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Oral disintegrating film compositions of paracetamol

A paracetamol, composition technology, applied in the field of fast dissolving film composition, can solve problems such as poor physical properties and brittleness

Inactive Publication Date: 2020-04-24
SHILPA MEDICARE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Bitter masking of an active ingredient inevitably leads to poorer physical properties and brittleness

Method used

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  • Oral disintegrating film compositions of paracetamol
  • Oral disintegrating film compositions of paracetamol
  • Oral disintegrating film compositions of paracetamol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] An orally disintegrating film having the following solvent system composition

[0087]

[0088] 1. Preparation method of orally disintegrating film

[0089] 1.1 Preparation of HPMC base material:

[0090] Put the weighed hot purified water into a beaker, slowly add HPMC powder under continuous stirring, then add purified water and stir for 7-10 minutes, leave overnight to remove air bubbles.

[0091] 1.2 Formula:

[0092] 1.2.1 Put the weighed purified water into a beaker, add paracetamol and stir for 4-5 minutes, then add sucralose and stir for 4-5 minutes.

[0093] 1.2.2 Add the weighed prosolv ODT G2 in step 1.2.1 and stir for 4-5 minutes, then add hydroxypropyl-β-cyclodextrin and stir for 2-3 minutes.

[0094] 1.2.3 Add the weighed ammonium glycyrrhizinate in step 1.2.2 and stir for 4-5 minutes, then add xylitol and stir for 7-10 minutes.

[0095] 1.2.4 Add the weighed HPMC base material in step 1.2.3 and sonicate for 12-15 minutes, then add glycerol and stir...

Embodiment 2-7

[0111] Table 2

[0112]

[0113] It can be seen from Table 2 that when sodium carbonate, citric acid and magnesium aluminosilicate are mixed in a ratio of 1:4.5:7.5 (Example-5), the bitter taste of paracetamol is effectively covered. The composition of Example-5 included 0.15% w / w sodium carbonate, 0.7% w / w citric acid and 1.2% magnesium aluminosilicate, which masked the taste of paracetamol.

Embodiment -8

[0114] Example-8: Dissolution

[0115] The stripping pattern of embodiment-5 is carried out with 50RPM in the paddle apparatus in the pH 1.2 medium (HCl buffer solution), pH 4.5 medium (acetic acid buffer solution) and pH 6.8 medium (phosphate buffer saline) of 900mL volume, and it releases The rules are shown in Table-3.

[0116] table 3

[0117]

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PUM

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Abstract

The present invention relates to a fast dissolving film composition comprising paracetamol or a pharmaceutically acceptable salt thereof as an active ingredient whose bitter taste is to be masked. More specifically, the present invention relates to a fast dissolving film composition containing paracetamol and taste masking agent; wherein taste masking agent is a mixture of sodium carbonate, citricacid and magnesium aluminometasilicate.

Description

technical field [0001] The present invention relates to a rapidly dissolving film composition comprising acetaminophen or a pharmaceutically acceptable salt thereof as an active ingredient to mask its bitter taste. More specifically, the present invention relates to a fast-dissolving film composition comprising paracetamol and a taste-masking agent; wherein the taste-masking agent is a mixture of sodium carbonate, citric acid and magnesium aluminosilicate. [0002] Further, the present invention relates to an orally rapidly dissolving film composition comprising at least 40% w / w paracetamol based on the total weight of the film composition, and a taste-masking agent; wherein the taste-masking agent It is a mixture of sodium carbonate, citric acid and magnesium aluminosilicate. Background technique [0003] Paracetamol or acetaminophen (Acetaminophen) or 4'-hydroxyacetanilide (4'-hydroxyacetanilide) is the most commonly used non-steroidal anti-inflammatory antipyretic analge...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/167A61K9/16
CPCA61K31/167A61K9/006A61K47/02A61K9/7007A61K47/10A61K47/12A61K47/38A61K47/40A61K47/58A61K9/0056A61K47/26
Inventor R·贡内斯瓦拉·苏布拉曼亚·瓦拉·普拉萨德
Owner SHILPA MEDICARE LTD