New film coating

A film and weight technology, applied in the direction of drug delivery, pharmaceutical formulations, etc., can solve the problems of film coating performance change, inappropriateness, stability impact, etc.

Inactive Publication Date: 2005-08-24
ASTRAZENECA AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the use of plasticizers in film coatings may have an impact on the stability of the film, possibly due to the migration of small molecules, which may lead to changes in the properties of the film coating over time (see e.g. GutierrezRocca, University of Texas ( Austin's doctoral dissertation, 1993)
Also, the presence of latex particle stabilizers in the dispersion creates problems similar to, for example, the addition of plasticizers, namely the migration of the stabilizer in the film, which can lead to changes in the properties of the film coating over time
[0011] Therefore, there are three main problems with existing latex polymers when used as coating materials: (a) Due to the low Tg, sticky pellets may result, thus additional anti-sticking agents or other additives / excipients will be required , (b) may result in brittle pellets due to high Tg, which will require additional plasticizers or other additives / excipients, and (c) migration of additives / excipients such as stabilizers such as emulsifiers Migration in thin films, which may exhibit changes in properties over time
This cross-linked ester is not suitable for coating pharmaceutical compounds due to the possible presence of active residual cross-linker

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0174] Example 1: Synthesis of polymer dispersions using M1, M2 and M3

[0175] The polymerization was carried out using ethyl acrylate, 2-methyl methacrylate and monomers M1, M2 and M3.

[0176] Dispersions D1, D2 and D3 were prepared using the following components:

[0177] D1

[0178] Water 677.55g

[0179]Ethyl acrylate 217.75g

[0180] Methyl methacrylate 108.88g

[0181] Monomer M1 2.18g

[0182] Sodium dodecyl sulfate (SDS) 2.18g

[0183] NaHCO 3 (0.005M) 0.27g

[0184] Na 2 S 2 o 8 (Initiator) 1.67g

[0185] D2

[0186] Water 677.42g

[0187] Ethyl acrylate 218.23g

[0188] Methyl methacrylate 109.12g

[0189] Monomer M2 3.75g

[0190] SDS 2.19g

[0191] NaHCO 3 (0.005M) 0.27g

[0192] Na 2 S 2 o 8 1.72g

[0193] D3

[0194] Water 675.31g

[0195] Ethyl acrylate 218.85g

[0196] Methyl methacrylate 109.43g

[0197] Monomer M3 7.15g

[0198] SDS 2.19g

[0199] NaHCO 3 (0.005M) 0.27g

[0200] Na 2 S 2 o 8...

Embodiment 2

[0202] Example 2: Synthesis of polymer dispersion using M4

[0203] Dispersion D4 was prepared using the following components:

[0204] water 600g

[0205] Ethyl acrylate 120g

[0206] Methyl methacrylate 70g

[0207] Monomer M4 (hydroxyethyl methacrylate, see Table 1) 10g

[0208] SDS 3g

[0209] NaOH(1M) 2.3g

[0210] K 2 S 2 o 8 (Initiator) 0.6g

[0211] The monomer is distilled to remove the initiator. The emulsion polymerization was performed in a tightly capped water-jacketed vessel equipped with nitrogen sparging and stirring. Disperse monomer, SDS and sodium hydroxide in water and stir (50 rpm). The temperature was raised to 50°C and the initiator was added. After the polymerization was carried out for 20 hours, the temperature was set to 70°C and carried out for another 2 hours. The dispersion was then filtered and cooled.

Embodiment 3

[0212] Embodiment 3: prepare film F1-F4 by embodiment 1 and 2

[0213] About 10 ml each of the dispersions D1-D4 were poured into a Teflon mold to obtain monomer films F1-F4. The mold was then placed in a temperature and humidity chamber at 25° C. and 60% relative humidity for 19 hours for drying and film formation.

[0214] result:

[0215] The tackiness of the film was tested by simply handling the film manually. The films were subjected to permeability testing as described in Example 5.

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Abstract

Disclosed herein is a film coating dispersion obtained by the polymerization of the following monomers in water: acrylic acid or an ester thereof in the range 40 to 80 % by weight; methacrylic acid or an ester thereof in the range 20 to 60 % by weight; and a polymerizable surfactant in the range 0.01 to 9 % by weight. The dispersion is suitable for coating pharmaceutical formulations to provide controlled release of the active ingredient.

Description

field of invention [0001] The present invention relates to a new film coating. More specifically, the present invention relates to a novel film coating for obtaining controlled release of pharmaceutical formulations such as tablets, pills etc., wherein said film coating can be applied in a predominantly aqueous environment. Furthermore, the present invention provides methods for preparing such film coatings. Background of the invention [0002] Oral administration is the most convenient mode of administration to the patient. The corresponding pharmaceutical preparations must also meet the requirements of safety and simplicity. Depending on the nature of the drug and the therapeutic requirements, the drug is formulated differently so that the formulation has a desired release profile. [0003] For many active substances or drugs, it is desirable to formulate formulations that provide controlled release of the active substance or drug. An example of s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08F2/24A61K9/58C08F220/00C08F220/12
CPCC08F220/12C08F220/10C08F220/06C08F2/24
Inventor O·J·卡尔松L·J·P·德费尔迪尔哈特斯S·尚茨
Owner ASTRAZENECA AB
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