Lonza excels in capsule development with CPHI award and Capsugel® Enprotect® capsule launch 2nd December 2022
Lonza celebrated at CPHI with an award for its titanium dioxide-free gelatine capsule and launching a coating-free solution for APIs.
Lonza had reason to celebrate at CPHI after they scooped the Excellence in Pharma: Regulatory Procedures and Compliance award for its Capsugel titanium dioxide-free white gelatine capsule.
Launched in May this year, news of the capsule’s success was announced at the 2022 CPHI Excellence in Pharma Awards that took place on the first evening of event in Frankfurt, Germany.
The capsule forms part of Lonza’s Capsugel® product range and meets new TiO2-free needs for foods in the European Union. Judges commented on the opacifying technology used, which delivers the same whiteness and masking as capsules containing TiO2.
Lonza also took the opportunity at CPHI to add another product to its range. The Capsugel® Enprotect® capsule claims to be first of its kind manufacturing technology, resulting in a capsule that supports intestinal delivery of acid-sensitive APIs.
According to the firm, the capsule does not disintegrate during stomach transit and only releases its contents in the intestine.
Functionality built into the capsule
“The capsule is an enteric format,” explained Julien Lamps, Associate Director, Global Product Management at Lonza Capsules & Health Ingredients.
“The functionality is built within the capsules. Normally APIs are either filled in capsules or compressed in tablets, and the enteric coating is made afterwards to ensure delivery’.
“With the Enprotect® capsule, this is not required because this is built in. You don’t have to do anything else other than filling it.”
Lonza believes the capsule can simplify the manufacturing process providing drug developers with a solution to deliver novel therapies such as small and large molecules, and oral vaccines.
The capsule’s new manufacturing process incorporates bilayer technology that uses Hydroxypropyl Methylcellulose Acetate Succinate (HPMCAS) in order to achieve enteric release and protection from acid.
Along with small molecules, peptides, proteins, and RNA-based therapeutics, the Capsugel® Enprotect® capsule can help delivery of live biotherapeutic products (LBP) – a new type of API designed to tackle conditions such as Ulcerative Colitis (UC),inflammatory bowel disease (IBD), Diabetes, C. Dificile infection or cancer
Ensuring LBPs stay active
“In a conventional coating approach, a capsule has to be treated using heat and solvents” Lamps said. “The process is not something that supports LBP efficacy.
“So, with Enprotect®, we are targeting customers that need to have smooth feeding operations as well as ensuring their LBP stay live and active.”
With LBP’s delicate nature a main concern amongst drug manufacturers, Lamps highlighted the simplified manufacturing process as a plus for the delivery solution that targets the intestine.
“Customers are able to access this easier manufacturing process, resulting in a quicker time to market, because ordinarily it is a long process with many complex steps “ he said.
“They don’t have to qualify additional raw material sources or additional processes to make the coating and so on. So that’s really a matter of gaining time in the development process.”