Formulations of ibuprofen

Claim 2

A pharmaceutical granulate composition which comprises, by weight thereof, 85 to 99% by weight ibuprofen and 1 to 15% by weight croscarmellose sodium.

Claim 3

A composition according to claim 1, which additionally comprises, by weight thereof, 0.4 to 1 % by weight colloidal silicon dioxide.

Claim 4

A composition according to claim 1 or claim 2, in the form of compressed tablets or filled capsules, each tablet or capsule containing from 100 to 1200 mg ibuprofen.

Claim 5

A composition according to claim 3, in which each tablet or capsule additionally comprises extragranular ingredients selected from up to 25 mg croscarmellose sodium, type A, up to 225 mg microcrystalline cellulose, and up to 25 mg talc.

Claim 6

A process for preparing a composition according to claim 1, which comprises: (1) dry mixing ibuprofen and croscarmellose sodium to an essentially uniform consistency; (2) roller-compacting or slugging the essentially uniform mixture; and (3) sizing the compacted or slugged mixture.

Claim 7

A process for making compressed tablets, which comprises (all parts by weight): (1) forming a dry granulate comprising 720 to 880 parts ibuprofen, 54 to 67 parts croscarmellose sodium, type A, 7 to 9 parts colloidal silicon dioxide and 0.5 to 1.5 parts magnesium stearate; (2) mixing the dry granulate, to an essentially uniform consistency, with 13 to 17 parts croscarmellose sodium, type A, 170 to 210 parts microcrystalline cellulose, 13 to 17 parts colloidal silicon dioxide and 8 to 12 parts talc; and (3) tabletting the essentially uniform mixture.

Claim 8

A process for making compressed tablets, which comprises (all parts by weight): (1) forming a dry granulate comprising 720 to 880 parts ibuprofen, 54 to 67 parts croscarmellose sodium, type A, 7 to 9 parts colloidal silicon dioxide and 0.5 to 1.5 parts magnesium stearate; (2) mixing the dry granulate, to an essentially uniform consistency, with 13 to 17 parts croscarmellose sodium, type A, 170 to 210 parts microcrystalline cellulose, 13 to 17 parts colloidal silicon dioxide and 8 to 12 parts talc; and (3) tabletting the essentially uniform mixture.

Claim 9

A process for making compressed tablets, which comprises (all parts by weight): (1) forming a dry granulate comprising 900 to 1100 parts ibuprofen, 68 to 84 parts croscarmellose sodium, type A, 9 to 11 parts colloidal silicon dioxide and 0.75 to 1.75 parts magnesium stearate; (2) mixing the dry granulate, to an essentially uniform consistency, with 13 to 17 parts croscarmellose sodium, type A, 3 to 7 parts colloidal silicon dioxide and 10 to 15 parts by talc; and (3) tabletting the essentially uniform mixture.

Claim 10

A process for making compressed tablets, which comprises (all parts by weight): (1) forming a dry granulate comprising 900 to 1100 parts ibuprofen, 68 to 84 parts croscarmellose sodium, type A, 9 to 11 parts colloidal silicon dioxide and 0.75 to 1.75 parts magnesium stearate; (2) mixing the dry granulate, to an essentially uniform consistency, with 13 to 17 parts croscarmellose sodium, type A, 3 to 7 parts colloidal silicon dioxide and 10 to 15 parts by talc; and (3) tabletting the essentially uniform mixture.

Claim 11

A process for making compressed gelatin capsules, which comprises (all parts by weight): (1) forming a dry granulate comprising 190 to 210 parts ibuprofen, 13.5 to 16.5 parts croscarmellose sodium, type A, 1.5 to 2.5 parts colloidal silicon dioxide and 0.23 to 0.3 parts magnesium stearate; (2) mixing the dry granulate, to an essentially uniform consistency, with 5 to 7 parts magnesium stearate, 6 to 8 parts mineral oil, 100 to 110 parts microcrystalline cellulose and 60 to 80 parts pregelatinised starch; and (3) encapsulating the essentially uniform mixture.

Claim 12

A process for making compressed gelatin capsules, which comprises (all parts by weight): (1) forming a dry granulate comprising 190 to 210 parts ibuprofen, 13.5 to 16.5 parts croscarmellose sodium, type A, 1.5 to 2.5 parts colloidal silicon dioxide and 0.23 to 0.3 parts magnesium stearate; (2) mixing the dry granulate, to an essentially uniform consistency, with 5 to 7 parts magnesium stearate, 6 to 8 parts mineral oil, 100 to 110 parts microcrystalline cellulose and 60 to 80 parts pregelatinised starch; and (3) encapsulating the essentially uniform mixture.

Claim 13

A process according to claim 6 or claim 7, in which each tablet contains from 720 to 880 mg ibuprofen or from 900 to 1100 mg ibuprofen, respectively.

Claim 14

A process according to claim 8, in which each capsule contains from 190 to 210 mg ibuprofen.