Issue:April 2019

GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 2, Notable Product Drug Delivery and Formulation Approvals of 2018

Two of a Four-Part Series

Part 1: A Global Review of 2018 Product Approvals

Part 2: Notable Product Drug Delivery and Formulation Approvals of 2018

Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2018

Part 4: The Drug Delivery and Formulation Pipeline

By: Kurt Sedo, VP of Operations, and Tugrul Kararli, PhD, President & Founder, PharmaCircle


Companies and patients continue to reap the benefits of the significant investments made in drug delivery and formulation technologies over the past few decades. Despite the absence of recent breakthrough drug delivery technologies, the pharmaceutical industry has harnessed well validated drug delivery and formulation technologies to deliver important product approvals in 2018.

One well validated technology that goes back almost 30 years with the approval of Adagen is PEGylation. Three Notable Approvals of 2018, Asparlas, Jivi, and Palynziq, all use PEGylation technologies, albeit with markedly diff erent strategies. Asparlas, a next-generation Oncaspar, uses the same non-specific multi 5-kDa PEGylation strategy of its predecessor, but with more stable linker chemistry to improve shelf stability. Jivi, sees a 170-kDa recombinant protein conjugated with a single 60-kDa branched PEG molecule to yield the 230-kDa product. Palynziq, a 62-kDa enzyme, uses a strategy similar to that of Asparlas but with an average of nine larger 20-kDa PEG molecules. What is notable about these products is their use of multisource PEG reagents. No longer are we hearing mention of Enzon, Shearwater and their successors as technology or reagent suppliers. A technology that once commanded as much as a 7% royalty has seemingly become just another reagent sold on the basis of purity and price.

Two of the more interesting small molecule drug delivery and formulation approvals in 2018 included Inbrija and Jornay PM. Inbrija, an inhaled formulation of levodopa, represents an interesting formulation/device approach to addressing issues related to off symptoms with Parkinson’s patients. Jornay PM, a colonic release formulation of methylphenidate administered in the evening, uses a totally different drug delivery facilitated dosing strategy to address the early day dosing requirements of children with ADHD.

In total, 20 products are highlighted that represent either fresh approaches or a new twist on well-understood drug delivery and formulation strategies. Click here to download/view part 2 of the entire report.