What Is Sildenafil Oral Solution?

of Madrid, Spain ( Aspargo’s leadership team has a proven background and a track record in successful drug product development, regulatory approval and commercialization.

What special dietary instructions should I follow?

Aspargo acquired the exclusive U.S. patent rights covering Sildenafil Oral Spray from Farmalider, S.A. in January 2020. Aspargo’s Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5 mg of sildenafil citrate per push of the pump (referred to as ASP-001) or via an individual single liquid unit dispensing 100 mg per unit (referred to as ASP-002). In May 2020, Aspargo announced the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed Aspargo’s questions and provided guidance on the Company’s Sildenafil Oral Spray for the treatment of erectile dysfunction (ED).

4.2. Manufacturing of ODFs

The FDA was supportive of a single dose bioequivalent study comparing Aspargo’s Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with VIAGRA® tablets as the basis for approval and deemed the 505(b)(2) regulatory pathway appropriate for the program. “The acquisition of global rights to Sildenafil Oral Spray represents a significant opportunity for Aspargo”, said Michael Demurjian, Aspargo’s Founder and Chief Executive Officer. “The erectile dysfunction market is one of the most expansive categories in the healthcare industry, as men continue to seek a more efficient and convenient solution to address their condition. Following our recent successful completion of a $7.5 million financing, Aspargo has transformed into a rapidly growing global specialty pharmaceutical company.” Aspargo’s oral spray suspension formulation of sildenafil citrate (Sildenafil Oral Spray), the active ingredient in VIAGRA®; is a novel and convenient route of administration for this commonly prescribed medication for erectile dysfunction. The oral suspension formulation of sildenafil citrate is approved for sale in 9 European countries in a liquid dosage form and in Spain in the spray dosage form; the spray dosage form is sildenafil citrate tablet undergoing registration in various jurisdictions worldwide, including 8 European countries and 8 Latin American countries.

How is sildenafil supplied (dosage forms)?

Aspargo’s Sildenafil Oral Spray is protected by US Patent No. 10,016,428 B2 (granted: July 10, 2018); European Patent No. EP3072515 (granted: February 28, 2018); and Russian Patent No. RU2016127223A (granted: April 4, 2018) entitled, Pharmaceutical Composition of Sildenafil Citrate in the Form of a Suspension for Oral Use – and by trade secrets and manufacturing know-how necessary to manufacture the oral spray formulation and to ensure drug stability. Aspargo is protecting its custom designed spray bottle with US and international patent applications. For additional information, please visit our website at Forward Looking StatementsThis press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events, they give no assurance that such expectations will prove to be correct.

How should this medicine be used?

Linearity was established over 0.01-60.00 µg/mL with a correlation coefficient of r² = 0.9999. Limits of detection (LOD) and quantification (LOQ) were 3.82 ng/mL and 11.57 ng/mL, respectively. The method serves as a stability-indicating procedure, effectively analyzing sildenafil in extemporaneous suspension. Structural basis for the activity of drugs that inhibit phosphodiesterases. Sildenafil/cyclodextrin complexation: Stability constants, thermodynamics, and guest-host interactions probed by 1H NMR and molecular modeling studies.

What should I do if I miss a dose of sildenafil?

Ghofrani HA, Osterloh IH, Grimminger F. Sildenafil: from angina to erectile dysfunction to pulmonary hypertension and beyond. Sildenafil for the treatment of pulmonary hypertension in pediatric patients. Handbook of extemporaneous preparation: A guide to pharmaceutical compounding. Great Britain: Pharmaceutical Press; 2010.

Fabrication of Sildenafil-Loaded Solid SNEDDS

p.363-7. Stability indicating RP-LC determination of sildenafil citrate (Viagra) in pure form and in pharmaceutical samples. Raf J Sci 2013;24:24-31. Reddy BPK, Reddy YR. Validation and stability indicating RP- HPLC method for the determination of sildenafil citrate in pharmaceutical formulations and human plasma. Forward-looking statements are subject to a number of risks and uncertainties, but not limited to, our liability to obtain additional capital on acceptable terms, or at all, including additional capital which will be necessary to complete the clinical trials, delays caused by institutional review boards or regulatory agencies, enrollments, shortage of clinical trial supplies, dependence on clinical trial collaborators, loss of any executive officers or key personnel or consultants.

Full Prescribing Information

Compatibility of sildenafil citrate and pharmaceutical excipients by thermal analysis and LC-UV. Determination of transdermal sildenafil in nude mouse skin by reversed-phase high-performance liquid chromatography. Stability indicating methods for the determination of sildenafil citrate in the presence of its degradation product. Bakshi M, Singh S. Development of validated stability- indicating assay methods -critical review.

