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Qbd analytical development of calcitonin bioadhesive formulation

Kevin Geenens UGent, NELE CLOTTENS UGent, Valentijn Vergote UGent, Delphine Coucke UGent, Els Mehuys UGent and Bart De Spiegeleer UGent (2009)
abstract
Calcitonin is a 32-amino acid polypeptide hormone ubiquitous in humans and animals. It acts i.a. to reduce blood calcium (Ca2+), opposing the effects of parathyroid hormone (PTH). Both human (hu) and salmon (sa) calcitonins are clinically effective and currently approved as active pharmaceutical ingredients (APIs). A new bioadhesive nasal formulation is currently under development, which contains low dose calcitonin in polymeric excipients (carbomer and starch). The analytical development is confronted with several challenges: the low dose of the peptide in the formulation, its inherent instability, the polymeric matrix interacting with the peptide influencing sample preparation and its undefined degradation impurity profile in this formulation. The aim of this investigation was to develop a suitable method to determine the concentration of sa-calcitonin in this formulation and to establish its degradation profile, using experimental designs which will also give us mechanistic information. Degradation profiling was developed towards the sensitive detection of all possible already-identified related compounds [1], using a selective gradient FA-based RP-HPLC with ESI/iontrap MS detection in the SIM mode The assay was developed using Onion and Plackett-Burman designs, evaluating and optimizing the sample treatment procedure. The chromatography method is based on a TFA-based gradient RP-HPLC with UV detection for quantification. Both methods are applied in short-term stability studies for the release of clinical trial material.
Please use this url to cite or link to this publication:
author
organization
year
type
conference
publication status
published
subject
keyword
calcitonin
conference location
Ghent
conference start
2009-05-20
conference end
2009-05-20
language
English
UGent publication?
yes
classification
C3
copyright statement
I have retained and own the full copyright for this publication
id
674361
handle
http://hdl.handle.net/1854/LU-674361
date created
2009-06-02 10:28:00
date last changed
2009-06-05 09:28:44
@inproceedings{674361,
  abstract     = {Calcitonin is a 32-amino acid polypeptide hormone ubiquitous in humans and animals.  It acts i.a. to reduce blood calcium (Ca2+), opposing the effects of parathyroid hormone (PTH).  Both human (hu) and salmon (sa) calcitonins are clinically effective and currently approved as active pharmaceutical ingredients (APIs).
A new bioadhesive nasal formulation is currently under development, which contains low dose calcitonin in polymeric excipients (carbomer and starch). The analytical development is confronted with several challenges: the low dose of the peptide in the formulation, its inherent instability, the polymeric matrix interacting with the peptide influencing sample preparation and its undefined degradation impurity profile in this formulation. 
The aim of this investigation was to develop a suitable method to determine the concentration of sa-calcitonin in this formulation and to establish its degradation profile, using experimental designs which will also give us mechanistic information.
Degradation profiling was developed towards the sensitive detection of all possible already-identified related compounds [1], using a selective gradient FA-based RP-HPLC with ESI/iontrap MS detection in the SIM mode 
The assay was developed using Onion and Plackett-Burman designs, evaluating and optimizing the sample treatment procedure.  The chromatography method is based on a TFA-based gradient RP-HPLC with UV detection for quantification. 
Both methods are applied in short-term stability studies for the release of clinical trial material.},
  author       = {Geenens, Kevin and CLOTTENS, NELE and Vergote, Valentijn and Coucke, Delphine and Mehuys, Els and De Spiegeleer, Bart},
  keyword      = {calcitonin},
  language     = {eng},
  location     = {Ghent},
  title        = {Qbd analytical development of calcitonin bioadhesive formulation},
  year         = {2009},
}

Chicago
Geenens, Kevin, NELE CLOTTENS, Valentijn Vergote, Delphine Coucke, Els Mehuys, and Bart De Spiegeleer. 2009. “Qbd Analytical Development of Calcitonin Bioadhesive Formulation.” In .
APA
Geenens, K., CLOTTENS, N., Vergote, V., Coucke, D., Mehuys, E., & De Spiegeleer, B. (2009). Qbd analytical development of calcitonin bioadhesive formulation.
Vancouver
1.
Geenens K, CLOTTENS N, Vergote V, Coucke D, Mehuys E, De Spiegeleer B. Qbd analytical development of calcitonin bioadhesive formulation. 2009.
MLA
Geenens, Kevin, NELE CLOTTENS, Valentijn Vergote, et al. “Qbd Analytical Development of Calcitonin Bioadhesive Formulation.” 2009. Print.