The uses and appeal of oral dissolving strips is growing.

Oral Dissolving Film Strips (ODFs) becoming a preferred delivery system

Whether it’s for prescription drugs or over-the-counter medications and supplements, the shift to using oral dissolving film strips (ODFs) is becoming more noticeable. Riize Health has been at the leading edge of this trend for some time now. Starting with telemedicine prescription products for erectile dysfunction (ED) and weight loss, Riize has developed some of the most advanced oral strip compounds for prescription and non-prescription products. Here is a look at the science and reasons behind the dramatic growth in the development and use of ODFs.

Oral dissolving film (ODF) strips, also known as oral thin films, represent a rapidly emerging drug‐delivery platform that combines rapid onset of action, enhanced bioavailability, and exceptional patient convenience. By dissolving in the mouth without the need for water, ODFs bypass first‐pass metabolism and deliver precise, flexible dosages directly through buccal or sublingual mucosa. Moreover, ODFs can reduce gastrointestinal side effects, offer taste‐masking capabilities, and simplify manufacturing and packaging.

Advantages of ODFs

• Rapid dissolution and onset of action
Oral dissolving films disintegrate within seconds upon contact with saliva, enabling the active pharmaceutical ingredient (API), or active supplemental ingredient (ASI) in the case of supplements, to be released almost immediately. The active ingredients penetrate the mucous membrane directly, prompting faster systemic absorption compared to swallowing tablets.
• Enhanced bioavailability
In bypassing the gastrointestinal tract and first‐pass hepatic metabolism, ODFs increase the fraction of drug reaching systemic circulation. In the case of Riize strips, they have been shown to deliver up to 90% more of the active ingredients.

• Precise dosage and flexibility
Dosing can be tailored by cutting films into smaller or larger segments, and offering flexible dose adjustments for individual products and treatments, while delivering accurate, consistent unit-dose amounts.
• Reduce possibility of gastrointestinal side-effects
ODFs can bypass the stomach, reducing direct gastrointestinal irritation and systemic side effects often associated with oral tablets.
• More appealing to taste and senses
By enhancing strips with such things as colorants and saliva‐stimulating ingredients the user experience is improved.
• Convenience – portability and ease of storage
Thin, lightweight, and individually packaged, ODFs are highly portable and convenient for on-the-go dosing.
• More efficient manufacturing and scalability
With the latest in casting and extrusion technologies, films are more durable in the manufacturing process, compared to dissolving tablets, during the manufacturing process, simplifying handling and packaging.

Oral dissolving film strips merge patient-centric design with pharmaceutical innovation, addressing challenges of traditional dosage forms while unlocking new therapeutic possibilities. As formulation science advances, ODFs are poised to expand in both prescription and OTC markets, offering safer, faster, and more convenient drug delivery for diverse patient populations. 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.
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.
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.
The fast onset of the active ingredient 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.

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.

Riize prescription and supplemental ODFs

• Prescription products for sexual health
Riize Max 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 oral film strip (ODF).

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.

Riize Health also has Riize Pinks strips for women. Riize Pinks use a proprietary compound with the peptide P-141, which studies have shown to increase feelings of intimacy, closeness and confidence for women. The same fast-acting, direct systemic delivery makes Riize Pinks a convenient, discreet way for women to enhance their libido and sexual satisfaction.

• Non-prescription OTC products
Riize has expanded their expertise in pharmaceutical ODFs to the area of non-pharmaceutical supplement products designed for specific general health and wellness results. Each product has specific use, with a custom compound formula designed to deliver the optimum results.

Riize Energy – For boosting energy levels and enhanced mental clarity with a compound of caffeine, L-theanine, vitamin B12 and electrolytes.

Riize Extra – Supports sexual health by enhancing libido and
vitality. Contains testofen, chromium, selenium and ashwagandha.

Riize Digestive – A fast-dissolving digestive strip melts on the tongue in seconds, for digestive relief with an antacid, anti-bloat and anti-gas compound.

Riize Hangover – Designed to help you recharge and recover faster
after possibly over-indulging. Contains glutathione, dihydromyricetin
(DHM), N-acetylcysteine (NAC) and mannitol to help get you feeling
your best again.

Riize Motion – Provides non-drowsy, soothing relief from motion sickness with a compound of ginseng extract, magnesium, vitamin B6 and electrolytes.

riize

Riize Sleep – Fast-acting natural ingredients to calm the mind and body for restful, rejuvenating sleep. Contains valerian root extract, melatonin, L-theanine and vitamin B6.

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

https://nstpharma.com/
https://en.wikipedia.org/wiki/Thin-film_drug_delivery
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3757902/
https://odfstrips.com/
https://www.sciencedirect.com/science/article/abs/pii/S1773224718310773
https://www.contractpharma.com/issues/2020-06-01/view_features/not-your-fathers-oral-thin-film/
https://drug-dev.com/oral-thin-films-the-quest-for-a-magic-pill-may-not-be-a-pill-at-all/
https://drug-dev.com/oral-thin-films-misconceptions-advantages-limitations-about-an-emerging-drug-delivery-system/
https://drug-dev.com/oral-thin-films-misconceptions-advantages-limitations-about-an-emerging-drug-delivery-system/
https://www.sciencedirect.com/science/article/pii/S1818087616300368

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