COMPOSITIONS AND METHODS FOR ENHANCED DELIVERY OF ANTIVIRAL AGENTS

1 . A pharmaceutical composition, comprising:

a) one or more antiviral agents chosen from protease inhibitors, endonuclease inhibitors, integrase inhibitors, enzyme inhibitors, non-nucleoside reverse transcriptase inhibitors, fusion inhibitors, cell entry inhibitors, mRNA and protein synthesis inhibitors cannabinoids, viral replication blockers, uncoating inhibitors, reverse transcriptase inhibitors, topoisomerase inhibitors, assembly inhibitors, M2 inhibitors, DNA polymerase inhibitors, DNA terminase complex inhibitors, HCV protein inhibitors, neuraminidase inhibitors, or virus-neutralizing antibodies; and

b) a bioavailability enhancing agent chosen from palm kernel oil, soybean oil, rapeseed oil (canola), sunflower oil, groundnut oil, sesame oil, flaxseed oil, palm oil, olive oil or corn oil.

2 . The composition according to claim 1 , comprising 25 mg to about 300 mg by weight of one or more antiviral agents.

3 . The composition according to claim 1 , wherein the antiviral agent is a protease inhibitor chosen from amprenavir (or the pro-drug fosamprenavir), atazanavir, bepridil, boceprevir, darunavir, ebastine, indinavir, lopinavir, nelfinavir, ritonavir, rupintrivir, saquinavir, simeprevir, telaprevir, or tipranavir.

4 . The composition according to claim 1 , wherein the antiviral agent is a nucleoside reverse transcriptase inhibitor chosen from doravirine, efavirenz, etravirine, loviride, or rilpivirine.

5 . The composition according to claim 1 , wherein the antiviral agent is chosen from GS-441524, remdesivir, indinavir, raltegravir, nevirapine, or azidothymidine.

6 . The composition according to claim 1 , further comprising colchicine.

7 . The composition according to claim 1 , wherein the ratio of the antiviral agent to the bioavailability agent is from about 1:1 to about 1:3.

8 . The composition according to claim 7 , wherein the bioavailability agent is sunflower oil.

9 . The composition according to claim 1 , further comprising from about 30% to about 80% one or more emulsifiers chosen from gum arabic, modified starch, pectin, xanthan gum, gum ghatti, gum tragacanth, fenugreek gum, mesquite gum, mono-glycerides and di-glycerides of long chain fatty acids, sucrose monoesters, sorbitan esters, polyethoxylated glycerols, stearic acid, palmitic acid, mono-glycerides, di-glycerides, propylene glycol esters, lecithin, lactylated mono- and di-glycerides, propylene glycol monoesters, polyglycerol esters, diacetylated tartaric acid esters of mono- and di-glycerides, citric acid esters of monoglycerides, stearoyl-2-lactylates, polysorbates, succinylated monoglycerides, acetylated monoglycerides, ethoxylated monoglycerides, quillaia, whey protein isolate, casein, soy protein, vegetable protein, pullulan, sodium alginate, guar gum, locust bean gum, tragacanth gum, tamarind gum, carrageenan, furcellaran, Gellan gum, psyllium, curdlan, konjac mannan, agar, and cellulose derivatives, and combinations thereof, or a sugar alcohol that can optionally have humectant properties such as ethylene glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, frucitol, iditol, sucrose, fructose, isomalt, maltitol, lactitol, sorbitol, dextrose or inositol, or mixtures thereof.

10 . The composition according to claim 9 , wherein the emulsifier is gum Arabic.

11 . The composition according to claim 1 , further comprising a bile salt chosen from cholic acid, cholate, deoxycholic acid, deoxycholate, hyodeoxycholic acid, hyodeoxycholate, glycocholic acid, glycocholate, taurocholic acid, taurocholate, chenodeoxycholic acid, chenodeoxycholate, lithocholic acid, or lithocolate.

12 . The composition according to claim 1 , further comprising ox bile.

13 . The composition according to claim 1 , further comprising a carrier, surfactant, or an anti-caking agent.

14 . A pharmaceutical composition, comprising:

i) from about 5% to about 20% by weight of an active base, comprising:

a) from about 25% to about 50% by weight of one or more antiviral agents;

b) from about 50% to about 75% by weight of a bioavailability enhancing agent; and

ii) from about 50% to about 70% gum arabic;

iii) the balance carriers and other adjunct ingredients.

15 . The composition according to claim 14 , comprising:

i) from about 5% to about 20% by weight of an active base, comprising:

a) from about 25% to about 50% by weight of darunavir;

b) from about 50% to about 75% by weight of sunflower oil; and

ii) from about 50% to about 70% gum arabic;

iii) the balance carriers and other adjunct ingredients.

16 . The composition according to claim 14 , comprising:

i) from about 5% to about 20% by weight of an active base, comprising:

a) from about 25% to about 50% by weight of efavirenz;

b) from about 50% to about 75% by weight of sunflower oil; and

ii) from about 50% to about 70% gum arabic;

iii) the balance carriers and other adjunct ingredients.

17 . The composition according to claim 14 , further comprising a bile salt chosen from cholic acid, cholate, deoxycholic acid, deoxycholate, hyodeoxycholic acid, hyodeoxycholate, glycocholic acid, glycocholate, taurocholic acid, taurocholate, chenodeoxycholic acid, chenodeoxycholate, lithocholic acid, or lithocolate.

18 . The composition according to claim 14 , further comprising ox bile.

19 . The composition according to claim 14 , further comprising a carrier, surfactant, or an anti-caking agent.

20 . A method for treating a subject having a viral infection comprising, administering to a person infected with a virus an effective amount of a composition comprising:

a) one or more antiviral agents chosen from protease inhibitors, endonuclease inhibitors, integrase inhibitors, enzyme inhibitors, non-nucleoside reverse transcriptase inhibitors, fusion inhibitors, cell entry inhibitors, mRNA and protein synthesis inhibitors cannabinoids, viral replication blockers, uncoating inhibitors, reverse transcriptase inhibitors, topoisomerase inhibitors, assembly inhibitors, M2 inhibitors, DNA polymerase inhibitors, DNA terminase complex inhibitors, HCV protein inhibitors, neuraminidase inhibitors, or virus-neutralizing antibodies; and

b) a bioavailability enhancing agent chosen from palm kernel oil, soybean oil, rapeseed oil (canola), sunflower oil, groundnut oil, sesame oil, flaxseed oil, palm oil, olive oil or corn oil.