IP Library › Granted Patent US 12,214,083
Granted Patent B2
US 12,214,083 · App. 18/355,475 · Granted Feb 4, 2025

Pharmaceutical composition and administrations thereof

Inventors: Eleni Dokou (Cambridge, MA); Shahla Jamzad (Belmont, MA); John P. Caesar, Jr. (Lancaster, MA); Majed Fawaz (Foxboro, MA); Laura Das (Charlestown, MA); Chong-Hui Gu (Waban, MA); Patricia Nell Hurter (Harvard, MA); Meghna Jai Israni (Boston, MA); Meghan M. Johnston (Wakefield, MA); Dragutin Knezic (Watertown, MA); Andrew G. Kuzmission (Shrewsbury, MA); HongRen Wang (Lexington, MA)
Assignee: Vertex Pharmaceuticals Incorporated
A61K9/205A61K9/143A61K9/145A61K9/146A61K9/1611A61K9/1617A61K9/1623A61K9/1652A61K9/2009A61K9/2013A61K9/2018A61K9/2054A61K9/2072A61K9/2077A61K9/4808A61K9/485A61K9/4858A61K9/4866A61K31/47A61K47/02A61K47/12A61K47/20A61K47/26A61K47/38C07D215/56
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Quick Facts
Patent No.
US 12,214,083
App. No.
18/355,475
Granted
Feb 4, 2025
Kind
B2
Abstract

The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.

Claims (31)

1. A pharmaceutical composition in a unit dose form comprising a plurality of granules or mini-tablets, wherein the composition comprises:

a) a solid dispersion in an amount from about 30 to about 40 percent by weight of the composition, wherein the dispersion comprises:

i. about 80 wt % of amorphous N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1) by weight of the dispersion,

ii. about 19.5 wt % of hydroxypropylmethylcellulose acetate succinate (HPMCAS) by weight of the dispersion, and

iii. about 0.5 wt % of sodium lauryl sulfate (SLS) by weight of the dispersion;

b) mannitol and lactose in an amount from about 30 to about 60 percent by weight of the composition, wherein mannitol and lactose are present in a ratio of about 1:3 mannitol to lactose;

c) sucralose in an amount from about 0.1 to about 5 percent by weight of the composition;

d) croscarmellose sodium in an amount from about 1.5 to about 8 percent by weight of the composition;

e) colloidal silicon dioxide in an amount from about 0.1 to about 5 percent by weight of the composition; and

f) magnesium stearate in an amount from about 0.1 to about 7 percent by weight of the composition;

wherein the unit dose form comprises at least about 5 mg of amorphous Compound 1, and

wherein less than about 15 wt % of the Compound 1 is crystalline.

2. The pharmaceutical composition of claim 1 , wherein less than about 5 wt % of Compound 1 is crystalline.

3. The pharmaceutical composition of claim 1 , wherein about 0 wt % of Compound 1 is crystalline.

4. The pharmaceutical composition of claim 1 , wherein the composition does not comprise SLS outside of the solid dispersion.

5. The pharmaceutical composition of claim 1 , wherein the unit dose form comprises about 50 mg of amorphous Compound 1.

6. The pharmaceutical composition of claim 1 , wherein the unit dose form comprises about 75 mg of amorphous Compound 1.

7. The pharmaceutical composition of claim 1 , wherein the unit dose form comprises from about 25 to about 40 mini-tablets.

8. The pharmaceutical composition of claim 7 , wherein the mini-tablet has a shape that is cylinder-like, oval-like, cone-like, sphere-like, ellipsis-like, polygon-like or combinations thereof, wherein the mini-tablet has as its longest dimension or diameter a length of about 2 mm.

9. The pharmaceutical composition of claim 1 , wherein the solid dispersion is present in an amount of about 35 percent by weight of the pharmaceutical composition and the unit dose form comprises about 26 mini-tablets.

10. The pharmaceutical composition of claim 9 , wherein the unit dose form comprises about 50 mg of amorphous Compound 1.

11. The pharmaceutical composition of claim 1 , wherein the solid dispersion is present in an amount of about 35 percent by weight of the pharmaceutical composition and the unit dose form comprises about 39 mini-tablets.

12. The pharmaceutical composition of claim 11 , wherein the unit dose form comprises about 75 mg of amorphous Compound 1.

13. A method of treating or lessening the severity of CFTR mediated disease in a pediatric patient comprising administering to the patient a pharmaceutical composition of claim 1 .

14. The method according to claim 13 , wherein the CFTR mediated disease is cystic fibrosis.

15. The method according to claim 14 , wherein the patient possesses a CFTR gating mutation.

16. The method according to claim 15 , wherein the gating mutation is selected from G551D, G178R, G551S, G970R, G1244E, S1255P, G1349D, S549N, S549R, and S1251N.

17. The method according to claim 13 , wherein the patient is 2 through 5 years of age.

18. The method according to claim 14 , wherein the patient is 0 through 2 years of age.

19. The method according to claim 13 , wherein the patient weighs 14 or more kilograms.

20. The method according to claim 13 , wherein the patient weighs less than 14 kilograms.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 14, 2024
From: DOKOU, ELENI; JAMZAD, SHAHLA; CAESAR, JOHN P., JR.; DAS, LAURA; FAWAZ, MAJED; GU, CHONG-HUI; HURTER, PATRICIA NELL; ISRANI, MEGHNA JAI; JOHNSTON, MEGHAN M.; KNEZIC, DRAGUTIN; KUZMISSION, ANDREW G.; WANG, HONGREN
To: VERTEX PHARMACEUTICALS INCORPORATED
Reel/Frame 066583/0398 →
CHANGE OF ADDRESS Recorded Feb 14, 2024
From: VERTEX PHARMACEUTICALS INCORPORATED
To: VERTEX PHARMACEUTICALS INCORPORATED
Reel/Frame 066583/0455 →
Continuity (10)
Continuation 17475622 · Sep 15, 2021
Continuation 16299675 · Mar 12, 2019
Continuation 15181114 · Jun 13, 2016
Continuation 14715682 · May 19, 2015
Continuation 14510507 · Oct 9, 2014
Continuation 14286856 · May 23, 2014
Continuation 13779654 · Feb 27, 2013
Provisional Application 61710352 · Oct 5, 2012
Provisional Application 61603882 · Feb 27, 2012
Related Publication 20240156738A1 · May 16, 2024
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