What Is Sildenafil Oral Solution?

These fabricated personalized films have the capability to be used in a clinical setting, as they substantially enhance the therapeutic efficacy, minimize adverse drug reactions, and aid in improved patient outcomes [Citation5,Citation68,Citation69]. Fused deposition modeling or fused filament fabrication is a nozzle-based deposition technique.

Related/similar drugs

Studies have shown that ODFs have exhibited fast disintegration time, appropriate printing resolution, and precise dimensions due to incorporation of 5% sodium carboxymethylcellulose during the preparation. Since this method avoids any processes at elevated temperatures, it allows usage of thermosensitive polymers for the fabrication of ODFs [Citation61,Citation71,Citation72]. The assessment and characterization of ODFs involve an array of essential tests to warrant their quality, organoleptic properties, and performance. These tests comprise assessments of thickness, weight uniformity, film robustness and durability, flexibility, water absorption or uptake capacity, swelling, surface features, and moisture content. The other tests involve disintegration and release tests, tensile properties, tensile strength, puncture resistance, elongation at break, elastic modulus, porosity, folding durability and endurance, taste evaluation, and uniformity of drug content.

Before taking sildenafil,

These tests are indispensable in pharmaceutical formulation development for evaluating the quality of ODFs. A compilation of commonly used in vitro techniques that evaluate the mechanical characteristics is provided in Supplementary Table S1. Several studies have demonstrated bioequivalence between sildenafil ODF formulation and conventional film-coated tablets (FCTs). This display of bioequivalent pharmacokinetics between the two formulations supports and recommends the use of innovative ODF formulation as a befitting alternative to the customary oral solid dosage form [Citation73–75]. Two randomized cross-over studies were conducted to examine the pharmaceutical equivalence of 50 mg sildenafil citrate ODF with the marketed 50 mg sildenafil citrate FCT with and without water.

What should I know about sildenafil before taking it?

The study recruited 42 and 80 healthy male volunteers in the first and sildenafil pick up second studies, respectively. Bioequivalence was demonstrated for sildenafil citrate ODF with water in comparison with the sildenafil citrate FCT as the ratios of adjusted geometric means (90% confidence interval [CI]) were utmost plasma concentration: 1.02 [94.91–108.78] and area under the plasma concentration–time curve: 1.09 [104.49–113.21]) for sildenafil citrate ODF with water vs sildenafil citrate FCT with water. The bioequivalence was demonstrated as the resultant ratios were within the approved range of 80% to 125%. Furthermore, the pharmacokinetic parameters in the successive study also established the bioequivalence for sildenafil citrate ODF (without water) with that of sildenafil citrate FCT with water. The ratios of adjusted geometric means (90% CI) were maximum plasma concentration: 1.02 (95.47–109.36) and area under the plasma concentration–time curve: 1.06 (103.42–108.40) for sildenafil citrate ODF without water vs sildenafil citrate FCT with water. In this 3D printing method, API is embedded in a molten thermoplastic polymer filament, which gets extruded through a nozzle, maintained at a high-temperature, and deposited as incremental layers—with quick solidification to a build plate. Several factors need to considered during the manufacturing of ODFs through this technique, including API content and filament dimension uniformity, optimum temperature and printing speed, and the impact of API presence in the polymer matrix on printing parameters. This technology is widely used in pharmaceutical industries for the manufacturing of immediate-release and extended-release formulations [Citation67]. This method is promising in fabricating those drugs that are poorly/sparingly water soluble, thus improving their dissolution rate. It does not require solvents making it environmentally safe, has a lesser cost, and is suitable for both large- and small-scale production [Citation70]. This 3D printing technique is also known as a pressure‐assisted microsyringe method used for the manufacture of ODFs. In this method, excipients, additives, and active ingredients are either dissolved or dispersed in a solution and dried at room temperature to form a semisolid mixture.

