Process for coating a pharmaceutical particle

A technology of coating and granulation, which is applied in the direction of coating granules, granulation of raw materials, drug combination, etc., which can solve the problems of poor protection, pungent smell, and low recovery efficiency of intestinal products

Inactive Publication Date: 2005-09-28
EI DU PONT DE NEMOURS & CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since these methods are not effective for discrete drug crystals (typically smaller than 200 μm, mostly 1-80 μm), a new technique is needed to provide the efficacy of drug tablet and particle coatings, but at the primary drug particle scale
Traditional coating methods for tablets, pills and granules can in some cases have quality and manufacturing processing issues, such as the coated product not being uniformly coated (or the coating cracked), causing the drug particles to exhibit undesirable Release profile, poor protection for enteral products, inconsistent bioavailability, off-flavor, pungent odor, ingredient interactions, and poor product stability
Traditional wet coating processes are more restrictive, where the material to be coated needs to be poorly soluble in the solvent in which it was first dipped or dispersed in order to achieve coating
This requires solvent handling, solid / liquid separation and drying operations, inefficiencies in recovery, generation of active ingredients and waste of solvents and coating agents

Method used

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  • Process for coating a pharmaceutical particle
  • Process for coating a pharmaceutical particle
  • Process for coating a pharmaceutical particle

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0112] use as figure 1 The device shown was coated with a sample of ibuprofen USP (Spectrum Chemical Co., Gardena, CA). This device had a 3.18 cm diameter mixing chamber 19.05 cm long with a 1.02 cm nozzle throat and a 0.39 cm diameter central liquid feed tube. This unit has a single screw metering feeder (AccuRate, Whitewater, WI) for metering solid particles. A peristaltic pump (Cole-Parmer, Vernon Hill IL) was fitted with a 6.5mm Tygon TM Elastic rubber tube for metering liquids. Ibuprofen was metered into the system (51.3, 71.6, 120.5 g / min). Eudragit  RL30D was metered into the base tube at a range (27.0, 28.1, 30.4 g / min) at an ambient temperature of 22°C. The pressure of the heating gas at the nozzle was 551 kPa, and the temperature at the nozzle was 125°C. Pressurized nitrogen is used to nebulize Eudragit  RL30D, create a negative pressure in the mixing area to promote the addition of ibuprofen, and provide heat to evaporate the residual water on the ibuprofen...

Embodiment 2

[0118] use as figure 1 The device shown is coated with ibuprofen USP (Spectrum Chemical Co., Gardena, CA). This device has a mixing chamber with a diameter of 2.54 cm and a length of 19.05 cm or a mixing chamber with a diameter of 3.18 cm and a length of 43.18 cm. The mixing chamber has a nozzle throat with a diameter of 0.64-1.02 cm and a diameter of 0.18-0.39 cm. Center liquid feed tube. This unit has a single-screw metering feeder (AccuRate) for metering solid particles. In this example, the ibuprofen feed rate was 300-400 g / min. Peristaltic pump (Masterflex model5718-10 Cole-Parmer, Vernon Hill. IL) equipped with Masterflex LS / 25 (4.8mmI.D) or Masterflex LS / 16 (3.1mmI.D) Tygon  Elastic rubber tube for metering liquids. Ethylcellulose (Ethocel Standard, Premium; Dow Chemical Co., Midland, MI) was dissolved in acetone to form a coating solution. In some cases, triethyl citrate (as a plasticizer; Spectrum Chemical Co., Gardena, CA) was also dissolved in the solution. T...

Embodiment 3

[0124] use as figure 1The device shown and described in Example 2 was coated with caffeine, USP (Spectrum Chemical Co., Gardena, CA). This unit has a single screw metering feeder (AccuRate, Whitewater, WI) for metering solid particles. In this example, the ibuprofen feed rate was 300-400 g / min. Peristaltic pumps (Masterflex model 5718-10) were fitted with Masterflex LS / 25 (4.8mm I.D) or Masterflex LS / 16 (3.1mm I.D) Tygon elastic rubber tubing for metering liquids. Eudragit was dissolved in acetone to form a coating solution. In some cases, triethyl citrate (as a plasticizer) was also dissolved in the solution. The coating solution was metered into the base tube at room temperature in the range of 20-30 g / min. Heated nitrogen is used to atomize the coating solution, create negative pressure in the mixing zone to introduce caffeine, and provide heat to evaporate the solvent. The mixed / dried product goes through the mixing chamber into the cyclone separator to collect the pr...

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Abstract

A process of coating to create pharmaceutical particles is disclosed. The coating can enhance the pharmaceutical particle by providing a controlled release barrier, moisture barrier, surface modifying agent, wetting agent, flowability or fluidizing agent, hydrophobicity or hydrophilicity agent, flavor masking agent, odor masking agent, release control agent, or coloring agent; or an inert particle can be coated with a pharmaceutically active liquid. Also disclosed are coated pharmaceutical particles made by one of the processes of the invention.

Description

[0001] This application claims the benefit of US Provisional Application 60 / 403487, filed August 14,2002. field of invention [0002] A method of coating drug particles with a liquid coating is disclosed. Coatings can provide useful properties to particles such as providing moisture barriers, improving stability, enhancing wettability, improving dispersion, flow and fluidization, increasing or delaying the release of pharmaceutically active ingredients, masking off-flavors, masking odors and Colorizes the particles. Background technique [0003] A considerable number of prescription and over-the-counter drugs currently sold have surface coatings to add value to the product. Coating techniques are known in the industry, e.g. to impart important properties such as odor masking, enhanced stability and controlled release of actives; where the rate of release can be increased, delayed or maintained over time to prolong freed. [0004] For example, the rate of drug release to t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/48A61K9/50B01J2/00B05D7/00
CPCA61K9/2081A61K9/4866A61K9/5047B01J2/006A61K9/5026B29B2009/163A61P29/00A61P43/00A61K9/28A61K9/50A61K9/16
Inventor L·L·伯格N·甘格拉德赵千秋S·M·达尔兹尔G·A·舒尔T·弗里德曼T·J·小特罗特
Owner EI DU PONT DE NEMOURS & CO
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