IP Library › Patent Application 18762102
Patent Application
App. No. 18/762,102

CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND

Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US None
App. No.
18/762,102
Abstract

The invention provides two crystalline freebase forms of biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl)piperidin-4-yl ester. The invention also provides pharmaceutical compositions comprising the crystalline freebase or prepared using the crystalline freebases; processes and intermediates for preparing the crystalline freebases; and methods of using the crystalline freebases to treat a pulmonary disorder.

Claims (7)

1 - 27 . (canceled)

28 . A drug delivery device comprising a dry powder inhaler containing a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a crystalline freebase of biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl)piperidin-4-yl ester characterized by a powder x-ray diffraction comprising diffraction peaks at 20 values of 6.6±0.1, 13.1±0.1, 18.6±0.1, 19.7±0.1, and 20.2±0.1, and further characterized by having five or more additional diffraction peaks at 20 values selected from 10.6±0.1, 15.0±0.1, 16.0±0.1, 17.3±0.1, 17.7±0.1, 20.9±0.1, 21.4±0.1, 22.6±0.1, 24.6±0.1, and 27.8±0.1; designated as Form IV.

29 . The drug delivery device of claim 28 , wherein the crystalline compound is further characterized by a powder x-ray diffraction pattern in which the peak positions are substantially in accordance with the peak positions of the pattern shown in FIG. 2 .

30 . The drug delivery device of claim 28 , wherein the crystalline compound is further characterized by a differential scanning calorimetry thermogram substantially in accordance with that shown in FIG. 5 .

31 . The drug delivery device of claim 28 , wherein the pharmaceutical composition further comprises an agent selected from β 2 adrenergic receptor agonists, steroidal anti-inflammatory agents, phosphodiesterase-4 inhibitors, and combinations thereof, wherein the crystalline compound and the agent are formulated together or separately.

32 . The drug delivery device of claim 31 , wherein the pharmaceutical composition further comprises a β 2 adrenergic receptor agonist and a steroidal anti-inflammatory agent.

33 . The drug delivery device of claim 28 , wherein the crystalline compound is in micronized form.

Assignments (1)
SECURITY INTEREST Recorded Sep 24, 2026
From: THERAVANCE BIOPHARMA R&D IP, LLC
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 076134/0790 →