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Jiang, Wenlei

Publications and source records attributed to Jiang, Wenlei.

9 records
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DOE OSTI2023

Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Immediate-release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective comparator products. In December 2022, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the first new draft guideline on BE for IR solid oral dosage forms (M13A). To support the development of ICH M13A, we comprehensively reviewed the landscape of oral IR products approved by the U.S. Food and Drug Administration (FDA) and compared BE recommendations for these products in the current U.S. FDA and European Medicines Agency (EMA) BE guidances. We utilized databases including Drugs@FDA, Orange Book, and product-specific guidances (PSGs) published on the U.S. FDA and EMA websites to collect information. Oral IR products account for 46% of all FDA-approved new drug applications currently listed in Orange Book with 82.5% solids, 0.9% semi-solids, and 16.6% liquids. For all published U.S. FDA PSGs for solid oral IR products, in vivo BE studies with pharmacokinetic (PK) endpoints account for 88% of BE approaches recommended. Of these PK BE studies, 86.5% recommended fasting and fed BE studies, while only 15.9% EMA PSGs recommended both fasting and fed BE studies. This review helps clarify the scope of U.S. solid oral IR products impacted by the new ICH M13A draft guideline and demonstrates how recommendations in draft ICH M13A could significantly harmonize BE recommendations for IR oral products to facilitate global drug development.

60 APPLIED LIFE SCIENCES↗
DOE OSTI2022

Analysis of phospholipids and triacylglycerols in intravenous lipid emulsions

Intravenous lipid emulsions (ILEs) are used for parenteral nutrition, providing a vital source of essential fatty acids and concentrated energy for patients who are unable to absorb nutrients via the digestive track. They are commonly used to treat local and non-local anesthetic toxicity, and lipophilic drug overdose. ILE are composed of natural lipids, and the composition of these natural lipids can be varied based on their source. The lipids are susceptible to hydrolytic degradation with time, resulting various lipid degradation products such as Lysophosphatidylcholines (LPs), affecting the actual composition of nutrients in the formulation. As a result, the identification and quantification of lipid components, including degradation products, in ILEs are crucial in quality control. In this study, lipids from different batches of ILE Intralipid® 20%, were separated and identified using a UHPLC-ESI-QTOF system and SimLipid® high throughput lipid identification software. Out of 47 lipids identified, 34 were phospholipids (PLs) and the others were triacylglycerols (TAGs). Most of the phospholipids detected were phosphatidylcholines (PC) and Lysophosphatidylcholines (LPC). A total of 9 LPCs, 18 PCs, 6 phosphoethanolamines (PEs), and 1 sphingomyelin (SM) were identified. The LPCs concentration changed with the manufacturing date and storage time. Furthermore, this UHPLC method enabled the identification and quantification of lipids and their decomposition products in complex ILE emulsion mixtures on a single 20-minute chromatographic run.

60 APPLIED LIFE SCIENCES↗