Pharmaceutical compositions of linezolid

a technology of linezolid and composition, which is applied in the direction of medical preparations, organic active ingredients, and pill delivery, etc., can solve the problems of unsuitable for both processes, special materials or equipmen

Inactive Publication Date: 2015-11-26
HETERO RES FOUND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The proposed solution ensures the stability of linezolid Form III in its crystalline form during manufacturing and storage, maintaining high crystallinity and preventing polymorphic form conversion, thereby ensuring consistent efficacy and shelf life stability.

Problems solved by technology

Both processes require either special material or equipment which are not desirable for commercial production.

Method used

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  • Pharmaceutical compositions of linezolid
  • Pharmaceutical compositions of linezolid
  • Pharmaceutical compositions of linezolid

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0048]

S. NoIngredientsMg / TabletIntragranular1Linezolid (Form III)6002Lactose monohydrate703Hydroxypropylmethyl cellulose124Polacrilin potassium55Magnesium stearate10Extragranular Ingredients6Lactose monohydrate1407Silica colloidal anhydrous108Polacrilin potassium59Magnesium stearate810Opadry White 03B5889513.0011Purified waterqsTotal weight873

Brief Manufacturing Process:

[0049]Linezolid, lactose monohydrate, hydroxypropylmethyl cellulose, polacrilin potassium and magnesium stearate are sifted through suitable mesh and blended. The dry mix is granulated by slugging method. The formed slug mass was milled and passed through suitable screen. The blend is pre-lubricated and lubricated with lactose monohydrate, silica colloidal anhydrous, polacrilin potassium, magnesium stearate and compressed into a tablet using appropriate tooling or the granules were filled into capsules / sachets.

example 2

[0050]

S. NoIngredientsMg / TabletIntragranular1Linezolid (Form III)6002Lactose monohydrate253Light magnesium carbonate254Hydroxypropylmethyl cellulose125Polacrilin potassium56Magnesium stearate10Extragranular Ingredients7Lactose monohydrate1458Silica colloidal anhydrous109Polacrilin potassium810Magnesium stearate8Total weight848

Brief Manuacturing Process: The dry granules were prepared with the procedure described in the example 1. The lublicated blend was compressed into tablets using appropriate tooling.

example 3

[0051]

S. NoIngredientsMg / TabletIntragranular1Linezolid (Form III)6002Lactose monohydrate253Light magnesium carbonate104Hydroxypropylmethyl cellulose125Magnesium stearate10Extragranular Ingredients6Lactose monohydrate1657Silica colloidal anhydrous108Polacrilin potassium39Magnesium stearate8Total weight843

Brief Manufacturing Process: The dry granules were prepared with the procedure described in the example 1. The lubricated blend was compressed into tablets using appropriate tooling.

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Abstract

The present invention relates to stable pharmaceutical compositions comprising linezolid crystalline Form III with one or more pharmaceutically acceptable excipients, wherein the composition retains linezolid in its original crystalline form.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application is a continuation of U.S. application Ser. No. 13 / 813,459 filed on Jan. 31, 2013 which is a 371 of PCT / IN2011 / 000583 filed on Aug. 29, 2011, which claims the benefit of priority to Indian Application No. 2557 / CHE2010, filed on Sep. 2, 2010, the contents of which are incorporated by reference here in.BACKGROUND OF THE INVENTION[0002]Linezolid is a synthetic antibacterial agent. Chemically, it is (S)—N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35.[0003]Linezolid is used in the treatment of vancomycin-resistant enterococcus faecium infections; nosocomial pneumonia; complicated skin and skin structure infections including diabetic foot infections, without concomitant osteomyelitis; uncomplicated skin and skin structure infections and community acquired pneumonia.[0004]Linezolid is sold in the U.S. under the brand name(s) of Z...

Claims

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Application Information

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Patent Type & AuthorityApplications(United States)
IPC IPC(8): A61K31/5377A61K9/14
CPCA61K31/5377A61K9/145A61K9/146A61K9/2027A61K9/2077A61K9/2095
InventorREDDY, BANDI PARTHASARADHIKHADGAPATHI, PODILIREDDY, GOLI KAMALAKARKRISHNA, LEKKALA VAMSHI
OwnerHETERO RES FOUND