Pharmaceutical formulation for use in hiv therapy

Abstract

The invention discloses a formulation prepared by granulating at least one anti-retro viral drug and at least one pharmaceutically acceptable additive, using an organic solvent; milling the product; finally processing the milled product to form tablets or capsules.

1 - 30 . (canceled) 
   
   
       31 . A process of preparing a pharmaceutical formulation, comprising essentially of:
 a. dissolving or suspending at least one anti-retro viral drug and optionally at least one pharmaceutically acceptable additive, in an organic solvent to obtain a solution or dispersion;   b. drying said solution or dispersion to obtain granules;   c. optionally lubricating said granules;   d. compressing said granules into tablets or filling it into capsules.   
   
   
       32 . The process according to  claim 31 , wherein said anti-retro viral drug is selected from the group consisting of HIV protease inhibitors, Nucleoside Reverse Transcriptase Inhibitors and/or Non-Nucleoside Reverse Transcriptase Inhibitors and their mixtures. 
   
   
       33 . The process according to  claim 32 , wherein said anti-retro viral drug is lopinavir, ritonavir or a combination thereof. 
   
   
       34 . The process according to  claim 31 , wherein said pharmaceutically acceptable additive is selected from a group consisting of:
 a. solubilizing agents;   b. muco-adhesive agents and optionally   c. glidants.   
   
   
       35 . The process according to  claim 34 , wherein said solubilizing agent is selected from a group consisting of: polyethylene-polypropylene glycol copolymer (Poloaxamer), glyceryl mono-oleate, sorbitan esters, polyoxyl castor oil, and polyoxyethylene stearates. 
   
   
       36 . The process according to  claim 34 , wherein said muco-adhesive agent is selected from a group consisting of: cellulose ethers, polyacrylic acid, polymethacrylates, polydextrose, co-povidone, polyvinyl alcohol, chitosan, guar gum, sodium alginate, dextrin and polyethylene glycol. 
   
   
       37 . The process according to  claim 31 , wherein said organic solvent is selected from a group consisting of: dichloromethane, methanol, ethanol, acetone, ethyl acetate, and isopropyl alcohol. 
   
   
       38 . The process according to  claim 31 , wherein said pharmaceutical formulation additionally contains acceptable pharmaceutical excipients selected from a group consisting of: diluents, binders, disintegrants, and surfactants. 
   
   
       39 . The process according to  claim 33 , wherein lopinavir and ritonavir is present in a proportion of 4:1 by weight. 
   
   
       40 . A method of treating an HIV infection comprising administering a pharmaceutical composition prepared by the process of  claim 31  to a mammal in need of such treatment. 
   
   
       41 . A process of preparing a pharmaceutical formulation, consisting essentially of:
 a. dissolving lopinavir, ritonavir, poloxamer, glyceryl mono-oleate and povidone, in methanol to obtain a solution;   b. drying said solution to obtain granules;   c. lubricating said granules with colloidal silicon dioxide, hydrogenated cotton seed oil and sodium lauryl sulfate;   d. compressing said lubricated granules into tablets or filling it into capsules.   
   
   
       42 . A method of treating an HIV infection comprising administering a pharmaceutical composition prepared by the process of  claim 41  to a mammal in need of such treatment. 
   
   
       43 . A bottle-pack for storing an anti-retro viral composition, wherein said bottle pack comprises a body having a mouth opening and a closure, said closure being designed to hold a desiccant within itself. 
   
   
       44 . The bottle-pack according to  claim 43 , wherein said closure has a cavity to hold said desiccant. 
   
   
       45 . The bottle-pack as claimed in  claim 44 , wherein said cavity is detachable or fixed permanently within said closure.