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Last Updated: May 19, 2024

Claims for Patent: 11,065,250

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Summary for Patent: 11,065,250

Title:	Solid dosage forms of palbociclib
Abstract:	The present invention relates to solid dosage forms of palbociclib comprising a water-soluble acid. The dosage forms described herein have desirable pharmacokinetic characteristics.
Inventor(s):	Ibrahim; Fady Makram Louiz (East Lyme, CT), Mullarney; Matthew Patrick (Niantic, CT), Shanker; Ravi M. (Stonington, CT), Spong; Barbara Rodriguez (Haddam, CT), Wang; Jian (Killingworth, CT)
Assignee:	Pfizer Inc. (New York, NY)
Application Number:	15/578,410
Patent Claims:	1. A tablet consisting of about 20 wt % of palbociclib, about 10 wt % of succinic acid, about 50 wt % to about 75 wt % of microcrystalline cellulose, about 5 wt % to about 10 wt % of crospovidone, about 0.5 wt % to about 6 wt % of magnesium stearate, and about 0.5 wt % to about 2 wt % of silicon dioxide. 2. The tablet of claim 1, wherein the tablet is film coated. 3. The tablet of claim 1, wherein the amount of palbociclib in the tablet is 25 mg, 75 mg, 100 mg or 125 mg. 4. The tablet of claim 3, wherein the amount of palbociclib in the tablet is 125 mg. 5. A tablet consisting of: (i) as intragranular components, about 20 wt % of palbociclib, about 39.2 wt % of microcrystalline cellulose, about 1 wt % of silicon dioxide, about 3 wt % of crospovidone, and about 0.3 wt % of magnesium stearate; and (ii) as extragranular components, about 10 wt % of succinic acid, about 21.5 wt % of microcrystalline cellulose, about 3 wt % of crospovidone, and about 2 wt % of magnesium stearate. 6. The tablet of claim 5, comprising 25.0 mg, 75.0 mg, 100.0 mg or 125.0 mg of palbociclib. 7. The tablet of claim 6, wherein the tablet is film coated to a weight gain of about 2% to about 4%. 8. A tablet consisting of: (i) intragranular components: TABLE-US-00025 palbociclib 125.000 mg microcrystalline cellulose (Avicel PH102) 244.812 mg colloidal silicon dioxide (Aerosil 200 Pharma) 6.250 mg crospovidone (Kollidon CL) 18.750 mg magnesium stearate 2.063 mg and (ii) extragranular components: TABLE-US-00026 succinic acid (100 to 350 micron) 62.500 mg microcrystalline Cellulose (Avicel PH200) 134.375 mg crospovidone (Kollidon CL-SF) 18.750 mg magnesium stearate (fine grade) 12.500 mg. 9. The tablet of claim 8, wherein the tablet is film coated to a weight gain of 4% with a film coating.

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