Sildenafil Strips – Orally Disintegrating Strip (viagra strips)
The pharmacokinetics of the sildenafil 100 mg orodispersible film (IBSA) was compared to that of the conventional marketed 100 mg film-coated tablet (Viagra®) after single-dose administration to 53 healthy male volunteers (aged 18–51 years) in a randomized, open, two-way crossover bioequivalence study.
- Sildenafil strips are an alternative to traditional pill forms.
- The strips dissolve quickly, eliminating need for water to swallow.
- They are convenient for on-the-go use and discreet consumption.
- Possible side effects include headache, flushing, and dizziness.
- Sildenafil strips should be used approximately one hour before activity.
- Not suitable for individuals with certain health conditions; consult a doctor.
- They are typically used in men aged 18 and above.
- The medication works by increasing blood flow to the penis.
- Sildenafil strips can be part of a broader erectile dysfunction treatment plan.
- Side effects may vary depending on individual health status.
- Erectile response may improve with proper use and dosing.
- They are available through licensed pharmacies and online sources.
Each subject received a single oral dose of 100 mg of sildenafil as test or reference formulation administered under fasting conditions at each of the two study periods according to a randomized crossover design. There was a washout interval of ≥7 days between the two administrations of the investigational medicinal products. Blood samples for pharmacokinetic analysis were collected up to 24 h post-dosing. The primary objective was to compare the rate (peak plasma concentration; Cmax) and extent (area under the curve [AUC] from administration to last observed concentration time; AUC0–t) of sildenafil absorption after single-dose administration of test and reference. Secondary endpoints were observed to describe the plasma pharmacokinetic profiles of sildenafil and its metabolite N-desmethyl-sildenafil relative bioavailability and safety profile after single-dose administration.
- Sildenafil oral strips provide a non-invasive way to treat ED.
- They avoid swallowing pills, which some patients find difficult.
- Strips are often manufactured with pleasant flavors to enhance appeal.
- The medication’s effect can be influenced by food intake.
- Alcohol consumption may reduce effectiveness or increase side effects.
- Sildenafil strips should be used as prescribed and not mixed with other ED drugs.
- These strips are designed for quick absorption in the oral mucosa.
- Overuse or misuse can lead to adverse health effects.
- Proper dosing helps minimize risks of prolonged erections or priapism.
- Sildenafil strips do not cure ED but help manage symptoms.
- They may be used in combination with psychological or lifestyle interventions.
- Always check expiration dates before using sildenafil strips.
The mean sildenafil and N-desmethyl-sildenafil plasma concentration–time profiles up to 24 h after single-dose administration of sildenafil 100 mg orodispersible film and film-coated tablet were nearly superimposable.
| Brand Name | Manufacturer | Price Range | Availability | FDA Approval Status |
|---|---|---|---|---|
| Strips of Eros | PharmaX Ltd. | $15 - $25 | Online, pharmacies | Approved |
| VistoStrips | MedSolutions Inc. | $20 - $30 | Distributors | Pending approval |
| OralEase | BioHealth Corp. | $17 - $24 | Specialty stores | Approved |
| QuickDissolve | NutraPharma | $18 - $28 | Online marketplaces | Approved |
| FastRelief | HealthGen | $16 - $22 | Pharmacies, online | Approved |
The bioequivalence test was fully satisfied for sildenafil and N-desmethyl-sildenafil in terms of rate and extent of bioavailability. Adverse events occurred at similar rates for the two formulations and were of mild-to-moderate severity. The results suggest that the new orodispersible film formulation can be used interchangeably with the conventional film-coated formulation. Keywords: sildenafil, pharmacokinetics, bioequivalence, orodispersible film, PDE5 inhibitor, N-desmethyl-sildenafil The first-in-class selective inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase type 5 (PDE5), sildenafil, has become well established as a safe and effective treatment for male erectile dysfunction since the approval of Viagra® (Pfizer Ltd, Tadworth, UK) by the US Food and Drug Administration (FDA) in 1998.
