IP Library Granted Patent US 11,364,196
Granted Patent B2
US 11,364,196 · App. 15/773,619 · Granted Jun 21, 2022

Levothyroxine formulations for oral use

Inventors: Kocherlakota Chandrashekhar (Secunderabad, IN); Banda Nagaraju (Hyderabad, IN)
Assignee: LEIUTIS PHARMACEUTICALS PVT. LTD.
A61K9/006A61K31/198A61K47/10A61K47/183A61K47/40
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Quick Facts
Patent No.
US 11,364,196
App. No.
15/773,619
Granted
Jun 21, 2022
Kind
B2
Abstract

The present invention relates to novel oral spray formulations of Levothyroxine. Further the invention also describes process for preparing such formulations.

Claims (16)

1. A spray formulation of Levothyroxine comprising:

(i) levothyroxine sodium in a concentration of 0.0025-5% by weight of the total formulation;

(ii) buffering agents or pH adjusting agents selected from arginine or alanine in a concentration of 0.0015-0.5% by weight of the total formulation;

(iii) one or more solvents, wherein the solvents are selected from one or more of propylene glycol, glycerol, polyethylene glycol (PEG), and water;

(iv) sulfobutylether-β-cyclodextrin (SBECD); and

(v) one or more pharmaceutically acceptable excipients, wherein the pH of the formulation is between 5.5 and 6.5.

2. A spray formulation of Levothyroxine according to claim 1 further comprising buffering agents selected from phosphate, citrate, sodium carbonate, sodium bicarbonate, tartarate, benzoate, lactate, acetate, glutaric, malic, succinic acid, carbonic acid, Tris, and meglumine.

3. A spray formulation of Levothyroxine according to claim 1 further comprising sodium hydroxide, potassium hydroxide, ammonium carbonate, hydrochloric acid, citric acid, lactic acid, phosphoric acid, or sulfuric acid.

4. The spray formulation of claim 1 , wherein the pharmaceutically acceptable excipients are selected from sweetening agents, flavoring agents, preservatives, penetration enhancers and stabilizers.

5. The formulation of claim 1 , wherein the concentration of SBECD ranges from 10-40% by weight of the total formulation.

6. A spray formulation of levothyroxine comprising:

(i) levothyroxine sodium in a concentration of 0.0025-5% by weight of the total formulation;

(ii) arginine in a concentration of 0.0015-0.5% by weight of the total formulation;

(iii) propylene glycol in a concentration of 0.002-0.05% by weight of the total formulation;

(iv) sulfobutylether-β-cyclodextrin (SBECD) in a concentration of 10-40% by weight of the total formulation; and

(v) one or more pharmaceutically acceptable excipients, wherein the pH of the formulation is between 5.5 and 6.5.

Assignments (2)
CHANGE OF NAME Recorded May 23, 2022
From: LEIUTIS PHARMACEUTICALS PVT. LTD.
To: LEIUTIS PHARMACEUTICALS LLP
Reel/Frame 060161/0776 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 4, 2018
From: CHANDRASHEKHAR, KOCHERLAKOTA; NAGARAJU, BANDA
To: LEIUTIS PHARMACEUTICALS PVT. LTD.
Reel/Frame 045715/0197 →
Priority Claims (1)
IN 5957/CHE/2015 · Nov 4, 2015 · national
Continuity (1)
Related Publication 20190060217A1 · Feb 28, 2019