The new form, specific details of which have not yet been disclosed, is designed to be easier to shallow and less likely to adhere to mucosal surfaces than existing oral dosage forms.
The company claims that, in clinical studies, the new tablet and capsule shapes accelerated esophageal transit by as much as 80 per cent compared with standard oral dosage forms.
Adherence to the mucosa is the primary cause of transit failure according to managing partner Joseph Fuisz, who told in-Pharmatechnologist.com that shape is the key factor determining this interaction.
“Our work showed that adhesion with mucosal surfaces is the primary driver of transit failure. We dramatically reduced the adhesion dynamic. Existing shapes use flat and long surfaces that readily mate to the esophageal mucosa.
Fuisz explained that the firm took existing tablet granulations and progressively modified tablet die and capsule mold shape until a form with improved characteristics was identified.
It also said that because little to no modification of the base formulation is needed, all characteristics aside from ‘swallowability’ and transit speed remain the same. This means, according to the firm, the new forms can be easily applied to existing products.
Demand
Mr Fuisz predicted that the company’s experience in dosage development, coupled with the new forms ‘tangible therapeutic benefits’ will make regulatory approval a relatively straightforward process.
“Market introduction will be dictated by our partners as we like to stay in our place – drug delivery technologies -- as opposed to product. Interestingly, we have extended our designs to the presses and molds themselves.
He went on to predict that, initially at least, the consumer health sector would be most interested in the new design, describing it as being “most aggressive in pursuing new dosage forms.”
“[However] we will not view our project as successful unless we see entire product lines transition into this dosage form. One might say that this is product differentiation at its finest and perhaps just as important, at its simplest. “