Preprint Review Version 1 This version is not peer-reviewed

Next-Generation Pharmaceuticals: The Rise of Orodispersible Formulation Technology for Male Sexual Health

Version 1 : Received: 26 July 2024 / Approved: 29 July 2024 / Online: 29 July 2024 (08:52:48 CEST)

How to cite: Jannini, E. A.; Vignesh, S. O.; Hassan, T. Next-Generation Pharmaceuticals: The Rise of Orodispersible Formulation Technology for Male Sexual Health. Preprints 2024, 2024072273. https://doi.org/10.20944/preprints202407.2273.v1 Jannini, E. A.; Vignesh, S. O.; Hassan, T. Next-Generation Pharmaceuticals: The Rise of Orodispersible Formulation Technology for Male Sexual Health. Preprints 2024, 2024072273. https://doi.org/10.20944/preprints202407.2273.v1

Abstract

Abstract: Orodispersible film (ODF) is one of the novel formulations that have been currently made available that disintegrates rapidly in the mouth without the requisite for water and offer several benefits over conventional oral solid dosage formulations. This delivery system serves as a discreet and convenient mode of administration, especially in patients who have dysphagia, 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 bioequivalence and stability studies of sildenafil ODF. This formulation offers unique benefit to patients with ED by improving their acceptance, compliance, and respecting their privacy. 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 (60oC). 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 

Subject

Medicine and Pharmacology, Urology and Nephrology

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