Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2025 Apr;16(4):365-378.
doi: 10.1080/20415990.2024.2445501. Epub 2025 Jan 12.

Next-generation pharmaceuticals: the rise of sildenafil citrate ODF for the treatment of men with erectile dysfunction

Emmanuele A Jannini  1 , Shivani Ohri Vignesh  2 , Tarek Hassan  3
Affiliations
Review

Next-generation pharmaceuticals: the rise of sildenafil citrate ODF for the treatment of men with erectile dysfunction

Emmanuele A Jannini et al. Ther Deliv. 2025 Apr.

Abstract

Orodispersible film (ODF) is one of the novel formulations that disintegrate rapidly in the mouth without the requisite for water compared to other conventional oral solid dosage formulations. This delivery system serves as a convenient mode of administration, especially in patients who have dysphagia and fluid restriction, being beneficial to pediatric, geriatric, and bedridden patients. A novel sildenafil ODF containing sildenafil citrate is formulated to be used in patients with erectile dysfunction (ED). This review discusses the advantages of ODF in improving compliance and satisfaction in these patients and describes the manufacturing techniques, evaluation tests, bioequivalence, and stability studies of sildenafil ODF. This formulation offers unique benefit to patients with ED by improving their acceptance and compliance and respecting their privacy and the need for a discreet treatment. Moreover, the comparison of pharmacokinetic parameters between the sildenafil ODF administered with and without water and the conventional film-coated tablet were similar. It also demonstrated reliable performance that yielded a consistent product, meeting all specifications at release and after three weeks of storage under stressed conditions (60°C). Sildenafil ODF warrants improved ease of intake, taste, portability, storage, and compliance among ED patients, making it the potential most preferred formulation and drug of choice.

Keywords: Erectile dysfunction; bioequivalence; compliance; orodispersible films; privacy; sildenafil citrate.

Plain language summary

Erectile dysfunction (ED) prevails as an unprecedented diagnosis and undertreated condition. It is considered as the perfect gender-dependent (early) biomarker of non-communicable diseases (NCDs) including central and peripheral cardiovascular disease, with a heightened risk of related mortality. The effective management of ED reduces these risk factors and halts the progression of disease. Sildenafil citrate, a selective phosphodiesterase-5 inhibitor, is recommended as a first-line treatment for ED owing to its proven efficacy and established safety profile. Recently, a novel sildenafil orodispersible film (ODF) dosage form, which offers rapid disintegration in seconds when placed on the tongue, was developed. We conducted this narrative review to understand the advancements, advantages, and disadvantages of these innovative formulations. ODFs are innovative and sophisticated drug delivery systems that offer several advantages over conventional formulations. The unique benefits of sildenafil ODF includes administration of the film before engaging in sexual activity without the need for water and rapid disintegration of ODF within seconds unlike traditional pills. The sildenafil ODF also demonstrated reliable performance at elevated temperature (stress test), ensuring the stability of the pharmaceutical product during transport, storage, and handling. ODFs have transformed the conventional ways of oral drug delivery. The sildenafil ODF is widely prescribed and preferred among ED patients as it respects patients’ privacy with its ease of use, portability, efficacy, and safety.

PubMed Disclaimer

Conflict of interest statement

EAJ is a Professor of endocrinology and sexual medicine, University of Rome Tor Vergata, Rome, Italy. He is a paid speaker for several pharmaceutical companies like Bayer, Ibsa, Menarini, Otsuyka, Recordati, Pfizer, and Viatris. SV is an employee of Mylan Pharmaceuticals Pvt Ltd., a Viatris Company. TH is an employee of Viatris Inc. and holds stocks. The authors have indicated that they have no other conflicts of interest regarding the content of this article.

Figures

Figure 1.
Figure 1.
Comparison between ODF and ODT.
Figure 2.
Figure 2.
Spray drying technique.
Figure 3.
Figure 3.
Solvent casting technique.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Alqahtani MS, Kazi M, Alsenaidy MA, et al. Advances in oral drug delivery. Front Pharmacol. 2021;12:618411. - PMC - PubMed
    1. Ferlak J, Guzenda W, Osmałek T.. Orodispersible films—current state of the art, limitations, advances and future perspectives. Pharmaceutics. 2023;15(2):361. - PMC - PubMed

    2. •• is of significant interest as it highlighted all the recent manufacturing techniques of ODFs. It also provided extensive summary on quality evaluation tests including in-vitro, invivo tests for ODFs.

    1. Lau ET, Steadman KJ, Cichero JA, et al. Dosage form modification and oral drug delivery in older people. Adv Drug Deliv Rev. 2018;135:75–84. - PubMed
    1. Bala R, Pawar P, Khanna S, et al. Orally dissolving strips: a new approach to oral drug delivery system. Int J Pharm Investig. 2013;3(2):67. - PMC - PubMed
    1. Jacob S, Nair AB, Boddu SH, et al. An updated overview of the emerging role of patch and film-based buccal delivery systems. Pharmaceutics. 2021;13(8):1206. - PMC - PubMed

    2. •• is of considerable interest as it provided all the available technologies for formulation of ODFs.

MeSH terms

Substances