New venture to tackle oral film delivery

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 a minty flavour. Drug companies are now exploring this approach as a way of delivering over-the-counter and prescription pharmaceuticals.

Oral-dissolve formulations of drugs - usually in the form of dispersible tablets that dissolve on the tongue - are well-represented on the market. For example, Eli Lilly sells a quick-dissolve version of its blockbuster schizophrenia drug Zyprexa (olanzapine), designed to make it easier for patients to comply with their medication.

The market for oral film strips is less well developed. 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).

To kick-start the programme, MonoSol​ has acquired drug delivery specialist Kosmos Pharma which has developed a film technology called FDTAB that dissolves directly on the tongue without the need for water or chewing.

Because FDTAB uses far less filling material than traditional tablets and because of its flat, postage stamp-like shape, it is much more compact. This means that unlike traditional tablets and capsules, individual doses can be packaged flush, which allows for high-density, low-space packaging of medications.

The initial applications of the technology are expected to be in over-the-counter medications, with prescription drugs following on thereafter.

Kosmos​ was set up by Richard Fuisz, who founded quick-dissolve tablet company Fuisz Technologies that was snapped up by speciality Canadian pharmaceutical company Biovail for C$245 million (€149m) in 1999.

The company has also developed a commercially-available over-the-counter beverage, used instead of water by patients taking traditional pills and capsules. Using boundary layer physics, the SwallowEasy product lifts and encapsulates the tablet/capsule in boundary layers of fluid so that patients are unaware that they are swallowing anything other than liquid.

MonoSol specialises in water-soluble films and recently launched a line of breath freshener and pet training oral films in the US, Europe and Asia. Scott Bening, the firm's chief executive, will take the same role at MonoSolRx, while Dr Fuisz and other Kosmos executives will also have positions in the new company.

Currently, worldwide sales of drugs that incorporate a fast dissolve technology are more than $1 billion and have an annual growth rate of more than 40 per cent. This growth is fueled by the patient demand,and industry estimates show that approximately 88 per cent of patients prefer taking medications that incorporate a fast dissolve technology compared to traditional tablets.

Furthermore, a recent study​ has been suggested that as many as 40 per cent of all people have difficulty swallowing traditional tablets.