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Ibuprofen composition

A technology of mixtures and polymers, applied in the directions of microcapsules, capsule delivery, organic active ingredients, etc., can solve the problems of reducing coating, disadvantage, etc.

Inactive Publication Date: 2009-09-09
MCNEIL PPC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the hydrophilic nature of the hydrocolloid, it promotes the rapid absorption of water into the drug particles after administration, thereby detrimentally reducing the masking effect of the coating on the burning sensation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Embodiment 1: ibuprofen tablet formula A

[0058] Part A: Preparation of ibuprofen granulation formula A

[0059] First in a Glatt 5 / 9 top-spray fluidized bed granulator, mix ibuprofen, dextrose, citric acid and hydroxypropyl methylcellulose with an air flow rate of 3.6 scfm (standard cubic feet per minute) to form The mixture was granulated, whereby a granulate comprising the ingredients in Table A below was prepared.

[0060] In a laboratory mixer set at a speed of 75 RPM, 90 grams of starch was added to 1497 grams of cold water while stirring to obtain a starch paste solution with 5.67% solids. The solution was heated with stirring until its temperature reached 75°C. The resulting solution was then sprayed into the granulation mixture at a rate of about 50 g / min at a product temperature of about 27°C and an atomization pressure of 1.5 bar before drying to a final product temperature of 32°C. use Computrac TM Max 2000 measured the loss on drying (LOD) value at ...

Embodiment 2

[0085] Embodiment 2: ibuprofen tablet formula B

[0086] Part A: Preparation of Ibuprofen Granules Formula B

[0087] Ibuprofen, dextrose, citric acid and hydroxypropyl methylcellulose were first mixed at an air flow rate of 350 scfm in a 90-liter fluidized bed granulator equipped with an 18-inch Worster column and spray gun to form Formulation mixture, thus prepared granules comprising the ingredients in Table E below.

[0088] Three batches of granulation solution were prepared simultaneously in a 55 gallon stainless steel tank. In preparing each batch of granulation solution, 480 g of starch was added to 7.99 kg of cold water while stirring using an air mixer equipped with low shear blades set at a speed of 50 RPM to obtain a starch paste solution containing 5.67% solids. This solution was heated with stirring until its temperature reached 79°C to obtain a granulation solution. The resulting granulation solution is then sprayed into the granulation mixture at a rate ...

Embodiment 3

[0114] Embodiment 3: ibuprofen tablet formula C

[0115] Part A: Preparation of Tablets for Evaluation - Formulation C

[0116] Preparation of Tablet Blend Base:

[0117] Table I - Tablet Base Blend Formulation C

[0118] Element

Percentage (weight / weight)

mg / tablet

Coated Granulated Ibuprofen *

17.3

241.5

Dextrose monohydrate (coarse grade)

75.4

1055.6

cross-linked polyvinylpyrrolidone

NF **

2.1

29.0

artificial grape flavoring

0.3

4.5

Magnesium stearate NF

1.07

15.0

Colloidal Silica NF

0.14

2.0

Fumaric acid NF

1.64

23.0

Citric Acid USP

0.21

3.0

[0119] FD&C Blue L#1 Aluminum Lake

0.10

1.4

D&C red calcium lake

0.07

1.0

Acesulfame Potassium

1.07

15.0

Sucralose NF

0.64

9.0

total

100.0

14...

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Abstract

The invention relates to an immediate release tablet capable of being chewed or disintegrated in the oral cavity, which comprises a plurality of particles in a matrix. The particles contain an active ingredient, such as ibuprofen, and a first water soluble acid having a solubility greater than about 10 g / 100mL water at 20 DEG C; and the matrix contains a second water soluble acid having a solubility less than about 5 g / 100mL water at 20 DEG C.

Description

[0001] The present invention relates to ibuprofen compositions, and more particularly, to ibuprofen compositions having reduced throat burning properties. Background of the invention [0002] Many flavorings and sweeteners are added to medicines to make them more palatable and to mask the unpleasant taste and aftertaste usually associated with such products. In addition to having an unpleasant taste, certain drug ingredients can cause a burning or chafing sensation in the throat when swallowed. This can manifest as a lump in the throat or a cough. Unfortunately, flavors and sweeteners can be difficult to overcome this burning sensation in the throat. Despite efforts to find effective means of counteracting this burning sensation, there remains a need for a method of effectively counteracting drug-induced burning sensation, or at least reducing it to some extent, in order to provide a chewable composition. [0003] Ibuprofen is a well-known drug that causes a burning sensatio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/192
CPCA61K9/1652A61K31/4172A61K9/2018A61K9/2027A61K31/192A61K9/5026A61K9/1623
Inventor R·沈
Owner MCNEIL PPC INC