Saint-Gobain Composite Solutions client, Corium International, a leading drug manufacturing company, encountered issues when developing a new line of drugs for use in transdermal delivery. Saint-Gobain had sampled numerous Medical release liners and all of them over time exhibited increased peels. High peels when removing a liner from an adhesive patch would be too difficult for a patient to remove the liner from the drug prior to placing on their body.
Aside from drug preparation with an adhesive system, transdermal development starts with the need for a reliable liner that exhibits ease of removability from the adhesive. There are a limited number of drugs that can be incorporated into an adhesive system. Some drugs can have a negative impact on liner removability. Much of this is based on the drug itself and the amount of the drug that is added to the adhesive. In the case with Corium, every liner they tested from Saint-Gobain and others all tended to initially perform well, but over time the peel release of the liner from the drug-loaded adhesive would be considered too difficult to remove.
Formulators of transdermal drug delivery systems (TDDS) products encounter release issues in early development as they try to incorporate as much of an active pharmaceutical ingredient (API) into a compatible adhesive system. Driven to have a specific drug in a TDDS patch that will deliver a specific amount of the drug over time can be a challenge.
Saint-Gobain resolved the problem by working with a new silicone release supplier. When Corium called on Saint-Gobain for medical liner needs, Saint-Gobain had only done initial lab work with this new supplier’s release components. As a last-ditch effort to provide a solution for Corium, Saint-Gobain formulators made up samples of 2 easy-release formulations. Samples submitted to the account were tested and the product aged out much better, (lower stable peels over time) as compared to other SG and competitive silicone release coatings.
• Provided a solution that aged very well over time as compared to competitors
• The new formulations fit in well with Worcester Massachusetts site capabilities, and processes, thus no need to purchase new or special equipment.
• Composition of 2 new coatings is currently permitted for direct and indirect food contact under Sections 21CFR175.320, 21CFR176.170, and 21CFR176.180 of the Federal Register.
• Opened the door for the use of other Saint-Gobain coatings for various development with new products. Some Saint-Gobain liners are being used as process liners to make the finished product, as well as the Saint-Gobain liner being with the finished product that goes to the consumer.
With the positive results of these 2 lab coatings, SG started manufacturing these 2 coatings, as well as other coatings for other projects. The end result was Corium’s increasing usage of Saint-Gobain Silicone Release formulations in their current and future development work. All of this started in 2010 with a sampling of 2 new coatings. Commercial production started in late 2011, and sales since then have been ~ $3.5 -$4 million USD.