Thesis On Orodispersible Films

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The onset of action after oral administration of the available PDE5 inhibitors may be within 30 min; however, most men require at least 60 min delay after taking the medication (up to 2 h with tadalafil, while avanafil and vardenafil have the shortest onsets of action).

Avanafil reaches peak plasma concentration (C for sildenafil and vardenafil is ~4 h.

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Drugs that have potency at low doses are most suitable for orodispersible film administration, as technical considerations limit the incorporation of the drug; generally, between 1% and 30% w/w of the active pharmaceutical ingredient can be introduced in film formulation.

Taste is an important factor in the development of oral pharmaceutical products to ensure patient acceptability and compliance and is one of the prime factors determining market penetration and commercial success of oral formulations.The PDE5 inhibitors sildenafil, tadalafil, vardenafil, and avanafil are currently approved for use for erectile dysfunction.Each PDE5 inhibitor has an individual pharmacokinetic and side effects profile, although no significant differences in efficacy among therapies are evident.Orodispersible films have advantages over orally disintegrating tablet formulations, which may require more complicated and expensive manufacturing processes, have issues of hardness and friability during manufacturing, storage, handling and administration, and may present a risk of choking.Orodispersible films are thin and flexible, can be manufactured in a range of sizes and shapes, and are easily transported and stored.Rapid dissolution, absorption, and onset of drug action are useful in motion sickness and sudden episodes of allergic attack of coughing, bronchitis, and asthma.Some drugs are absorbed from the mouth, pharynx, and esophagus: pre-gastric absorption can improve bioavailability with consequent reduction of dosage and unwanted effects.Adverse events occurred at similar rates for the two formulations and were of mild-to-moderate severity.The results suggest that the new orodispersible film formulation can be used interchangeably with the conventional film-coated formulation.The mean sildenafil and N-desmethyl-sildenafil plasma concentration–time profiles up to 24 h after single-dose administration of sildenafil 100 mg orodispersible film and film-coated tablet were nearly superimposable.The bioequivalence test was fully satisfied for sildenafil and N-desmethyl-sildenafil in terms of rate and extent of bioavailability.

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