6. Discussion
Keywords: sildenafil, pharmacokinetics, bioequivalence, orodispersible film, PDE5 inhibitor, N-desmethyl-sildenafil The first-in-class selective inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase type 5 (PDE5), sildenafil, has become well established as a safe and effective treatment for male erectile dysfunction since the approval of Viagra® (Pfizer Ltd, Tadworth, UK) by the US Food and Drug Administration (FDA) in 1998. Guidelines on male sexual dysfunction established by the European Association of Urology recommend oral pharmacotherapy with PDE5 inhibitors as first-line therapy for erectile dysfunction.1 The PDE5 inhibitors sildenafil, tadalafil, vardenafil, and avanafil are currently approved for use for erectile dysfunction. Each PDE5 inhibitor has an individual pharmacokinetic and side effects profile, although no significant differences in efficacy among therapies are evident.1–5 The onset of action after oral administration of the available PDE5 inhibitors may be within 30 min; however, most men require at least 60 min delay after taking the medication (up to 2 h with tadalafil, while avanafil and vardenafil have the shortest onsets of action). Avanafil reaches peak plasma concentration (Cmax) 30–45 min after oral dosing and has a t1/2 of 1.1–1.23 h. Tadalafil has the longest t1/2 (~17.5 h), and the t1/2 for sildenafil and vardenafil is ~4 h.
5.1. Bioequivalence and stability testing
More than 25 years of clinical experience has confirmed the risk/benefit profile of sildenafil and established it as an effective treatment option for erectile dysfunction. Sildenafil could also be taken by men with comorbidities, such as hypertension, stable coronary artery disease, congestive heart failure, diabetes mellitus, traumatic spinal cord injury, obstructive sleep apnea, multiple sclerosis, renal dysfunction, prostate cancer, Parkinson’s disease, depression, and traumatic stress disorders.6 It is usually administered in doses of 25, 50, and 100 mg, with the recommended starting dose of 50 mg to be adapted according to response and side effects.1 Commonly reported adverse events (AEs) with sildenafil, as with the other available PDE5 inhibitors, include headache, flushing, dyspepsia, dizziness, and vision disturbances and are generally mild in nature and self-limiting.1 Since the expiry of Pfizer’s sildenafil 5mg for sale patent on sildenafil citrate for the treatment of erectile dysfunction in a number of European countries in 2013, several different formulations of sildenafil have become available. Orally disintegrating film and tablet formulations of PDE5 inhibitors that disintegrate in the patient’s mouth without the need for swallowing with water have been developed.7–12 Orodispersible films are defined as single or multilayer sheets of suitable materials, to be placed in the mouth where they disperse rapidly,13 requiring only a small amount of saliva on the tongue to dissolve within a few minutes of administration. In addition to not requiring water for administration, orodispersible films share the advantages of tablet formulations (accurate dosage and ease of administration) with those of liquid dosing forms (ease of swallowing and rapid bioavailability due to bypassing the hepatic first-pass effect when the absorption of active substance occurs mainly through the oral mucosae). Although orodispersible formulations have particular relevance by improving compliance in special patient populations, such as children, geriatric patients, and dysphasic patients who have difficulty in swallowing tablets or capsules, their convenience, superior dosing accuracy, and rapid onset of action contribute to strong patient preference over conventional solid dosage forms across a wide range of patient groups.14–16 Rapid dissolution, absorption, and onset of drug action are useful in motion sickness and sudden episodes of allergic attack of coughing, bronchitis, and asthma. Guidelines on male sexual dysfunction established by the European Association of Urology recommend oral pharmacotherapy with PDE5 inhibitors as first-line therapy for erectile dysfunction.1 The PDE5 inhibitors sildenafil, tadalafil, vardenafil, and avanafil are currently approved for use for erectile dysfunction. Each PDE5 inhibitor has an individual pharmacokinetic and side effects profile, although no significant differences in efficacy among therapies are evident.1–5 The onset of action after oral administration of the available PDE5 inhibitors may be within 30 min; however, most men require at least 60 min delay after taking the medication (up to 2 h with tadalafil, while avanafil and vardenafil have the shortest onsets of action). Avanafil reaches peak plasma concentration (Cmax) 30–45 min after oral dosing and has a t1/2 of 1.1–1.23 h. Tadalafil has the longest t1/2 (~17.5 h), and the t1/2 for sildenafil and vardenafil is ~4 h.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 150mg | 270 + 10 Pills | 326.61€ 311.06€ | |
| Viagra Generic | 150mg | 20 Pills | 55.02€ 52.40€ | |
