Understanding Topical Sildenafil Formulations

S. 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.

• Sildenafil gel use requires patient education for proper technique.
• Patients should not exceed recommended dose frequency.
• Combining sildenafil gel with other ED treatments should be medically supervised.
• Gel containers are often designed for one-time dosing to avoid contamination.
• The gel consistency affects the ease and speed of application.
• Some topical gels include ingredients to enhance penile sensitivity.
• Avoid applying near the eyes or mucous membranes.

11Paudel, K. S.; Milewski, M.; Swadley, C.

General Instructions

Creative Commons (CC): This is a Creative Commons license. 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.

2.4. Characterization and Optimization of SDF-BS

It is not a license and has no legal value. 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. L.; Brogden, N. K.; Ghosh, P.; Stinchcomb, A.

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L. Challenges and opportunities in dermal/transdermal delivery. Ther Deliv 2010, 1, 109– 131, DOI: 10.4155/tde.10.16Google Scholar11Challenges and opportunities in dermal/transdermal deliveryPaudel, Kalpana S.; Milewski, Mikolaj; Swadley, Courtney L.; Brogden, Nicole K.; Ghosh, Priyanka; Stinchcomb, Audra L.Therapeutic Delivery (2010), 1 (1), 109-131CODEN: TDHEA7; ISSN:2041-5990. Transdermal drug delivery is an exciting and challenging area. There are numerous transdermal delivery systems currently available on the market. However, the transdermal market still remains limited to a narrow range of drugs. Further advances in transdermal delivery depend on the ability to overcome the challenges faced regarding the permeation and skin irritation of the drug mols. Emergence of novel techniques for skin permeation enhancement and development of methods to lessen skin irritation would widen the transdermal market for hydrophilic compds., macromols.

Uses / Indications

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. 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 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).

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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). 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. and conventional drugs for new therapeutic indications. trials of a wide variety of drugs for various clin.

What special dietary instructions should I follow?

BMC Cardiovasc Disord 2017, 17, 177, DOI: 10.1186/s12872-017-0569-3Google ScholarThere is no corresponding record for this reference. 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.

3.2. Effect of Independent Factors on SDF-BS Characteristics

Children 2023, 10, 270, DOI: 10.3390/children10020270Google ScholarThere is no corresponding record for this reference. 8Nichols, D. J.; Muirhead, G. J.; Harness, J. A. conditions, there is a great future for transdermal delivery of drugs. 12Tanner, T.; Marks, R.

• Sildenafil gel absorption is influenced by skin hydration and integrity.
• Use of occlusive dressings after application may increase drug absorption.
• Contraindicated with nitrates due to risk of severe hypotension.
• Users should consult healthcare providers if experiencing intense side effects.
• The gel delivery system represents a modern approach to ED treatment.
• Application instructions emphasize gentle rubbing for optimal absorption.
• Detailed adverse effect profiles remain under investigation.

Delivering drugs by the transdermal route: review and comment. Skin Research and Technology 2008, 14, 249– 260, DOI: 10.1111/j.1600-0846.2008.00316.xGoogle ScholarThere is no corresponding record for this reference. 13Andrews, S.

• 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.

N.; Jeong, E.; Prausnitz, M.

Feature	Gel	Tablet	Comment
Speed of Absorption	Faster	Slower	Gel bypasses GI tract
Convenience	Easy to apply directly	Swallowed whole	Discreet use
Dosage Flexibility	Customizable per application	Fixed doses	Better for dose titration
Side Effects	Lower GI irritation	More systemic exposure	Reduced gastrointestinal side effects

R. Transdermal delivery of molecules is limited by full epidermis, not just stratum corneum. 2013, 30, 1099– 1109, DOI: 10.1007/s11095-012-0946-7Google ScholarThere is no corresponding record for this reference. 14Dhote, V.; Bhatnagar, P.; Mishra, P. K.; Mahajan, S. C.; Mishra, D. K.

Instructions for Use

10Abdallah, M. H.; Abu Lila, A. S.; Unissa, R.; Elsewedy, H. S.; Elghamry, H. A.; Soliman, M. Iontophoresis: a potential emergence of a transdermal drug delivery system. 2012, 80, 1– 28, DOI: 10.3797/scipharm.1108-20Google ScholarThere is no corresponding record for this reference.

Comparison with Other ED Treatments

Pharmacokinetics sildenafil pills 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. 9Hosny, K. M.; Alhakamy, N. A.; Almodhwahi, M.

How does sildenafil work (mechanism of action)?

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. 15Denet, A. R.; Vanbever, R.; Préat, V. Skin electroporation for transdermal and topical delivery.

About the Reviewer

Aging 2006, 1, 403– 414, DOI: 10.2147/ciia.2006.1.4.403Google ScholarThere is no corresponding record for this reference. J. Ther 2019, 26, e520– e526, DOI: 10.1097/MJT.0000000000000766Google ScholarThere is no corresponding record for this reference. 4Morcos, S. K.

Q. Can I take it with food?

Can selective inhibitors of cyclic guanosine monophosphate (cGMP)-specific phosphadiesterase type 5 (PDE 5) offer protection against contrast induced nephropathy?. 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. 2004, 56, 659– 674, DOI: 10.1016/j.addr.2003.10.027Google Scholar15Skin electroporation for transdermal and topical deliveryDenet, Anne-Rose; Vanbever, Rita; Preat, VeroniqueAdvanced Drug Delivery Reviews (2004), 56 (5), 659-674CODEN: ADDREP; ISSN:0169-409X. Electroporation is the transitory structural perturbation of lipid bilayer membranes due to the application of high voltage pulses.

Before Using

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. 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 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.

2.9. Ex Vivo Skin Permeation Studies

Skin permeation study revealed a remarkable improvement in SDF penetration from bilosomal gel compared to plain SDF gel. 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. Its application to the skin has been shown to increase transdermal drug delivery by several orders of magnitude.

• Sildenafil gel clinical trials report variable efficacy across populations.
• Polymeric gels can enhance skin penetration of sildenafil.
• Storage at room temperature preserves gel stability and potency.
• Avoid sharing the gel to prevent contamination.
• Combining with vacuum erection devices may improve efficacy.
• The onset of action can be delayed if applied over non-intact skin.
• Using the gel immediately before intercourse yields the best results.