Pharmaceutical formulation for use in HIV therapy
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. A process of preparing a pharmaceutical formulation, comprising the steps of:
a. preparing a paste comprising ritonavir, copovidone, colloidal silicon dioxide and a solubilizing agent, using dichloromethane;
b. removing dichloromethane from said paste under vacuum and milling the paste to form granules;
c. lubricating said granules with a lubricant;
d. compressing said lubricated granules into tablets or filling it into capsules.
2. The process according to claim 1 , wherein the lubricant is sodium stearyl fumarate.
3. The process according to claim 1 , wherein the paste components of step (a) further comprises lopinavir.
4. The process according to claim 1 , wherein the solubilizing agent is sorbitan laurate.
5. The process according to claim 1 , wherein the solubilizing agent is glycerol monooleate.
6. The process according to claim 1 , wherein the paste further comprises poloxamer or hydroxypropylmethyl cellulose.
7. The process according to claim 1 , wherein the paste is prepared by mixing ritinovir, sorbitan oleate, copovidone and colloidal silicon dioxide, and subsequently granulating said mixture with dichloromethane.
8. The process of claim 1 , wherein the paste is prepared by dissolving ritonavir and sorbitan laureate in dichloromethane and granulating said solution with copovidone and colloidal silicon dioxide.