| Kamagra Oral Jelly | 100mg | 110 + 9 Sachets | 334.87€ 318.92€ | |
| Viagra Generic | 200mg | 60 + 4 Pills | 125.19€ 119.23€ | |
| Viagra Generic | 200mg | 180 + 10 Pills | 277.56€ 264.34€ | |
| Viagra Generic | 25mg | 20 Pills | 37.74€ 35.94€ | |
| Kamagra Oral Jelly | 100mg | 63 + 7 Sachets | 224.18€ 213.50€ | |
| Viagra Generic | 50mg | 180 + 8 Pills | 158.82€ 151.26€ | |
| Kamagra Oral Jelly | 100mg | 220 + 18 Sachets | 662.24€ 630.70€ | |
| Viagra Generic | 150mg | 360 + 10 Pills | 423.48€ 403.31€ | |
| Kamagra Oral Jelly | 100mg | 21 Sachets | 95.92€ 91.35€ | |
| Viagra Generic | 100mg | 10 Pills | 28.91€ 27.53€ | |
| Kamagra | 100mg | 120 + 6 Pills | 330.74€ 314.99€ |
More than 25 years of clinical experience has confirmed the risk/benefit profile of sildenafil and established it as an effective treatment option for erectile dysfunction. Sildenafil could also be taken by men with comorbidities, such as hypertension, stable coronary artery disease, congestive heart failure, diabetes mellitus, traumatic spinal cord injury, obstructive sleep apnea, multiple sclerosis, renal dysfunction, prostate cancer, Parkinson’s disease, depression, and traumatic stress disorders.6 It is usually administered in doses of 25, 50, and 100 mg, with the recommended starting dose of 50 mg to be adapted according to response and side effects.1 Commonly reported adverse events (AEs) with sildenafil, as with the other available PDE5 inhibitors, include headache, flushing, dyspepsia, dizziness, and vision disturbances and are generally mild in nature and self-limiting.1 Since the expiry of Pfizer’s sildenafil 5mg for sale patent on sildenafil citrate for the treatment of erectile dysfunction in a number of European countries in 2013, several different formulations of sildenafil have become available.
Tazzle 20 FM (Tadalafil Orally Disintegrating Strips)
The pharmacokinetics of the sildenafil 100 mg orodispersible film (IBSA) was compared to that of the conventional marketed 100 mg film-coated tablet (Viagra®) after single-dose administration to 53 healthy male volunteers (aged 18–51 years) in a randomized, open, two-way crossover bioequivalence study. Each subject received a single oral dose of 100 mg of sildenafil as test or reference formulation administered under fasting conditions at each of the two study periods according to a randomized crossover design. There was a washout interval of ≥7 days between the two administrations of the investigational medicinal products. Blood samples for pharmacokinetic analysis were collected up to 24 h post-dosing. The primary objective was to compare the rate (peak plasma concentration; Cmax) and extent (area under the curve [AUC] from administration to last observed concentration time; AUC0–t) of sildenafil absorption after single-dose administration of test and reference.
2.3 RecommendedDosage inSpecificPopulations
Secondary endpoints were observed to describe the plasma pharmacokinetic profiles of sildenafil and its metabolite N-desmethyl-sildenafil relative bioavailability and safety profile after single-dose administration. The mean sildenafil and N-desmethyl-sildenafil plasma concentration–time profiles up to 24 h after single-dose administration of sildenafil 100 mg orodispersible film and film-coated tablet were nearly superimposable. The bioequivalence test was fully satisfied for sildenafil and N-desmethyl-sildenafil in terms of rate and extent of bioavailability. Adverse events occurred at similar rates for the two formulations and were of mild-to-moderate severity. The results suggest that the new orodispersible film formulation can be used interchangeably with the conventional film-coated formulation. Orally disintegrating film and tablet formulations of PDE5 inhibitors that disintegrate in the patient’s mouth without the need for swallowing with water have been developed.7–12 Orodispersible films are defined as single or multilayer sheets of suitable materials, to be placed in the mouth where they disperse rapidly,13 requiring only a small amount of saliva on the tongue to dissolve within a few minutes of administration. In addition to not requiring water for administration, orodispersible films share the advantages of tablet formulations (accurate dosage and ease of administration) with those of liquid dosing forms (ease of swallowing and rapid bioavailability due to bypassing the hepatic first-pass effect when the absorption of active substance occurs mainly through the oral mucosae). Although orodispersible formulations have particular relevance by improving compliance in special patient populations, such as children, geriatric patients, and dysphasic patients who have difficulty in swallowing tablets or capsules, their convenience, superior dosing accuracy, and rapid onset of action contribute to strong patient preference over conventional solid dosage forms across a wide range of patient groups.14–16 Rapid dissolution, absorption, and onset of drug action are useful in motion sickness and sudden episodes of allergic attack of coughing, bronchitis, and asthma.