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This semisolid material is extruded incessantly layer-by-layer through a syringe‐based nozzle onto the build plate. This is followed by in‐process drying, which forms a critical step and may influence the physical properties of the incorporated excipients, drug, and overall quality of ODFs [Citation18]. This method fabricates ODFs through a one‐step process without necessitating the preparation of API-loaded filaments, unlike other 3D printing technologies. The SSE is the utmost successful 3D printing method for fabricating ODFs. The optimum mixture of drug, excipients, and solvent defines the ideal rheological characteristics of the semi-solid formulation. This is extremely important as it affects the extrudability of semi-solid formulation in desired flow through the nozzle before printing. Studies have shown that ODFs have exhibited fast disintegration time, appropriate printing resolution, and precise dimensions due to incorporation of 5% sodium carboxymethylcellulose during the preparation. Since this method avoids any processes at elevated temperatures, it allows usage of thermosensitive polymers for the fabrication of ODFs [Citation61,Citation71,Citation72]. The assessment and characterization of ODFs involve an array of essential tests to warrant their quality, organoleptic properties, and performance. These tests comprise assessments of thickness, weight uniformity, film robustness and durability, flexibility, water absorption or uptake capacity, swelling, surface features, and moisture content. The other tests involve disintegration and release tests, tensile properties, tensile strength, puncture resistance, elongation at break, elastic modulus, porosity, folding durability and endurance, taste evaluation, and uniformity of drug content. These tests are indispensable in pharmaceutical formulation development for evaluating the quality of ODFs. A compilation of commonly used in vitro techniques that evaluate the mechanical characteristics is provided in Supplementary Table S1. Several studies have demonstrated bioequivalence between sildenafil ODF formulation and conventional film-coated tablets (FCTs). This display of bioequivalent pharmacokinetics between the two formulations supports and recommends the use of innovative ODF formulation as a befitting alternative to the customary oral solid dosage form [Citation73–75]. Two randomized cross-over studies were conducted to examine the pharmaceutical equivalence of 50 mg sildenafil citrate ODF with the marketed 50 mg sildenafil citrate FCT with and without water.

• Patients should avoid heavy meals before taking sildenafil solution.
• Use caution if combining with other blood pressure medications.
• Regular medical check-ups are advised during treatment.

The study recruited 42 and 80 healthy male volunteers in the first and sildenafil pick up second studies, respectively.

3. Orodispersible dosage forms

The primary risk factors include diabetes mellitus, hypertension, and hyperlipidemia and modifiable risk factors like obesity, physical inactivity, alcoholism, and cigarette smoking [Citation88–90]. In addition, there is increasing evidence that ED can be considered as the perfect gender-dependent (early) biomarker of non-communicable diseases (NCDs) including peripheral vascular disease and cardiovascular disease, with a heightened risk of cardiovascular mortality as largely demonstrated by epidemiological studies [Citation91]. Bioequivalence was demonstrated for sildenafil citrate ODF with water in comparison with the sildenafil citrate FCT as the ratios of adjusted geometric means (90% confidence interval [CI]) were utmost plasma concentration: 1.02 [94.91–108.78] and area under the plasma concentration–time curve: 1.09 [104.49–113.21]) for sildenafil citrate ODF with water vs sildenafil citrate FCT with water.

Aspect	Oral Solution	Tablets
Onset of action	Faster due to quicker absorption	Slightly slower
Ease of dose adjustment	Easy to modify dose in small increments	Fixed doses
Swallowing difficulties	Easier for children and elderly	Requires swallowing whole
Taste masking	Usually palatable with flavors	No taste masking needed
Storage and stability	Sensitive to temperature and light	Generally more stable

The bioequivalence was demonstrated as the resultant ratios were within the approved range of 80% to 125%.

• Sildenafil oral solution is a liquid form of erectile dysfunction medication.
• It allows for easier swallowing compared to pills.
• Typically, it's used when oral tablets are unsuitable.

Furthermore, the pharmacokinetic parameters in the successive study also established the bioequivalence for sildenafil citrate ODF (without water) with that of sildenafil citrate FCT with water. The ratios of adjusted geometric means (90% CI) were maximum plasma concentration: 1.02 (95.47–109.36) and area under the plasma concentration–time curve: 1.06 (103.42–108.40) for sildenafil citrate ODF without water vs sildenafil citrate FCT with water.

3. Dosage Forms and Strengths

The purity testing for the degradation product (0.2% or less) showed significant results (p value < 0.05) at initial and 60°C in all the three samples. The process was evaluated across a range of manufacturing conditions, and all intermediates and sildenafil ODF showed reliable performance that yielded a consistent product meeting all specifications at release and after three weeks of storage under stressed conditions. These results, shown in , indicate the robust performance of the sildenafil ODF across a range of manufacturing conditions. In addition, the water content stayed in a tight range regardless of the film casting parameters, and this remains true of the packaged product even after 3 weeks at 60°C. ED is defined as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance [Citation76,Citation79–81].

What should I do if I accidentally use too much sildenafil?

