Next-generation pharmaceuticals: the rise of sildenafil citrate ODF for the treatment of men with erectile dysfunction
Creators: name: Jannini, Emmanuele A.
name: Vignesh, Shivani Ohri
name: Hassan, Tarek
Publisher: name: Taylor & Francis
Year: 2025
Subjects: Medicine
Pharmacology
Biological Sciences not elsewhere classified
Cancer
Science Policy

description: 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. 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.