sildenafil-citrate and dapoxetine

There are ongoing debates about the definition, classification and prevalence of premature ejaculation (PE). The first evidence-based definition of PE was limited to heterosexual men with lifelong PE who engage in vaginal intercourse. Unfortunately, many patients with the complaint of PE do not meet these criteria. However, these men can be diagnosed as one of the PE subtypes, namely acquired PE, natural variable PE or premature-like ejaculatory dysfunction. Nevertheless, the validity of these subtypes has not yet been supported by evidence. The absence of a universally accepted PE definition and lack of standards for data acquisition have resulted in prevalence studies that have reported conflicting rates. The very high prevalence of 20%-30% is probably due to the vague terminology used in the definitions at the time when such surveys were conducted. Although many men may complain of PE when questioned for a population-based prevalence study, only a few of them will actively seek treatment for their complaint, even though most of these patients would define symptoms congruent with PE. The complaints of acquired PE patients may be more severe, whereas complaints of patients experiencing premature-like ejaculatory dysfunction seem to be least severe among men with various forms of PE. Although numerous treatment modalities have been proposed for management of PE, only antidepressants and topical anaesthetic creams have currently been proven to be effective. However, as none of the treatment modalities have been approved by the regulatory agencies, further studies must be carried to develop a beneficial treatment strategy for PE.

Topics: Animals; Benzylamines; Coitus; Humans; Lidocaine; Male; Naphthalenes; Piperazines; Premature Ejaculation; Prevalence; Prilocaine; Purines; Selective Serotonin Reuptake Inhibitors; Sexual Dysfunction, Physiological; Sildenafil Citrate; Sulfones

The aim of the study was to compare the clinical efficacy and safety of the on-demand use of paroxetine, dapoxetine, sildenafil and combined dapoxetine with sildenafil in treatment of patients with premature ejaculation (PE). In a single-blind placebo-controlled clinical study, 150 PE patients without erectile dysfunction (ED) were included during the period of March 2015 to May 2016. Patients were randomly divided into five groups (30 patients each). On demand placebo, paroxetine (30 mg), dapoxetine (30 mg), sildenafil citrate (50 mg) and combined dapoxetine (30 mg) with sildenafil citrate (50 mg) were given for patients for 6 weeks in each group respectively. All patients were instructed to record intravaginal ejaculatory latency time (IELT) and evaluated with Premature Ejaculation Diagnostic Tool (PEDT) and the patient satisfaction score before and after treatment. The mean of IELT, satisfaction score and PEDT in all groups was significantly improved after treatment (p value = .001). Combined dapoxetine with sildenafil group had the best values of IELT, satisfaction scores and PEDT in comparison with other treatment groups (p value <.001). The combined dapoxetine with sildenafil therapy could significantly improve PE patients without ED as compared to paroxetine alone or dapoxetine alone or sildenafil alone with tolerated adverse effects.

Topics: Adult; Benzylamines; Drug Therapy, Combination; Ejaculation; Humans; Male; Middle Aged; Naphthalenes; Paroxetine; Patient Satisfaction; Premature Ejaculation; Sildenafil Citrate; Single-Blind Method; Young Adult

