SINGLE LAYER CHEWABLE TABLET COMPRISING CETIRIZINE

1 . A single layer chewable tablet comprising cetirizine, an optical isomer, or a pharmaceutically active salt thereof and at least one polyol.

2 . The single layer chewable tablet of claim 1 , wherein the at least one polyol is a sugar alcohol.

3 . The single layer chewable tablet of claim 1 , wherein the at least one polyol has a molecular weight of less than 1000.

4 . The single layer chewable tablet of claim 1 , wherein the sugar alcohol is selected from a group consisting of mannitol, xylitol, sorbitol, erythritol, lactitol, maltitol, isomalt or a mixture thereof.

5 . The single layer chewable tablet of claim 1 , wherein the at least one polyol is mannitol.

6 . The single layer chewable tablet of claim 1 , further comprising starch.

7 . The single layer chewable tablet of claim 6 , wherein the at least one polyol and starch are preformed into a mixture.

8 . The single layer chewable tablet of claim 7 , wherein the at least one polyol is about 70%-90% by weight and the starch is about 10%-30% by weight, relative to the total weight of the mixture.

9 . The single layer chewable tablet of claim 1 , further comprising a cyclodextrin.

10 . The single layer chewable tablet of claim 9 , wherein the cyclodextrin is selected from a group consisting of α-cyclodextrin, β-cyclodextrin, and γ-cyclodextrin.

11 . The single layer chewable tablet of claim 10 , wherein the cyclodextrin is β-cyclodextrin.

12 . The single layer chewable tablet of claim 10 , wherein the cyclodextrin is about 5%-30%, 10%-25%, or 12%-20% by weight, relative to the total weight of the chewable tablet.

13 . The single layer chewable tablet of claim 1 , wherein the chewable tablet remains stable up to 6 months under accelerated conditions of 40° C. and 75% relative humidity (RH), up to 12 months under conditions of 30° C. and 65% relative humidity (RH), and/or up to 12 months under conditions of 25° C. and 60% relative humidity (RH).

14 . The single layer chewable tablet of claim 1 , wherein the chewable tablet remains stable up to 24 months under conditions of 30° C. and 65% relative humidity (RH).

15 . The single layer chewable tablet of claim 1 , wherein the chewable tablet remains stable up to 36 months under conditions of 25° C. and 60% relative humidity (RH).

16 . The single layer chewable tablet of claim 1 , wherein the chewable tablet has a hardness of about 2-12, 3-11, or 4-10 kp.

17 . The single layer chewable tablet of claim 1 , wherein cetirizine is about 0.5%-20%, 0.5%-15%, 1%-10%, 1%-8%, 1%-6%, 1%-5%, by weight, relative to the total weight of the chewable tablet.

18 . The single layer chewable tablet of claim 9 , wherein the weight ratio of cetirizine and the cyclodextrin in the chewable tablet is about 1:1 to 1:10, 1:2 to 1:9, or 1:2.5 to 1:8.5.

19 . The single layer chewable tablet of claim 1 , further comprising additional pharmaceutically acceptable excipients.

20 . The single layer chewable tablet of claim 19 , wherein the additional pharmaceutically acceptable excipients comprise fillers, adsorbents, binders, disintegrants, lubricants, glidants, sweeteners, superdisintegrants, flavor and aroma agents, antioxidants, texture enhancers, or mixtures thereof.

21 . The single layer chewable tablet of claim 20 , wherein the fillers comprise monosaccharides, disaccharides, or mixtures thereof.

22 . The single layer chewable tablet of claim 21 , wherein the disaccharides are lactose monohydrates.

23 . The single layer chewable tablet of claim 22 , wherein the lactose monohydrates are about 5%-25% or 10-20% by weight, relative to the total weight of the chewable tablet.

24 . The single layer chewable tablet of claim 1 , further comprising a second active ingredient.

25 . The single layer chewable tablet of claim 24 , wherein the second active ingredient is selected from the group consisting of phenylephrine, loratadine, fexofenadine, diphenhydramine, dextromethorphan, chlorpheniramine, chlophedianol, guaifenesin and pseudoephedrine.

26 . The single layer chewable tablet of claim 1 , wherein the chewable tablet is substantially free from coloring agents.

27 . The single layer chewable tablet of claim 26 , wherein the coloring agents comprise azo dyes, quinopthalone dyes, triphenylmethane dyes, xanthene dyes, indigoid dyes, iron oxides, iron hydroxides, titanium dioxide, natural dyes, or mixtures thereof.

28 . The single layer chewable tablet of claim 1 , further comprising sucralose.

