US 2023/0398111 A1 · ORAL FORMULATIONS OF NINTEDANIB AND METHOD OF MANUFACTURING THEREOF

Oral formulations of nintedanib and method of manufacturing thereof

AssigneeBdr Pharmaceuticals International Private Limited

InventorsShah Dharmesh MAHENDRABHAI, Badiger Aravind Manappa, Sharma Mukeshkumar SUBHASHCHANDRA, Trivedi Madhavkumar DILIPBHAI, Choksi Rakshit KETANBHAI, Panchal Samirkumar BABULAL, Vora Pratik ASHWINBHAI, Patel Harikrishnabhai VINUBHAI, Shah Shreyash PRAKASHKUMAR, Gandhi Prashant KANAIYALAL

Life of this patent

Estimating the term…

Abstract

The present invention relates to an oral soft-gelatin capsule dosage form of Nintedanib and pharmaceutically acceptable salt thereof. The invention also relates to provide patient-compliant, economical and technically advanced dosage form over existing marketed dosage form as well as nearest prior-arts. Moreover, the dissolution rate and stability of the patient compliant Nintedanib formulation, prepared as per the present invention, is proven higher when compared to prior art inventions. Furthermore, the present invention also provides an oily dispersion without using lecithin is prepared by a process which is relatively simple, easy to commercially manufacture, and functionally reproducible.

Claims10

Dependent claims

An oral pharmaceutical formulation comprising of oily dispersion which consisting essentially of:

a) Nintedanib or pharmaceutically acceptable salt thereof;
b) Medium chain fatty acid glycerides;
wherein the above formulation,
i) does not contain Lecithin;
ii) shows more than 90% of drug dissolution within 15 minutes;
and,
iii) shows total impurities content less than 0.2% after stability study of 9 months at (40±2)° C. and (75±5)% RH.

4 more elements

Dependencies are inferred from the claim text.

Facts

Application

18/249,344Filed 14 Oct 2021

Priority

IN 20202104487315 Oct 2020

Published

14 Dec 2023

Term ends

Not estimatedThe source records don’t support an estimate.

Classification5 codes

A61K 31/496
Having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines: non-condensed piperazines…
A61K 9/4825
Wall or shell material: proteins, e.g. gelatin
A61K 9/4858
Filling excipients; Inactive ingredients: organic compounds
A61K 9/4875
Filling excipients; Inactive ingredients: compounds of unknown constitution, e.g. material from plants or animals