Safety Profile and Common Side Effects

8Nichols, D.

J.; Muirhead, G.

• Sildenafil gel allows more discreet and flexible dosing schedules.
• It offers an alternative for men experiencing side effects from oral sildenafil.
• Proper hygiene before application reduces infection risk.
• The gel base typically evaporates or absorbs fully without leaving residue.
• The product may be marketed as a cosmetic or pharmaceutical depending on region.
• Some gels have flavor or scent additives to improve user experience.
• Patients should report any adverse skin reactions promptly.

J.; Harness, J. A.

3. Results and Discussion

AldawsariDepartment of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-kharj 11942, Saudi ArabiaMore by Mohammed F. Aldawsari Abdullah AlshetailiAbdullah AlshetailiDepartment of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-kharj 11942, Saudi ArabiaMore by Abdullah Alshetaili Hadil Faris AlotaibiHadil Faris AlotaibiDepartment of Pharmaceutical Sciences, College of Pharmacy, Princess Nourah Bint AbdulRahman University, P.O. Box 84428, Riyadh 11671, Saudi ArabiaMore by Hadil Faris Alotaibi Amr Selim Abu LilaAmr Selim Abu LilaDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Zagazig University, Zagazig 44519, EgyptDepartment of Pharmaceutics, College of Pharmacy, University of Hail, Hail 81442, Saudi ArabiaMedical and Diagnostic Research Center, University of Hail, Hail 81442, Saudi ArabiaMore by Amr Selim Abu Lila Pediatric pulmonary hypertension is a serious syndrome with significant morbidity and mortality. Sildenafil is widely used off-label in pediatric patients with pulmonary arterial hypertension. In this study, bile salt-stabilized nanovesicles (bilosomes) were screened for their efficacy to enhance the transdermal delivery of the phosphodiesterase type 5 inhibitor, sildenafil citrate, in an attempt to augment its therapeutic efficacy in pediatric pulmonary hypertension.

2.9. Ex Vivo Skin Permeation Studies

A response surface methodology was implemented for fabricating and optimizing a bilosomal formulation of sildenafil (SDF-BS). The optimized SDF-BS formulation was characterized in terms of its entrapment efficiency (EE), zeta potential, vesicle size, and in vitro release profile. The optimized sildenafil 130mg formula was then loaded onto hydroxypropyl methyl cellulose (HPMC) hydrogel and assessed for skin permeation, in vivo pharmacokinetics, and pharmacodynamic studies. The optimized SDF-BS showed the following characteristic features; EE of 88.7 ± 1.1%, vesicle size of 185.0 + 9.2 nm, zeta potential of −20.4 ± 1.1 mV, and efficiently sustained SDF release for 12 h. Skin permeation study revealed a remarkable improvement in SDF penetration from bilosomal gel compared to plain SDF gel.

Before taking sildenafil,

In addition, pharmacokinetic results revealed that encapsulating SDF within bilosomal vesicles significantly enhanced its systemic bioavailability (∼3 folds), compared to SDF oral suspension. In addition, pharmacodynamic investigation revealed that, compared to plain SDF gel or oral drug suspension, SDF-BS gel applied topically triggered a significant elevation (p < 0.05) in cGMP serum levels, underscoring the superior therapeutic efficacy of SDF-BS gel. Conclusively, bilosomes can be viewed as a promising nanocarrier for transdermal delivery of SDF that would grant higher therapeutic efficiency while alleviating the limitations encountered with SDF oral administration. You are free to share(copy and redistribute) this article in any medium or format within the parameters below: Creative Commons (CC): This is a Creative Commons license. Creative Commons (CC): This is a Creative Commons license. Pharmacokinetics of sildenafil after single oral doses in healthy male subjects: absolute bioavailability, food effects and dose proportionality. 2002, 53 (Suppl 1), 5S– 12S, DOI: 10.1046/j.0306-5251.2001.00027.xGoogle ScholarThere is no corresponding record for this reference.

