Abstract: ABSTRACT “A PROCESS FOR THE PREPARATION OF CRYSTALLINE FORM OF TAFAMIDIS” The present invention relates to a stable crystalline form of Tafamidis having characteristic 2-theta peaks at 13.6±0.2, 20.4±0.2 and 27.5±0.2. The present invention provides Tafamidis having particle size (d90) less than 100microns. Furthermore, the present invention relates to a novel process for the preparation of crystalline form of Tafamidis (1) with particle size (d90) less than 100microns and specific surface area less than 30sq.m/g.The present invention relates to a stable oral dosage form comprising composition containing Tafamidis, particularly, a soft gel capsule comprising composition containing Tafamidis and to methods for their preparation.The present invention relates to a stable oral dosage form comprising composition containing Tafamidis which is indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
DESC:Enclosed ,CLAIMS:Enclosed
| # | Name | Date |
|---|---|---|
| 1 | 202241059152-PROVISIONAL SPECIFICATION [17-10-2022(online)].pdf | 2022-10-17 |
| 2 | 202241059152-FORM 1 [17-10-2022(online)].pdf | 2022-10-17 |
| 3 | 202241059152-DRAWINGS [17-10-2022(online)].pdf | 2022-10-17 |
| 4 | 202241059152-FORM 3 [14-10-2023(online)].pdf | 2023-10-14 |
| 5 | 202241059152-ENDORSEMENT BY INVENTORS [14-10-2023(online)].pdf | 2023-10-14 |
| 6 | 202241059152-DRAWING [14-10-2023(online)].pdf | 2023-10-14 |
| 7 | 202241059152-COMPLETE SPECIFICATION [14-10-2023(online)].pdf | 2023-10-14 |
| 8 | 202241059152-Request Letter-Correspondence [19-10-2023(online)].pdf | 2023-10-19 |
| 9 | 202241059152-RELEVANT DOCUMENTS [19-10-2023(online)].pdf | 2023-10-19 |
| 10 | 202241059152-Power of Attorney [19-10-2023(online)].pdf | 2023-10-19 |
| 11 | 202241059152-POA [19-10-2023(online)].pdf | 2023-10-19 |
| 12 | 202241059152-FORM28 [19-10-2023(online)].pdf | 2023-10-19 |
| 13 | 202241059152-FORM-26 [19-10-2023(online)].pdf | 2023-10-19 |
| 14 | 202241059152-FORM 13 [19-10-2023(online)].pdf | 2023-10-19 |
| 15 | 202241059152-Form 1 (Submitted on date of filing) [19-10-2023(online)].pdf | 2023-10-19 |
| 16 | 202241059152-Covering Letter [19-10-2023(online)].pdf | 2023-10-19 |
| 17 | 202241059152-AMENDED DOCUMENTS [19-10-2023(online)].pdf | 2023-10-19 |
| 18 | 202241059152-FORM 3 [27-12-2023(online)].pdf | 2023-12-27 |