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Coated particles and pharmaceutical dosage forms

a technology of coated particles and dosage forms, applied in the field of pharmaceutical industry, can solve the problems of limited use, scarce publications available, and no general way to predict optimal solutions

Inactive Publication Date: 2006-05-04
LEK PHARMA D D
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For individual active substances there is no general way to predict optimal solution for oxidation prevention and the publications available are scarce (Waterman, K. C., et al, Stabilization of Pharmaceuticals to Oxidative Degradation, Pharmaceutical Development and Technology, 7(1), 2002, 1-32).
Their use is limited because in this process a free hydroxyl radical is formed.
Blisters which are less permeable or impermeable to oxygen (e.g. foil-foil) are usually more expensive.
Despite the numerous different described methods of stabilization in different ways, for example, with the addition of antioxidants to a pharmaceutical dosage forms by packaging a pharmaceutical formulation into a suitable package, these solutions have not shown to be convenient for all active substances and all markets, respectively (Waterman, K. C., et al, Stabilization of Pharmaceuticals to Oxidative Degradation, Pharmaceutical Development and Technology, 7(1), 2002, 1-32).

Method used

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  • Coated particles and pharmaceutical dosage forms

Examples

Experimental program
Comparison scheme
Effect test

example 1

Composition of One Coated Tablet

[0169] 1.1. Tablet Core

TABLE 2Composition of the coreIngredientMass (mg)Atorvastatin (in the form of atorvastatin Ca)20.00Microcrystalline cellulose143.20Lactose monohydrate34.80Crosslinked carboxymethylcellulose19.20Hydroxypropyl cellulose2.00Polysorbate 802.60Magnesium oxide26.00Colloidal silicon dioxide1.20Magnesium stearate1.00

Preparation of Tablet Core

[0170] Atorvastatin, half of microcrystalline cellulose, lactose monohydrate, half of crosslinked carboxymethylcellulose and 11% of the total magnesium oxide were homogeneously mixed and granulated with a solution of hydroxypropyl cellulose and polysorbate in water. The granulate was dried in a fluid bed dryer and the sieved granulate was homogeneously mixed with the other half of microcrystalline cellulose and crosslinked carboxymethylcellulose, the rest of magnesium oxide, colloidal silicon dioxide and magnesium stearate. The homogeneous granulate was compressed into tablets, mass 250 mg, on...

example 2

Composition of One Coated Tablet

[0175] 2.1. Tablet Core

TABLE 5Composition of the coreIngredientMass (mg)Atorvastatin (in the form of atorvastatin Ca)10.00Microcrystalline cellulose153.20Lactose monohydrate34.80Crosslinked carboxymethylcellulose19.20Hydroxypropyl cellulose2.00Polysorbate 802.60Magnesium oxide26.00Colloidal silicon dioxide1.20Magnesium stearate1.00

Preparation of Tablet Core

[0176] Atorvastatin, 53% of the total microcrystalline cellulose, lactose monohydrate, half of crosslinked carboxymethylcellulose and 11% of the total magnesium oxide were homogeneously mixed and granulated with a solution of hydroxypropyl cellulose and polysorbate in water. The granulate was dried in a fluid bed dryer and the sieved granulate was homogeneously mixed with the rest of microcrystalline cellulose, crosslinked carboxymethylcellulose and magnesium oxide, colloidal silicon dioxide and magnesium stearate. The homogeneous granulate was compressed into tablets, mass 250 mg, on a conven...

example 3

Composition of One Coated Tablet

[0181] 3.1. Tablet Core

TABLE 8Composition of the coreIngredientMass (mg)Atorvastatin (in the form of atorvastatin Ca)10.00Microcrystalline cellulose153.20Lactose monohydrate34.80Crosslinked carboxymethylcellulose19.20Hydroxypropyl cellulose2.00Polysorbate 802.60Magnesium ixide26.00Colloidal silicon dioxide1.20Magnesium stearate1.00

Preparation of Tablet Core

[0182] Atorvastatin, 53% of the total microcrystalline cellulose, lactose monohydrate, half of crosslinked carboxymethylcellulose and 11% of the total magnesium oxide were homogeneously mixed and granulated with a solution of hydroxypropyl cellulose and polysorbate in water. The granulate was dried in a fluid bed dryer and the sieved granulate was homogeneously mixed with the rest of microcrystalline cellulose, crosslinked carboxymethylcellulose and magnesium oxide, colloidal silicon dioxide and magnesium stearate. The homogeneous granulate was compressed into tablets, mass 250 mg, on a conven...

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Abstract

The present invention relates to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. The coating of the present invention provides stability and protection of the active substance to environmental influences and in particular from oxidation and / or environmental humidity by coating.

Description

FIELD OF THE INVENTION [0001] The present invention relates to the field of pharmaceutical industry, more specifically to coated particles and pharmaceutical dosage forms comprising the active substances sensitive to environmental influences. [0002] The coated particles of the present invention are the particles of the active substance or the particles of the active substance and one or more pharmaceutical excipients in the form of particles of regular or irregular shapes, such as microcapsules, microspheres, granules, pellets and the like said particles are protected from environmental influences and in particular from oxidation and / or environmental humidity by coating. Said particles are embeded either in an uncoated pharmaceutical dosage form or in a coated pharmaceutical dosage form wherein the coating of the present invention affords protection and consequently stability of the active substance and one or more pharmaceutical excipients from environmental influences and in parti...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/401A61K9/50A61K9/16A61KA61K9/20A61K9/28A61K9/56A61K31/40A61P3/06
CPCA61K9/2009A61K9/2018A61K31/40A61K9/2866A61K9/2054A61P3/06A61K9/5047
Inventor HUMAR, VLASTABURJAK, MATEJAGRAHEK, ROKSALOBIR, MATEJAKERC, JANEZKOCEVAR, KLEMEN
Owner LEK PHARMA D D
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