• The gel allows easier dose adjustment compared to fixed-dose tablets.
• Some patients prefer the non-invasive nature of gel application.
• Patient counseling addresses realistic expectations from topical sildenafil.
• Use on damaged skin should be strictly avoided to prevent systemic absorption spikes.
• Can be incorporated into broader male sexual health management.
• Clinical effectiveness depends on consistent and correct application.
• Discreet packaging aids in user privacy and compliance.

9Hosny, K.

• Sildenafil gel is a topical formulation designed for localized erectile dysfunction treatment.
• It is absorbed through the skin, offering a quicker onset of action compared to oral pills.
• Gel form may reduce systemic side effects commonly associated with oral sildenafil.
• Users apply the gel directly to the penile area for targeted effect.
• Dosage can be controlled more precisely due to localized application.
• Sildenafil gel might be preferred by patients who have difficulty swallowing pills.
• It is important to follow application guidelines to avoid skin irritation.

M.; Alhakamy, N. A.; Almodhwahi, M.

A.; Kurakula, M.; Almehmady, A. M.; Elgebaly, S. S. Self-Nanoemulsifying System Loaded with Sildenafil Citrate and Incorporated within Oral Lyophilized Flash Tablets: Preparation, Optimization, and In Vivo Evaluation. Pharmaceutics 2020, 12, 1124, DOI: 10.3390/pharmaceutics12111124Google ScholarThere is no corresponding record for this reference.

Before Using

7Desai, K.; Di Lorenzo, M.; Zuckerman, W. A.; Emeruwa, E.; Krishnan, U. S. Safety and Efficacy of Sildenafil for Group 2 Pulmonary Hypertension in Left Heart Failure. Children 2023, 10, 270, DOI: 10.3390/children10020270Google ScholarThere is no corresponding record for this reference. 10Abdallah, M. H.; Abu Lila, A.

• Alternative delivery forms like gels provide options for personalized therapy.
• Patient preference studies show interest in topical vs oral ED treatments.
• The gel form may afford decreased systemic exposure and drug interactions.
• Education on gel use reduces misuse and increases effectiveness.
• Some formulations include preservatives to maintain product safety.
• Clinical review highlights benefits for patients with certain comorbidities.
• Not recommended for use in men under 18 years of age.

S.; Unissa, R.; Elsewedy, H.

Why is this medication prescribed?

Treatment of pulmonary arterial hypertension by vardenafil-solid dispersion lozenges as a potential alternative drug delivery system. Journal of Drug Delivery Science and Technology 2020, 55, 101444 DOI: 10.1016/j.jddst.2019.101444Google ScholarThere is no corresponding record for this reference. 2Hatzimouratidis, K. Sildenafil in the treatment of erectile dysfunction: an overview of the clinical evidence. Aging 2006, 1, 403– 414, DOI: 10.2147/ciia.2006.1.4.403Google ScholarThere is no corresponding record for this reference.

Less common

J. Ther canadian sildenafil citrate 2019, 26, e520– e526, DOI: 10.1097/MJT.0000000000000766Google ScholarThere is no corresponding record for this reference. 4Morcos, S. K. Can selective inhibitors of cyclic guanosine monophosphate (cGMP)-specific phosphadiesterase type 5 (PDE 5) offer protection against contrast induced nephropathy?. S.; Elghamry, H.

A.; Soliman, M.

Interactions with Other Medications

Attribution (BY): Credit must be given to the creator. Non-Commercial (NC): Only non-commercial uses of the work are permitted. No Derivatives (ND): Derivative works may be created for non-commercial purposes, but sharing is prohibited. This summary highlights only some of the key features and terms of the actual license. It is not a license and has no legal value.