Dapoxetine hydrochloride (DAP) and sildenafil citrate (SIL) have proven clinically effective in the treatment of comorbid conditions like erectile dysfunction and premature ejaculation. The analysis of DAP and SIL combinations represents a challenge because of the severe overlap of these compounds' spectra. Six newly developed methods were proven effective for resolving such a challenging overlap. They also exhibited the advantage of simplicity as they depend on the zero-order spectrum and only require simple mathematical handling.. We suggested six simple, precise, and sensitive spectrophotometric methods based on mathematical filtration techniques and ratio spectra manipulations to resolve the spectra of DAP and SIL in their bulk and combined pharmaceutical dosage form and estimate the relevant individual concentrations.. The first three methods were based on the zero-order range and involved modest mathematical manipulations. They are the induced dual-wavelength, Fourier self-deconvolution, and absorptivity factor spectrophotometric methods. Three other methods that are based on ratio spectra manipulation were developed: ratio difference, mean centering of the ratio spectra, and derivative ratio spectrum.. We determined the performance of the suggested methods for estimating DAP and SIL in their laboratory mixtures and their combined pharmaceutical dosage form. The linear ranges for DAP and SIL were 1-40 µg/ml and 2-60 µg/ml, respectively. The detection limits were in the 0.18-1.10 µg/ml range for DAP and in the 0.68-1.11 µg/ml range for SIL. The developed methods were validated as per the ICH guidelines for linearity, detection limit, quantitation limit, selectivity, precision, and accuracy. Normal probability, interval, and Tukey's simultaneous significant difference plots were utilized to confirm and better visualize the analysis of variance test results. Statistically, no significant difference was observed to exist between results obtained from the hereby developed and the previously reported methods.

Topics: Benzylamines; Naphthalenes; Sildenafil Citrate; Spectrophotometry

A stability-indicating HPLC-UV method for the simultaneous determination of sildenafil citrate and dapoxetine hydrochloride in solution and tablet was developed. The mobile phase was comprised of acetonitrile and 0.2M ammonium acetate buffer. The analyte was eluted at 3.392min and 7.255min for sildenafil citrate and dapoxetine HCl respectively using gradient system at a flow rate of 1.5mL/min. The theoretical plates count was>2000, tailing factor <.30, capacity factor 3.19-7.58 and peak asymmetry factor <.08.The method was linear from 5-180 and 1-40μg/mL with a correlation coefficient of 0.9999 and 0.9994 for sildenafil citrate and dapoxetine HCl respectively. The drug solution was stable at ambient room temperature (26˚C) for 48hours.Both drugs were found susceptible to oxidation and the drug content dropped slightly in acid and alkali condition but stable under UV light and heat. No interference from tablet excipients and degradation products was found.

Topics: Benzylamines; Chromatography, High Pressure Liquid; Drug Stability; Hot Temperature; Hydrogen-Ion Concentration; Naphthalenes; Oxidation-Reduction; Pharmaceutical Solutions; Photolysis; Reproducibility of Results; Sildenafil Citrate; Spectrophotometry, Ultraviolet; Tablets; Time Factors

A method was established for rapid screening and quantifying 11 illegally added anti-impotence preparations (yohimbine, acetildenafil, nor-acetildenafil, homosildenafil, hydroxy-homosildenafil, sildenafil, vardenafil, thioaildenafil, tadalafil, pseudovardenafil, dapoxetine) in health care products by high performance liquid chromatography-high resolution mass spectrometry. The samples were extracted with methanol and analyzed by positive mode in the MS detection. The results showed that the limits of detection were 25.0 ng/mLexcept for nor-acetildenafil (5.0 ng/mL), the linear ranges were 5.0-200.0 ng/mL except for nor-acetildenafil (25.0-500.0 ng/mL) with the correlation coefficients not less than 0.999 0. The recoveries were in the range of 82.0%-105.9% with the relative standard deviations of 4.7%-16.5%. This method is accurate, simple and rapid, and can be used in rapid screening and quantitative analysis of the 11 illegally added anti-impotence in health care products.

Topics: Benzylamines; Chromatography, High Pressure Liquid; Drug Contamination; Erectile Dysfunction; Humans; Indole Alkaloids; Male; Mass Spectrometry; Naphthalenes; Sildenafil Citrate; Tadalafil; Vardenafil Dihydrochloride; Vasodilator Agents

Topics: Adult; Benzylamines; Chromatography, High Pressure Liquid; Counterfeit Drugs; Erectile Dysfunction; Humans; Internet; Male; Middle Aged; Naphthalenes; Phosphodiesterase 5 Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones; Young Adult