Event name:

Tobacco Science Research Conference 2024

Session Date:

September 8, 2024 –

Session Speakers:

Ed Carmines, PHD - Chemular Inc.
Chris Woodruff - Chemular Inc.
Tom Barrett - Chemular Inc.
Scott Crekmur - Chemular Inc.
Lise Fraissinet, MSC, MBA, PMP - Chemular Inc.

Session: Extractables Testing of Fleece Material Used in Modern Oral Nicotine Pouches

Speaker: – Ed Carmines, Chris Woodruff, Lise Fraissinet, Scott Crekmur, Tom Barrett

Date: September 8th, 2024 – Atlanta, GA

About The Poster:

Modern oral nicotine pouch products are made by forming a paper-like fleece material into a tube, heat sealing the bottom of the tube, filling with the granulate material containing nicotine and then heat sealing the top. This fleece material has the potential to leach chemicals into the granulate materials and also be extracted by saliva during use. The fleece material is similar to a teabag. The fleece material is considered the primary packaging for the product. The Product Quality Research Institute (“PQRI”) Leachables and Extractables Working Group’s recommended approach was followed to evaluate different sizes of sealed empty pouches made from Dynatec 117/8/CFW material. Specifically, the pouch material was tested using the USP 1663 method (Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems). Samples were extracted with aqueous solutions at pH 5.2 and 9.5 and a 50/50% solution of isopropanol and deionized water. The solutions were analyzed by GC/MS (volatiles and semi-volatiles), LC/MS (non-volatiles) and ICP/MS (metals). The fleece did not appear to have the potential to leach materials of toxicological concern above the Safety Concern Threshold (SCT) or Toxicological Threshold of Concern (TTC). Under the conditions of use, the fleece was deemed acceptable for its intended use.