Quantifying low amorphous or crystalline amounts of alpha-lactose-monohydrate using X-ray powder diffraction, near-infrared spectroscopy, and differential scanning calorimetry

Drug Development and Industrial Pharmacy
I Fix, K J Steffens

Abstract

Efficient and accurate quantification of low amorphous and crystalline contents within pharmaceutical materials still remains a challenging task in the pharmaceutical industry. Since X-ray powder diffraction (XRPD) equipment has improved in recent years, our aim was 1) to investigate the possibility of substantially lowering the detection limits of amorphous or crystalline material to about 1% or 0.5% w/w respectively by applying conventional Bragg Brentano optics, combined with a fast and simple evaluation technique; 2) to perform these measurements within a short time to make it suitable for routine analysis; and 3) to subject the same data sets to a partial least squares regression (PLSR) in order to investigate whether it is possible to improve accuracy and precision compared to the standard integration method. Near-infrared spectroscopy (NIRS) and differential scanning calorimetry (DSC) were chosen as reference method. As model substance, alpha lactose monohydrate was chosen to create calibration curves based on predetermined mixtures of highly crystalline and amorphous substance. In contrast to DSC, XRPD and NIRS revealed an excellent linearity, precision, and accuracy with the percent of crystalline amount and a detectab...Continue Reading

References

Feb 1, 1995·Journal of Pharmaceutical Sciences·L S Crocker, J A McCauley
Jan 1, 1997·Journal of Pharmaceutical Sciences·B C Hancock, G Zografi
Jun 10, 1998·Pharmaceutical Research·L S Taylor, G Zografi
Mar 4, 1999·International Journal of Pharmaceutics·G Buckton, P Darcy
Nov 26, 1999·International Journal of Pharmaceutics·S Guinot, F Leveiller
May 16, 2000·Pharmaceutical Development and Technology·P E LunerM S Kemper
Sep 12, 2000·Journal of Pharmaceutical Sciences·J J SeyerM S Kemper
Jul 14, 2001·Journal of Pharmaceutical and Biomedical Analysis·X ChenK R Morris
Apr 16, 2003·International Journal of Pharmaceutics·Agota GombásIstván Erõs
Nov 1, 1985·Pharmaceutical Research·R HüttenrauchP Zielke

❮ Previous
Next ❯

Citations

Sep 5, 2008·Pharmaceutical Research·Paul T WhitesideMichael W George
Feb 26, 2009·Pharmaceutical Development and Technology·Radha R VippaguntaMichael Motto
Nov 19, 2011·Drug Development and Industrial Pharmacy·Luis PadrelaSitaram P Velaga
Apr 5, 2011·Drug Development and Industrial Pharmacy·Orsolya Jójárt-Laczkovich, Piroska Szabó-Révész
May 16, 2014·Journal of Pharmaceutical Sciences·Paul E Luner, Jeffery J Seyer
Sep 25, 2012·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Yusuke Hattori, Makoto Otsuka
Aug 4, 2010·International Journal of Pharmaceutics·Alfred C F Rumondor, Lynne S Taylor
Jul 12, 2008·International Journal of Pharmaceutics·S GarnierG Coquerel
Jan 27, 2009·Journal of Pharmaceutical and Biomedical Analysis·Michael D MoorePeter L D Wildfong
Jul 12, 2016·International Journal of Pharmaceutics·Samaneh PazeshJohan Gråsjö
Jan 13, 2017·Bioscience, Biotechnology, and Biochemistry·Thao M HoBhesh R Bhandari
Dec 10, 2013·Journal of Pharmaceutical and Biomedical Analysis·Duohai PanJohn Grosso
Dec 2, 2017·Drug Development and Industrial Pharmacy·Futoshi ShikataMakoto Otsuka
Dec 30, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Laura Dall'OlioLucia Maini
May 29, 2021·International Journal of Pharmaceutics·Thamer AlzoubiPaul G Royall

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.