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Last Updated: November 28, 2020

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Claims for Patent: 10,004,743

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Summary for Patent: 10,004,743
Title:Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Abstract: The present invention relates to a drying process of BIBW 2992 or the salts thereof, preferably the dimaleate salt, as well as of solid pharmaceutical formulations comprising BIBW2992 or a salt thereof, and to pharmaceutical compositions comprising BIBW 2992 or a salt thereof as the active product ingredient, characterized by a water activity of the formulation of not more than 0.20 or a water content (Karl-Fischer) of not more than 4.2%.
Inventor(s): Barta; Albert (Warthausen, DE)
Assignee: Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:15/371,252
Patent Claims: 1. A pharmaceutical composition comprising BIBW 2992 or a salt thereof as the active product ingredient (API) and at least one further excipient, characterized by a water activity of the formulation of not more than 0.17.

2. A pharmaceutical composition comprising BIBW 2992 or a salt thereof as the active product ingredient (API) and at least one further excipient, characterized by a water content of not more than 4.0% as measured by Karl Fischer titration method.

3. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is an uncoated or film-coated tablet.

4. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is selected from uncoated and film-coated tablets comprising BIBW 2992 dimaleate salt as the active product ingredient (API) and each of the tablets is a composition selected from the group consisting of compositions A, B, C, D and E: TABLE-US-00007 Formulation A B C D E % per mg per mg per mg per mg per mg per Ingredient tablet tablet tablet tablet tablet tablet BIBW 2992 MA.sub.2, 16.42 29.5600 44.3400 59.1200 73.9000 103.4600 un-milled (20.0000) (30.0000) (40.0000) (50.0000) (70.0000) (corresponding to free base BIBW 2992) Lactose monohydrate 68.81 123.8600 185.7900 247.7200 309.6500 433.5100 Microcrystalline 10.27 18.4800 27.7200 36.9600 46.2000 64.6800 cellulose Crospovidone 2.00 3.6000 5.4000 7.2000 9.0000 12.6000 Colloidal anhydrous 0.50 0.9000 1.3500 1.8000 2.2500 3.1500 silica Magnesium stearate 2.00 3.6000 5.4000 7.2000 9.0000 12.6000 Total 100.00 180.0000 270.0000 360.0000 450.0000 630.0000

and wherein said film coat, if present, is selected from the group consisting of formulations A, B, C, D and E: TABLE-US-00008 Coating for Formulation A B C D E Ingredient mg per tablet Hypromellose 2.5000 3.5000 4.0000 5.0000 6.0000 Polyethylene 0.5000 0.7000 0.8000 1.0000 1.2000 glycol 400 Titanium dioxide 1.1300 0.6825 1.8080 0.9750 1.1700 Indigo Carmine 0.0700 0.2450 0.1120 0.3500 0.4200 aluminum lake Talcum 0.6500 1.6625 1.0400 2.3750 2.8500 Polysorbate 80 0.1500 0.2100 0.2400 0.3000 0.3600 Purified water -- -- -- -- -- (volatile component) Total 5.0000 7.0000 8.0000 10.0000 12.0000.

5. The pharmaceutical composition according to claim 4, wherein each of the tablets is a composition selected from the group consisting of compositions A, B, C and D.

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