Orally disintegrating tablet formulations of mirtazapine and process for preparing the same
AssigneeSanovel Ilac Sanayi Ve Ticaret Anonim Sirketi
InventorsUmit Cifter, Ali Turkyilmaz, Hasan Ali Turp, Gulay Yelken
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Abstract
Silicon dioxide free orally disintegrating tablet formulations of mirtazapine or a pharmaceutically acceptable salt thereof having crospovidone and sodium stearyl fumarate and one or more pharmaceutically acceptable excipients and a process for preparing such a formulation.
Claims20
A silicon dioxide free orally disintegrating tablet formulation of mirtazapine or a pharmaceutically acceptable salt thereof comprising crospovidone and sodium stearyl fumarate in a weight ratio of between 1:25 to 25:1 (w/w) and one or more pharmaceutically acceptable excipient.
An orally disintegrating tablet formulation of mirtazapine or a pharmaceutically acceptable salt thereof, said formulation comprising:
- a) 0.10 to 10.0% by weight of mirtazapine hemihydrates;
- b) 5.0 to 85.0% by weight of mannitol;
- c) 1.0 to 30.0% by weight of crospovidone;
- d) 5.0 to 85.0% by weight of microcrystalline cellulose;
- e) 0.01 to 3.00% by weight of sucralose;
- f) 0.01 to 5.0% by weight of orange flavor;
- g) 0.1 to 10.0% by weight of sodium stearyl fumarate;
- h) 0.01 to 2.00% by weight of butylated hydroxyanisole (BHA);
- and
- i) 0.01 to 2.00% by weight of butylated hydroxytoluene (BHT).
A process for preparing an orally disintegrating tablet formulation of mirtazapine or a pharmaceutically acceptable salt thereof, said process comprising the steps of:
- a) dissolving butylated hydroxyanisole and butylated hydroxytoluene in an alcohol to form a solution;
- b) sieving mirtazapine and two-thirds (⅔) of mannitol and mixing them;
- c) granulating the mixture with the solution;
- d) sieving and drying the wet granules and milling the dried granules;
- e) adding the rest of the mannitol, crospovidone, microcrystalline cellulose, sucralose, flavor and mixing them;
- f) adding sodium stearyl fumarate to this mixture and blending them until obtaining a homogenous powder mixture;
- and
- g) compressing the blended mixture to form tablets.
Dependencies are inferred from the claim text.