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The analyses were performed in compliance with the general principles of Good Laboratory Practice regulations. The complete details of the analytical procedures used to determine drug concentrations are presented in the Supplementary materials. Data quality was assured by Clinical Medical Services Sagl, Switzerland, who conducted regular onsite monitoring visits and regular inspections of the case report forms. All study documentation and results were reviewed according to the quality assurance standard operating procedures of CROSS Research, Switzerland. The primary objective of this study was to compare the rate (Cmax) and extent (AUC0–t) of sildenafil absorption after single-dose administration of test and reference. Secondary endpoints were to describe the plasma pharmacokinetic profiles of sildenafil and its metabolite N-desmethyl-sildenafil after single-dose administration of test and reference, including Cmax, AUC from administration to the last observed concentration time (AUC0–t), AUC extrapolated to infinity (AUC0–8), t½, time to Cmax (tmax), terminal elimination constant rate (λz), and relative bioavailability (Frel), and to evaluate the sildenafil safety profile after single-dose administration.

Disclosure statement

The bioequivalence test was fully satisfied for sildenafil and N-desmethyl-sildenafil in terms of rate and extent of bioavailability (Cmax, AUC0–t, and AUC0–f). Specifically, 90% CIs of the test/reference ratio of geometric means were fully comprised within the bioequivalence acceptance range 80%–125% (Table 3, sildenafil; Table 4, N-desmethyl-sildenafil). The majority of subjects (28/53; 52.8%) judged the palatability of the sildenafil 100 mg orodispersible film to be good/acceptable. Sildenafil administered as a single dose of test or reference product was well tolerated. With the exception of a transient aspartate aminotransferase increase, possibly pfizer sildenafil 100 related to the reference product, in one subject, no unexpected TEAEs were observed.

Rapid Acting

Overall, 37 TEAEs were reported by 22 (41.5%) subjects: 20 TEAEs were experienced by 14 (26.4%) subjects with the test product and 17 TEAEs were experienced by 13 (24.5%) subjects with the reference product (Table 5). All reported TEAEs were deemed related to the treatment by the investigator. The most common TEAE was headache, which was observed in 7 (13.2%) subjects with test and 9 (17.0%) subjects with reference. No subjects withdrew from the study as a consequence of a TEAE. One subject discontinued the study due to pretreatment AEs.

7.3 Amlodipine

No serious AEs or other significant AEs occurred in the study. Apart from the single transient increase in aspartate aminotransferase levels, no significant effects of treatment on blood pressure, heart rate, body weight, electrocardiogram, or other laboratory parameters were observed. Over recent years, various innovative drug delivery systems, including films, gels, chewing gums, and drug-loaded micro- and nanoparticles, have been developed as alternatives to conventional dosage forms with the aim of improving patient convenience and acceptability and enhancing compliance. Orodispersible films (variously termed as quick dissolving film, thin strips, oral films, orally dissolving film, etc) disintegrate in patients’ mouth without the need for water and consist of a thin oral strip comprising a hydrophilic, film-forming polymer, and the active pharmaceutical ingredient. The film is hydrated by saliva when placed on the tongue or oral cavity, and disintegrates rapidly to release the medication for local (oromucosal) and systemic (gastrointestinal) absorption. Safety evaluations consisted of treatment-emergent AEs (TEAEs), vital signs (blood pressure and heart rate), physical examination and body weight, laboratory parameters, and electrocardiogram. The sample size for the study was determined with reference to the relevant, recent literature available on the pharmacokinetics of sildenafil, in particular the results of a study conducted after administration of two 25 mg capsules of Viagra film-coated tablets in a population of 12 male subjects.19 The highest coefficient of variance for the pharmacokinetic parameters Cmax and AUC was estimated to be 0.383. The sample size was calculated using the SAS 9.1.3 software (SAS Institute, Cary, NC, USA) Power Procedure with paired means option. Fixing the significance level α at 5% and the hypothesized test/reference mean ratio to 1, 50 subjects were considered sufficient to attain a power of 80% to correctly conclude the bioequivalence between the two formulations within the range 80.00%–125.00% for all parameters (Cmax and AUC). Data were described using classic descriptive statistics for quantitative variables and frequencies for qualitative variables.

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The pharmacokinetic analysis and the statistical analysis of pharmacokinetic parameters were performed using Phoenix WinNonlin® version 6.3 (Pharsight Corporation, Mountain View, CA, USA) and SAS version 9.3 (TS1M1). Sildenafil and N-desmethyl-sildenafil rate (Cmax) and extent (AUC) of absorption were compared between test and reference using analysis of variance for a crossover design on log-transformed data. Period, treatment, sequence, and subject within sequence were taken into account as sources of variation. tmax was sildenafil 25mg tablets analyzed using the nonparametric Friedman test. A total of 54 subjects met the eligibility criteria and were included in the study and randomized, and 53 of them received both test and reference treatments and completed the study per protocol. The flow of subjects throughout the study is shown in Figure 1.

