US 10,537,562 B2 · Delayed release pharmaceutical composition of pantoprazole and process for formulation thereof

Abstract

The present invention discloses stable delayed release multiparticulate powder for oral suspension of proton pump inhibitor compounds comprising: a) a core with an effective amount of proton pump inhibitor and at least one or more pharmaceutical excipients, b) at least one water-soluble seal coating over core c) at least one enteric coating layer over the seal coat wherein the said core comprises disintegrant (0-10%) and/or surfactant (0-2%) w/w of core. The prior art discloses restrictive formulation technique and suggest high amount of various excipients to achieve desired technical attributes. The prepared test formulations exhibited desired pharmaceutical technical attributes like drug release, assay, stability, no polymorphic change, reduced sticking to nasogastric and gastronomy tubes, and packaging material.

Claims19

Dependent claims

A delayed release multiparticulate powder for oral suspension comprising:

a) a core comprising an effective amount of Pantoprazole or its pharmaceutically acceptable salts as the sole active pharmaceutical ingredient, at least one diluent and an alkaline agent,
b) at least one seal coating layer over the core, and
c) at least one enteric coating layer over the seal coat,
wherein the core is free of disintegrant and surfactant and the particle size of the Pantoprazole or its pharmaceutically acceptable salt has a D90 value less than about 100 mm, wherein the powder for oral suspension is not a tablet.

1 more element

Dependencies are inferred from the claim text.

Facts

Application

16/087,043Filed 6 Oct 2017

Priority

IN 2016110342716 Oct 2016

Published

US 2019/0099408 A14 Apr 2019

Granted

21 Jan 2020

Term ends

Not estimatedThe source records don’t support an estimate.

Classification12 codes

A61K 31/4439
Containing further heterocyclic ring systems: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
A61K 9/0095
Galenical forms not covered by A61K9/02 - A61K9/7023: drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets…
A61K 9/5047
Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose: cellulose ethers containing no…
A61K 9/5073
Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated…:…

Delayed release pharmaceutical composition of pantoprazole and process for formulation thereof

Life of this patent

Delayed release pharmaceutical composition of pantoprazole and process for formulation thereof

Life of this patent

Abstract

Claims19