“Oral Dissolving Strips change how you take your supplements”.

QUICK / CONVENIENT / PRECISE / EFFECTIVE

What are ODFs?

Background

Oral Dissolving Film (ODF) is an emerging dosage form. Developing polymeric films has made it possible to improve the bioavailability and customer adherence to supplementation via the oral route, especially buccal and sublingual route. The anatomical and physiological characteristics of the buccal mucosa, such as the existence of smooth muscles with high vascular perfusion, easy accessibility, and the bypassing of first pass metabolism make it a favorable route for drug and nutrition delivery [1]

 Advantages of Oral Dissolving Films as an emerging dosage form

Traditional supplementation delivery methods such as tablets and capsules are not ideal. They require the user to drink, wait for it to dissolve, then wait for the nutrition to dissolve and make its way through the first pass metabolism before the consumer can benefit from the nutrition. Challenges persist in pediatrics, geriatrics and others that have challenges or aversion to swallowing pills. Supplementation that comes from liquids, drinks, or drink mix-ins are challenged with requiring water, inconsistent dosage, added sugars and other unnecessary ingredients, bulky containers that are hard to travel with, and spilling.

ODFs have overcome these challenges.

An ODF dissolves more rapidly than other conventional dosage forms. ODFs are less friable and easy to carry dosage form compared to commercialized orally fast disintegrating tablets, which need special packing. Likewise, a single dose of strip can be carried individually without requiring the secondary container. It is very important to address the poor stability of liquid dosage forms, especially the aqueous formulations. ODFs do not require precise measurements or the need to shake before using. They are consistently dosed each time right from the manufacturer.

Clinical advantages over the other dosage forms

Consumers show preference toward thin film due to its appellative form and ease of administration [4]. Furthermore, oral dissolving film is extensively useful for pediatric, geriatric, and psychiatric patients and pets since it is easy to administer and avoid the risk of choking or suffocation, thus ensuring consumer and pets safety.

• Fast Acting
• High bioavailability
• Easy to consume (non-choking hazard)
• Ultra-portable (each strip is individually packaged)
• Provide discreet consumption of your daily vitamins.
• Can be used safely even when access to water is not available.
• Easy application to kids, elderly and pets.
• Bypass the gastrointestinal tract and thus increase bioavailability.
• Low dosage and low side effects
• No need to measure, which is an important advantage over liquid dosage forms. 

Bioavailability Study – ODF Vs. Other dosage forms

ODF (Oral Fast Dissolving Film) can increase bioavailability due to their rapid dissolution in saliva, without needing water, and the rapid absorption of the nutrition through the buccal mucosa [5].

A comparative dissolution study between the ODF, powdered drug/nutrition, and a tablet was performed to investigate the success of the optimized ODF in increasing the dissolution rate.

The optimized ODF (F1) showed a significant increase in dissolution rate and extent in comparison with the dissolution from pure powder and the tablet. This figure illustrates that 96.02% was dissolved within just 10 min from the optimized ODF (F1), compared with 10.04 and 26.37% from pure powder and the tablet, respectively. The extent of dissolution of the ODF after 10 min was increased by more than 9.5 and 3.6-fold compared to the drug released from the pure powder and tablet, respectively [5]. ** PX is Paroxetine

Oral and intravenous melatonin bioavailability study

This crossover cohort study investigated the pharmacokinetics of oral and intravenous melatonin in healthy male volunteers. Oral melatonin was rapidly absorbed, and Tmax was achieved after 41 min. Cmax and AUC varied extensively between volunteers. Elimination half-lives following oral and intravenous melatonin administration was 54 min and 39 min, respectively. The bioavailability of oral melatonin was only 3%, but considerable variability between volunteers was noted [7].

Permeation Study – ODF Vs. Other dosage forms

Many permeability studies have revealed the importance of choosing an appropriate mucosal membrane; where, the buccal mucosa of many experimental animals, such as rabbits and rats, is entirely covered with keratin [6]. On the other hand, chicken buccal mucosa is considered the best alternative, because it resembles the human non-keratinized and thin oral lining mucosa. The permeation from the optimized ODF and pure powder through the freshly excised chicken buccal mucosa was examined [5]. 

The optimized ODF (F1) showed a significant increase in permeation rate and extent when compared to pure powder, as illustrated in Figure 6. The flux (J) values were detected and there was a significant difference (p value < 0.001) between the optimized ODF (F1) (85.00 _g/h/cm2) when compared with pure powder (26.66 _g/h/cm2) [5].

FlashRelease Technology

Not all ODFs are created equally. There are many factors that contribute to the bioavailability, dissolution time, and user experience.  

A FlashRelase Strip will include the following characteristics:

While each strip will include its own nutrition or active ingredients, flavor, sweeteners, and other ingredients, a FlashRelease strip is small, thin, single layered, and combines polymers and plasticizers in specific ratios that promote film structure and are fast dissolving. Adding a saliva inducing component will also reduce the dissolve time. 

References

1. https://www.sciencedirect.com/science/article/abs/pii/S0141813014004875

2. https://journals.sagepub.com/doi/10.1177/00220345890680091101

3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7957312/  

4. https://www.sciencedirect.com/science/article/abs/pii/S016836590900426X  

5. https://pubmed.ncbi.nlm.nih.gov/34834284/  

6. https://sites.ualberta.ca/~csps/JPPS1(1)/A.Shojaei/buccalreview.htm  

7. https://pubmed.ncbi.nlm.nih.gov/26893170