Accepted for publication 14 December 2016 Published 11 April 2017 Volume 20 Pages 1183—1192 DOI https://doi.org/10.2147/DDDT. S124034 Checked for plagiarism Yes Review by Single-blind Peer reviewers approved by Dr Rammohan Devulapally Peer reviewer comments 2 Editor who approved publication: Dr Sukesh Voruganti IBSA Institut Biochimique S. A., Pambio-Noranco, Switzerland Abstract: A new orodispersible film formulation of the phosphodiesterase type 5 inhibitor, sildenafil, has been developed to examine the advantages of an orally disintegrating film formulation and provide an alternative to the current marketed products for the treatment of erectile dysfunction. 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. Package leaflet: Information for the patient SILDENAFIL IBSA 25 mg orodispersible film SILDENAFIL IBSA 50 mg orodispersible film SILDENAFIL IBSA 75 mg orodispersible film SILDENAFIL IBSA 100 mg orodispersible film Sildenafil Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This includes any possible side effects not listed in this leaflet. • If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. If you have any further questions, ask your doctor, pharmacist or nurse. If you get any side effects, talk to your doctor, pharmacist or nurse. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. What you need to know before you take SILDENAFIL IBSA Do not take SILDENAFIL IBSA • If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6). It may harm them, even if their signs of illness are the same as yours. SILDENAFIL IBSA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. SILDENAFIL IBSA will only help you to get an erection if you are sexually stimulated. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. What SILDENAFIL IBSA is and what it is used for SILDENAFIL IBSA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. What SILDENAFIL IBSA is and what it is used for What you need to know before you take SILDENAFIL IBSA How to take SILDENAFIL IBSA Possible side effects How to store SILDENAFIL IBSA Contents of the pack and other information 1. Sildenafil ebay Zoloft at night Prednisolone vs pred forte Sertraline 50 mg weight loss 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. Sildenafil Orodispersible Tablets contain Sildenafil Citrate. The tablets comply with the requirements stated under Tablets and with the following requirements. This is a summary of the public assessment report PAR for Sildenafil Sandoz 25 mg, 50 mg and 75 mg orodispersible films PL 04416/1330-1332;. Sildenafil citrate is indicated for the treatment of erectile dysfunction. An orally disintegrating tablet (ODT) of sildenafil citrate has been developed for the benefit of patients who have difficulty swallowing solid dosage forms. The main goal of this study was to evaluate the bioequivalence of sildenafil ODT with and without water versus marketed sildenafil oral film-coated tablets. A secondary objective was to evaluate the effects of a high-fat meal on the pharmacokinetics of sildenafil ODT. The bioequivalence study of sildenafil ODT given with and without water versus marketed sildenafil citrate film-coated oral tablets was conducted in 36 subjects. In a food-effect study, the effect of a standard high-fat meal on the pharmacokinetics of sildenafil ODT was evaluated in 12 subjects. Both studies were randomized, open-label, crossover, single-dose (50 mg) studies in healthy men aged ≥45 years. PACKAGE LEAFLET: INFORMATION FOR THE USER Sildenafil 25 mg Orodispersible Film Sildenafil 50 mg Orodispersible Film Sildenafil 75 mg Orodispersible Film SZ00000LT000 Sildenafil Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • If you get any side effects, talk to your doctor or pharmacist. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you only. It may harm them, even if their signs of illness are the same as yours. What you need to know before you take Sildenafil 3. What Sildenafil is and what it is used for Sildenafil belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. This includes any possible side effects not listed in this leaflet. Sildenafil will only help you to get an erection if you are sexually stimulated. Always tell your doctor or pharmacist if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”). Contents of the pack and other information 1 You should not take Sildenafil if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. You should not take Sildenafil if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure. Tell your doctor or pharmacist if you are already taking riociguat. Sildenafil orodispersible Formulation and Evaluation of Oro-Dispersible Paediatric Sildenafil., Sildenafil Orodispersible Tablets Ciprofloxacin for sinus infectionPrednisone arthritis pain Patient information for SILDENAFIL SANDOZ 50MG ORODISPERSIBLE FILM Including dosage instructions and possible side effects. SILDENAFIL SANDOZ 50MG ORODISPERSIBLE FILM. Public Assessment Report Decentralised Procedure Sildenafil.. Viagra, INN-sildenafil - European Medicines Agency - europa.eu. Clinical Therapeutics/Volume 36, Number 2, 2014. Pharmacokinetics of a Novel Orodispersible Tablet of. Sildenafil in Healthy Subjects. Bharat Damle, PhD. 1. Feb 5, 2014. citrate and the prepared sildenafil citrate oral films were studied the. Keywords Orodispersible Film, Sildenafil Citrate, Fast Dissolving Films. A novel sildenafil orodispersible film ODF containing sildenafil citrate has recently been marketed. The ODF formulation disintegrates rapidly.