The company is gearing up to introduce two over-the-counter cough/cold treatments based on the technology, which consists of a thin film that dissolves rapidly on the tongue, in the US market. Novartis claims its products - Triaminic and Theraflu Thin Strips - are the first systemic medicines to be delivered in this form.
Oral film strips have hit the mainstream in the last few years as a new way of freshening the breath. The gel-like wafers are slipped into the mouth and dissolve quickly to release the minty flavour. But drug companies have been interested in this technology as it provides fast, accurate dosing that is expected to increase compliance, particularly among children. There is no need for water or measuring, and upon melting, the dose of medicine is swallowed.
Last year, US company Zengen launched a strip delivering benzocaine, a local anaesthetic, for the treatment of sore throat. At the time, the company claimed this was the first time that this type of delivery system had been used for an active pharmaceutical ingredient (API).
Explaining the rationale behind the new products, Novartis said: "today's consumers cite better portability, ease and accuracy of dosing, and overall convenience as the product attributes they seek most in a cough/cold medicine."
The new products are line extensions of two of Novartis' leading OTC brands: Theraflu and Triaminic.
The OTC pharmaceutical sector tends to be driven by innovations in products format, given the relatively slow appearance of new active compounds for OTC use. In the US, the cough and cold segment enjoyed a 17.6 percent growth in sales in the 2002-2003 and 2003-2004 cough/cold seasons, most of which was attributable to new product launches.
"Product innovation … is critical to the category and fuels growth by continuing to improve consumer compliance and bringing new consumers to the category," said Jeff Vernimb, vice president of marketing for the OTC sector at Novartis North America.
Being first on the scene is also important in the OTC cough and cold category, and Vernimb said Novartis was able to leapfrog competitors in the market to bring this novel delivery form to market in time for the 2004-2005 cough/cold season in the US.
One of the reasons for this rapid development was the development of a novel taste-masking technology and a process by which the flavours where blended alongside the APIs during production. The result, says Novartis, is a product that has a pleasant taste but that still retains a medicinal flavour that should discourage overdosing.
The bitter taste of many APIs is a primary obstacle to formulating them in these dissolve-in-the-mouth formulations.
Growing sector
Currently, worldwide sales of drugs that incorporate a fast dissolve technology - usually in the for rapid-dissolve tablets - are more than $1 billion (€815m) and have an annual growth rate of more than 40 per cent. This growth is fuelled by the patient demand, with industry=sponsored surveys suggesting that approximately 88 per cent of patients prefer taking medications that incorporate a fast dissolve technology compared to traditional tablets.
Furthermore, a study reported last year found that as many as 40 per cent of all people have difficulty swallowing traditional tablets.
Theraflu Thin Strips treat the most common symptoms of a cold in adults and children 12 and older and will be available in two cherry-flavoured treatment options: Long Acting Cough that quiets coughs for up to eight hours, and Multi-Symptom that, as well as tackling coughs, is said to provide temporary relief from a runny nose and sneezing, and soothes itchy, watery eyes and throat. Both will cost approximately $5.49 for a 12-strip pack.
Meanwhile, Triaminic Thin Strips, for children ages 6-12, will also be available in two treatment options: Long Acting Cough that quiets coughs for up to eight hours, in cherry flavor, and Cough & Runny Nose, in grape flavour. They will cost approximately $5.99 for a 16-strip pack, according to Novartis.