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NIR spectroscopy-a non-destructive analytical tool for protein quantification within lipid implants.

Tilo Schönbrodt¹, Silke Mohl, Gerhard Winter

¹Ruprecht-Karls-University Heidelberg, Germany.

Journal of Controlled Release : Official Journal of the Controlled Release Society

|July 29, 2006

Summary

Near infrared spectroscopy (NIRS) accurately quantifies proteins in lipid implants, even small amounts. This non-destructive method works during manufacturing and release studies for sustained drug delivery.

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Area of Science:

Pharmaceutical Sciences
Biotechnology
Analytical Chemistry

Background:

Lipid implants offer sustained parenteral protein delivery.
Poly-(lactic-co-glycolic) acid (PLGA) matrices are suitable for controlled release.
Near infrared spectroscopy (NIRS) is a non-destructive tool for drug quantification in PLGA systems.

Purpose of the Study:

To evaluate NIRS for protein content determination in lipid matrices.
To assess NIRS applicability with stabilizing and release-modifying additives.
To validate NIRS for protein quantification during implant manufacturing and release.

Main Methods:

Proteins (BSA, IFN alpha-2a) lyophilized with trehalose.
Blended with tristearin and polyethylene glycol 6000 (PEG).

Related Experiment Videos

Implants prepared by compression; NIR spectra measured; PLSR models developed.

Main Results:

NIRS accurately quantified protein content in complex lipid matrices.
Good accuracy achieved post-manufacture and during release studies (SEP 57–176 μg).
Low detection limit demonstrated, quantifying protein amounts as low as 70 μg.

Conclusions:

NIRS is a viable non-destructive technique for protein quantification in lipid implants.
NIRS facilitates real-time monitoring of protein content during sustained release.
The method shows potential for quality control in parenteral protein formulations.