ED still prevails as an unprecedented diagnosis and undertreated condition that contributes to increased physical and psychosocial burden. It negatively impacts the wellbeing, relationships, and health-related quality of life (HR-QoL) of patients and their partners [Citation82,Citation83], and thus, any treatment interventions that substantially revive sexual function have the prospect to reinforce patient health and overall HR-QoL. ED may present with clinically relevant forms but also subclinical conditions deserving medical attention. Worldwide, various forms of ED are diagnosed in up to 150 million men and it has been projected to surge to 322 million cases by 2025. ED has affected 52% of men in the age group of 40 and 70 years and 70% of men above 70 years [Citation84–87]. The occurrence of adverse events was observed at similar rates for both the formulations in all the studies, which were of mild intensity. The study results demonstrated the bioequivalence and supported the interchangeability of new sildenafil citrate ODF formulation with the marketed FCT formulation [Citation76]. The usage of ODFs is convenient among patients due to its durability, ease of administration with no suffocation risk, and ease of carrying the strips without the need for a secondary container [Citation8]. Among other advantages, the sildenafil ODF offers unique benefit to patients with ED in respecting their privacy. While the shame and the stigma culturally linked to the ED management is considered a major unmet need of the patients treated with phosphodiesterase 5 inhibitors (PDE5-Is), the ODF allows them to carry the drug in their pockets, in the most discreet way, and then be placed on the tongue before engaging in sexual activity [Citation8,Citation77,Citation78]. Furthermore, the absence of the need to swallow the drug with water further increases the ease of use and the potential reduction of the stigma of being treated with a traditional pill.

Supplemental data

The occurrence of adverse events was observed at similar rates for both the formulations in all the studies, which were of mild intensity. The study results demonstrated the bioequivalence and supported the interchangeability of new sildenafil citrate ODF formulation with the marketed FCT formulation [Citation76]. The usage of ODFs is convenient among patients due to its durability, ease of administration with no suffocation risk, and ease of carrying the strips without the need for a secondary container [Citation8]. Among other advantages, the sildenafil ODF offers unique benefit to patients with ED in respecting their privacy. While the shame and the stigma culturally linked to the ED management is considered a major unmet need of the patients treated with phosphodiesterase 5 inhibitors (PDE5-Is), the ODF allows them to carry the drug in their pockets, in the most discreet way, and then be placed on the tongue before engaging in sexual activity [Citation8,Citation77,Citation78].

Allergy warning

Furthermore, the absence of the need to swallow the drug with water further increases the ease of use and the potential reduction of the stigma of being treated with a traditional pill. In fact, when the film is placed upon the tongue or in the oral cavity, it gets immediately hydrated by saliva without any need of water followed by rapid disintegration and drug release for oro-mucosal and/or systemic absorption [Citation76]. To further demonstrate the possibility to safely store the drug in the pocket, maximizing the need for a discreet treatment, a stress test has been conducted on sildenafil ODF by exposing it to elevated temperatures (60 degrees Celsius) for three weeks, mimicking extreme storage conditions and followed by evaluation of its physical and chemical stability. Ensuring the stability of pharmaceutical products is crucial to maintain their efficacy, safety, and quality throughout their shelf life, particularly critical in the case of sildenafil ODF. This test was conducted in Kyukyu Pharmaceutical Co., Ltd, Toyama Plant, Japan.

What are the serious side effects of sildenafil?

A thin pale red-colored ODF containing 50 mg sildenafil was formulated to dissolve in the oral cavity. Three batches of samples were subjected to a stability study at 60°C stress for three weeks. Subsequently, they were assessed for the amount of API assay (95.0%−105.0% of labeled amount), degradation, disintegration, dissolution rate (over 80% for 45 mm), and water content. All the test items of this stability study met the specifications and showed negligible differences between the samples. The amount of degradation products demonstrated an increasing trend over time in all conditions, but all met the required specification. In fact, when the film is placed upon the tongue or in the oral cavity, it gets immediately hydrated by saliva without any need of water followed by rapid disintegration and drug release for oro-mucosal and/or systemic absorption [Citation76]. To further demonstrate the possibility to safely store the drug in the pocket, maximizing the need for a discreet treatment, a stress test has been conducted on sildenafil ODF by exposing it to elevated temperatures (60 degrees Celsius) for three weeks, mimicking extreme storage conditions and followed by evaluation of its physical and chemical stability. Ensuring the stability of pharmaceutical products is crucial to maintain their efficacy, safety, and quality throughout their shelf life, particularly critical in the case of sildenafil ODF. This test was conducted in Kyukyu Pharmaceutical Co., Ltd, Toyama Plant, Japan. A thin pale red-colored ODF containing 50 mg sildenafil was formulated to dissolve in the oral cavity. Three batches of samples were subjected to a stability study at 60°C stress for three weeks. Subsequently, they were assessed for the amount of API assay (95.0%−105.0% of labeled amount), degradation, disintegration, dissolution rate (over 80% for 45 mm), and water content. All the test items of this stability study met the specifications and showed negligible differences between the samples.

