Taste-masking oral dosage form and method of preparing the same

1 . A taste-masked microparticle comprising:

active pharmaceutical ingredient (API) crystal masked by a hydrophilic polymer to form a taste-masked API crystal; and

a starch

wherein said taste-masked API and said starch are packaged together to form said taste-masked microparticle.

2 . The taste-masked microparticle according to claim 1 , wherein said taste-masked API crystal is morphologically different from said API crystal.

3 . The taste-masked microparticle according to claim 1 , wherein said microparticle comprises ≧95% by weight of said taste-masked API crystal.

4 . The taste-masked microparticle according to claim 1 , wherein the hydrophilic polymer is at least one selected from group consisting of PEG, PVP, carbopol, polysaccharide, agar, MC, and HPMC.

5 . The taste-masked microparticle according to claim 1 , wherein the hydrophilic polymer is polyethylene glycol.

6 . The taste-masked microparticle according to claim 5 , wherein the polyethylene glycol is PEG 6000.

7 . The taste-masked microparticle according to claim 1 , wherein the API is an orally administrated drug.

8 . The taste-masked microparticle according to claim 8 , wherein the API has bitter taste and wherein the taste-masked API crystal does not have bitter taste.

9 . The taste-masked microparticle according to claim 1 , wherein the API is acetaminophen and wherein the hydrophilic polymer is PEG 6000.

10 . The taste-masked microparticle according to claim 9 , wherein the taste-masked API crystal is polyhedron in shape.

11 . The taste-masked microparticle according to claim 1 , wherein the starch is at least one selected from the group consisting of amylodextrin, hydroxyethyl starch, hydropropyl starch, carboxymethyl starch, acetylated starch, and phosphorylated starch.

12 . The taste-masked microparticle according to claim 1 , wherein the taste-masked microparticle has a diameter in the range between about 150 μm and about 350 μm.

13 . A taste-masking oral dosage form comprising said taste-masked microparticle according to claim 1 and an excipient.

14 . The taste-masking oral dosage form according to claim 13 , wherein said taste-masking oral dosage form is a tablet.

15 . The taste-masking oral dosage form according to claim 1 , wherein said taste-masking oral dosage form further comprises a surfactant.

16 . The taste-masking oral dosage form according to claim 15 , wherein the surfactant is an edible surfactant.

17 . The taste-masking oral dosage form according to claim 15 , wherein the surfactant is a lecithin.

18 . The taste-masking oral dosage form as claimed in claim 15 , wherein the surfactant comprises lecithin.

19 . The taste-masking oral dosage form according to claim 13 , wherein the excipient is at least one selected from the group consisting of disintegrating agents, effervescent, lubricants, sweeteners, saccharide, alcohol, and sugar alcohol.

20 . The taste-masking oral dosage form according to claim 19 , wherein said saccharide is monosaccharide or disaccharide.

21 . The taste-masking oral dosage form according to claim 19 , wherein the sugar alcohol is at least one selected from the group consisting of mannitol, sorbitol, xylitol, and glycerol.

27 . The taste-masking oral dosage form as claimed in claim 14 , wherein the porosity of the tablet is about 30˜70%.

28 . The taste-masking oral dosage form as claimed in claim 13 , wherein the brittleness of the tablet is less than 2%.

29 . A taste-masked active pharmaceutical ingredient (API), comprising an API with a bitter taste and a hydrophilic polymer, wherein the hydrophilic polymer masks the bitter taste of the API.

30 . The taste-masked API of claim 29 , wherein the API and the hydrophilic polymer form a crystalline structure.

31 . The taste-masked API of claim 29 , wherein the API is acetaminophen and wherein the hydrophilic polymer is PEG 6000.