Enteris BioPharma, a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation, published a white paper entitled, "HPAPI Drug Solid Oral Dosage (SOD) Manufacturing – Ensuring Content Uniformity."
The paper, co-authored by Thomas Daggs, Vice President of Product Development & Quality Control, and Angelo Consalvo, Director of Manufacturing, Enteris BioPharma, provides insight into the variables that impact content uniformity with high potency active pharmaceutical ingredients (HPAPIs), the benefits of dry production techniques over wet granulation when manufacturing HPAPI tablets, and the criteria drugmakers should consider when selecting a contract development and manufacturing organization (CDMO). The whitepaper is available to download via Drug Development & Delivery at https://drug-dev.com/whitepapers/white-paper-hpapi-drug-solid-oral-dosage-sod-manufacturing-ensuring-content-uniformity/
"The HPAPI market is a growing and increasingly important segment of the overall pharmaceutical industry that could, by 2026, generate sales that exceed $32 billion," stated Paul Shields, Ph.D., Chief Operating Officer for Enteris. "These are medicines that are more potent than a traditional pharmaceutical agent but use a fraction of the drug substance, thereby lowering the cost of goods. Despite the benefits that HPAPIs offer, manufacturing comes with considerable challenges, chief among them ensuring content uniformity, and often require specialized formulating technologies. Drugmakers are increasingly looking to outsource this work to CDMOs, but it is imperative that any prospective manufacturing partner is equipped to work with such challenging APIs, including both the expertise and tools to ensure safe, efficient, and precise production. This is especially the case when developing solid oral dosage (SOD) forms containing HPAPIs."