Compressed tablet formulation

1. A process for the preparation of a drug loaded compressed tablet containing about 50% efavirenz comprising the following steps:

(a) blending efavirenz with a filler/disintegrant, superdisintegrant, binder and surfactant;

(b) adding at least 1.1% by weight of water per weight of efavirenz to wet granulate the blended mixture to agglomerate the mixture;

(c) drying the granulated mixture to a moisture content of about 0% to about 10%;

(d) milling the dried mixture to granulate to a uniform size;

(e) blending the milled mixture with a filler/compression aid;

(f) lubricating the blended mixture with a lubricant; and

(g) compressing the lubricated mixture to a compressed tablet of the desired shape;

wherein the superdisintegrant is croscarmellose sodium and has a concentration in the tablet between about 1% to about 5% by weight.

2. The process as recited in claim 1 which comprises the additional step of film coating the compressed tablet with a film coating suspension to produce the desired film coated compressed tablet.

3. The process as recited in claim 2 wherein the granulated mixture is dried to a moisture content of about 2% to about 5%.

4. A process for the preparation of a drug loaded film coated compressed tablet containing about 50% efavirenz comprising the following steps:

(a) blending efavirenz with microcrystalline cellulose, sodium lauryl sulfate, hydroxypropyl cellulose and croscarmellose sodium as a superdisintegrant;

(b) adding at least 1.1 weight % water per weight of efavirenz to wet granulate the blended mixture for about 3 minutes to about 8 minutes to agglomerate the mixture;

(c) drying the granulated mixture to a moisture content of about 2% to about 5%;

(d) milling the dried mixture to a granulate of about 250μ to about 75μ;

(e) blending the milled mixture with lactose;

(f) lubricating the blended mixture with magnesium stearate;

(g) compressing the lubricated mixture to a compressed tablet of the desired shape, wherein the superdisintegrant has a concentration in the tablet between about 1% to about 5% by weight; and

(h) film coating the compressed tablet with a film coating suspension to about 1% to about 10% by weight of the weight of compressed tablet.

5. The process as recited claim 4 , wherein the blended mixture is wet granulated for about 6 minutes.

6. The process as recited claim 5 , wherein the film coating suspension comprises hydroxypropylcellulose, hydroxypropyl methylcellulose, and titanium dioxide.

7. The process as recited claim 6 , wherein the compressed tablet is film coated with the film coating suspension to about 3.1% to about 3.3% by weight of the weight of compressed tablet.

8. A process for preparing a compressed tablet comprising crystalline efavirenz, filler/disintegrant, superdisintegrant, binder, surfactant, diluent/compression aid, and lubricant, which comprises:

(a) blending a mixture of the crystalline efavirenz, filler/disintegrant, superdisintegrant, binder and surfactant;

(b) adding water to the blended mixture to obtain a wet granulate;

(c) drying the wet granulate;

(d) milling the dried granulate;

(e) blending the milled granulate with a filler/compression aid;

(f) lubricating the blend; and

(g) compressing the lubricated blend to obtain the compressed tablet, wherein the efavirenz is about 50% by weight of the total composition of the compressed tablet and the superdisintegrant is croscarmellose sodium and has a concentration in the tablet between about 1% to about 5% by weight and the filler/compression aid is lactose.

9. A process according to claim 8 , wherein:

the filler/disintegrant is microcrystalline cellulose;

the binder is hydroxypropyl cellulose;

the surfactant is sodium lauryl sulfate; and

the lubricant is magnesium stearate.