September 4, 2024

The uses and appeal of oral dissolving strips is growing.

The Appeal of Oral Dissolving Film Strips

Oral dissolving film strips are hard to resist. After all, what better way to take a prescription, a medicine, that to simply put something light on your tongue, that melts away in seconds and tastes good at the same time? It’s easy to see why dissolvable oral film strips have become not only widely accepted, but preferred whenever they are available as an option for taking a particular substance. And why they are being explored as a delivery system not only for more and more pharmaceutical products, but also for non-pharma products for health, beauty and nutrition. After all, that’s where they started in the first place.

The need to develop oral film strips

Tablets, capsules and liquids (syrups) were first in the line of oral delivery means for drugs. However, there is always a percentage of the patient population that has difficulty with those forms because of swallowing problems. Namely, geriatric and pediatric patients, as well as those with swallowing disorders caused by dysphagia. This can be due to a medical incidents, such as stroke or head injury, as well as certain types of cancers or esophageal disorders. Oral dissolving film strips were developed in response to these needs.

What is the advantage of dissolving oral strips?

The most obvious advantages of oral film strips are ease-of-use and convenience. They dissolve rapidly and disperse their active ingredient when placed in the mouth, without the need for water. This helps to avoid any swallowing difficulties a patient might have. Given common and standard packaging used, they are also highly portable and discreet.

Another advantage is highly accurate and consistent dosing. Most other forms of oral drugs, namely pills and capsules, contain as much as 60% excipients – usually non-therapeutic “junk” that has been added for stability or bulk. With oral dissolving film strips, there is neither the room nor the need for additives beyond the active pharmaceutical ingredient (API). Other oral formats, such as gummies or lozenges, can also contain excipients, but are more likely to contain sugar.

But perhaps the most significant advantage of oral film drug delivery is in their bioavailability. Being absorbed directly in the mouth limits exposure to the gastrointestinal tract and the effects of what’s known as first-pass metabolism. This is when the drug is first metabolized through the digestive tract, which degrades it and results in a reduced concentration of the active ingredients being delivered. The first-pass effect is often associated with the ingredient being metabolized in the liver, but it can also happen in other body tissues, such as in the lungs and vascular system. Studies of some drugs have shown that only about 4% of the API was reaching the system after going through first-pass metabolism.
All of these advantages are making dissolving oral film strips a growing, preferred choice for the administration of traditional drugs, biologics, supplements and possibly even vaccines. The use of oral dissolving film strips is growing as a viable means of administration and delivery of both active pharmaceutical ingredients (APIs) and active non-pharmaceutical ingredients (ANPIs). In addition to over-the-counter medications and non-pharma supplements, such as nutraceuticals, oral dissolving strips are even being used for veterinary and pet supplement applications.

Oral dissolving film strips are polymeric films that deliver their active ingredient upon dissolving, by maintaining contact with the delivery tissue. The format of the film strip as a substance delivery device was introduced to the consumer market in the 1970s for personal care and over-the-counter products. The first rapidly dissolving oral film strip (RDF) was for Listerine® pocket packs™, a personal care product, a breath freshener developed by Pfizer. The first oral thin film strip (OTF) was Chloraseptic®, for over-the-counter therapeutic treatment of sore throat.
Riize Health has been a leader in the use of highly effective oral film strips for the treatment of erectile dysfunction (ED) and overall sexual health and wellness for both men and women.

ORAL DISSOLVABLE FILMS

Accurate dosing
• No water needed – reduced choking risk
• Taste
• Enhanced ingredient stability
• Greater patient compliance
• Fast acting – site specific
• Direct delivery to systemic circulation – reduced first-pass metabolism degradation

Ideal characteristics for ingredients

The traditional focus of the oral dissolving film market has been on therapeutic substances with a small molecular size and low molecular weight. They also have to have the ability to easily permeate oral mucosal tissue, with a similar pH. They need good solubility and stability in water as well as saliva. In addition, oral strips are limited in the amount of dosage they can deliver, with 40mg being a standard threshold level.

With the growth and increasing demand for oral film delivery, manufacturing technology has allowed some advancements in the efficacy of the strips themselves as well as the types and concentrations of the formulas they can deliver.

The oral film market is now moving beyond its traditional focus on small molecules to deliver biologics. These are a class of drugs that are produced using a living system, such as a microorganism, plant cell, or animal cell. Vaccines also hold potential for delivery via oral dissolving film strips. Emerging vaccines based on DNA and virus-like particles could be optimized in such a way that delivery to the buccal mucosa would be an ideal avenue, as it contains many immune cells.

Riize Health innovation in oral dissolving films

What Riize Health created with Riize Strips for ED was a breakthrough in areas of both formulation and delivery. It is the first and only product for ED to use a proprietary, compound formula combining the two most powerful ED treatment medications – sildenafil and tadalafil – with the added natural hormone, oxytocin. Sildenafil and Tadalafil being the same ingredients as in Viagra® and Cialis®, respectively. With the latest technology in thin film manufacturing, these multiple active ingredients are layered onto one rapidly dissolving film strip (RDF).

The result is a truly innovative ED product that goes to work anywhere from 3x to 6x faster than other similar products (pill, chew and troch forms), and has an efficacy of delivering up to 90% of the medications directly to the system. Riize Strips are packaged to insure maximum stability and easy, discreet handling. Riize Health has also eliminated the need for in-person doctor visits and trips to the pharmacy through a state-of-the-art telemedicine platform.

Continued growth for oral dissolving films

The current market for oral thin films is a little over $2.5 billion, and is projected to double in the next 5 to 7 years. The three largest markets where prescriptions for fast dissolving films are now approved are the US, EU and Japan. Innovations in technology and science have extended the use of oral dissolving films beyond drugs to treat a broad range of diseases and conditions to many over-the-counter, therapeutic and general health and wellness uses. Oral dissolving film strips can now be found for sleep, beauty, nutrition, children’s health, immune support, pet health, motion sickness, memory and mood.

Oral films are also becoming an attractive delivery vehicle for cannabis and other controlled substances due to their discrete nature and fast onset of results.

The success of Riize Strips for ED has proven the power of innovation when it comes to oral films. Riize Health will continue to find ways to expand the use of oral dissolving film technology, and making prescribed products available through a secure and convenient telemedicine platform.