Abstract

Research Article

Clinical Study of Tadaflexe (Tadalafil 10 mg) Oral Gel Sachet in Yemeni Honey in Patients with Erectile Dysfunction

Hussien O Kadi*, Mohammed H Kadi and Taha H Kadi

Published: 25 November, 2025 | Volume 9 - Issue 2 | Pages: 028-030

Introduction: Erectile dysfunction (ED) is a common issue impacting millions of men around the globe, with notable effects on both life quality and mental health. This clinical trial evaluated the clinical efficacy, onset of action, safety, and patient satisfaction of Tadaflexe (Tadalafil 10 mg) formulated as an oral gel in Yemeni honey sachets. The formulation was designed to enhance absorption and provide a natural delivery vehicle for Tadalafil, a selective phosphodiesterase type 5 inhibitor used for erectile dysfunction (ED). This study aimed to assess the effectiveness, safety, and tolerability of Seldiflexe, which is a new oral gel sachet formulation of Tadaflexe (Tadalafil 10 mg) with 5 g of Yemeni honey, in comparison with standard Tadalafil 10 mg tablets. 
Materials and methods: A randomized, double-blind, controlled trial was carried out with 80 male participants who had been diagnosed with erectile dysfunction (ED). Subjects were divided into two groups: the Tadaflexe (Tadalafil 10 mg) oral gel sachet group A (n = 40) and the standard Tadalafil 10 mg tablet group B (n = 40) for a duration of 4 weeks. The main measures included changes in the scores of the International Index of Erectile Function (IIEF), time until effects began, and the profile of any adverse events.
Results: The analysis revealed a statistically significant improvement in erectile function scores post-treatment with Tadaflex oral gel. The onset of action was notably faster compared to standard Tadalafil tablets. Adverse effects were minimal, and overall satisfaction was high among participants. The time it takes for Tadaflexe (Tadalafil 10 mg) in Yemeni honey oral gel sachet to start working is 22.5 ± 4.2 minutes, which is significantly faster than Tadalafil 10 mg tablets was 38.7 ± 5.6 minutes at p < 0.001. However, after four weeks, there was no significant difference in the IIEF scores between Tadaflexe oral gel (20.1 ± 2.8) and Tadalafil tablets (18.2 ± 3.1) were significantly different at p < 0.05. On the other hand, the adverse effects were significantly less with Tadaflexe oral gel sachet as compared with Tadalafil tablets.
Conclusion: The study demonstrated a significantly faster onset of action, excellent tolerability, and improved patient preference compared with conventional tablet formulations.

Read Full Article HTML DOI: 10.29328/journal.ijcv.1001066 Cite this Article Read Full Article PDF

Keywords:

Tadaflexe; Tadalafil; Oral; Gel; Sachet; Yemeni; Honey

References

  1. Salonia A, Bettocchi C, Boeri L, Capogrosso P, Carvalho J, Cilesiz NC, et al. European Association of Urology Guidelines on Sexual and Reproductive Health-2021 Update: Male Sexual Dysfunction. Eur Urol. 2021;80(3):333-357. Available from: https://doi.org/10.1016/j.eururo.2021.06.007
  2. Czapla M, Kler A, Marciniak R, Kowalik A, Grzesiak Z, Leszek J. The multifunctional role of phosphodiesterase 5 inhibitors in medicine. J Sex Ment Health. 2025;23:104-117. Available from: https://journals.viamedica.pl/sexual_and_mental_health/article/view/106713
  3. Shreya L, Suma US, Zohmingliani R. Recent advances in oral in-situ gel drug delivery system: a polymeric approach. Drug Dev Ind Pharm. 2025 Sep;1-11. Available from: https://doi.org/10.1080/03639045.2025.2559033
  4. Hossain ML, Lim LY, Hammer K, Hettiarachchi D, Locher C. Honey-based medicinal formulations: a critical review. Appl Sci. 2021;11(11):5159. Available from: https://doi.org/10.3390/app11115159
  5. Fakhar ud Din, Kim DS, Kim JS, Cheon S, Park S, Woo S, et al. Comparative analysis of novel modified drug delivery systems for improving the oral bioavailability of water-insoluble tadalafil using copovidone, TPGS, and hydroxypropyl-β-cyclodextrin. Biomed Pharmacother. 2025;186:118039. Available from: https://doi.org/10.1016/j.biopha.2025.118039
  6. Wang C, Zhang H, Liu Z, Tu X, Zhang Y. A modified procedure to diagnose erectile dysfunction using the International Index of Erectile Function (IIEF-6) combined with the Premature Ejaculation Diagnosis Tool (PEDT) via an Internet survey. Sex Med. 2022 Jun;10(3):1-8. Available from: https://doi.org/10.1016/j.esxm.2022.100506
  7. de Aquino ACQ, Sarmento ACA, Teixeira RLA, Batista TN, de Freitas CL, Pérez Mármol JM, et al. Pharmacological treatment of antidepressant-induced sexual dysfunction in women: a systematic review and meta-analysis of randomized clinical trials. Clinics. 2025;80:100602. Available from: https://doi.org/10.1016/j.clinsp.2025.100602
  8. Salonia A, Bettocchi C, Boeri L, Capogrosso P, Carvalho J, et al. European Association of Urology Guidelines on Sexual and Reproductive Health—2021 Update: Male Sexual Dysfunction. Eur Urol. 2021;80:333-357. Available from: https://doi.org/10.1016/j.eururo.2021.06.007
  9. Park SI, Heo SH, Kim G, Chang S, Song KH, Kim MG, et al. Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated table Drug Des Devel Ther. 2018;12:935-942. Available from: https://doi.org/10.2147/dddt.s155040
  10. Trifu DM, Leucuța DC, Pintea-Trifu ML, Elec F, Crișan N, Eniu D, et al. Comparative effects of tadalafil cream versus oral tadalafil on males with erectile dysfunction regarding relationship dynamics: a secondary analysis of dyadic adjustment outcomes in a randomized crossover trial. Life (Basel). 2025;15(4):668. Available from: https://doi.org/10.3390/life15040668
  11. Forgue ST, Patterson BE, Bedding AW, Payne CD, Phillips DL, Wrishko RE, et al. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol. 2006;61(3):280-8. Available from: https://doi.org/10.1111/j.1365-2125.2005.02553.x
  12. Masuku NP, Unuofin JO, Lebelo SL. Advances in nanoparticle delivery system for erectile dysfunction: an updated review. Sex Med. 2021 Oct;9(5):1. Available from: https://doi.org/10.1016/j.esxm.2021.100420
  13. Abu Dayyih W, Rasras AA, Hailat M, Karaki R, Deeb AA, Al-Ani I, et al. Determination of five phosphodiesterase-5 inhibitors in multiple honey-based consumer products by chromatographic technique in rat plasma. Processes. 2023;11(10):3019. Available from: https://doi.org/10.3390/pr11103019
  14. Frem J-P. Novel natural-based chewable lozenges for the treatment of erectile dysfunction. Lebanese University, School of Pharmacy. Thesis. 2022. Available from: https://doi.org/10.26756/th.2022.517
  15. Masuku NP, Unuofin JO, Lebelo SL. Advances in nanoparticle delivery systems for erectile dysfunction: an updated review. Sex Med. 2021;9(5):100420. Available from: https://doi.org/10.1016/j.esxm.2021.100420

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