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Cellulosic films incorporating a pharmaceutically acceptable plasticizer with enhanced wettability

A technology of cellulose and plasticizer, applied in the field of drug delivery, can solve problems such as hindering the disintegration or absorption of active agents

Inactive Publication Date: 2008-04-23
EASTMAN CHEM CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] A problem with previously known plasticizers for enteric polymeric coatings is that the plasticizer may prevent disintegration or absorption of the active agent during release

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0032] These examples demonstrate that the use of TPGS as a plasticizer in an acetone solvent system improves the % elongation of polymer films. The use of TPGS as a plasticizer strongly affects cellulose acetate butyrate films. Using TPGS as a plasticizer, especially in the range of 20 to 30 wt%, can enhance the elongation. The film also showed improvement when TPGS was used as a secondary plasticizer. The cellulose acetate butyrate polymer films tested showed a higher % stretch than the cellulose acetate polymer films. The results are listed in Tables I-III below.

[0033] Table I

[0034] CA 398-10NF% Elongation

plasticizer

solvent system

Plasticizer wt%

0

10

20

30

PEG1000

acetone

8.5

8.98

10.04

23.88

PEG / TPGS

acetone

8.5

6.04

10.14

27.26

TPGS

acetone

8.5

4.88

5.26

26.52

PEG1...

Embodiment 4-6

[0040] In Examples 4-6, all films showed a decrease in tensile strength when plasticizer was used. This decrease in tensile strength is directly related to the amount of plasticizer used. The results are listed in Tables IV-VI below.

[0041] Table IV

[0042] CA 398-10NF Tensile Strength

plasticizer

solvent system

Plasticizer wt%

0

10

20

30

PEG1000

acetone

81.1

52.07

36.24

26.97

PEG / TPGS

acetone

81.1

68.98

32.25

30.36

TPGS

acetone

81.1

52.88

45.21

32.89

PEG1000

acetone / water

58.0

38.80

23.70

9.80

PEG / TPGS

acetone / water

58.0

49.49

27.99

18.66

TPGS

acetone / water

58.0

40.79

30.45

26.47

[0043] Table V

[0044] CAB 171-15PG Tensile Strength

...

Embodiment 7-9

[0048]Examples 7-9 demonstrate the stability of the films in nitrogen. The stability of the films was examined using thermogravitmetric analysis, which refers to the temperature at which each film sample loses 10% of its weight. It can be seen that in cellulose acetate polymer (CA398-10NF), in the acetone / water solvent system, TPGS outperformed PEG 1000 at all concentration levels and was substantially equal to the performance of PEG 1000 in the acetone solvent system. The results are presented in Tables VII-IX below.

[0049] Table VII

[0050] CA 398-10NFT10 (Nitrogen) Stability / Flexibility

plasticizer

solvent system

Plasticizer wt%

0

10

20

30

PEG1000

acetone

334.23

334.90

335.80

336.90

PEG / TPGS

acetone

334.23

339.40

340.90

338.30

TPGS

acetone

334.23

333.80

338.40

342.10

PEG1000...

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PUM

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Abstract

An enteric coating for a solid pharmaceutical carrier or substrate wherein the enteric coating includes a cellulosic polymeric material selected from selected from the group consisting of hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, cellulose acetate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose acetate succinate, cellulose acetate propionate, cellulose acetate trimellitate, hydroxypropylmethyl cellulose phthalate, hydroxypropylmethyl cellulose succinate, hydroxypropylmethyl cellulose acetate succinate, cellulose acetate succinate butyrate, cellulose acetate succinate propionate, carboxymethylcellulose sodium, cellulose butyrate, and mixtures thereof and a plasticizer selected from a water-soluble preparation of a fat-soluble vitamin. A preferred plasticizer is Vitamin E polyethylene glycol 1000 succinate.

Description

Background technique [0001] The present invention relates to drug delivery, and more particularly, to an enteric coating of a pharmaceutical dosage form for oral administration of a drug. More specifically, the enteric coating comprises cellulose ester into which a tocopherol derivative has been mixed as a plasticizer. [0002] Cellulose esters are well known in the art, e.g. for the preparation of cellulose esters, see Kirk-Othmer Encyclopedia of Chemical Technology, 4th Edition, Volume 5, pages 496-529, the disclosure of which is incorporated by reference This article. Cellulose esters are widely used in various commercial applications. For example, US Patent 6,828,089 discloses the application of cellulose esters in photographic film; US Patent 6,828,006 discloses the application of cellulose esters in liquid crystal displays; US Patent 6,821,602 discloses the application of cellulose esters in magnetic recording media. [0003] Enteric coatings of pharmaceutically accep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24
CPCA61K31/717A61K31/355A61K9/5031A61K31/25A61K9/2866A61K9/2853A61K9/5042A61K9/5047
Inventor B·L·伯纳德
Owner EASTMAN CHEM CO
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