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Colloidal precipitates

Colloidal precipitates

The high insolubility of some precipitates can result in an unfavorable relative supersaturation. This can lead to colloidal particles with a large surface-to-mass ratio, where adsorption is promoted. For instance, in the precipitation of silver chloride, silver ions are adsorbed on the surface of the colloidal particles, forming a primary layer. This layer attracts ions of opposite charge (such as nitrate ions), forming a diffuse secondary layer of adsorbed ions. This electric double layer...

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Updated: Oct 21, 2025

Preparation, Purification, and Use of Fatty Acid-containing Liposomes

Preparation, Purification, and Use of Fatty Acid-containing Liposomes

Published on: February 9, 2018

Evaluating a Modified High Purity Polysorbate 20 Designed to Reduce the Risk of Free Fatty Acid Particle Formation.

Nidhi Doshi¹, Kyle Ritchie², Tamanna Shobha³

¹Pharmaceutical Development, Genentech Inc., 1 DNA Way, South San Francisco, California, 94080, USA. doshin1@gene.com.

Pharmaceutical Research

|September 8, 2021

Summary

A modified polysorbate 20 (RO HP PS20) shows delayed free fatty acid (FFA) particle formation in biopharmaceutical drug products. This new surfactant offers functional equivalence with improved stability, reducing variability in particle onset.

Keywords:

Drug product stability Free fatty acids Particles Polysorbate 20 Polysorbate degradation Surfactants

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Last Updated: Oct 21, 2025

Preparation, Purification, and Use of Fatty Acid-containing Liposomes

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Published on: February 9, 2018

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Published on: July 27, 2022

Area of Science:

Biopharmaceutical drug development
Polymer chemistry
Analytical chemistry

Background:

Polysorbate 20 (PS20) is a critical excipient in biopharmaceutical formulations.
Hydrolytic degradation of PS20 can lead to free fatty acid (FFA) particle formation, impacting drug product stability.
Current PS20 grades exhibit variability in ester composition, influencing degradation pathways.

Purpose of the Study:

To evaluate a modified high purity polysorbate 20 (RO HP PS20) as a surfactant in biopharmaceutical drug products.
To assess if RO HP PS20 offers delayed onset of FFA particle formation compared to standard HP PS20.
To determine the functional equivalence of RO HP PS20 as a surfactant.

Main Methods:

Analytical characterization of RO HP PS20, including fatty acid ester (FAE) distribution and FFA levels.
Functional assessments: agitation, oxidation propensity, and hydrolytic degradation studies.
Evaluation of FFA particle formation under various conditions, including metal nucleation.

Main Results:

RO HP PS20 demonstrated comparable interfacial protection and oxidation propensity to standard HP PS20.
A significant delay in FFA particle formation upon hydrolytic degradation was observed with RO HP PS20.
Fewer particles formed from RO HP PS20 hydrolytic degradants in the presence of aluminum.

Conclusions:

Tighter control over long-chain FAE levels in PS20 is crucial for reducing FFA particle formation and variability.
RO HP PS20, with controlled FAE composition, is a promising alternative to HP PS20 for biopharmaceutical applications.
This modified PS20 meets compendial specifications while offering enhanced hydrolytic stability.