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Clinical Drug Investigation

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Open Access 01-08-2018 | Original Research Article

Pharmacokinetics of a Novel Sildenafil Orodispersible Film Administered by the Supralingual and the Sublingual Route to Healthy Men

Authors: Luca Loprete, Chiara Leuratti, Valeria Frangione, Milko Radicioni

Published in: Clinical Drug Investigation | Issue 8/2018

Abstract

Background

Sildenafil was the first selective drug available on the market as oral therapy for erectile dysfunction (ED). A novel sildenafil orodispersible film (ODF) for ED treatment, containing sildenafil citrate, has recently been marketed.

Objectives

Study objective was to investigate sildenafil bioavailability of the novel ODF formulation after sublingual and supralingual administration.

Methods

In this randomised, two-way cross-over study, 12 healthy male volunteers received a single 50 mg sildenafil dose by the sublingual and supralingual administration routes. Plasma sildenafil was determined up to 12 h post-dose. Peak concentration (C_max) and area under concentration-time curve (AUC_0–t) were calculated and compared between the two administration routes by analysis of variance (ANOVA).

Results

Sublingual and supralingual administration can be claimed equivalent regarding the extent of sildenafil exposure since AUC_0–t 90 % CIs corresponded to 94.90–110.58% and were within the pre-specified acceptance range. C_max 90% CIs (79.92–125.57%) were only slightly outside the 80.00–125.00% limits, due to the small sample size, while the time to achieve C_max did not differ between treatments (p = 0.9277). Rate of exposure of the two administration routes was therefore similar. Reported treatment-related adverse events were mild to moderate headache (33.3% of subjects) and vomiting (8.3%).

Conclusions

In healthy men, sublingual and supralingual administration of sildenafil ODF resulted in a remarkably similar pharmacokinetic profile and confirmed the safety of both study treatments. The recently marketed sildenafil ODF, administered by both investigated routes, can provide a valuable alternative to the marketed solid oral forms (tablets) in ED treatment.

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Title: Pharmacokinetics of a Novel Sildenafil Orodispersible Film Administered by the Supralingual and the Sublingual Route to Healthy Men
Authors: Luca Loprete
Chiara Leuratti
Valeria Frangione
Milko Radicioni
Publication date: 01-08-2018
Publisher: Springer International Publishing
Published in: Clinical Drug Investigation / Issue 8/2018
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI: https://doi.org/10.1007/s40261-018-0665-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Pharmacokinetics of a Novel Sildenafil Orodispersible Film Administered by the Supralingual and the Sublingual Route to Healthy Men

Abstract

Background

Objectives

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Objectives

Methods

Results

Conclusions

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