Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate
The invention provides multilayer tablets that contain rilpivirine hydrochloride, emtricitabine, and tenofivir disoproxil fumarate. The tablets are useful for the treatment of HIV.
1. A tablet comprising a first layer and a second layer, wherein the first layer consists of 27.5 mg rilpivirine HCl, 60.0 mg microcrystalline cellulose, 189.8 mg lactose monohydrate, 3.3 mg povidone, 0.4 mg polysorbate 20, 16.1 mg croscarmellose sodium, and 3.0 mg magnesium stearate;
and the second layer consists of 200.0 mg emtricitabine, 300.0 mg tenofovir disoproxil fumarate, 150.0 mg microcrystalline cellulose, 80.0 mg lactose monohydrate, 50.0 mg pregelatinized starch, 60.0 mg croscarmellose sodium, and 10.0 mg magnesium stearate.
2. A tablet comprising a first layer, a second layer, and a third layer that is between and that separates the first layer and the second layer, wherein the first layer consists of 27.5 mg rilpivirine HCl, 60.0 mg microcrystalline cellulose, 189.8 mg lactose monohydrate, 3.3 mg povidone, 0.4 mg polysorbate 20, 16.1 mg croscarmellose sodium, and 3.0 mg magnesium stearate;
the second layer consists of 200.0 mg emtricitabine, 300.0 mg tenofovir disoproxil fumarate, 150.0 mg microcrystalline cellulose, 80.0 mg lactose monohydrate, 50.0 mg pregelatinized starch, 60.0 mg croscarmellose sodium, and 10.0 mg magnesium stearate;
and the third layer comprises 150±8.0 mg of microcrystalline cellulose or lactose monohydrate, or a mixture thereof.
3. A tablet having a first layer that consists of 27.5 mg rilpivirine HCl, 60.0 microcrystalline cellulose, 189.8 mg lactose monohydrate, 3.3 mg povidone, 0.4 mg polysorbate 20, 16.1 mg croscarmellose sodium, and 3.0 mg magnesium stearate;
a second layer that consists of 200.0 mg emtricitabine, 300.0 mg tenofovir DF, 150.0 mg microcrystalline cellulose, 80.0 mg lactose monohydrate, 50.0 mg pregelatinized starch, 60.0 mg croscarmellose sodium, and 10.0 mg magnesium stearate;
and 34.5 mg of a film coating.
4. The tablet of claim 1 , wherein the tablet further comprises a film coating.
5. The tablet of claim 4 , wherein the film coating comprises a hydrophilic polymer material.