ORAL FORMULATIONS OF NINTEDANIB AND METHOD OF MANUFACTURING THEREOF

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-a...

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Hauptverfasser: MUKESHKUMAR SUBHASHCHANDRA, Sharma, DHARMESH MAHENDRABHAI, Shah, PRASHANT KANAIYALAL, Gandhi, RAKSHIT KETANBHAI, Choksi, ARAVIND MANAPPA, Badiger, SAMIRKUMAR BABULAL, Panchal, SHREYASH PRAKASHKUMAR, Shah, MADHAVKUMAR DILIPBHAI, Trivedi, PRATIK ASHWINBHAI, Vora, HARIKRISHNABHAI VINUBHAI, Patel
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creator MUKESHKUMAR SUBHASHCHANDRA, Sharma
DHARMESH MAHENDRABHAI, Shah
PRASHANT KANAIYALAL, Gandhi
RAKSHIT KETANBHAI, Choksi
ARAVIND MANAPPA, Badiger
SAMIRKUMAR BABULAL, Panchal
SHREYASH PRAKASHKUMAR, Shah
MADHAVKUMAR DILIPBHAI, Trivedi
PRATIK ASHWINBHAI, Vora
HARIKRISHNABHAI VINUBHAI, Patel
description 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. La présente invention concerne une forme galénique orale en capsule de gélatine molle de Nintedanib et de son sel pharmaceutiquement acceptable. L'invention concerne également une forme galénique adaptée au patient, économique et techniquement avancée par rapport aux formes galéniques actuellement commercialisées ainsi qu'à l'art antérieur le plus proche. De plus, la vitesse de dissolution et la stabilité de la formulation de Nintedanib adaptée au patient, préparée selon la présente invention, s'avèrent supérieures par rapport aux inventions de l'art antérieur. En outre, la présente invention concerne également une dispersion huileuse sans utilisation de lécithine, préparée par un procédé qui est relativement simple, facile à fabriquer commercialement, et fonctionnellement reproductible.
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subjects HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
title ORAL FORMULATIONS OF NINTEDANIB AND METHOD OF MANUFACTURING THEREOF
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