Abstract: The invention relates to a process for producing tablet compositions of etravirine comprising solid dispersion of etravirine, hydroxylpropyl methyl cellulose and optionally one or more pharmaceutically acceptable excipients, wherein the solid dispersion doesn"t contain microcrystalline cellulose.
WE CLAIM:
1.A process for producing tablet compositions of etravirine comprising the steps of:
(i) providing a mixture of etravirine, hydroxypropyl methyl cellulose and optionally one or more pharmaceutically acceptable excipients in a suitable solvent and spray drying the mixture to form a solid dispersion, wherein the .solid dispersion doesn't contain microcrystalline cellulose,
(ii) processing the solid dispersion of step (i) with one or more pharmaceutically acceptable excipient, into tablet dosage form.
2.The process of claim 1, wherein the amount of etravirine in the tablet composition is about 10% w/w to about 25% w/w.
3.The process of claim 1, wherein the pharmaceutically acceptable excipient is selected from diluents, binders, disintegrants, surfactants, lubricants, glidants and the like.
4.The process of claim 2, wherein the pharmaceutically acceptable excipient is mannitol, crospovidone, croscarmellose sodium and sodium starch glycolate.
5.The process of claim 1, wherein the ratio of etravirine to hydroxypropyl methyl cellulose is 1:2 to 1:4.
6.The process of claim 1, wherein the solvent is selected from water, acetone,
dichloromethane, ethanol, methanol, dimethyl sulfoxide or mixtures thereof.
7.The process of claim 1, wherein the solvent is mixture of ethanol, acetone and methylene
chloride in a ratio of 1:1:8.
8.The process of claim 1, wherein the etravirine in the tablet composition is in
amorphous form.
9.The process of claim 8, wherein the tablet composition is prepared by dry granulation.
10. The process of daim 1, wherein the tablet composition is prepared by a process comprising:
a)preparing a solution comprising etravirine, hydroxypropyl methyl cellulose and
optionally pharmaceutically acceptable excipient in a solvent,
b)spray drying the solution of step (a),
c)granulating the spary dried powder of step (b) with one or more pharmaceutically acceptable excipients.
d)blending the granules with one or more pharmaceutically acceptable excipients, and
e)compressing the blend into tablet dosage form.
| # | Name | Date |
|---|---|---|
| 1 | Form5_As Filed_25-09-2017.pdf | 2017-09-25 |
| 2 | Form2 Title Page_Complete_25-09-2017.pdf | 2017-09-25 |
| 3 | Form1_As Filed_25-09-2017.pdf | 2017-09-25 |
| 4 | Description Complete_As Filed_25-09-2017.pdf | 2017-09-25 |
| 5 | Correspondence by Applicant_As Filed_25-09-2017.pdf | 2017-09-25 |
| 6 | Claims_As Filed_25-09-2017.pdf | 2017-09-25 |
| 7 | Abstract_As Filed_25-09-2017.pdf | 2017-09-25 |
| 8 | Correspondence by Agent_Certified Copy_15-12-2017.pdf | 2017-12-15 |