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Oral lyophylizate formulation of desmopressin: superior pharmacodynamics compared to tablet due to low food interaction

Ann De Guchtenaere UGent, Charlotte Van Herzeele UGent, Ann Raes UGent, Joke Dehoorne, Piet Hoebeke UGent, Erik Van Laecke UGent and Johan Vande Walle UGent (2011) JOURNAL OF UROLOGY. 185(6). p.2308-2313
abstract
Purpose: Desmopressin is a standard treatment for monosymptomatic nocturnal enuresis. Different formulations are promoted as bioequivalent, although these claims are not supported by comparative pharmacodynamic data in children. Food interaction is known to influence the bioavailability of desmopressin. We compared the pharmacodynamics of the 2 most frequently used desmopressin formulations, tablet and lyophilizate, with a standardized meal, allowing extrapolation to clinical reality, where the interval between evening meal and medication intake is limited for school-age children. We hypothesized there would be a faster pharmacodynamic response, and greater concentrating and antidiuretic activity for the fast dissolving (melt) formulation compared to the tablet with simultaneous food intake. Materials and Methods: Two tests were performed on separate days in identical standardized conditions, starting with a 15 ml/kg water load. After achieving maximal diluting capacity a standardized meal was administered, followed by desmopressin tablet (t test) or melt (M-test). Diuresis rate and urinary osmolality were measured hourly. Paired data from 4 girls and 15 boys with a mean age of 12.1 years were obtained. Results: In the early response phase more than 25% of patients had a higher diuresis rate with tablet vs melt formulation, reaching statistical significance in the plateau phase (urine collected at hours 3 to 5, p < 0.02) and in duration of action (urine collected at hours 5 to 8, p < 0.005). For desmopressin melt smaller standard deviations in diuresis rate were remarkable. Concentrating capacity demonstrated no significant differences between formulations in the early response phase, in contrast to the plateau phase (p < 0.036) and duration of action (p < 0.001). Conclusions: With meal combination desmopressin melt formulation has a superior pharmacodynamic profile to tablet, making it more suitable for the younger age group with a limited interval between meal and drug administration.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
DIURESIS, freeze drying, ABSORPTION, INTRANASAL, ADOLESCENTS, DAYTIME, ADULTS, POLYURIA, administration, sublingual, biological availability, food-drug interactions, deamino, arginine vasopressin, PRIMARY NOCTURNAL ENURESIS, PHARMACOKINETICS, CHILDREN
journal title
JOURNAL OF UROLOGY
J. Urol.
volume
185
issue
6
pages
2308 - 2313
Web of Science type
Article
Web of Science id
000290389600106
JCR category
UROLOGY & NEPHROLOGY
JCR impact factor
3.746 (2011)
JCR rank
11/72 (2011)
JCR quartile
1 (2011)
ISSN
0022-5347
DOI
10.1016/j.juro.2011.02.039
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1196961
handle
http://hdl.handle.net/1854/LU-1196961
date created
2011-03-25 14:25:32
date last changed
2016-12-19 15:46:38
@article{1196961,
  abstract     = {Purpose: Desmopressin is a standard treatment for monosymptomatic nocturnal enuresis. Different formulations are promoted as bioequivalent, although these claims are not supported by comparative pharmacodynamic data in children. Food interaction is known to influence the bioavailability of desmopressin. We compared the pharmacodynamics of the 2 most frequently used desmopressin formulations, tablet and lyophilizate, with a standardized meal, allowing extrapolation to clinical reality, where the interval between evening meal and medication intake is limited for school-age children. We hypothesized there would be a faster pharmacodynamic response, and greater concentrating and antidiuretic activity for the fast dissolving (melt) formulation compared to the tablet with simultaneous food intake.
Materials and Methods: Two tests were performed on separate days in identical standardized conditions, starting with a 15 ml/kg water load. After achieving maximal diluting capacity a standardized meal was administered, followed by desmopressin tablet (t test) or melt (M-test). Diuresis rate and urinary osmolality were measured hourly. Paired data from 4 girls and 15 boys with a mean age of 12.1 years were obtained.
Results: In the early response phase more than 25\% of patients had a higher diuresis rate with tablet vs melt formulation, reaching statistical significance in the plateau phase (urine collected at hours 3 to 5, p {\textlangle} 0.02) and in duration of action (urine collected at hours 5 to 8, p {\textlangle} 0.005). For desmopressin melt smaller standard deviations in diuresis rate were remarkable. Concentrating capacity demonstrated no significant differences between formulations in the early response phase, in contrast to the plateau phase (p {\textlangle} 0.036) and duration of action (p {\textlangle} 0.001).
Conclusions: With meal combination desmopressin melt formulation has a superior pharmacodynamic profile to tablet, making it more suitable for the younger age group with a limited interval between meal and drug administration.},
  author       = {De Guchtenaere, Ann and Van Herzeele, Charlotte and Raes, Ann and Dehoorne, Joke and Hoebeke, Piet and Van Laecke, Erik and Vande Walle, Johan},
  issn         = {0022-5347},
  journal      = {JOURNAL OF UROLOGY},
  keyword      = {DIURESIS,freeze drying,ABSORPTION,INTRANASAL,ADOLESCENTS,DAYTIME,ADULTS,POLYURIA,administration,sublingual,biological availability,food-drug interactions,deamino,arginine vasopressin,PRIMARY NOCTURNAL ENURESIS,PHARMACOKINETICS,CHILDREN},
  language     = {eng},
  number       = {6},
  pages        = {2308--2313},
  title        = {Oral lyophylizate formulation of desmopressin: superior pharmacodynamics compared to tablet due to low food interaction},
  url          = {http://dx.doi.org/10.1016/j.juro.2011.02.039},
  volume       = {185},
  year         = {2011},
}

Chicago
De Guchtenaere, Ann, Charlotte Van Herzeele, Ann Raes, Joke Dehoorne, Piet Hoebeke, Erik Van Laecke, and Johan Vande Walle. 2011. “Oral Lyophylizate Formulation of Desmopressin: Superior Pharmacodynamics Compared to Tablet Due to Low Food Interaction.” Journal of Urology 185 (6): 2308–2313.
APA
De Guchtenaere, A., Van Herzeele, C., Raes, A., Dehoorne, J., Hoebeke, P., Van Laecke, E., & Vande Walle, J. (2011). Oral lyophylizate formulation of desmopressin: superior pharmacodynamics compared to tablet due to low food interaction. JOURNAL OF UROLOGY, 185(6), 2308–2313.
Vancouver
1.
De Guchtenaere A, Van Herzeele C, Raes A, Dehoorne J, Hoebeke P, Van Laecke E, et al. Oral lyophylizate formulation of desmopressin: superior pharmacodynamics compared to tablet due to low food interaction. JOURNAL OF UROLOGY. 2011;185(6):2308–13.
MLA
De Guchtenaere, Ann, Charlotte Van Herzeele, Ann Raes, et al. “Oral Lyophylizate Formulation of Desmopressin: Superior Pharmacodynamics Compared to Tablet Due to Low Food Interaction.” JOURNAL OF UROLOGY 185.6 (2011): 2308–2313. Print.