Nicotine Orodispersible Film, a New Development Opportunity

Nicotine oral dissolvable films, also known as oral dissolvable strips, dissolvable films, or sublingual strips, are thin films made from hydrophilic polymers that contain nicotine. They dissolve in the mouth, offering a convenient and portable method for nicotine intake, representing a novel form of smokeless nicotine delivery. This innovation is an extension of medical oral dissolvable films.

The world's first medical oral dissolvable film is considered to be the breath freshening strip launched by Pfizer's Listerine® brand in 2001, which was named one of Time magazine's Best Inventions. Currently, there are over 50 types of medical oral films available on the market. As of February 2023, China has approved six varieties of medical oral dissolvable films for sale, with more than 20 applications for market approval received by the Center for Drug Evaluation (CDE) and over 50 clinical applications submitted.

Nicotine oral dissolvable films draw inspiration from the product concepts and fabrication techniques of medical oral dissolvable films, incorporating nicotine into the innovative tobacco industry. Their primary constituents include hydroxypropyl methylcellulose, microcrystalline cellulose, carrageenan, glycerin, and polysorbate; along with peppermint oil, artificial sweeteners, flavorings, and other ingredients.

In the current nicotine pouch market, characterized by the dominance of international tobacco giants, patent barriers, and a saturation of mid- to low-end products, some companies have adopted differentiated competition strategies to navigate the fiercely competitive landscape of nicotine pouches. After conducting thorough research and analysis, they have identified nicotine oral dissolvable films as a promising new development opportunity.

Compared to nicotine pouches and other oral tobacco products, nicotine oral dissolvable films dissolve upon placement on the tongue, offering greater discretion and convenience. They eliminate the hassles of swallowing or chewing and do not require spitting out, making them particularly suitable for use in smoke-free environments such as high-speed trains, airplanes, and meetings.

Regarding market conditions, nicotine oral dissolvable films made their debut in March of this year, with a retail price of approximately £6. The primary markets include the United States, the United Kingdom, Germany, and France.

According to reports, at least five domestic e-cigarette companies are planning to produce nicotine oral dissolvable films. In the international market, notable brands include Orgco from NUSO, which is manufactured in Indonesia and currently experiences high demand that exceeds supply. Another brand, "Melta," is produced in India and has already entered the European and American markets, with a nicotine content of 2% per pack of 20 films.

After testing, the technical challenges identified include the discrepancy between the advertised onset of effects lasting 30 minutes and the actual experience, which ranges from 5 to 10 minutes. Additionally, it is optimal for the moisture content of nicotine oral dissolvable films to be below 4%. Achieving consistency in large-scale production remains a significant difficulty.

After prolonged storage, the dissolvable films tend to stick to the plastic packaging, requiring effort to detach them, often resulting in blemishes. Ideally, they should remain pristine. Common discomforts experienced during use include palpitations, a burning sensation in the mouth, and throat irritation.

As a newly emerging category of tobacco products this year, the global market for nicotine oral dissolvable films is currently in development and is expected to continue growing in the coming years. Based on current sales data from various websites, it is projected that in the European and American markets, sales will reach 100 million boxes within the next year.

来源：品宝龙