Table 5.
Excipients in film‐coated tablet formulation from Pfizer, ODT formulation from Pfizer, and ODF formulation from IBSA as reported in the respective data sheets
| Film‐coated tablet formulation from Pfizera | ODT formulation from Pfizerb | ODF formulation from IBSAc , d | |
|---|---|---|---|
| Excipients | Microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate (only the tablet core) | Mannitol, crospovidone, polyvinyl acetate, povidone (the four ingredients of the diluent), croscarmellose sodium (disintegrant), microcrystalline cellulose (filler), silica colloidal anhydrous (glidant), sucralose (sweetener), indigo carmine aluminum lake E132 (colorant), magnesium stearate (lubricant), maltodextrin, dextrin, propylene glycol, glycerol, alpha‐tocopherol and flavoring ingredients (the latter six ingredients are part of commercially available sweeteners and flavors) | Maltodextrin, glycerol, polysorbate 20, monocaprylate of propylene glycol, polyvinyl acetate in dispersion (30%), lemon and grapefruit flavoring (essential oil of lemon, citrate, linalool, essential oil of grapefruit, essential oil of orange, nootkatone, butylated hydroxyanisole E320, ascorbic acid E300, maltodextrin, Arabic gum E414), sucralose, titanium dioxide, indigo carmine |
Formulation obtained from datasheet queried on January 2019 and available at the URL: https://www.ema.europa.eu/documents/product-information/viagra-epar-product-information_en.pdf.
Formulation obtained from datasheet queried on January 2019 and available at the URL: https://www.ema.europa.eu/documents/variation-report/viagra-h-c-202-x-0070-epar-assessment-report-extension_en.pdf.
Formulation obtained from datasheet queried on January 2019 and available at the URL: https://farmaci.agenziafarmaco.gov.it/aifa/servlet/PdfDownloadServlet?pdfFileName=footer_000299_044358_FI.pdf&retry=0&sys=m0b1l3.
Translated from the Italian data sheet.