Case 1 — Nicotine ODF Scale-Up
Transferred lab film to a 400 mm casting line; achieved ±5% content uniformity and <30 s disintegration. Validated packaging with nitrogen flush.
Selected projects in oral dissolving film scale-up and ODF machine validation.
Transferred lab film to a 400 mm casting line; achieved ±5% content uniformity and <30 s disintegration. Validated packaging with nitrogen flush.
Optimized polymer-plasticizer ratio to prevent brittleness across ICH stability zones; shelf-life supported by moisture barrier sachets.
Completed process qualification (PQ) with defined CPPs/CMAs: coating gap, web speed, dryer temperature, and final moisture window.
Author: Sihan Meng, Leyu Zhu, Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc
Author: Sihan Meng, Leyu Zhu, Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc
Author: Sihan Meng, Leyu Zhu, Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc
Essential Reading for Oral Film Newcomers: What Conditions Are Needed to Produce a “Mass-Producible
The Fundamental Answer After Creating 12 Best-Sellers Myself**Anyone who has been in business long e
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Sihan Meng,Leyu Zhu,Pengcheng ShiAffiliation: RSBMEmail: pengchengshi@biotechrs.com; pcspc9@
Author: Pengcheng(Frank) Shi,Leyu Zhu,Sihan MengAffiliation: RSBMEmail: pengchengshi@biotechrs.com;
Systematic Formulation–Process–Evaluation Approach and QbD Practice for Oral Dissolving Films (ODFs)
Storage Method of Melatonin Oral Dissolving Films Keep melatonin ODFs in their original, high-barri
Key Points on Packaging with Qualified ODF Machines Packaging for oral dissolving films must protec