Almac expands capabilities to meet pediatric formulations demand

According to the company, the investment was made in partnership with a with a long-term commercial US client with whom “Almac has enjoyed a successful strategic relationship​” since 2010, David Downey, VP Commercial Operations, Almac Pharma Services, told Outsourcing-Pharma.com.

As part of the client’s requirement to provide its products to pediatric patients, Downey explained they engaged Almac on suitable packaging technology, in addition to the manufacture of the bulk product mini-tablets.

Subsequently, both parties identified the Merz equipment “as providing the best, most appropriate and flexible solution for packaging​.” The two parties then made the necessary investment to install, validate, and operate the equipment – a fully automated forming, filling, and sealing machine capable of filling 80 stickpacks per minute.

The technology also enables Alamc to process new pediatric drug products, such as powders, granules, and minitabs, that require the specialist packaging, in addition to meeting the stickpack needs of its current client.

There are “a number of other opportunities that required a pediatric packaging solution for which the Merz equipment can provide a solution for, which Almac can now service​,” said Downey.

These pediatric requirements are a growing area of interest resulting from the EU Pediatric Regulation (EC1901/2006 and EC1902/2006) and the US requirement for Pediatric Investigation Plan (PIP).

As with all pharmaceutical products, Downey said the selection of packaging presentation for pediatric patients should be driven by the quality target product profile (QTPP).

As he further explained, oral formations have been the preferred dosage form for pediatric medicines in recent years. However, challenges surrounding product instability and inadequate taste making has caused a shift towards solid oral dose formulations, such as granules and minitablets.

“Packaging of multiparticulates into presentations such as Stickpacks have the advantage of increasing palatability for the patient whilst ensuring a high level of dose accuracy essential for paediatric populations​,” explained Downey, adding that equipment performance is now providing pack yields in excess of 90-95% for a very modest batch size.

“This demonstrates the suitability of the solution to the requirements identified​,” he said. “All parties; Almac, its client and Merz worked very closely together to deliver upon these specific user requirements​.”