Orodispersible formulations comprise solid layer coated with APIs that are released when they dissolve in the oral cavity.
A number of such technologies are available, however, it is orodispersible films (ODF) that are set to capture a larger share of the market according to Jörg Breitkreutz, Chairman of the Germany-based scientific Association for Pharmaceutical Technology (APV).
He told attendees at TechnoPharm in Nuremberg, Germany, yesterday that “ODF will increasingly be an option for oral administration,” adding that while it will not replace tablet technology it is “definitely suited for the delivery of personalized medicines.”
Breitkreutz – who is also Director of the Institute of Pharmaceutical Technology and Biopharmacy at Dusseldorf University – explained that this is primarily due to technical innovations that now make it possible to “print” specific dosages.
“The first idea was to print the exact dose onto paper using a commercial inkjet printer,” he said, but developers found only about 0.05mg of the API was added by each pass and repeating the cycle would lead to abrasion and the loss of product.
However, he continued, German firm Tesa got around this problem for its product Setofilm - which treats chemotherapy and radiotherapy induced nausea - using a printing process known as flexography, this is widely used in the newspaper industry.
Breitkreutz explained that the ability to use a flexible relief plate made the process much less abrasive and although it is “still limited to just six or seven print cycles, it is sufficient to add approximately 10mg of API to the film.”
Marketed products and oral lyophilisates
As well as Setofilm, there are a couple of other ODFs on the market but the first use of the technology was by Pfizer in 2001 in its consumer healthcare product Listerine.
However, Novartis’ Triaminic was the first drug approved in 2004, Breitkreutz said, but more regulatory updates and guidance for the dosage form is needed before this takes off.
Other rapidly dissolving drugs are currently on the market, with contract development and manufacturing firm Catalent using its Zydis sublingual oral dosage platform in over 20 approved products, including Eli Lilly’s bipolar drug Zyprexa.
However, Zydis is an oral lyophilisate and suffers from the “fragile behavior of its materials,” Breitkreutz said, and this technology is evolving into orodispersible tablets, mini-tablets and ODF as drugmakers “search for cheaper methods of manufacture than the energy-intensive and costly lyophilisation process for freeze-dried platelets.”