Crystallization inhibitors maintain super saturation of free drug during the absorption window upon oral administration. Formulators can achieve this by utilizing function excipients which provide solubilization enhancement and crystallization inhibition. We recently used the inhibitors to limit precipitation of drugs during the lipolysis of SEDDS and correlated with the Vivo performance. Additionally, these functional inhibitors effectively increased drug load and improved overall bioavailability by forming supersaturated-SEDDS. This podcast will cover the role of crystallization inhibitors in formulation and how to use in SEDDS formulation effetely.
This week addressed AI accountability, CPHI award winners, NFC anticounterfeiting, first-in-class FDA approvals, and a shelved FDA voucher pilot lead this week’s roundup.
Cole and Jaenisch explain why defending against AI poisoning in pharma manufacturing calls for a data steward role, immutable instruction ledgers, and automation.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how the company’s product is worth the investment by protecting products and patients.
The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
Regulators will test pharma companies against their own internal AI policies. Jaenisch, Muraru, and Pandey explain how to build defensible, inspection-ready AI practices.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how its connected technology can enhance anticounterfeiting and how data are handled within the product.
Celtic Renewables won the CPHI Award for Sustainable Pharma Excellence for its green chemicals used in pharmaceutical manufacturing. Bettina Brierley, chief commercial officer, talks about the adoption, capacity, and pricing of biosolvents.