Pharmaceutical composition of doxycycline
The present invention relates to a pharmaceutical composition comprising (i) 50% to 99% of doxycycline as an immediate-release portion; (ii) 1% to 50% of doxycycline as a controlled-release portion; and (iii) one or more pharmaceutically acceptable excipients; wherein the pharmaceutical composition provides a total daily dosage of 40 mg when administered once daily. It also relates to process for preparation of the pharmaceutical composition and its use for treating rosacea.
1. A pharmaceutical composition comprising (i) 50-99% of doxycycline and one or more pharmaceutically acceptable excipients as an immediate-release portion; and (ii) 1-50% of doxycycline, a controlled-release polymer, and one or more pharmaceutically acceptable excipients as a controlled-release portion, wherein the pharmaceutical composition provides a total daily dosage of 40 mg when administered once daily.
2. The pharmaceutical composition according to claim 1 , wherein the immediate-release portion contains 75% of doxycycline and the controlled-release portion contains 25% of doxycycline.
3. The pharmaceutical composition according to claim 1 , wherein the immediate-release portion contains 30 mg of doxycycline and the controlled-release portion contains 10 mg of doxycycline.
4. The pharmaceutical composition according to claim 1 , wherein the immediate-release portion contains 65% of doxycycline and the controlled-release portion contains 35% of doxycycline.
5. The pharmaceutical composition according to claim 1 , wherein the immediate-release portion contains 26 mg of doxycycline and the controlled-release portion contains 14 mg of doxycycline.
6. The pharmaceutical composition according to claim 1 , wherein the immediate-release portion contains 60% of doxycycline and the controlled-release portion contains 40% of doxycycline.
7. The pharmaceutical composition according to claim 1 , wherein the immediate-release portion contains 24 mg of doxycycline and the controlled-release portion contains 16 mg of doxycycline.
8. The pharmaceutical composition according to claim 1 , wherein the controlled-release polymer is a cellulose polymer.
9. The pharmaceutical composition according to claim 1 , wherein the one or more pharmaceutically acceptable excipients are selected from the group comprising binders, diluents, disintegrants, lubricants/glidants/antiadherants, plasticizers, or mixtures thereof.
10. The pharmaceutical composition according to claim 1 , wherein the pharmaceutical composition is in the form of tablet.
11. A process for the preparation of a pharmaceutical composition comprising (i) 50% to 99% of doxycycline and one or more pharmaceutically acceptable excipients as an immediate-release portion; and (ii) 1% to 50% of doxycycline, a controlled-release polymer, and one or more pharmaceutically acceptable excipients as a controlled-release portion, wherein the pharmaceutical composition provides a total daily dosage of 40 mg when administered once daily, and wherein the process comprises:
a) preparing the immediate-release portion comprising doxycycline and one or more pharmaceutically acceptable excipients;
b) preparing the controlled-release portion comprising doxycycline, a controlled-release polymer, and one or more pharmaceutically acceptable excipients; and
c) processing the immediate-release portion and the controlled-release portion to form the pharmaceutical composition.
12. A method of treating rosacea by administering to a patient in need thereof a pharmaceutical composition comprising (i) 50% to 99% of doxycycline and one or more pharmaceutically acceptable excipients as an immediate-release portion; and (ii) 1% to 50% of doxycycline, a controlled-release polymer, and one or more pharmaceutically acceptable excipients as a controlled-release portion, wherein the pharmaceutical composition provides a total daily dosage of 40 mg when administered once daily.