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Dispersion of taste masked crystals or granules of active substances, chewable soft capsules filled with said dispersion, and process for preparing same

A technology of active substances and dispersions, applied in the field of preparation of this novel dosage form, can solve problems such as unpleasantness

Inactive Publication Date: 2013-06-26
R P SCHERER TECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, such lozenges have a tendency to leave a doughy, grainy or so-called sandy sensation in the mouth, which can be unpleasant

Method used

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  • Dispersion of taste masked crystals or granules of active substances, chewable soft capsules filled with said dispersion, and process for preparing same
  • Dispersion of taste masked crystals or granules of active substances, chewable soft capsules filled with said dispersion, and process for preparing same
  • Dispersion of taste masked crystals or granules of active substances, chewable soft capsules filled with said dispersion, and process for preparing same

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0086] Example 1: Lipophilic Vehicle

[0087] In this example, lipophilic vehicles with different solubilizing abilities for ibuprofen were observed.

[0088] The solubility of ibuprofen at 25 °C was measured using the HPLC method in the following lipophilic vehicles:

[0089] 1) by SASOL under the trade name Medium chain triglycerides sold at 812N. The solubility is 65mg / ml.

[0090] 2) soybean oil. The solubility is 44 mg / ml.

[0091] 3) Dimethicone 100 silicone oil from Rhodia. The solubility is 1mg / ml.

[0092] Using a two (2) human taste panel, we determined that the bitterness of ibuprofen was detected at concentrations above 10 mg / ml in both aqueous buffer and lipophilic dispersion. This taste limit was also confirmed in other lipophilic vehicles. Dimethicone is an acceptable vehicle using the teachings of the present invention. This was cross-checked with the following studies. Three formulations were prepared using ibuprofen-coated particles prepared by c...

example 2

[0126] Example 2: Coated Particles

[0127] Coated particles of ibuprofen were prepared by spraying a hydroalkanol solution of ethylcellulose and hydroxypropylmethylcellulose onto 70 micron ibuprofen particles in an air fluid bed. The conditions described previously were used to obtain the resulting coated particles present in the following compositions.

[0128]

[0129]

[0130] Characterization:

[0131] Mineral oil was used as the dispersion medium, and the size of the coated particles was measured by laser granulometry on a Mastersizer 2000 (Malvem) device. 10% by volume has a particle size of 76 μm or less (D10=76 μm), while 50% by volume has a diameter of 152 μm or less (D50=152 μm) and 90% of the volume has a size of 281 μm or less (D90=280 μm ).

[0132] The stability of the different coated particles was measured in the different lipophilic vehicles used in Example 1. To give further evidence for the choice of a lipophilic vehicle, the coated particles ...

example 3

[0169] Example 3: Coated Particles

[0170] According to the method described in U.S. Patent No. 6,194,005, by adding Coated granules of ibuprofen were prepared by spraying Ato 5 onto ibuprofen granules in a fluid air bed apparatus. The obtained coated particles have the following formula:

[0171]

[0172] Characterization:

[0173] Mineral oil was used as the dispersion medium, and the size of the coated particles was measured by laser granulometry on a Mastersizer 2000 (Malvem) device.

[0174] D10=62μm

[0175] D50=139μm

[0176] D90=285μm

[0177] The stability of the different coated particles was measured in the different lipophilic vehicles used in Example 1. Stability studies of dimethicone were confirmed at a concentration of 10% and taste masking stability was demonstrated for at least 3 months.

[0178] Stability of Coated Granules:

[0179] The coated particles were bulk packed in glass containers placed in a stable enclosure at a controlled temp...

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Abstract

The present invention concerns a dispersion of crystals or granules of active substance in a lipophilic vehicle, said crystals or granules being coated by a coating for taste masking purposes. The invention also it concerns unit dosage forms and preferentially chewable or fast dissolving soft gelatin capsules filled with said dispersion as well as process for manufacturing same.

Description

[0001] The application date is January 21, 2004, the application number is 200480002670.1, and the title of the invention is a dispersion of taste-masked crystals or particles of active substances, a chewable soft capsule filled with the dispersion and its preparation A divisional application of an application for method. technical field [0002] The present invention relates to a new dosage form providing a fast dissolving soft capsule containing a liquid fill comprising a dispersion of taste-masked crystals or granules of an off-tasting active ingredient. In particular, the dosage form is a dispersion of crystals or granules of the active substance in a lipophilic vehicle. The crystals or particles are coated with a paint for taste-masking purposes. The present invention also relates to chewable soft capsules that quickly dissolve in the mouth and contain the dispersion and a method of preparing the novel dosage form. Background technique [0003] Drugs administered oral...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K9/48A61K47/44A61K47/14A61K47/34A61K47/04A61K47/38A61K47/32A61K47/10A61K9/00A61K9/64A61K47/06A61P29/00
CPCA61K9/0056A61K9/4808A61K9/4816A61K9/4858A61K47/06A61P29/00
Inventor 朱利安·梅索尼耶法布里斯·罗斯马里耶·马德莱娜·博恩
Owner R P SCHERER TECH INC
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