16. How is Sildenafil Oral Suspension supplied

These fabricated personalized films have the capability to be used in a clinical setting, as they substantially enhance the therapeutic efficacy, minimize adverse drug reactions, and aid in improved patient outcomes [Citation5,Citation68,Citation69]. Fused deposition modeling or fused filament fabrication is a nozzle-based deposition technique. In this 3D printing method, API is embedded in a molten thermoplastic polymer filament, which gets extruded through a nozzle, maintained at a high-temperature, and deposited as incremental layers—with quick solidification to a build plate. Several factors need to considered during the manufacturing of ODFs through this technique, including API content and filament dimension uniformity, optimum temperature and printing speed, and the impact of API presence in the polymer matrix on printing parameters. This technology is widely used in pharmaceutical industries for the manufacturing of immediate-release and extended-release formulations [Citation67].

Indications and Usage for Sildenafil Oral Suspension

This method is promising in fabricating those drugs that are poorly/sparingly water soluble, thus improving their dissolution rate. It does not require solvents making it environmentally safe, has a lesser cost, and is suitable for both large- and small-scale production [Citation70]. This 3D printing technique is also known as a pressure‐assisted microsyringe method used for the manufacture of ODFs. In this method, excipients, additives, and active ingredients are either dissolved or dispersed in a solution and dried at room temperature to form a semisolid mixture. This semisolid material is extruded incessantly layer-by-layer through a syringe‐based nozzle onto the build plate.

What should I tell my healthcare provider before taking sildenafil?

This is followed by in‐process drying, which forms a critical step and may influence the physical properties of the incorporated excipients, drug, and overall quality of ODFs [Citation18]. This method fabricates ODFs through a one‐step process without necessitating the preparation of API-loaded filaments, unlike other 3D printing technologies. The SSE is the utmost successful 3D printing method for fabricating ODFs. The optimum mixture of drug, excipients, and solvent defines the ideal rheological characteristics of the semi-solid formulation. This is extremely important as it affects the extrudability of semi-solid formulation in desired flow through the nozzle before printing. The amount of degradation products demonstrated an increasing trend over time in all conditions, but all met the required specification. The purity testing for the degradation product (0.2% or less) showed significant results (p value < 0.05) at initial and 60°C in all the three samples. The process was evaluated across a range of manufacturing conditions, and all intermediates and sildenafil ODF showed reliable performance that yielded a consistent product meeting all specifications at release and after three weeks of storage under stressed conditions. These results, shown in , indicate the robust performance of the sildenafil ODF across a range of manufacturing conditions. In addition, the water content stayed in a tight range regardless of the film casting parameters, and this remains true of the packaged product even after 3 weeks at 60°C.

Brand Name	Manufacturer	Available Strengths	Notes
Viagra Oral Solution	Pfizer	10 mg/mL	Widely known; prescription only
Sildenafil Oral Solution	Generic or compounded brands	10 mg/mL	Often more affordable; compounded options
Revatio Oral Solution	Pfizer (for PAH)	10 mg/mL	Approved for pulmonary hypertension
Kamagra Oral Solution	Ajanta Pharma (generic)	10 mg/mL	Not officially approved in many markets

ED is defined as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance [Citation76,Citation79–81]. ED still prevails as an unprecedented diagnosis and undertreated condition that contributes to increased physical and psychosocial burden.

Side Effect	Frequency	Severity	Notes
Headache	Common	Mild	Usually resolves with continued use
Flushing	Common	Mild	Dilation of blood vessels
Dyspepsia	Less common	Mild	Indigestion or stomach discomfort
Nasal congestion	Less common	Mild	Due to vasodilation
Visual disturbances	Rare	Moderate	Blurred vision or color perception changes

It negatively impacts the wellbeing, relationships, and health-related quality of life (HR-QoL) of patients and their partners [Citation82,Citation83], and thus, any treatment interventions that substantially revive sexual function have the prospect to reinforce patient health and overall HR-QoL. ED may present with clinically relevant forms but also subclinical conditions deserving medical attention. Worldwide, various forms of ED are diagnosed in up to 150 million men and it has been projected to surge to 322 million cases by 2025. ED has affected 52% of men in the age group of 40 and 70 years and 70% of men above 70 years [Citation84–87]. The primary risk factors include diabetes mellitus, hypertension, and hyperlipidemia and modifiable risk factors like obesity, physical inactivity, alcoholism, and cigarette smoking [Citation88–90]. In addition, there is increasing evidence that ED can be considered as the perfect gender-dependent (early) biomarker of non-communicable diseases (NCDs) including peripheral vascular disease and cardiovascular disease, with a heightened risk of cardiovascular mortality as largely demonstrated by epidemiological studies [Citation91].

What other information should I know?