TFL 20 mg Disintegrating Strip

One subject prematurely discontinued the study on day 1 of period 1 before administration of the study medication due to pretreatment AEs. All the 53 subjects were included in the safety and pharmacokinetic analysis sets. Minor protocol deviations (vital signs measured earlier than the specified 10 min before scheduled time point) were observed for 15/54 subjects and were not considered relevant.

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Although the exact film disintegration time was not recorded, complete dissolution in 1 min after administration was confirmed in all the volunteers (the study protocol required the investigator to check the oral cavity exactly 1 min after drug intake to confirm oral film dissolution). Demographics of the subjects are summarized in Table 2.

Advantage	Description	Evidence/Reference
Rapid Dissolution	Dissolve in mouth within seconds	Pharmacokinetic studies
Ease of Administration	No swallowing needed, suitable for dysphagia	Patient surveys
Precise Dosing	Accurate dose delivery without pills	Manufacturing standards
Discreet Usage	No need for water, discreet intake	User testimonials
Better Bioavailability	Faster absorption through oral mucosa	Clinical pharmacology reports

The mean age of the subjects was 36.3 years (range 18–51 years) and the majority were Caucasian (98.1%). All enrolled subjects were in good physical and mental health, as determined on the basis of medical and surgical history and physical examination. Mean body weight was 75.91 kg (range 56.2–99.6 kg). The mean ± standard deviation (SD) of plasma sildenafil pharmacokinetic parameters and the results of their statistical comparisons for the pharmacokinetic set (n=53) are summarized in Table 3. Figure 2 shows the sildenafil pharmacokinetic profiles of the two investigational medicinal products up to 24 h after sildenafil 100 mg test and reference treatments. The mean plasma concentration–time profiles up to 24 h of sildenafil 100 mg orodispersible film and the film-coated tablet were nearly superimposable. The mean ± SD of plasma N-desmethyl-sildenafil pharmacokinetic parameters and the results of their statistical comparisons for the pharmacokinetic set (n=53) are summarized in Table 4.

Step	Description	Equipment Needed	Quality Control Measures
Ingredient Mixing	Blend active and excipients uniformly	Mixers, blenders	Homogeneity testing
Casting	Pouring mixture into strip molds	Molding machines	Thickness and uniformity checks
Drying	Removing moisture to solidify strips	Drying ovens	Moisture content analysis
Cutting & Packaging	Cutting into individual strips and sealing	Cutting machines, sealers	Weight, appearance, and sterility tests

The mean plasma concentration–time profiles of N-desmethyl-sildenafil were nearly superimposable (Figure 3).

5. Warnings and Precautions

The analyses were performed in compliance with the general principles of Good Laboratory Practice regulations. The complete details of the analytical procedures used to determine drug concentrations are presented in the Supplementary materials. Data quality was assured by Clinical Medical Services Sagl, Switzerland, who conducted regular onsite monitoring visits and regular inspections of the case report forms. All study documentation and results were reviewed according to the quality assurance standard operating procedures of CROSS Research, Switzerland. The primary objective of this study was to compare the rate (Cmax) and extent (AUC0–t) of sildenafil absorption after single-dose administration of test and reference.

5.8 Effects on Bleeding

Secondary endpoints were to describe the plasma pharmacokinetic profiles of sildenafil and its metabolite N-desmethyl-sildenafil after single-dose administration of test and reference, including Cmax, AUC from administration to the last observed concentration time (AUC0–t), AUC extrapolated to infinity (AUC0–8), t½, time to Cmax (tmax), terminal elimination constant rate (λz), and relative bioavailability (Frel), and to evaluate the sildenafil safety profile after single-dose administration. Safety evaluations consisted of treatment-emergent AEs (TEAEs), vital signs (blood pressure and heart rate), physical examination and body weight, laboratory parameters, and electrocardiogram. The sample size for the study was determined with reference to the relevant, recent literature available on the pharmacokinetics of sildenafil, in particular the results of a study conducted after administration of two 25 mg capsules of Viagra film-coated tablets in a population of 12 male subjects.19 The highest coefficient of variance for the pharmacokinetic parameters Cmax and AUC was estimated to be 0.383. The sample size was calculated using the SAS 9.1.3 software (SAS Institute, Cary, NC, USA) Power Procedure with paired means option. Fixing the significance level α at 5% and the hypothesized test/reference mean ratio to 1, 50 subjects were considered sufficient to attain a power of 80% to correctly conclude the bioequivalence between the two formulations within the range 80.00%–125.00% for all parameters (Cmax and AUC).

