Claims for Patent: 12,011,506

Summary for Patent: 12,011,506

Title:	Combination and uses and treatments thereof
Abstract:	Methods are provided for treating or preventing human immunodeficiency virus-1 (HIV-1) or human immunodeficiency virus-2 (HIV-2) in a virologically suppressed patient in need thereof comprising switching the patient from an antiretroviral treatment regimen comprising at least three antiretroviral agents to a treatment regimen comprising only two antiretroviral agents. In one aspect the two treatment regimen consists of dolutegravir, rilpivirine and at least one pharmaceutically acceptable excipient, diluent or carrier. In another aspect of the invention, there is provided a multilayer tablet comprising dolutegravir or a pharmaceutically acceptable salt thereof and rilpivirine or a pharmaceutically acceptable salt thereof.
Inventor(s):	Kenneth Churchill Campbell, Urbain Alfons C. Delaet, James M. GOODRICH, Juliette Segolène GUAQUIÈRE, Thomas LAUGHERY, Dominique J. LIMET, John C. POTTAGE, Ludovic Sylvain Marc RENOU, Trevor R. SCOTT, Christian Seiler, Mary WOODWARD
Assignee:	Janssen Pharmaceutica NV , GlaxoSmithKline Services ULC , ViiV Healthcare UK Ltd , GlaxoSmithKline Research and Development Ltd , Janssen Sciences Ireland ULC , ViiV Healthcare Co
Application Number:	US16/621,309
Patent Claims:	1. A bilayer tablet comprising a) a first layer comprising dolutegravir sodium; and b) a second layer comprising rilpivirine hydrochloride; wherein said first layer and said second layer are in direct contact, and wherein the first layer consists of: Ingredient Mass (mg) Intragranular Dolutegravir sodium 52.62 D-mannitol 145.38 Microcrystalline cellulose 60.00 Povidone K29/32 15.00 Sodium starch glycolate 15.00 Purified water q.s. Extragranular Sodium starch glycolate 6.00 Sodium stearyl fumarate 6.00 and the second layer consists of: Ingredient Mass (mg) Intragranular Rilpivirine hydrochloride 27.50 Lactose monohydrate 55.145 Croscarmellose sodium 1.10 Povidone K30 3.25 Polysorbate 20 0.35 Purified water q.s. Extragranular D-mannitol 57.755 Silicified microcrystalline cellulose 40.00 Sodium starch glycolate 12.90 Magnesium stearate 2.00. 2. The bilayer tablet of claim 1 wherein the bilayer tablet further comprises a coating. 3. The bilayer tablet of claim 2, wherein the coating comprises polyvinyl alcohol, titanium dioxide, macrogol/PEG, talc, yellow and red iron oxide. 4. The bilayer tablet of claim 2, wherein the bilayer tablet comprises about 1 mg to about 30 mg of the coating. 5. The bilayer tablet of claim 2, wherein the bilayer tablet comprises about 0.2% to about 6% w/w of the coating. 6. The bilayer tablet of claim 5, wherein the bilayer tablet comprises about 2% to about 4% w/w of the coating. 7. The bilayer tablet of claim 5, wherein the bilayer tablet comprises about 3% w/w of the coating. 8. The tablet of claim 2, the multilayer tablet comprises about 15 mg of the film coating.