this growing, innovative drug delivery system.
How does oral thin film drug delivery work?
Upon contact with a wet surface, OTFs dissolve as quickly as their formulated action. They are typically administered under the tongue (sublingual OTF) or against the cheek (buccal OTF). Either route allows the drug to be quickly and efficiently absorbed into the bloodstream.
The film contains the drug, and it is developed with rapidly dissolving polymers that react when they come into contact with any liquid. The natural moisture content of a patient’s mouth is oftentimes enough to dissolve the film.
One of the key benefits of this drug delivery system is the simplicity of the drug administration process. Due to the quick-dissolving nature of OTF medication, it is virtually impossible to reject the dose once administered. This makes it an ideal method for patients who have a difficult time taking more drugs via more traditional systems, like capsules, pills, and chewable tablets.
OTFs vs Pills and Chewables
OTFs make drug delivery more accessible for patients. There is a sizable portion of the population that struggle with existing forms of drug delivery like oral solids. Just about everyone knows someone who has a hard time swallowing pills, and OTF formulations provide an excellent alternative.
OTFs are also a great option for individuals who struggle with chewing and swallowing and need a simpler, more accessible option. While there are individuals of all ages who stand to benefit from OTF drug delivery, children and the elderly members of our population are notable groups.
Why choose oral thin film drug delivery?
When OTC and RX drugs became available in pill form, the ease and accessibility they provided forever changed the patient experience and the pharmaceutical industry as a whole. Suddenly, individuals could access and ingest single, pre-packaged pills as a form of treatment. The pills could deliver a consistent dose, time after time, in an easy to manage manner. While a game changer in oral drug delivery systems, pills were never the ideal solution for all patient populations, leaving room in the market for more innovation in the arena of drug delivery. Here is a look at the primary benefits of OTF drug delivery.
Benefits of oral thin film drug delivery
Because OTFs are absorbed directly into systemic circulation via the oral cavity, the drug being administered bypasses the GI tract. This bypass yields a handful of meaningful benefits.
First, it means OTFs are not subject to the first pass effect, which removes a handful of variables from the formulation process.
Next, bypassing the GI tract eliminates many of the common side effects of other orally administered drugs that often accompany pills or chewable tablets. Many patients present gastrointestinal distress after swallowing drugs, but since OTFs are never swallowed, they are not likely to cause an upset stomach.
But these aren’t the only benefits that make OTFs an ideal method for pediatric and geriatric patients, as well as other patient demographics that may struggle with swallowing or maintain a fear of choking.
OTFs do not require chewing, swallowing, or drinking liquids for administration. They dissolve quickly, making it difficult for the patient to reject the dose once administered.
OTFs also work well for administering precise dosing. Whether you’re working with adults who require partial dosing or children who respond best with smaller doses, OTFs can satisfy that need given they are more precise than tablets.
Simple manufacturing process
While there is near-infinite complexity in the development of OTF medication, the actual manufacturing process is relatively simple. For pharmaceutical companies, much of the heavy lifting is done on the front end of development. Once a viable drug is developed, the remaining steps of bringing it to market are relatively short, especially when compared to that of other drug delivery systems.
If you’ve ever tried to take a pill or capsule by mixing the medicine with a food item like applesauce or pudding, you already know how unpleasant medicine designed for oral delivery can taste.
OTF formulation includes a process called taste masking where the film is formulated to contain a more palatable flavor, like mint. Taste masking can be especially helpful when administering the drug to children.
As a result of these many benefits, pharmaceutical companies large and small are working to develop new formulations for OTF drug delivery. As the number of OTF drugs in the market increase, their benefits become more understood by patients and healthcare providers.
Oral thin film drug development process
To develop a successful oral thin film for drug delivery is a major undertaking. It requires a level of expertise most pharmaceutical companies do not have in-house. As a result, many are choosing to partner with a full-service CDMO for the development of OTF drugs.
Still, it’s common for drug developers to underestimate the complexity that goes into formulating a compound for sublingual or buccal film delivery for transdermal delivery. With 20years of experience developing, manufacturing, converting, and packaging soluble film, Tapemark is the industry leader in oral thin film drug delivery.
Watch this video with Tapemark's Andrew Day to learn about sublingual film formulation:
We partner with clients at every step on their oral thin film projects. Our services include early-stage drug development services—like formulation and small-scale, handmade prototyping—through large-scale registration and commercialization. In addition to early-stage development expertise, we bring significant, successful experience with numerous tech transfer projects as well as site-change initiatives.
OTF vs Transdermal Drug Delivery
The expertise required to develop OTF drugs has a fair amount of crossover with transdermal drug development. Yes, these routes of administration are absolutely different, but someone with expertise in one is going to start out with a leg up on the other. At Tapemark, our expertise in the realm of transdermal drug delivery technologies lends us a unique advantage in the development of thin film drug delivery.
Consider Tapemark Your OTF Expert
Our oral thin film experience includes buccal, sublingual, dissolvables, and multi-layer complex films. We have partnered with many companies to produce therapeutics for various treatment modalities, including pain, CNS, and addiction. Whether your transmucosal project involves branded, generic, or an OTC pharmaceutical, we have the experience to help you be successful in bringing an OTF drug to market.
Our clients rely on us to guide them through every stage of product and process development. With industry-leading expertise in sublingual films, oral dissolvable films, and integrated overlays, we bring our resources and experience to every new client relationship.
For us, there is no OTF project too complex. If you have something you want to accomplish, let’s discuss your project one-on-one.