Back to results
US 11,883,403 B2Granted
Pharmaceutical compositions comprising Afatinib
AssigneeFresenius Kabi Oncology Limited
InventorsRajesh Khanna, Neeraj Kumar, Vijay Kumar Sharma, Ankit Gaur, Dhiraj Khattar
Life of this patent
Estimating the term…
Abstract
The present invention relates to a tablet comprising Afatinib or a pharmaceutically acceptable salt thereof, wherein the tablet is obtained by direct compression. The present invention further relates to a process for manufacturing a tablet of the invention as well as the use of the tablet of the invention.
Claims20
A process for manufacturing a tablet, the process comprising:
- (i) providing a mixture of afatinib or a pharmaceutically acceptable salt thereof and lactose;
- (ii) combining the mixture of step (i) with at least one lubricant, to produce a lubricated mixture;
- and
- (iii) directly compressing the lubricated mixture of step (ii) to form the tablet, wherein a granulation step is not performed in the process.
1 more element
A process for manufacturing a batch of tablets, the process comprising:
- (i) providing a mixture of afatinib dimaleate and lactose;
- (ii) combining the mixture of step (i) with at least one lubricant, to produce a lubricated mixture;
- and
- (iii) directly compressing the lubricated mixture of step (ii) to form the tablets, wherein a granulation step is not performed in the process, and wherein each tablet comprises a therapeutically effective amount of afatinib specified by a label claim.
1 more element
Dependencies are inferred from the claim text.