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US 2025/0367186 A1Published application
C-Met Modulator Pharmaceutical Compositions
AssigneeExelixis, Inc.
InventorsJo Ann Wilson, Khalid Shah
Life of this patent
Estimating the term…
Abstract
Pharmaceutical compositions and unit dosage forms comprising Compound (I) are disclosed.
Claims30
A pharmaceutical composition comprising:
- Ingredient
- (% w/w)
- Compound I
- 31.68
- Microcrystalline Cellulose
- 38.85
- Lactose anhydrous
- 19.42
- Hydroxypropyl Cellulose
- 3.00
- Croscarmellose Sodium
- 3.00
- Total Intra-granular
- 95.95
- Silicon dioxide, Colloidal
- 0.30
- Croscarmellose Sodium
- 3.00
- Magnesium Stearate
- 0.75
- Total
- 100.00
19 more elements
A pharmaceutical composition comprising:
- Ingredient
- (% w/w)
- Compound I
- 25.0-33.3
- Microcrystalline Cellulose
- q.s
- Hydroxypropyl Cellulose
- 3
- Poloxamer
- 0-3
- Croscarmellose Sodium
- 6.0
- Colloidal Silicon Dioxide
- 0.5
- Magnesium Stearate
- 0.5-1.0
- Total
- 100
15 more elements
A pharmaceutical composition comprising:
- Theoretical Quantity
- Ingredient
- (mg/unit dose)
- Compound I
- 100.0
- Microcrystalline Cellulose PH-102
- 155.4
- Lactose Anhydrous 60M
- 77.7
- Hydroxypropyl Cellulose, EXF
- 12.0
- Croscarmellose Sodium
- 24
- Colloidal Silicon Dioxide
- 1.2
- Magnesium Stearate (Non-Bovine)
- 3.0
- Opadry Yellow
- 16.0
- Total
- 416
18 more elements
A pharmaceutical composition comprising:
- 30-32 percent by weight of Compound I in at least one of the forms disclosed herein;
- 50-70 percent by weight of a filler;
- 2-4 percent by weight of a binder;
- 4-8 percent by weight of a disintegrant;
- and
- 0.2-0.6 percent by weight of a glidant;
- and 0.5-1 percent by weight of a lubricant.
4 more elements
A pharmaceutical composition comprising:
- Weight/Weight
- Component
- Percent
- Compound I
- 25-29
- Microcrystalline Cellulose
- q.s.
- Lactose Anhydrous
- 40-44
- Hydroxypropyl Cellulose
- 2-4
- Croscarmellose Sodium
- 2-8
- Colloidal Silicon Dioxide
- 0.1-0.4
- Magnesium Stearate
- 0.7-0.9
- Total
- 100
16 more elements
A process for manufacturing a pharmaceutical composition comprising Compound I, comprising the steps of:
- a. Delumping unmilled Compound I;
- b. Premixing the delumped Compound I with microcrystalline cellulose, anhydrous lactose, and croscarmellose sodium to form a binder solution;
- c. Wet high shear granulation of the binder solution to produce wet granules;
- d. Wet screening of the wet granules to produce wet screened granules;
- e. Fluid bed drying of the wet screened granules to produce dried granules;
- f. Dry milling of the dried granules to produce dried milled granules;
- g. Blending the dried milled granules with colloidal silicon and croscarmellose to produce an extragranular blend;
- h. Lubricant blending of the extragranular blend and magnesium stearate to produce a final blend;
- and
- i. Tablet compression of the final blend to form an uncoated core tablet.
7 more elements
Dependencies are inferred from the claim text.