29 . The single layer chewable tablet of claim 28 , wherein the sucralose is about 0.1%-5%, 0.1%-2%, 0.2%-2%, 0.2%-1.5%, 0.2%-1%, 0.3%-0.9%, 0.3%-0.8%, or 0.35%-0.7% by weight, relative to the total weight of the chewable tablet.

30 . A method for alleviating a sign or symptom of allergy by orally administering a single layer chewable tablet comprising cetirizine and or a pharmaceutically active salt thereof and at least one polyol.

31 . The method of claim 30 , wherein the at least one polyol is a sugar alcohol.

32 . The method of claim 30 , wherein the at least one polyol has a molecular weight of less than 1000.

33 . The method of claim 30 , wherein the sugar alcohol is selected from a group consisting of mannitol, xylitol, sorbitol, erythritol, lactitol, maltitol, isomalt or a mixture thereof.

34 . The method of claim 30 , wherein the at least one polyol is mannitol.

35 . The method of claim 30 , wherein the chewable tablet further comprises starch.

36 . The method of claim 35 , wherein the at least one polyol and starch are preformed into a mixture.

37 . The method of claim 36 , wherein the at least one polyol is about 70%-90% by weight and the starch is about 10%-30% by weight, relative to the total weight of the mixture.

38 . The method of claim 30 , wherein the chewable tablet further comprises a cyclodextrin.

39 . The method of claim 38 , wherein the cyclodextrin is selected from a group consisting of α-cyclodextrin, β-cyclodextrin, and γ-cyclodextrin.

40 . The method of claim 39 , wherein the cyclodextrin is β-cyclodextrin.

41 . The method of claim 38 , wherein the cyclodextrin is about 5%-30%, 10%-25%, or 12%-20% by weight, relative to the total weight of the chewable tablet.

42 . The method of claim 30 , wherein the chewable tablet remains stable up to 6 months under accelerated conditions of 40° C. and 75% relative humidity (RH), up to 12 months under conditions of 30° C. and 65% relative humidity (RH), and/or up to 12 months under conditions of 25° C. and 60% relative humidity (RH).

43 . The method of claim 30 , wherein the chewable tablet remains stable up to 24 months under conditions of 30° C. and 65% relative humidity (RH).

44 . The method of claim 30 , wherein the chewable tablet remains stable up to 36 months under conditions of 25° C. and 60% relative humidity (RH).

45 . The method of claim 30 , wherein the chewable tablet has a hardness of about 2-12, 3-11, or 4-10 kp.

46 . The method of claim 30 , wherein cetirizine is about 0.5%-20%, 0.5%-15%, 1%-10%, 1%-8%, 1%-6%, 1%-5%, by weight, relative to the total weight of the chewable tablet.

47 . The method of claim 38 , wherein the weight ratio of cetirizine and the cyclodextrin in the chewable tablet is about 1:1 to 1:10, 1:2 to 1:9, or 1:2.5 to 1:8.5.

48 . The method of claim 30 , further comprising additional pharmaceutically acceptable excipients.

49 . The method of claim 48 , wherein the additional pharmaceutically acceptable excipients comprise fillers, adsorbents, binders, disintegrants, lubricants, glidants, sweeteners, superdisintegrants, flavor and aroma agents, antioxidants, texture enhancers, or mixtures thereof.

50 . The method of claim 49 , wherein the fillers comprise monosaccharides, disaccharides, or mixtures thereof.

51 . The method of claim 50 , wherein the disaccharides are lactose monohydrates.

52 . The method of claim 51 , wherein the lactose monohydrates are about 5%-25% or 10%-20% by weight, relative to the total weight of the chewable tablet.

53 . The method of claim 30 , wherein the chewable tablet further comprises a second active ingredient.

54 . The method of claim 53 , wherein the second active ingredient is selected from the group consisting of phenylephrine, loratadine, fexofenadine, diphenhydramine, dextromethorphan, chlorpheniramine, chlophedianol, guaifenesin and pseudoephedrine.

55 . The method of claim 30 wherein the chewable tablet is substantially free from coloring agents.

56 . The method of claim 55 , wherein the coloring agents comprise azo dyes, quinopthalone dyes, triphenylmethane dyes, xanthene dyes, indigoid dyes, iron oxides, iron hydroxides, titanium dioxide, natural dyes, or mixtures thereof.

57 . The method of claim 30 , wherein the chewable tablet comprises sucralose.

58 . The method of claim 57 , wherein the sucralose is about 0.1%-5%, 0.1%-2%, 0.2%-2%, 0.2%-1.5%, 0.2%-1%, 0.3%-0.9%, 0.3%-0.8%, or 0.35%-0.7% by weight, relative to the total weight of the chewable tablet.