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A Process For The Preparation Of Crystalline Form Of Tafamidis

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.

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Patent Information

Application #
Filing Date
17 October 2022
Publication Number
16/2024
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

Biophore India pharmaceuticals Pvt. Ltd
Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad, Telangana India-500033.

Inventors

1. Manik Reddy Pullagurla
Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad, Telangana India-500033.
2. Jagadeesh Babu Rangisetty
Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad, Telangana India-500033.
3. Bhaskar Reddy Pitta
Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad, Telangana India-500033.
4. Kiran Kumar Kothakonda
Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad, Telangana India-500033.
5. Rajesham Boge
Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad, Telangana India-500033.

Specification

DESC:Enclosed ,CLAIMS:Enclosed

Documents

Application Documents

# 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