Regional issues

Data were described using classic descriptive statistics for quantitative variables and frequencies for qualitative variables. The pharmacokinetic analysis and the statistical analysis of pharmacokinetic parameters were performed using Phoenix WinNonlin® version 6.3 (Pharsight Corporation, Mountain View, CA, USA) and SAS version 9.3 (TS1M1). Sildenafil and N-desmethyl-sildenafil rate (Cmax) and extent (AUC) of absorption were compared between test and reference using analysis of variance for a crossover design on log-transformed data. Period, treatment, sequence, and subject within sequence were taken into account as sources of variation. tmax was sildenafil 25mg tablets analyzed using the nonparametric Friedman test. The bioequivalence test was fully satisfied for sildenafil and N-desmethyl-sildenafil in terms of rate and extent of bioavailability (Cmax, AUC0–t, and AUC0–f). Specifically, 90% CIs of the test/reference ratio of geometric means were fully comprised within the bioequivalence acceptance range 80%–125% (Table 3, sildenafil; Table 4, N-desmethyl-sildenafil). The majority of subjects (28/53; 52.8%) judged the palatability of the sildenafil 100 mg orodispersible film to be good/acceptable. Sildenafil administered as a single dose of test or reference product was well tolerated.

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With the exception of a transient aspartate aminotransferase increase, possibly pfizer sildenafil 100 related to the reference product, in one subject, no unexpected TEAEs were observed. Overall, 37 TEAEs were reported by 22 (41.5%) subjects: 20 TEAEs were experienced by 14 (26.4%) subjects with the test product and 17 TEAEs were experienced by 13 (24.5%) subjects with the reference product (Table 5). All reported TEAEs were deemed related to the treatment by the investigator. The most common TEAE was headache, which was observed in 7 (13.2%) subjects with test and 9 (17.0%) subjects with reference. No subjects withdrew from the study as a consequence of a TEAE. One subject discontinued the study due to pretreatment AEs. No serious AEs or other significant AEs occurred in the study. Apart from the single transient increase in aspartate aminotransferase levels, no significant effects of treatment on blood pressure, heart rate, body weight, electrocardiogram, or other laboratory parameters were observed. Over recent years, various innovative drug delivery systems, including films, gels, chewing gums, and drug-loaded micro- and nanoparticles, have been developed as alternatives to conventional dosage forms with the aim of improving patient convenience and acceptability and enhancing compliance. Orodispersible films (variously termed as quick dissolving film, thin strips, oral films, orally dissolving film, etc) disintegrate in patients’ mouth without the need for water and consist of a thin oral strip comprising a hydrophilic, film-forming polymer, and the active pharmaceutical ingredient. The film is hydrated by saliva when placed on the tongue or oral cavity, and disintegrates rapidly to release the medication for local (oromucosal) and systemic (gastrointestinal) absorption. Ideally, film-forming hydrophilic polymers for use in orodispersible films should be nonirritant, nontoxic, and tasteless; quickly disintegrate, possess sufficient peel, shear, and tensile strength; and inexpensive and stable.14 The hydrophilic polymers are combined with other excipients to improve the physical properties (eg, plasticizers), to incorporate active pharmaceutical substances (eg, surfactants) and to improve palatability. The films are formulated using various methods, including solvent casting, hot-melt extrusion, semisolid casting, solid dispersion extrusion, and rolling; solvent casting and spraying methods are most commonly used.14,16 The pharmaceutical development of the IBSA 100 mg orodispersible film was based on the use of maltodextrins as the film-forming agent, glycerin as a plasticizer, and water as a solvent. Polyvinyl acetate was introduced to improve the mechanical properties and tensile strength of the films. The sildenafil IBSA 100 mg orodispersible film was prepared by the solvent casting method, consisting of spreading and drying of a viscous mixture composed of active principle and excipients in a suitable solvent. The mixture, homogeneous and without bubble and clumps, is spread on a liner and dried, allowing the production of a film with a homogeneous and smooth surface and a thickness of ~220 μm. The resulting film is then cut into pieces of required size. The novelty of the IBSA orodispersible film is described in the patent WO 2014/049548. Unlike many of the films that have been considered to be state-of-the-art, the sildenafil IBSA orodispersible film does not use pullulan, an ingredient that is expensive and difficult to source, as the film-forming component.

