Buccal formulation of avanafil with enhanced bioavailability and prolonged duration
AssigneeKing Abdulaziz University
InventorsOmar D. Al-hejaili, Khalid M. El-Say, Tarek A. Ahmed, Hossam S. El-Sawy, Fathy I. Abd-Allah
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Abstract
A buccal tablet formulation has a polyvinylpyrrolidone K-90 as a solid dispersion polymer, a hydroxypropyl methylcellulose as a mucoadhesive polymer, a sodium deoxycholate as mucopenetration enhancer, a porous silicon dioxide (e.g., FujiSil), mannitol, and avanafil. The ratio of PVP K-90 to AVA is approximately 2:1 (e.g., 2.3:1 to 1.7:1) in the tablet. Methods of making the buccal tablet with enhanced bioavailability and prolonged duration and methods of using the formulation for the treatment of erectile dysfunction are also provided.
Claims2
A method of preparing a buccal tablet formulation, comprising
- mixing a specified amount of solid dispersion of avanafil and PVP K-90, a specified amount of hydroxypropyl methylcellulose, a predetermined amount of sodium deoxycholate, porous silicon dioxide, and mannitol and then passing through mesh sieves to form a powder blend;
- de-lumping a talc powder and magnesium stearate through a sieve and adding retrieved talc powder to the powder blend;
- mixing the talc powder mixture and the powder blend to form a dry mixture;
- and
- compressing the dry mixture to form a buccal tablet,
- wherein the buccal tablet formulation comprises
- 100 mg of polyvinylpyrrolidone K-90 (PVP K-90);
- 36 mg of hydroxypropyl methylcellulose functioning in the buccal tablet formulation as a mucoadhesive polymer;
- a sodium deoxycholate functioning in the buccal tablet formulation as a mucopenetration enhancer;
- 10 mg of porous silicon dioxide;
- 4 mg of mannitol;
- and
- 50 mg of avanafil,
- wherein the PVP K-90 to avanafil ratio ranges from 2.3:1 to 1.7:1.
Dependencies are inferred from the claim text.