The present study aims at the formulation and evaluation of orodispersible tablets (ODTs) containing tadalafil self emulsifying system (SEDDS) loaded on Neusilin® US2 carrier. The study included the investigation of different binders and disintegrants to promote the formation of a tablet with fast disintegration and suitable hardness. The ODT tablet of choice was compared to hard gelatin capsule and market product. Direct compression method was adopted. Seven different binders were evaluated to determine the one obtaining the highest hardness. Afterwards, four different disintegrants were investigated at 5% addition. The tadalafil SEDDS was loaded on Neusilin® US2 at a ratio of (3:1) SEDDS liquid to carrier. The solidified SEDDS was then mixed geometrically with different binders. The binder of choice was further tested with 5% different disintegrants. ODTs were evaluated for thickness and weight variation, hardness, friability, disintegration and wetting test and in vitro drug release studies. The optimized ODT in-vitro release was compared to hard gelatin capsule containing solidified SEDDS and market tablet. The best ODT was prepared using microcrystalline cellulose (MCC) type 102 as a binder and croscarmellose sodium (Ac-Di-Sol) as a superdisintegrant. The disintegration time, thickness and weight variation of the tablet met the compendial limits. Hardness, friability and wetting time were acceptable. The in-vitro release of the ODT of choice was significantly faster than the capsule and the market tablet. MCC type 102 and Ac-Di-Sol were suitable excipients for the formulation of ODT containing solidified tadalafil SEDDS.
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