Dissolving Oral Film Strips Are Revolutionizing Drug Prescriptions
When you think of a prescription, most of us picture something that is written or electronically sent to a pharmacy by a doctor. And when we pick it up, it is in the form of a pill (tablet), capsule or liquid, and maybe sometimes a lozenge (troche). While that’s an accurate description for many medications, oral dissolving strips are now either in development, or available for more drugs than ever before. This is due to several factors such as advancements in the technology of manufacturing oral strips as well as the formulations of the drugs themselves. In addition, there is a growing acceptance and preference for oral dissolving strips among consumers. It is estimated that many as 45% of consumers are pill averse.
Oral strips are now considered potentially viable for a wide range of therapeutics to treat things such as migraines, dementia, asthma and allergies. One source noted that an oral strip to treat ED using the standard treatment drug, sildenafil, was also in development. Riize already has such a strip, and it has been available for some time. It has a proprietary compounded formula that includes not only sildenafil (same as Viagra®), but also tadalafil (same as Cialis®) and oxytocin (known as the “love hormone”). Riize is far ahead of the curve when it comes to delivering ED treatment medication using oral dissolving strips.
How did oral drug film strips start?
Dissolving oral drug delivery products were invented in the late 1970s. The initial interest in their application was to help administer medication to patients prone to have difficulty swallowing tablets or capsules, namely pediatric and geriatric patients. However, soon after they were introduced, they found a more widespread consumer application in the personal care products market. Oral strips evolved to a rapidly dissolving film strip (RDF) marketed as the breath fresheners, Listerine® Pocket Packs™.
Advances in manufacturing
Despite their obvious benefits, the early oral film strips were limited in their stability and the dosage amounts they could deliver. Innovations in drug development, as well as manufacturing technology have changed that. The need and demand for more convenient and effective drugs, and drug administration, has driven advancements in the way oral dissolving film strips are made and used.
Oral dissolving films are composed of single or multiple polymer-based layers. The dose of the active pharmaceutical ingredient (API) is controlled by the size and thickness of the film. The API is either dissolved or held in suspension in the polymer material in the manufacturing process. Recently, new techniques have been developed to deal with solubility differences in the APIs being used, including nanoparticle technology to reduce particle size.
Multiple active pharmaceutical ingredients (APIs) can now be layered in one strip, in high concentrations, with a minimal amount of excipient ingredients added. Both water-soluble and insoluble APIs can be integrated in the same film, some with different absorption profiles. There have also been advancements in extended-release formulations, as well as enhancements for taste. Continuing advancements in oral dissolving film strips are in response to a rapidly growing market, which has increased by approximately 80% in the last ten years.
How dissolving oral films work
Oral film strips can be used buccally (between the cheek and gum), sublingually (under the tongue) or on top of the tongue. For example, Riize strips for ED, using a compound formula of sildenafil, tadalafil and oxytocin, are placed on top of the tongue. The material used to make the film is designed to dissolve when it comes in contact with the wet saliva surface in the mouth (be it the cheek or tongue). As that occurs, the active ingredients are rapidly released and absorbed directly into the systemic circulation.
The process is illustrated below, using Riize ED Strips as an example.
The tissue inside the mouth and on the tongue has a thin, highly permeable membrane structure, over a very dense presence of capillaries. The thin walls of the capillaries diffuse blood directly to veins and arteries. With rapidly dissolving film strips (RDFs), like Riize Strips for ED, the process of the film dissolving, and absorption of the ingredients is typically under 30 seconds, resulting in quick bioavailability.
Advantages of dissolving oral films
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. In addition, oral dissolving films provide highly accurate and consistent dosing.
The most obvious advantage of oral film strips is convenience and ease-of-use. They do not need to be taken with water, and help to avoid any swallowing difficulties a patient might have. Given common and standard packaging used, they are also highly portable and discreet.
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 drug 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.
The fast onset of the drug effect along with overall increased bioavailability is making dissolving oral film strips a growing, preferred choice for the administration of traditional drugs, biologics, supplements and possibly even vaccines.
Exceptional delivery for ED medication
Riize strips have established an exceptional standard for the delivery of ED medications. 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. With the latest technology in thin film manufacturing, these multiple active ingredients are layered onto one rapidly dissolving film strip (RDF).
The expertise that goes into Riize strips has results in an ED product that goes to work anywhere from 3x to 6x faster than other similar products, and has an efficacy of delivering up to 90% of the medications directly to the system. And Riize strips are packaged to insure maximum stability and easy, discreet handling. Riize has also eliminated the need for in-person doctor visits and trips to the pharmacy through a state-of-the-art telemedicine platform.
It’s easy to see that dissolving oral film strips are changing how the administration of pharmaceuticals, nutraceuticals and supplements is viewed. Demand will continue to grow for the efficacy, quality and convenience of substance delivery that oral film strips provide. As a leading med-tech company utilizing film strip technology, Riize will continue to be part of that growth.
SOURCES
2. https://en.wikipedia.org/wiki/Thin-film_drug_delivery
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3757902/
5. https://www.sciencedirect.com/science/article/abs/pii/S1773224718310773
6. https://www.contractpharma.com/issues/2020-06-01/view_features/not-your-fathers-oral-thin-film/
7. https://drug-dev.com/oral-thin-films-the-quest-for-a-magic-pill-may-not-be-a-pill-at-all/
