Plasma pharmacokinetics of desmopressin following sublingual administration: an exploratory dose-escalation study in healthy male volunteers

Steiner, Ilka; Kaehler, Stefan T.; Sauermann, Robert; Rinösl, Harald; Müller, Markus; Joukhadar, Christian

doi:10.5414/cpp44172

Cited by 10 publications

(6 citation statements)

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“…Although the nonkeratinised sublingual mucosa should be the most permeable in the oral cavity (1), it is not comparable to the nasal mucosa (2). Previously published studies on a sublingual spray and an instantly dissolving tablet (34,35) have shown plasma desmopressin concentrations in the same range as were also seen herein after sublingual administration. A prolonged residence time sublingually facilitates both a site-specific absorption and possibilities for absorption enhancement and should therefore be more beneficial for the bioavailability than a formulation that is instantly dissolved and swallowed; yet, this requires that the drug is dissolved and accessible for absorption.…”

Section: Discussionsupporting

confidence: 73%

Clinical Study Shows Improved Absorption of Desmopressin with Novel Formulation

2009

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Section: Discussionsupporting

confidence: 73%

Clinical Study Shows Improved Absorption of Desmopressin with Novel Formulation

2009

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“…Pharmacological studies demonstrated that sublingual route results in a more stable absorption compared to intranasal or oral route. Additionally, oral lyophilisate has a higher bioavailability compared to tablet, allowing lower dosing ( 11 ). In the absence of pharmacokinetic data of oral lyophilisate in neonates, size-dependent dosing schemes are absent.…”

Section: Discussionmentioning

confidence: 99%

Desmopressin Lyophilisate for the Treatment of Central Diabetes Insipidus: First Experience in Very Young Infants

Waele

Cools

Guchtenaere

et al. 2014

Int J Endocrinol Metab

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Introduction:In neonates and small infants, early diagnosis of central diabetes insipidus (CDI) and treatment with desmopressin in low doses (avoiding severe hypo- or hypernatremia) are important to prevent associated high morbidity and mortality in this particular age group.Case Presentation:We described pharmacokinetic and pharmacodynamic results of the use of recently launched oral desmopressin lyophilisate (Minirin Melt®) in two infants with CDI, diagnosed at the age of 12 and 62 days, respectively. We observed that a starting dose of 60 μg of Minirin Melt® in the first case resulted in a pharmacokinetic profile largely exceeding the reference frame observed in children with nocturnal enuresis, while a dose of 15 μg in the second case resulted in acceptable concentrations. After initial dose adjustments, administration of sublingual lyophilisate resulted in rather stable serum sodium concentrations.Conclusions:Using Minirin Melt® in infants with CDI appears to be effective, easy to use and well tolerated.

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“…With respect to DDAVP, nasal spray (58) is used clinically. In addition, sublingual spray has been attempted (59). However, very large intersubject variation on the plasma DDAVP concentration vs. time curves are reported.…”

Section: Rate and Extent Of Bioavailabilitymentioning

confidence: 97%