Safety Advice for S-FILM Orally Disintegrating Strip
Some drugs are absorbed from the mouth, pharynx, and esophagus: pre-gastric absorption can improve bioavailability with consequent reduction of dosage and unwanted effects.
| Parameter | Description | Typical Values | Notes |
|---|---|---|---|
| Absorption Time | Time to reach peak plasma levels | 15-30 minutes | Faster than tablets |
| Peak Plasma Concentration | Max concentration after dose | 120-250 ng/mL | Varies with dose |
| Half-life | Time for plasma levels to reduce by half | 3-5 hours | Limits dosing frequency |
| Bioavailability | Percentage of dose reaching systemic circulation | Approx. 80% | Enhanced via mucosal absorption |
Orodispersible films have advantages over orally disintegrating tablet formulations, which may require more complicated and expensive manufacturing processes, have issues of hardness and friability during manufacturing, storage, handling and administration, and may present a risk of choking.16 Orodispersible films are thin and flexible, can be manufactured in a range of sizes and shapes, and are easily transported and stored. Research has shown that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosage forms.15 As orodispersible film formulations do not require administration with water, they may provide additional benefit where comorbid conditions such as renal impairment, congestive heart failure, or other disorders impose a restriction on fluid intake, or where dysphagia creates difficulty with swallowing conventional film tablet dosage forms. Drugs that have potency at low doses are most suitable for orodispersible film administration, as technical considerations limit the incorporation of the drug; generally, between 1% and 30% w/w of the active pharmaceutical ingredient can be introduced in film formulation.17 Taste is an important factor in the development of oral pharmaceutical products to ensure patient acceptability and compliance and is one of the prime factors determining market penetration and commercial success of oral formulations.
TFL 20 mg Disintegrating Strip
According to the Biopharmaceutics Classification System, sildenafil is classified as a class II drug substance (high permeability and low solubility). The new sildenafil orodispersible film developed by IBSA is approved in Europe in doses of 25, 50, 75, and 100 mg. Each orodispersible film contained 140.4 mg of sildenafil citrate, equivalent to 100 mg of sildenafil in the form of a rectangular, flexible, opaque, light blue film 40×45 mm. Details of the pharmaceutical excipients and their functions in the formulation are presented in Table 1. The product is an innovative, patented formulation developed in accordance with patents EP 1689374 (self-supporting films for pharmaceutical and food use) and WO 2014/049548 (orodispersible films having quick dissolution times for therapeutic and food use).
Facts & Effects
The preparation process according to the patent WO 2014/049548 comprises, briefly, the following steps: Maltodextrin, plasticizer, active ingredient, and the other excipients are solubilized/dispersed in water. The mixture is coated onto a release liner and dried in the oven controlling for temperature, air circulation, and coating speed. The dried mass is cut into reels and the films are then punched, pouched, and sealed in suitable single-dose sachets. Palatability and pleasant taste are necessary for fast dissolving films, and various techniques are available to mask drug taste. Flavors, sweeteners, and amino acids can be added to the formulation, generally in association with other taste-masking components. The classical sources of sweeteners are sucrose, dextrose, fructose, glucose, liquid glucose, and maltose.
- Sildenafil oral strips are a fast-acting form of erectile dysfunction medication.
- They are administered orally, dissolving quickly on the tongue for rapid effect.
- Sildenafil strips are often flavored to improve the user experience.
- They contain the same active ingredient as traditional sildenafil tablets.
- These strips are designed for people seeking discreet medication options.
- Onset of action for sildenafil strips can be within 15-30 minutes.
- Proper storage of sildenafil strips involves keeping them in a cool, dry place.
- Dosage strength varies, typically available in 25mg, 50mg, and 100mg.
- Using sildenafil strips without medical consultation is not recommended.
- They may interact with other medications like nitrates or alpha-blockers.
- Sildenafil oral strips are approved for the treatment of erectile dysfunction.
- Users should follow prescribed dosages for safety and effectiveness.
A pharmacokinetic comparison of an orally disintegrating film formulation of sildenafil marketed in South Korea suggested that the pharmacokinetics of the orodispersible formulation was similar to that of the conventional film-coated tablet and met the criterion of assumed bioequivalence according to Korean FDA regulatory criteria.18 In the study, the 90% confidence interval (CI) of the geometric mean ratio of test/reference for the area under the curve (AUC0–last) for the sildenafil 100 mg dose was 101.68%–114.78% and the 90% CI was 93.76%–109.76% for Cmax.18 Both the formulations were well tolerated, and no serious AEs were observed.
