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High content sodium ibuprofen granules, their preparation and their use in preparing non-effervescent solid dosage forms

A technology of ibuprofen sodium and granules, which is applied in the field of high-content ibuprofen pharmaceutical granules, and can solve the problem of large tablets

Inactive Publication Date: 2015-09-02
SI GROUP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, doing so would result in unacceptably large tablets, since to achieve the same amount of ibuprofen in a single tablet, the tablet size would have to be increased to accommodate the increased amount of inert excipients

Method used

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  • High content sodium ibuprofen granules, their preparation and their use in preparing non-effervescent solid dosage forms
  • High content sodium ibuprofen granules, their preparation and their use in preparing non-effervescent solid dosage forms
  • High content sodium ibuprofen granules, their preparation and their use in preparing non-effervescent solid dosage forms

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preparation example Construction

[0057] Preparation of Granules of the Invention

[0058] To prepare the granules of the present invention, the above three main components are mixed in a suitable ratio to each other in a high shear granulator while wetting with water. In actual preparation, it is desirable to form a solution of polyvinylpyrrolidone in water before forming the overall mixture of the three components. This results in a more uniform distribution of the polyvinylpyrrolidone in the granules. After blending and granulation in a high shear granulator, water is removed from the wet granules by conventional drying procedures such as pan drying in an oven or fluid bed drying. Typically, drying is carried out at temperatures up to about 100°C. Preferably the oven temperature for drying the granules is in the range of about 60 to about 70°C. In the case of fluid bed dryers, the inlet temperature is also preferably in the range of about 60 to about 70°C. In a particularly preferred drying operation,...

example 1

[0084] Granule preparation

[0085] Prepared by the wet granulation method of the present invention is composed of 95.5% by weight of sodium ibuprofen hydrate, 2% by weight of sodium carbonate and 2.5% by weight of polyvinylpyrrolidone (Plasdone K-90, International Specialty Products Inc., Wayne, NJ). composed of particles. The method employed involved dissolving Plasdone K-90 in water, adding the solution to a V-blender equipped with a high shear intensifier drive (MAXI-BLENDLAB V-BLENDER, manufactured by GlobePharma, Inc., New Brunswick, NJ ) and form granules by operating the mixer using high shear, adding sieved sodium carbonate powder to the wet mixture in the mixer and mixing for an additional 5 minutes using the intensifier drive. After draining the contents of the mixer into a pan, the granules were dried in an oven maintained at 50°C until all added water was removed. The product was then screened through a stainless steel No. 16 mesh US Standard sieve.

example 2

[0087] Tablet preparation

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Abstract

Disclosed is a method for the preparation of easily-swallowed, reliably-dosed, esthetically-improved tablets of sodium ibuprofen dihydrate, the method comprising the formation of the tablets with punches or presses comprising contact surfaces which are chrome or chrome-plated.

Description

technical field [0001] The invention relates to high-content ibuprofen granules prepared from ibuprofen sodium salt dihydrate, to a method for preparing the granules, and to the use of the granules in the preparation of oral non-effervescent solid dosage forms. technical background [0002] One of the advantages associated with sodium ibuprofen being a potent pain reliever is that it is readily absorbed through the lining of the stomach and thus can be easily ingested in oral dosage form. According to the published literature, solid dosage forms made from sodium ibuprofen have pharmacokinetic advantages (ie, they enter the bloodstream and peak more rapidly than other solid dosage forms of ibuprofen). In fact, sodium ibuprofen is believed to be more effective than its hydrogen-substituted analogue, ibuprofen, even in smaller amounts due to its ease of absorption. [0003] Sodium ibuprofen is readily available as a powder. However, despite intensive research in this field, t...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/20
CPCA61K9/2009A61K9/2077A61K9/2027A61K31/192A61K9/2095
Inventor L·N·布顿G·H·兰贝思E·W·利马塔帕特里克·C·胡
Owner SI GROUP INC
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