How It Works

Carefully review the actual license before using these materials. License Summary* You are free to share(copy and redistribute) this article in any medium or format within the parameters below: Creative Commons (CC): This is a Creative Commons license. *Disclaimer This summary highlights only some of the key features and terms of the actual license. Each value is the mean ± SD of the three experiments. Q12: cumulative amount of SDF permeated per unit area in 12 h, Jss: steady state flux, and Jmax: maximum average drug flux after 12 h per unit area per hour.

3.1. Fabrication of Sildenafil-Loaded Bilosomes (SDF-BS)

Data presented as mean ± SD (n = 5). The Supporting Information is available free of charge at Impact of formulation variables (A) SPC amount; (B) Span 60 amount; and (C) SDC amount on the in vitro SDF release from various bilosomal formulations; regression analysis of Y1 according to different polynomial models; results of statistical analysis for Y1 response according to the quadratic model; regression analysis of Y2 according to different polynomial models; results of statistical analysis for Y2 response according to the quadratic model; and stability study results of SDF-BS stored at 4 °C for 90 days (PDF) Impact of formulation variables (A) SPC amount; (B) Span 60 amount; and (C) SDC amount on the in vitro SDF release from various bilosomal formulations; regression analysis of Y1 according to different polynomial models; results of statistical analysis for Y1 response according to the quadratic model; regression analysis of Y2 according to different polynomial models; results of statistical analysis for Y2 response according to sildenafil citrates the quadratic model; and stability study results of SDF-BS stored at 4 °C for 90 days (PDF) Most electronic Supporting Information files are available without a subscription to ACS Web Editions. Such files may be downloaded by article for research use (if there is a public use license linked to the relevant article, that license may permit other uses). Permission may be obtained from ACS for other uses through requests via the RightsLink permission system: This study is supported via funding from Prince Sattam Bin Abdulaziz University project number (PSAU/2024/R/1445). The authors also extend their appreciation to the Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia, for supporting this work under the researcher supporting project number (PNURSP2024R205). S.

Uses / Indications

Moreover, we are providing these products in various packaging options to choose from. We are exporting globally.With the help of our sophisticated infrastructure facility, we are prepared our products as per the well-defined norms. Also, we hired a group of talented and experienced personals. To achieve our organizational goals, our professionals are working hard and close coordination with each other. Our personnel maintain the entire product range in a systematic manner.

2.4. Characterization and Optimization of SDF-BS

Moreover, to increased productivity and greater revenues, we believe in quality instead of quantity. With the help of our high-quality products, we have the huge client base across the nation. Apart from this, we are able to deliver the products on time and safely at client premises with the help of our well-connected distribution network. With the help of our sophisticated infrastructure facility, we are prepared our products as per the well-defined norms. Bjad K.

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

AlmutairyBjad K. AlmutairyDepartment of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-kharj 11942, Saudi ArabiaMore by Bjad K. Almutairy El-Sayed Khafagy*El-Sayed Khafagy*Email: [email protected]. : +966-533-564-286.Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-kharj 11942, Saudi ArabiaDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Suez Canal University, Ismailia 41522, EgyptMore by El-Sayed Khafagy Mohammed F. AldawsariMohammed F. Preparation, characterization and evaluation of anti-inflammatory and anti-nociceptive effects of brucine-loaded nanoemulgel. Colloids Surf., B 2021, 205, 111868 DOI: 10.1016/j.colsurfb.2021.111868Google ScholarThere is no corresponding record for this reference.

About the Reviewer

2014, 4, 214– 215, DOI: 10.3978/j.issn.2223-4292.2014.06.01Google ScholarThere is no corresponding record for this reference. 2015, 61, 181– 192, DOI: 10.4103/0022-3859.159421Google ScholarThere is no corresponding record for this reference. 6Beghetti, M.; Rudzinski, A.; Zhang, M. Efficacy and safety of oral sildenafil in children with Down syndrome and pulmonary hypertension. BMC Cardiovasc Disord 2017, 17, 177, DOI: 10.1186/s12872-017-0569-3Google ScholarThere is no corresponding record for this reference.