Flashmelt oral dosage formulation
DCFirst Claim
1. A flash-melt pharmaceutical dosage form comprising a medicament, a superdisintegrant, a dispersing agent and a binder,wherein said medicament is aripiprazole, wherein said dispersing agent is calcium silicate,wherein said superdisintegrant is selected from the group of crospovidone and croscarmellose sodium, andwherein the flash-melt pharmaceutical dosage form dissolves or disintegrates in the mouth of a patient in less than one minute.
1 Assignment
Litigations
0 Petitions
Accused Products
Abstract
There is provided granules for the production of flash-melt pharmaceutical oral dosage forms. In addition to one or more medicaments, the granules are composed of an excipient combination consisting of a superdisintegrant, a dispersing agent, a distributing agent, and a binder and may also include other conventional ingredients such as sweetening and flavoring agents. The subject granules are advantageous in that they are stable and can be prepared without the aid of solvents and without the need for special environments or handling. Dosage forms, especially tablets, prepared therefrom on conventional equipment disintegrate in the mouth in under about twenty five seconds.
4 Citations
20 Claims
-
1. A flash-melt pharmaceutical dosage form comprising a medicament, a superdisintegrant, a dispersing agent and a binder,
wherein said medicament is aripiprazole, wherein said dispersing agent is calcium silicate, wherein said superdisintegrant is selected from the group of crospovidone and croscarmellose sodium, and wherein the flash-melt pharmaceutical dosage form dissolves or disintegrates in the mouth of a patient in less than one minute.
-
16. A flash-melt pharmaceutical dosage form comprising a medicament, a superdisintegrant, a dispersing agent, a distributing agent and a binder,
wherein said medicament is aripiprazole which is present in an amount of not more than about 30 percent by weight based on the total weight of said dosage form, said dispersing agent is calcium silicate having a surface area of 1.0 m2/gm to 210 m2/gm, bulk density of 0.075 g/cc to 0.90 g/cc, true density of 1.70 g/cc to 2.90 g/cc and volatile content of less than 1 percent to 14 percent w/w and which is present in an amount ranging from about 35 to about 45 percent by weight based on the total weight of said dosage form, said superdisintegrant is crospovidone and croscarmellose sodium, said crospovidone is present in an amount ranging from about 6 to about 8 percent by weight based on the total weight of said dosage form and said croscarmellose sodium is present in an amount ranging from about 2 to about 4 percent by weight based on the total weight of said dosage form, wherein said distributing agent is amorphous silica, fumed silica, diatomaceous earth, talc, kaolin or magnesium aluminum trisilicate which is present in an amount ranging from about 1 to about 10 percent by weight based on the total weight of said dosage form, and wherein the flash-melt pharmaceutical dosage form dissolves or disintegrates in the mouth of a patient in less than one minute.
-
17. A flash melt pharmaceutical dosage form comprising a medicament, a superdisintegrant, a dispersing agent, a distributing agent and a binder,
wherein said medicament is aripiprazole which is present in an amountof not more than about 30 percent by weight based on the total weight of said dosage form, said dispersing agent is calcium silicate having a surface area of 1.0 m2/gm to 210 m2/gm, bulk density of 0.075 g/cc to 0.90 g/cc, true density of 1.70 g/cc to 2.90 g/cc and volatile content of less than 1 percent to 14 percent w/w and which is present in an amount ranging from about 35 to about 45 percent by weight based on the total weight of said dosage form, said superdisintegrant is crospovidone and croscarmellose sodium, wherein said crospovidone is present in an amount ranging from about 7 percent by weight based on the total weight of said dosage form and wherein said croscarmellose is present in an amount ranging from about 3 percent by weight based on the total weight of said dosage form, wherein said distributing agent is amorphous silica, fumed silica, diatomaceous earth, talc, kaolin or magnesium aluminum trisilicate and is present in an amount ranging from about 10 to about 50 percent by weight basded on the total weight of said dosage form, and wherein the flash-melt pharmaceutical dosage form dissolves or disintegrates in the mouth of a patient in less than one minute.
-
18. A flash-melt pharmaceutical dosage form comprising a medicament, a superdisintegrant, a dispersing agent, a distributing agent and a binder,
wherein said medicament is aripiprazole which is present in an amount of not more than about 20 percent by weight based on the total weight of said dosage form, said dispersing agent is calcium silicate having a surface area of 1.0 m2/gm to 210 m2/gm, bulk density of 0.075 g/cc to 0.90 g/cc, true density of 1.70 g/cc to 2.90 g/cc and volatile content of less than 1 percent to 14 percent w/w and which is present in an amount ranging from about 35 to about 45 percent by weight based on the total weight of said dosage form, said superdisintegrant is crospovidone and croscarmellose sodium, wherein said crospovidone is present in an amount ranging from about 7 percent by weight based on the total weight of said dosage form and wherein said croscarmellose is present in an amount ranging from about 3 percent by weight based on the total weight of said dosage form, wherein said distributing agent is amorphous silica, fumed silica, diatomaceous earth, talc, kaolin or magnesium aluminum trisilicate and is present in an amount ranging from about 10 to about 50 percent by weight based on the total weight of said dosage form, and wherein the flash-melt pharmaceutical dosage form dissolves or disintegrates in the mouth of a patient in less than one minute.
-
19. A flash-melt pharmaceutical dosage form comprising a medicament, a superdisintegrant, a dispersing agent, a distributing agent and a binder,
wherein said medicament is aripiprazole which is present in an amount of not more than about 10 percent by weight based on the total weight of said dosage form, said dispersing agent is calcium silicate having a surface area of 1.0 m2/gm to 210 m2/gm, bulk density of 0.075 g/cc to 0.90 g/cc, true density of 1.70 g/cc to 2.90 g/cc and volatile content of less than 1 percent to 14 percent w/w and which is present in an amount ranging from about 35 to about 45 percent by weight based on the total weight of said dosage form, said superdisintegrant is crospovidone and croscarmellose sodium, wherein said crospovidone is present in an amount ranging from about 7 percent by weight based on the total weight of said dosage form and wherein said croscarmellose sodium is present in an amount ranging from about 3 percent by weight based on the total weight of said dosage form, and wherein the flash-melt pharmaceutical dosage form dissolves or disintegrates in the mouth of a patient in less than one minute.
-
20. A flash-melt pharmaceutical dosage form comprising a medicament, a superdisintegrant, a dispersing agent, a distributing agent and a binder,
wherein said medicament is aripiprazole which is present in an amount of not more than about 5 percent by weight based on the total weight of said dosage form, said dispersing agent is calcium silicate having a surface area of 1.0 m2/gm to 210 m2/gm, bulk density of 0.075 g/cc to 0.90 g/cc, true density of 1.70 g/cc to 2.90 g/cc and volatile content of less than 1 percent to 14 percent w/w and is present in an amount ranging from about 35 to about 45 percent by weight based on the total weight of said dosage form, said superdisintegrant is crospovidone and croscarmellose sodium, wherein said crospovidone is present in an amount ranging from about 7 percent by weight based on the total weight of said dosage form and wherein said croscarmellose is present in an amount ranging from about 3 percent by weight based on the total weight of said dosage form, and wherein the flash-melt pharmaceutical dosage form dissolves or disintegrates in the mouth of a patient in less than one minute.
Specification