Formulation and In-Vitro Evaluation of Tadalafil Oral Disintegrating Strips for Enhanced Bioavailability
Abstract
Background: Erectile dysfunction (ED) is a
prevalent disorder affecting men worldwide, often
managed with oral phosphodiesterase type-5
(PDE5) inhibitors such as tadalafil. However, its
limited oral bioavailability (~28%) necessitates the
exploration of novel dosage forms. Oral
disintegrating strips (ODS) provide a promising
alternative due to rapid disintegration, improved
patient compliance, and avoidance of first-pass
metabolism.
Aim: To formulate and evaluate tadalafil oral
disintegrating strips (ODS) using solvent casting
method for enhanced dissolution and
bioavailability.
Methods: Six formulations (F1–F6) were prepared
using hydroxypropyl methylcellulose (HPMC K15) as film-forming agent, glycerol as plasticizer,
Tween 80 and sodium lauryl sulphate (SLS) as
surfactants, citric acid as saliva stimulator, and
sucrose with vanillin as sweetening/flavoring
agents. The strips were evaluated for thickness,
folding endurance, weight variation, drug content,
disintegration time, in-vitro dissolution, and
stability as per ICH guidelines. Drug–excipient
compatibility was assessed via FT-IR.
Results: Among all formulations, F4 demonstrated
superior performance with 92.83% drug content,
disintegration time <30 seconds, and 94.2%
cumulative drug release within 30 minutes. FT-IR
spectra confirmed no significant drug–excipient
interactions. Stability studies at 40±2°C/75% RH
for 2 months showed no major changes in
physicochemical parameters.
Conclusion: Tadalafil ODS prepared by…
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