Parteck m200

Example 6

Mannitol (Parteck® M200, Merck) and colloidal silicon dioxide were mixed with lecithin, PEG stearate and polyvinylpyrrolidone. After the addition of crystalline insulin and a sweetener, the mixture was screened and then round 8 mm tablets (approximate weight 213 mg) were compressed to form tablets of hardness 7-10 kP hardness that dissolved in the mouth in 15-20 minutes.

Example 2

60.90 g of mannitol (Parteck M200, Merck) and 3.60 g croscarmellose sodium were added to 53.70 g of maleate of Compound A and the mixture was mixed for 10 minutes. 1.80 g of magnesium stearate was added to the mixed powder and the mixture was mixed for 30 minutes. The mixed powder was tableted at a tableting pressure of about 10 kN using a pestle having a double rounded surface with a tablet diameter of 8.5 mm to obtain round uncoated tablets each weighing 250 mg. The uncoated tablets were coated with 8 mg of a coating agent (Opadry 03F44057, 00F440000 (hypromellose 2910: 71.5%, Macrogol 6000: 14.166%, talc: 7.167%, titanium oxide: 7.067%, iron sesquioxide: 0.1%), Colorcon Japan LLC) per tablet, and then a small amount of carnauba wax was added thereto to give film-coated tablets.

Example 2

60.90 g of mannitol (Parteck M200, Merck) and 3.60 g croscarmellose sodium were added to 53.70 g of maleate of Compound A and the mixture was mixed for 10 minutes. L80 g of magnesium stearate was added to the mixed powder and the mixture was mixed for 30 minutes. The mixed powder was tableted at a tableting pressure of about 10 kN using a pestle having a double rounded surface with a tablet diameter of 8.5 mm to obtain round uncoated tablets each weighing 250 mg. The uncoated tablets were coated with 8 mg of a coating agent (Opadry 03F44057, 00F440000 (hypromellose 2910: 71.5%, Macrogol 6000: 14.166%, talc: 7.167%, titanium oxide: 7.067%©, iron sesquioxide: 0.1%), Colorcon Japan LLC) per tablet, and then a small amount of carnauba wax was added thereto to give film-coated tablets.

Example 5

Formulation with Carbopol 974P NF (Lubrizol Corp.) was prepared similarly, but without addition of an amino acid. Mannitol (Parteck® M200, Merck), microcrystalline cellulose (Vivapur® 102), Carbopol 974P NF (Lubrizol Corp.), lecithin, polyvinylpyrrolidone and colloidal silicon dioxide were combined. After the addition of crystalline insulin and a sweetener, the blend was mixed, screened and then round 8 mm tablets (approximate weight 257 mg) were compressed to form tablets with 5-9 kP hardness. The formed tablets dissolved in the mouth in 20-35 minutes.