Other Interactions

Stability indicating RP-HPLC method development and validation of sildenafil citrate in pure form. The study found that sildenafil citrate had a retention time of 8.82 minutes when analyzed via HPLC. Linearity was assessed using a concentration range of 0.01 - 60.00 µg/mL, achieving a correlation coefficient of 0.9999. The method yielded a limit of detection (LOD) of 3.82 ng/mL and a limit of quantification (LOQ) of 11.57 ng/mL. Under forced degradation, 95.99% of sildenafil remained after treatment with acidic and basic hydrolysis, indicating good stability.

8.5 Geriatric Use

The accuracy tests showed an overall recovery of 100.18% across spiked concentrations, demonstrating method reliability. Acquisition significantly boosts Aspargo’s presence as a global biopharmaceutical company in erectile dysfunction Company acquires international rights to Sildenafil Oral Spray from Farmalider, S.A. for 5 million shares of Aspargo common stock Acquisition follows the Company’s recent completion of a $7.5 million common stock financing ENGLEWOOD CLIFFS, NEW JERSEY – SEPTEMBER 29, 2020 – Aspargo Laboratories, Inc. (Aspargo), a privately held, clinical stage, specialty pharmaceutical company, announced today that it has entered into a definitive agreement with Farmalider, S.A. of Madrid, Spain to acquire the exclusive international patent rights related to a proprietary oral spray suspension formulation of sildenafil citrate (Sildenafil Oral Spray) for five million common shares. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made, and the facts and assumptions underlying the forward-looking statements may change.

• It is not recommended for use in children or women.
• Overdose symptoms include dizziness, vision changes, and prolonged erections.
• Seek urgent medical help in case of overdose.

Except as required by law, Aspargo disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

6. Discussion

About Erectile Dysfunction (ED)Erectile dysfunction (ED), also known as impotence, is a type of sexual dysfunction characterized by the persistent difficulty achieving and maintaining an erection sufficient to have sexual intercourse. Common causes of ED include: heart disease, clogged blood vessels (atherosclerosis), high cholesterol, high blood pressure, diabetes, obesity, metabolic syndrome, Parkinson’s disease, Multiple Sclerosis, certain prescription medications, tobacco use, Peyronie’s disease, alcoholism and other forms of substance abuse, sleep disorders, treatments for prostate cancer or enlarged prostate, surgeries or injuries that affect the pelvic area or spinal cord; and low testosterone. Psychological conditions, such as stress, anxiety or depression, can contribute to erectile dysfunction. About Aspargo Laboratories, Inc.Aspargo Laboratories, Inc., located in Englewood Cliffs, New Jersey, is a clinical stage, specialty pharmaceutical company focused on developing an oral spray formulation of sildenafil citrate, the active ingredient in VIAGRA®. Aspargo is the US and international licensee of the patent rights covering Sildenafil Oral Spray from Farmalider, S.A. Click here for the full press release.

• Sildenafil oral solution can interact with nitrates and certain medications.
• Always inform your doctor of all medicines being taken.
• Failure to do so can cause serious adverse effects.

has filed a patent for a liquid oral formulation containing 10 mg/mL of sildenafil citrate and glycerin as a wetting agent.

The formulation is designed for the treatment of conditions like pulmonary arterial hypertension and erectile dysfunction.

• The cost of sildenafil oral solution varies depending on brand and pharmacy.
• Generic versions are typically less expensive.
• Availability might be limited in some regions or countries.

GlobalData’s report on Zydus Lifesciences gives a 360-degree view of the company including its patenting strategy.

8. Future perspective

Quantitative determination of sildenafil citrate in commercial tablet dosage form marked in Maidugri Metropolitan Council (MMC). A validated HPLC method for the measurement of sildenafil citrate in different formulations. Pak J Sci 2010;62:192-7. El-Gindy AE, Shokry E, Farouk M, El-Aziz A. Validated methods for determination of sildenafil citrate in the presence of its potential impurities.

Why it’s used

Rajyalakshmi CH, Benjamin T, Rambabu C. Stability indicating RP-HPLC method for simultaneous determination of sildenafil and duloxetine in pharmaceutical dosage form. Sawatdee S, Srichana T. Analytical validation of sildenafil citrate inhaler preparation. Preparation of sildenafil citrate microcapsules and in vitro/in vivo evaluation of taste masking efficiency.

Authors and Affiliations

Intranasal microemulsion of sildenafil citrate: in vitro evaluation and in vivo pharmacokinetic study sildenafil citrate 150 mg red pill in rabbits. Nonthaburi: Bureau of Drug Control, Food and Drug Administration; 2004. p.1-18. Am J Health Syst Pharm 2006;63:254-7. Determination of sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC. Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

• The solution is usually flavored for better taste.
• Dosing involves measuring with a provided syringe or dropper.
• It offers rapid absorption into the bloodstream.