Pharmaceutical composition having improved content uniformity
This present invention relates to pharmaceutical compositions comprising cyclophosphamide alone and/or in combination with one or more pharmaceutical active ingredients and one or more pharmaceutically acceptable excipients wherein the cyclophosphamide has D90 particle size less than 100 microns.
1. A pharmaceutical composition comprising cyclophosphamide and one or more pharmaceutically acceptable excipients, wherein cyclophosphamide has D90 particle size less than 100 microns.
2. The pharmaceutical composition according to claim 1 , wherein the said pharmaceutical composition further comprises one or more pharmaceutical active ingredients.
3. The pharmaceutical composition according to claim 2 , wherein the said pharmaceutical active ingredient is capecitabine or its pharmaceutically acceptable salts thereof.
4. The pharmaceutical composition according to claim 1 , wherein the said pharmaceutical composition is present in a solid oral dosage form comprising of monolayer tablet, bilayer tablet, multilayer tablet, film-coated tablet, powders, lozenges, sachets and hard gelatin capsules.
5. The pharmaceutical composition according to claim 4 , wherein the said pharmaceutical composition is in the form of bilayer tablet.
6. The pharmaceutical composition according to claim 5 , wherein the bilayer tablet comprises a first layer & second layer, wherein the first layer comprises capecitabine and one or more excipients, and the second layer comprises cyclophosphamide and one or more excipients.
7. The pharmaceutical composition according to claim 5 , wherein the first layer comprises capecitabine in the amount of 10 to 1500 mg and one or more excipients, and the second layer comprises cyclophosphamide in the amount of 20 to 80 mg and one or more excipients.
8. The pharmaceutical composition according to claim 1 , wherein the said pharmaceutical composition have a content uniformity between 95% and 105% and acceptance value less than 15 as per USP <905> uniformity of dosage units.
9. A pharmaceutical composition comprising cyclophosphamide and capecitabine in the form of bilayer tablet, wherein the first layer comprises capecitabine and one or more excipients, and the second layer comprises cyclophosphamide and one or more excipients, wherein the cyclophosphamide has D90 particle size less than 100 microns.
10. A pharmaceutical composition comprising cyclophosphamide and capecitabine in the form bilayer tablet, wherein the first layer comprises capecitabine and one or more excipients, and the second layer comprises cyclophosphamide and one or more excipients, wherein the cyclophosphamide has D90 particle size less than 100 microns; wherein the said pharmaceutical composition have a content uniformity between 95% and 105% and acceptance value less than 15 as per USP <905> uniformity of dosage units.