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A total of 54 subjects met the eligibility criteria and were included in the study and randomized, and 53 of them received both test and reference treatments and completed the study per protocol. The flow of subjects throughout the study is shown in Figure 1. One subject prematurely discontinued the study on day 1 of period 1 before administration of the study medication due to pretreatment AEs. All the 53 subjects were included in the safety and pharmacokinetic analysis sets. Minor protocol deviations (vital signs measured earlier than the specified 10 min before scheduled time point) were observed for 15/54 subjects and were not considered relevant.

5.4 SuddenHearing Loss

Although the exact film disintegration time was not recorded, complete dissolution in 1 min after administration was confirmed in all the volunteers (the study protocol required the investigator to check the oral cavity exactly 1 min after drug intake to confirm oral film dissolution). Demographics of the subjects are summarized in Table 2. The mean age of the subjects was 36.3 years (range 18–51 years) and the majority were Caucasian (98.1%). All enrolled subjects were in good physical and mental health, as determined on the basis of medical and surgical history and physical examination. Mean body weight was 75.91 kg (range 56.2–99.6 kg).

8.1 Pregnancy

The mean ± standard deviation (SD) of plasma sildenafil pharmacokinetic parameters and the results of their statistical comparisons for the pharmacokinetic set (n=53) are summarized in Table 3. Figure 2 shows the sildenafil pharmacokinetic profiles of the two investigational medicinal products up to 24 h after sildenafil 100 mg test and reference treatments. The mean plasma concentration–time profiles up to 24 h of sildenafil 100 mg orodispersible film and the film-coated tablet were nearly superimposable. The mean ± SD of plasma N-desmethyl-sildenafil pharmacokinetic parameters and the results of their statistical comparisons for the pharmacokinetic set (n=53) are summarized in Table 4. The mean plasma concentration–time profiles of N-desmethyl-sildenafil were nearly superimposable (Figure 3). Formulations based on other film-forming polymers are available, but with some limitations in terms of physical properties or dissolution behavior. Maltodextrins, defined as non-sweet, nutritive saccharide mixtures with a dextrose equivalent (DE) of <20,20 are obtained from the partial hydrolysis of starch with suitable acids and/or enzymes and are a suitable ingredient for manufacturing orodispersible films. They can differ in average molecular size, with the DE value (ie, the proportion of reducing sugars relative to dextrose expressed as a percentage on a dry basis) commonly used in classification.

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Ideally, film-forming hydrophilic polymers for use in orodispersible films should be nonirritant, nontoxic, and tasteless; quickly disintegrate, possess sufficient peel, shear, and tensile strength; and inexpensive and stable.14 The hydrophilic polymers are combined with other excipients to improve the physical properties (eg, plasticizers), to incorporate active pharmaceutical substances (eg, surfactants) and to improve palatability. The films are formulated using various methods, including solvent casting, hot-melt extrusion, semisolid casting, solid dispersion extrusion, and rolling; solvent casting and spraying methods are most commonly used.14,16 The pharmaceutical development of the IBSA 100 mg orodispersible film was based on the use of maltodextrins as the film-forming agent, glycerin as a plasticizer, and water as a solvent. Polyvinyl acetate was introduced to improve the mechanical properties and tensile strength of the films. The sildenafil IBSA 100 mg orodispersible film was prepared by the solvent casting method, consisting of spreading and drying of a viscous mixture composed of active principle and excipients in a suitable solvent. The mixture, homogeneous and without bubble and clumps, is spread on a liner and dried, allowing the production of a film with a homogeneous and smooth surface and a thickness of ~220 μm.

Other Interactions

The resulting film is then cut into pieces of required size. The novelty of the IBSA orodispersible film is described in the patent WO 2014/049548. Unlike many of the films that have been considered to be state-of-the-art, the sildenafil IBSA orodispersible film does not use pullulan, an ingredient that is expensive and difficult to source, as the film-forming component. Formulations based on other film-forming polymers are available, but with some limitations in terms of physical properties or dissolution behavior. Maltodextrins, defined as non-sweet, nutritive saccharide mixtures with a dextrose equivalent (DE) of <20,20 are obtained from the partial hydrolysis of starch with suitable acids and/or enzymes and are a suitable ingredient for manufacturing orodispersible films.

Marketing and sales

They can differ in average molecular size, with the DE value (ie, the proportion of reducing sugars relative to dextrose expressed as a percentage on a dry basis) commonly used in classification. However, maltodextrins usually require the addition of a hydrocolloid at concentrations >10% to reduce dissolution time. However, hydrocolloids tend to become a gel when they are in contact with saliva; thus, they give the sensation of poor dissolution in the mouth. However, maltodextrins usually require the addition of a hydrocolloid at concentrations >10% to reduce dissolution time. However, hydrocolloids tend to become a gel when they are in contact with saliva; thus, they give the sensation of poor dissolution in the mouth.