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Processes and apparatuses for the production of crystalline organic microparticle compositions by micro-milling and crystallization on micro-seed and their use

A grinder, the technology of crystallizing particles, applied in the field of endeavor

Inactive Publication Date: 2009-06-10
MERCK & CO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Recently, media milling has been used to produce final product streams for direct formulation of pharmaceuticals with particles smaller than 400 mm (see U.S. Patent No. 5,145,684), but the use of wet-milled microseeds in subsequent crystallization has not previously been shown

Method used

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  • Processes and apparatuses for the production of crystalline organic microparticle compositions by micro-milling and crystallization on micro-seed and their use
  • Processes and apparatuses for the production of crystalline organic microparticle compositions by micro-milling and crystallization on micro-seed and their use
  • Processes and apparatuses for the production of crystalline organic microparticle compositions by micro-milling and crystallization on micro-seed and their use

Examples

Experimental program
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Effect test

example

[0098] The microcrystalline seed particles are prepared by one of two mills: a 600ml disc mill indicated by the KDL model, produced by -Mill made. The mill compartment is chrome treated and the agitation disc is yttrium stabilized zirconia. The mill was loaded with approximately 1900 grams of yttrium stabilized zirconia beads of uniform diameter. The 160ml agitated Mini-Cer grinder includes a ceramic compartment and a ceramic stirrer and is manufactured by Netzsch Inc. The mill was loaded with approximately 500 grams of yttrium-stabilized zirconia beads of varying sizes and uniform diameter. Beads for these grinders are made from Inc., Wyncote, Pennsylvania. They are highly polished and originally manufactured by TOSOHUSA, Inc.

[0099] Particle surface area was determined using BET multipoint analysis on GEMINI 2360 (by Instrument Corporation Inc., Norcross, Georgia) unless otherwise stated.

Embodiment

Embodiment 8

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Abstract

The present invention relates to a process, for the production of crystalline particles of an active organic compound. The process includes the steps of generating a micro-seed by a wet-milling process and subjecting the micro-seed to a crystallization process. The resulting crxystalline particles have a mean particle size of less than about 100 [mu] m. The present invention also provides for a pharmaceutical composition which includes the crystalline particles produced by the method described herein and a pharmaceutically acceptable carrier.

Description

Background of the invention [0001] During the production of active organic compounds, such as active pharmaceutical ingredients ("APIs"), solid formation is most commonly achieved by crystallization in the solution phase, followed by isolation and drying. Often, the dry reactive organic compound must be further processed to achieve a particle size distribution that ensures proper formulation of the final product. Whilst the resulting particle size can vary considerably in most cases, the fine powder of the pharmaceutically active ingredient has an average size of less than 300 microns. However, crystallization with particles smaller than 40 microns is strongly desired because pharmaceutical targets have low water solubility and / or low permeability. Small particles in the formulation provide a higher surface area for transport into the body. [0002] A dry milling step, such as air jet classifier milling, pin milling or hammer milling, is usually performed to achieve an accep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14C13F1/02C13B30/02
CPCA61K9/14A61P11/06A61P11/14A61P19/08A61P21/02A61P25/00A61P25/02A61P25/04A61P25/08A61P25/20A61P25/22A61P25/24A61P29/02A61P3/14A61P31/04A61P31/12A61P33/00A61P35/00A61P3/06A61P37/00A61P37/06A61P37/08A61P43/00A61P5/14A61P5/18A61P5/24A61P7/02A61P7/04A61P9/06A61P9/08A61P9/12A61P3/10C13B30/02
Inventor B·K·约翰逊H·H·腾I·李M·米德勒A·库特C·斯达巴克
Owner MERCK & CO INC
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