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Enteric film coating composition containing enteric polymer micronized with detackifier

A technology of enteric-coated polymers and compositions, which can be used in microcapsules, sugar-coated pills, drug delivery, etc., and can solve the problem of laborious coating

Active Publication Date: 2007-11-28
BPSI HLDG LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

PPI products have been formulated using this principle (US6,207,198; US6,569,457; and US6,623,759); however, the coatings used to build the dosage form are often laborious in a stepwise process

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A 4:1 ratio of micronized premix of Eudragit L100-55 and talc (75 parts; average particle size = 8 microns), PEG 3350 (18 parts), Syloid 244FP silica (2 parts) and Extended Talc (5 parts). The resulting mixture was mixed for five minutes. An aqueous dispersion is then prepared by stirring 15 parts of the mixed composition to 85 parts deionized water (15% solids suspension). The resulting aqueous dispersion was then passed through a 60 mesh screen and only a very small amount of particles (<2% wet weight relative to the coating composition) was observed to remain. Using an O'Hara Labcoat I coating pan with a 12" insert, the screened aqueous dispersion was then coated onto the placebo and aspirin mix, which had been precoated with Opadry YS-1-7027 Subcoat to 4% theoretical weight gain. During coating operation, maintain bed temperature at 30 to 33.5°C. At 10, 12, and 14% predicted theoretical weight gain, periodically remove samples from coating pan. Coat to Aspirin an...

Embodiment 2

[0031] Example 2 comparison

[0032] Eudragit L100-55 (60 parts) and talc (15 parts) from the respective suppliers were premixed for five minutes in a food processor. To this mixture was added PEG 3350 (18 parts), Syloid 244FP silica (2 parts) and extending talc (5 parts). The mixture was stirred for another five minutes. 15 parts of the resulting mixture were then stirred into 85 parts of deionized water. After stirring for forty minutes, a large number of clumps were observed and eventually remained on the 60 mesh screen. The dispersion was considered uncoatable. Conclusion: The coating system prepared based on the Eudragit L100-55 / talc premix could not be sufficiently dispersed in water and could not be coated by conventional mixing (ie, without particle size reduction).

Embodiment 3

[0033] Embodiment 3 comparison

[0034] Micronized Eudragit L100-55 (60 parts, average particle size = 8 microns), talc from supplier (20 parts), PEG 3350 from supplier (18 parts), and Syloid 244FP silica (2 parts). The resulting mixture was mixed for five minutes. An aqueous dispersion is then prepared by stirring 15 parts of the mixed composition to 85 parts deionized water (15% solids suspension). After stirring for forty minutes, the resulting aqueous dispersion was passed through a 60 mesh screen. Only a very small amount of particles (<0.5% dry weight, relative to the dry coating composition) remained on the sieve. The screened aqueous dispersion was then coated onto placebo tablets which had been previously coated with Opadry YS-1-7027 times using an O'Hara Labcoat I coater with a 10" pan insert Up to a theoretical weight gain of 4%. After a few minutes, the coating operation was stopped due to the gelation of the dispersion in the pipeline, which resulted in a comp...

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PUM

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Abstract

Dry, enteric, film-coating compositions and aqueous dispersions containing the same are disclosed. When applied to orally-ingestible substrates such as oral solid dosage forms, the film coatings are capable of preventing the substrates from disintegrating in media with pH values from about 1 to about 4.5 or higher values. One preferred film-coating composition contains a micronized intermediate comprised of an acrylic resin and talc. Advantageously and surprisingly, the preferred film-coating composition does not contain an alkalizing agent.

Description

[0001] A brief description [0002] The present invention relates to a dry, fully formulated, enteric, coating composition which, when used as an aqueous dispersion to coat an orally administrable base, is capable of maintaining said orally administrable base at a pH of about 1 to No decomposition in media with values ​​of about 4.5 or higher. A preferred coating composition comprises a micronized vehicle consisting of acrylic resin and talc. Advantageously and surprisingly, the preferred coating composition does not contain alkalizing agents. The present invention discloses a process for preparing: 1) a micronized vehicle; 2) a dry, fully formulated coating composition comprising said vehicle; 3) an aqueous dispersion comprising said coating composition and 4) ) An orally acceptable substrate coated with an aqueous dispersion of the invention. Background of the invention [0003] It is well known that the pH of the stomach can vary from about 1 to about 4.5 based on a numb...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/26
CPCA61K9/501A61K9/2813A61K9/2846A61K9/5026A61K9/28A61K9/20
Inventor 托马斯·法雷尔库尔特·费格里阿里·拉贾比-塞亚布米乔治·雷耶斯布德希·西蒙卡拉·扬
Owner BPSI HLDG LLC
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