# US 9,750,700 B2 · Imatinib mesylate oral pharmaceutical composition and process for preparation thereof

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- Number: US 9,750,700 B2
- Document ID: US9750700B2
- Status: Granted
- Kind: B2
- Application number: 13/166,499
- Filed: 2011-06-22
- Published: 2012-12-27
- Granted: 2017-09-05
- Earliest claimed: 2011-06-22
- Assignees: Natco Pharma Limited
- Applicants: Kali Satya Bhujanga Rao Adibhatla; Venkaiah Chowdary Nannapaneni
- Inventors: Kali Satya Bhujanga Rao Adibhatla; Venkaiah Chowdary Nannapaneni
- Web page: https://patentgrep.com/patent/US9750700B2

## CPC

- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/1688: {resulting in pure drug agglomerate optionally containing up to 5% of excipient}
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 35/04: specific for metastasis
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to an oral pharmaceutical composition comprising, greater than 80% of Imatinib, by weight based on the total weight of the composition and the process for preparation thereof.

## Claims

### Claim 1

A tablet composition comprising an intragranular and an extragranular portion;
at least 97% Imatinib mesylate by weight based on the total weight of the tablet composition; and
a lubricant, wherein
the lubricant is present in the extragranular portion of the tablet composition; and
the lubricant is sodium stearyl fumarate.

### Claim 2 (depends on 1)

A tablet composition of claim 1, wherein the lubricant is present in both the intragranular and extragranular portions of the tablet composition.

### Claim 3 (depends on 1)

A tablet composition of claim 1, wherein the amount of lubricant is at least about 1% w/w of the total composition.

### Claim 4

A process for the preparation of a tablet composition comprising at least 97% Imatinib mesylate by weight based on the total weight of the tablet composition, wherein the tablet composition comprises an intragranular and an extragranular portion, said process comprising wet granulation; wherein
a lubricant is present in the extragranular portion of the tablet composition; and
the lubricant is sodium stearyl fumarate.

### Claim 5 (depends on 4)

A process according to claim 4 wherein the lubricant is present in both the extragranular and intragranular portions of the tablet composition.