NDLI: Multivariate Analysis of Phenol in Freeze-Dried and Spray-Dried Insulin Formulations by NIR and FTIR

Content Provider	Springer Nature Link
Author	Maltesen, Morten Jonas Bjerregaard, Simon Hovgaard, Lars Havelund, Svend Weert, Marco Grohganz, Holger
Copyright Year	2011
Abstract	Dehydration is a commonly used method to stabilise protein formulations. Upon dehydration, there is a significant risk the composition of the formulation will change especially if the protein formulation contains volatile compounds. Phenol is often used as excipient in insulin formulations, stabilising the insulin hexamer by changing the secondary structure. We have previously shown that it is possible to maintain this structural change after drying. The aim of this study was to evaluate the residual phenol content in spray-dried and freeze-dried insulin formulations by Fourier transform infrared (FTIR) spectroscopy and near infrared (NIR) spectroscopy using multivariate data analysis. A principal component analysis (PCA) and partial least squares (PLS) projections were used to analyse spectral data. After drying, there was a difference between the two drying methods in the phenol/insulin ratio and the water content of the dried samples. The spray-dried samples contained more water and less phenol compared with the freeze-dried samples. For the FTIR spectra, the best model used one PLS component to describe the phenol/insulin ratio in the powders, and was based on the second derivative pre-treated spectra in the 850–650 cm$^{−1}$ region. The best PLS model based on the NIR spectra utilised three PLS components to describe the phenol/insulin ratio and was based on the standard normal variate transformed spectra in the 6,200–5,800 cm$^{−1}$ region. The root mean square error of cross validation was 0.69% and 0.60% (w/w) for the models based on the FTIR and NIR spectra, respectively. In general, both methods were suitable for phenol quantification in dried phenol/insulin samples.
Starting Page	627
Ending Page	636
Page Count	10
File Format	PDF
Journal	AAPS PharmSciTech
Volume Number	12
Issue Number	2
e-ISSN	15309932
Language	English
Publisher	Springer US
Publisher Date	2011-05-11
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacy Biochemistry Biotechnology Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Multivariate Analysis of Phenol in Freeze-Dried and Spray-Dried Insulin Formulations by NIR and FTIR

Biologic Comparison of Inhaled Insulin Formulations: Exubera$^{TM}$ and Novel Spray-Dried Engineered Particles of Dextran-10

Aerodynamic Droplet Stream Expansion for the Production of Spray Freeze-Dried Powders

Design of Experiments-Based Monitoring of Critical Quality Attributes for the Spray-Drying Process of Insulin by NIR Spectroscopy

Erratum to: Design of Experiments-Based Monitoring of Critical Quality Attributes for the Spray-Drying Process of Insulin by NIR Spectroscopy

Prediction of Glass Transition Temperature of Freeze-Dried Formulations by Molecular Dynamics Simulation

Effect of Sugars on the Molecular Motion of Freeze-Dried Protein Formulations Reflected by NMR Relaxation Times

Poly(Lactide-Co-Glycolide) Microsphere Formulations of Darbepoetin Alfa: Spray Drying Is an Alternative to Encapsulation by Spray-Freeze Drying

Effect of Cholesterol on the Properties of Spray-Dried Lysozyme-Loaded Liposomal Powders

Multivariate Analysis of Phenol in Freeze-Dried and Spray-Dried Insulin Formulations by NIR and FTIR

Similar Documents

Multivariate Analysis of Phenol in Freeze-Dried and Spray-Dried Insulin Formulations by NIR and FTIR

Biologic Comparison of Inhaled Insulin Formulations: Exubera$^{TM}$ and Novel Spray-Dried Engineered Particles of Dextran-10

Aerodynamic Droplet Stream Expansion for the Production of Spray Freeze-Dried Powders

Design of Experiments-Based Monitoring of Critical Quality Attributes for the Spray-Drying Process of Insulin by NIR Spectroscopy

Erratum to: Design of Experiments-Based Monitoring of Critical Quality Attributes for the Spray-Drying Process of Insulin by NIR Spectroscopy

Prediction of Glass Transition Temperature of Freeze-Dried Formulations by Molecular Dynamics Simulation

Effect of Sugars on the Molecular Motion of Freeze-Dried Protein Formulations Reflected by NMR Relaxation Times

Poly(Lactide-Co-Glycolide) Microsphere Formulations of Darbepoetin Alfa: Spray Drying Is an Alternative to Encapsulation by Spray-Freeze Drying

Effect of Cholesterol on the Properties of Spray-Dried Lysozyme-Loaded Liposomal Powders

Multivariate Analysis of Phenol in Freeze-Dried and Spray-Dried Insulin Formulations by NIR and FTIR