Granted Patent
B2
US 12,661,323 · App. 19/461,014 · Granted Jun 23, 2026
Pharmaceutical formulations comprising tenofovir alafenamide and emtricitabine
Assignee:
Gilead Sciences, Inc.
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Abstract
The invention provides a solid oral dosage form comprising tenofovir alafenamide or a pharmaceutically acceptable salt thereof, and emtricitabine or a pharmaceutically acceptable salt thereof.
Claims (43)
1 . A tablet, consisting of:
about 10 mg to about 30 mg tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, calculated as tenofovir alafenamide free base;
emtricitabine, or a pharmaceutically acceptable salt thereof;
one or more excipients selected from a disintegrant, a lubricant, and a filler, or any combination thereof, wherein the one or more excipients do not include starch; and
a coating;
wherein the tablet has a total weight of less than 600 mg;
wherein about 40% to about 75% by weight of the tablet is emtricitabine, or a pharmaceutically acceptable salt thereof, and tenofovir alafenamide, or a pharmaceutically acceptable salt thereof; and
wherein the tablet contains only two active pharmaceutical ingredients: tenofovir alafenamide, or a pharmaceutically acceptable salt thereof, and emtricitabine, or a pharmaceutically acceptable salt thereof.
2 . The tablet according to claim 1 , wherein the tablet contains a pharmaceutically acceptable salt of tenofovir alafenamide, wherein the pharmaceutically acceptable salt is a fumarate salt.
3 . The tablet according to claim 2 , wherein less than about 300 mg of the tablet is the one or more excipients.
4 . The tablet according to claim 2 , wherein less than about 250 mg of the tablet is the one or more excipients.
5 . The tablet according to claim 2 , wherein less than about 40% by weight of the tablet is the filler.
6 . The tablet according to claim 2 , wherein less than about 20% by weight of the tablet is the disintegrant.
7 . The tablet according to claim 2 , wherein about 0.5 w/w % to about 5 w/w % of the tablet is the lubricant.
8 . The tablet according to claim 2 , wherein:
less than about 40% by weight of the tablet is the filler;
less than about 20% by weight of the tablet is the disintegrant; and
about 0.5 w/w % to about 5 w/w % of the tablet is the lubricant.
9 . The tablet according to claim 2 , wherein less than about 20% by weight of the tablet is the disintegrant; and about 0.5 w/w % to about 5 w/w % of the tablet is the lubricant.
10 . The tablet according to claim 2 , wherein the one or more excipients are selected from microcrystalline cellulose, croscarmellose sodium, lactose, crospovidone, and magnesium stearate, or any combination thereof.
11 . The tablet according to claim 10 , wherein:
less than about 40% by weight of the tablet is microcrystalline cellulose or lactose;
less than about 20% by weight of the tablet is croscarmellose sodium or crospovidone; and
about 0.5 w/w % to about 5 w/w % of the tablet is magnesium stearate.
12 . The tablet according to claim 10 , wherein less than about 20% by weight of the tablet is the croscarmellose sodium or crospovidone; and about 0.5 w/w % to about 5 w/w % of the tablet is magnesium stearate.
13 . The tablet according to claim 10 , wherein the tablet contains less than 200 mg of the microcrystalline cellulose or less than 200 mg of the lactose.
14 . The tablet according to claim 2 , wherein the tablet has a total weight of less than about 500 mg.
15 . The tablet according to claim 14 , wherein less than about 300 mg of the tablet is the one or more excipients.
16 . The tablet according to claim 14 , wherein less than about 250 mg of the tablet is the one or more excipients.
17 . The tablet according to claim 14 , wherein less than about 20% by weight of the tablet is the disintegrant; and about 0.5 w/w % to about 5 w/w % of the tablet is the lubricant.
18 . The tablet according to claim 14 , wherein the one or more excipients are selected from microcrystalline cellulose, croscarmellose sodium, lactose, crospovidone, and magnesium stearate, or any combination thereof.
19 . The tablet according to claim 18 , wherein:
less than about 40% by weight of the tablet is microcrystalline cellulose or lactose;
less than about 20% by weight of the tablet is croscarmellose sodium or crospovidone; and
about 0.5 w/w % to about 5 w/w % of the tablet is magnesium stearate.
20 . The tablet according to claim 18 , wherein the tablet contains less than 200 mg of the microcrystalline cellulose or less than 200 mg of the lactose.
21 . The tablet according to claim 2 , wherein the fumarate salt is tenofovir alafenamide hemifumarate.
22 . The tablet according to claim 2 , wherein the coating is a polymeric film coating.
23 . The tablet according to claim 22 , wherein the polymeric film coating contains polyvinyl alcohol, titanium dioxide, macrogol, and talc.
24 . The tablet according to claim 1 , wherein the term “about” refers to ±5%.
25 . The tablet according to claim 1 , wherein the term “about” refers to ±1%.
26 . The tablet according to claim 2 , wherein the term “about” refers to ±5%.
27 . The tablet according to claim 2 , wherein the term “about” refers to ±1%.
Continuity (16)
Continuation
18782290
· Jul 24, 2024
Continuation
18539583
· Dec 14, 2023
Continuation
18204012
· May 31, 2023
Continuation
17984290
· Nov 10, 2022
Continuation
17667674
· Feb 9, 2022
Continuation
17386089
· Jul 27, 2021
Continuation
17148765
· Jan 14, 2021
Continuation
16923139
· Jul 8, 2020
Continuation
16690272
· Nov 21, 2019
Provisional Application
62317286
· Apr 1, 2016
Provisional Application
62301429
· Feb 29, 2016
Provisional Application
62298373
· Feb 22, 2016
Provisional Application
62187113
· Jun 30, 2015
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