Shire said that while there is no product safety issue associated with the defect, they have decided to recall two lots – batch numbers 2819811 and 2764211- because “patients and caregivers could have difficulties removing the release liner when they peel the patch open.”
In September last year the firms recalled batches of the product, which is sold under license by the UK drugmaker, following reports that up to five per cent of patients were having similar difficulties with the liner.
Shire spokesman Matt Cabrey told in-PharmaTechnologist.com that around 469,000 patches are affected by the recall, although the firm does not expect all the products to be defective.
Cabrey said that: “We have increased the release coating on the release liner. No changes to the medication itself have been made. Shire and Noven are committed to a continuous ongoing effort towards product improvement and enhancement.”
He added that: “While much progress has been realised, more work is ongoing to improve the ease of use with this medicine.”
Cabrey went on to say that, in terms of financial impact, the recall “is not a material issue for Shire.”
DOT matrix technology
Daytrana, which is manufactured at Noven’s facility in Florida, is based on the firm’s proprietary DOT Matrix transdermal technology, which the company claims has significant advantages over standard patch products.
The system uses a patented multiple adhesive mix of silicone, acrylic and the required drug so that the drug is mixed in with the adhesive that holds the patch on the skin. Each patch is a thin, three-layer laminate made up of the patch backing, the drug/adhesive mix and the release liner.
The patches themselves are compatible with a wide range of medications, and as they deliver the drug more effectively than other competing products they tend to be smaller than other transdermal systems. In addition to this, the patches use one adhesive to hold the drug, and another to make the patch stick to the skin, resulting in superior adhesion to the skin.
The Noven transdermal system is already in use in other products beyond Shire's ADHD patch, including DentiPatch (a transmucosal patch for dental pain), Vivelle-Dot (the world's smallest transdermal estrogen patch), and a number of other hormone therapy patches.