Route of administration
Roh et al noted that the new formulation could be used interchangeably with the tablet formulation and may be preferred because of enhanced dosing convenience.18 An orodispersible film formulation of sildenafil 100 mg has been developed by Institut Biochimique SA (IBSA, Pambio-Noranco, Switzerland). The aim of this study was to assess the bioequivalence between the new sildenafil 100 mg orodispersible film and the conventional marketed 100 mg film-coated tablet after single-dose administration to healthy male volunteers. According to the Biopharmaceutics Classification System, sildenafil is classified as a class II drug substance (high permeability and low solubility). The new sildenafil orodispersible film developed by IBSA is approved in Europe in doses of 25, 50, 75, and 100 mg.
6. Adverse Reactions/Side Effects
Some drugs are absorbed from the mouth, pharynx, and esophagus: pre-gastric absorption can improve bioavailability with consequent reduction of dosage and unwanted effects. Orodispersible films have advantages over orally disintegrating tablet formulations, which may require more complicated and expensive manufacturing processes, have issues of hardness and friability during manufacturing, storage, handling and administration, and may present a risk of choking.16 Orodispersible films are thin and flexible, can be manufactured in a range of sizes and shapes, and are easily transported and stored. Research has shown that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosage forms.15 As orodispersible film formulations do not require administration with water, they may provide additional benefit where comorbid conditions such as renal impairment, congestive heart failure, or other disorders impose a restriction on fluid intake, or where dysphagia creates difficulty with swallowing conventional film tablet dosage forms. Drugs that have potency at low doses are most suitable for orodispersible film administration, as technical considerations limit the incorporation of the drug; generally, between 1% and 30% w/w of the active pharmaceutical ingredient can be introduced in film formulation.17 Taste is an important factor in the development of oral pharmaceutical products to ensure patient acceptability and compliance and is one of the prime factors determining market penetration and commercial success of oral formulations. Palatability and pleasant taste are necessary for fast dissolving films, and various techniques are available to mask drug taste.
What is the average Sildenafil strips price?
Flavors, sweeteners, and amino acids can be added to the formulation, generally in association with other taste-masking components. The classical sources of sweeteners are sucrose, dextrose, fructose, glucose, liquid glucose, and maltose. A pharmacokinetic comparison of an orally disintegrating film formulation of sildenafil marketed in South Korea suggested that the pharmacokinetics of the orodispersible formulation was similar to that of the conventional film-coated tablet and met the criterion of assumed bioequivalence according to Korean FDA regulatory criteria.18 In the study, the 90% confidence interval (CI) of the geometric mean ratio of test/reference for the area under the curve (AUC0–last) for the sildenafil 100 mg dose was 101.68%–114.78% and the 90% CI was 93.76%–109.76% for Cmax.18 Both the formulations were well tolerated, and no serious AEs were observed. Roh et al noted that the new formulation could be used interchangeably with the tablet formulation and may be preferred because of enhanced dosing convenience.18 An orodispersible film formulation of sildenafil 100 mg has been developed by Institut Biochimique SA (IBSA, Pambio-Noranco, Switzerland). The aim of this study was to assess the bioequivalence between the new sildenafil 100 mg orodispersible film and the conventional marketed 100 mg film-coated tablet after single-dose administration to healthy male volunteers. Each orodispersible film contained 140.4 mg of sildenafil citrate, equivalent to 100 mg of sildenafil in the form of a rectangular, flexible, opaque, light blue film 40×45 mm.
The love Hormone
Product Image
Details of the pharmaceutical excipients and their functions in the formulation are presented in Table 1. The product is an innovative, patented formulation developed in accordance with patents EP 1689374 (self-supporting films for pharmaceutical and food use) and WO 2014/049548 (orodispersible films having quick dissolution times for therapeutic and food use). The preparation process according to the patent WO 2014/049548 comprises, briefly, the following steps: Maltodextrin, plasticizer, active ingredient, and the other excipients are solubilized/dispersed in water.
| Step | Instruction | Precautions |
|---|---|---|
| Dose Placement | Place strip under tongue or inside cheek | Avoid swallowing immediately |
| Expect Dissolution | Wait until fully dissolved before eating/drinking | No water during dissolution |
| Timing Before Activity | Take 15-30 minutes before anticipated sexual activity | Avoid heavy meals near dosing |
| Storage | Keep strips in a cool, dry place, away from children | Keep away from moisture |
| Overdose Warning | Do not exceed prescribed dose | Seek medical attention if overdose suspected |
The mixture is coated onto a release liner and dried in the oven controlling for temperature, air circulation, and coating speed. The dried mass is cut into reels and the films are then punched, pouched, and sealed in suitable single-dose sachets.