IP Library › Granted Patent US 11,471,447
Granted Patent B2
US 11,471,447 · App. 16/896,744 · Granted Oct 18, 2022

Stable pharmaceutical product and vessel comprising sodium picosulfate, magnesium oxide and citric acid

Inventors: Parthasaradhi Reddy Bandi (Hyderabad, IN); Khadgapathi Podile (Hyderabad, IN); Sunil Deviprasad Tiwari (Hyderabad, IN); Vijay Nasare (Hyderabad, IN); Prakash Shetiya (Hyderabad, IN); Patchigolla Satyanarayana Rao (Hyderabad, IN); Chidara Ravi Chandra Gupta (Hyderabad, IN)
Assignee: HETERO LABS LIMITED
A61K31/4402A61K47/02A61K47/12A61M3/02A61K9/0053
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Quick Facts
Patent No.
US 11,471,447
App. No.
16/896,744
Granted
Oct 18, 2022
Kind
B2
Abstract

Described herein is a stable oral liquid pharmaceutical product comprising sodium picosulfate, magnesium oxide and citric acid. Particularly, sodium picosulfate is physically separated from magnesium oxide and citric acid prior to dispensing and is mixed at the time of administration.

Claims (11)

1. A stable oral liquid pharmaceutical product comprising:

sodium picosulfate, and

a combination of magnesium oxide and citric acid,

wherein the sodium picosulfate is physically separated from the combination of magnesium oxide and citric acid in a two-compartment vessel, which holds a sodium picosulfate solution in a first compartment and a magnesium oxide and citric acid solution in a second compartment, wherein the vessel permits the components of the first and second compartments to be dispensed together simultaneously as a liquid solution, and

wherein the first and second compartments do not include malic acid.

2. The pharmaceutical product of claim 1 , comprising a (4-[(Pyridin-2-yl) (4-hydroxyphenyl)methyl] phenyl sodium sulfate impurity in an amount of less than 0.5% after storage for three months at 40° C.

3. The pharmaceutical product of claim 1 , further comprising one or more pharmaceutically acceptable excipients selected from alkalizing agents, preservatives, stabilizers, antioxidants, buffering agents, sweeteners and flavoring agents.

4. A vessel comprising the first compartment and the second compartment of claim 1 .

5. The vessel of claim 4 , wherein the vessel further comprises a lid separately sealing the first and second compartments.

6. The vessel of claim 4 , wherein the first and/or second compartment further comprises one or more pharmaceutically acceptable excipients selected from alkalizing agents, preservatives, stabilizers, antioxidants, buffering agents, sweeteners and flavoring agents.

7. A method of cleansing the colon of a subject as a preparation for colonoscopy, comprising administering the dispensed composition of claim 1 .

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 10, 2020
From: BANDI, PARTHASARADHI REDDY; PODILE, KHADGAPATHI; TIWARI, SUNIL DEVIPRASAD; NASARE, VIJAY; SHETIYA, PRAKASH; RAO, PATCHIGOLLA SATYANARAYANA; GUPTA, CHIDARA RAVI CHANDRA
To: HETERO LABS LIMITED
Reel/Frame 053177/0007 →
Priority Claims (1)
IN 201941024546 · Jun 20, 2019 · national
Continuity (1)
Related Publication 20200397767A1 · Dec 24, 2020