Tween 80 Clinical Trials

Clinical Trials

A clinical trial evaluates Tween 80's utility as a synthetic emulsifier in nutrient delivery by investigating the relative bioavailability of encapsulated vitamin D for managing vitamin D deficiency. Sponsored by the Rambam Health Care Campus, the study lacks a designated clinical phase and currently maintains an unknown recruitment status. This research highlights the application of Tween 80 as a physical formulation vehicle to optimize nutrient absorption rather than as an active disease-modifying drug.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01807845	UNKNOWN	Vitamin D Deficiency	Rambam Health Care Campus	2013-01

(data from https://clinicaltrials.gov, updated on 2013-03-14)

Check the Tween 80 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a nonionic polysorbate surfactant, Tween 80 integrates into lipid interfaces to reduce surface tension, thereby promoting the solubilization and stabilization of lipophilic molecules. This emulsifying action enhances the dispersion and systemic absorption of hydrophobic active agents, directly supporting its investigation as a delivery vehicle to improve oral bioavailability in studies of vitamin D deficiency.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).