Multiparticulate pharmaceutical composition of tamsulosin and solifenacin
AssigneeZim Laboratories Limited
InventorsAnwar Daud, Chandrashekhar Mainde, Anil Jadhav, Yuvraj Rathod, Uttam Kedar
Life of this patent
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Abstract
The present disclosure relates to a multiparticulate and multilayered composition. The inner layer has tamsulosin or a pharmaceutically acceptable salt thereof in a modified release form. The outer layer has solifenacin or a pharmaceutically acceptable salt there of in an immediate release form. There are one or more protective layers configured to protect the outer layer. The composition also contains pharmaceutically acceptable excipients. The composition has a plurality of discrete or aggregated particles irrespective of their size, shape or morphology, and releases the drug at a predetermined rate.
Claims14
A composition comprising:
- a plurality of discrete or aggregate particles acting as a separate dosage form unit, wherein each particle comprises:
- a) an inner layer comprising tamsulosin or a pharmaceutically acceptable salt thereof, and diluents, wherein the inner layer is in a modified release form;
- b) a first seal coat over the inner layer, wherein the first seal coat comprises Hypromellose 5 cps;
- c) a sustained-release coating over the first seal coat, wherein the sustained release coating comprises modified-release polymers;
- d) a second seal coat over the sustained-release coating, wherein the first second seal coat comprises Hypromellose 5 cps, and antioxidants;
- e) an outer layer over the second seal coat, wherein the outer layer comprises solifenacin or a pharmaceutically acceptable salt thereof, Hypromellose 5 cps, and antioxidants, wherein the outer layer is in an immediate release form;
- and
- f) one or more protective layers configured to protect the outer layer, wherein the one or more protective layers comprise Hypromellose 5 cps, and butylated hydroxyl toluene;
- wherein each of the plurality of the discrete or aggregate particles has an average particle diameter ranging from 20 to 1200 μm.
A process of manufacturing a composition, the process comprising the step of:
- i) mixing tamsulosin or a pharmaceutically acceptable salt thereof with diluents to obtain a mixture, and spheronizing the mixture in a spheronizer to form an inner layer;
- ii) seal coating the inner layer prepared in step i) by using Hypromellose 5 cps to obtain a first seal coat;
- iii) coating the first seal coat prepared in step ii) by modified-release polymers to obtain a sustained-release coating;
- iv) seal coating the sustained-release coating by using Hypromellose 5 cps, and antioxidants to obtain a second seal coat;
- v) coating solifenacin or a pharmaceutically acceptable salt thereof over the second seal coat prepared in step iv) along with Hypromellose 5 cps, and antioxidants to obtain an outer layer, wherein the outer layer is in an immediate release form;
- vi) coating the outer layer with one or more protective layers, wherein the one or more protective layers comprise Hypromellose 5 cps, and butylated hydroxyl toluene, wherein each of the plurality of the discrete or aggregate particles has an average particle diameter ranging from 20 to 1200 μm, and wherein each of the plurality of the discrete or aggregate particles acts as a separate dosage form unit.
Dependencies are inferred from the claim text.