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Dosage form having a saccharide matrix

A dosage form and matrix technology, applied in the field of non-compressible rapidly dispersing solid dosage forms

Inactive Publication Date: 2006-04-12
ALK ABELLO SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no disclosure on how to achieve the goal

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0264] grass extract

[0265] Grass pollen extract according to Ipsen and L Prepared as described in wensten (1983) Jour. Allergy. Clin. Immunol. 72:2, pp. 150-159. Briefly, grass pollen was extracted in ammonium bicarbonate at 5°C for 20 hours. Particulate matter was removed by centrifugation and the supernatant was dialyzed 3 times against water, freeze-dried and stored under refrigerated conditions until reconstitution.

[0266] Solid dosage form:

[0267] Manufacturing process:

[0268] 1. MQ water is added to a beaker with a magnetic stirrer,

[0269] 2. Mannitol and Sorbitol, if desired, are added and dissolved under stirring,

[0270] 3. Maltodextrin and PEG, if required, are added and dissolved under stirring,

[0271] 4. Allergen extracts, if desired, are added,

[0272] 5. If the allergen is present, the pH is adjusted to pH=7-8, and adjusted with hydrochloric acid (2N) or sodium hydroxide (2N),

[0273] 6. Under ambient temperature conditions, 250 μl of the...

Embodiment 5

[0292] This example relates to the preparation of a granular composition of granules having a matrix consisting of mannitol, maltodextrin and sorbitol, wherein the matrix contains microencapsulated allergens (MEA), this example also It relates to the preparation of compressed tablets from a granular composition.

[0293] Material

[0294] Encapsulant: Poly-D,L-lactide-glycolide (DL-PLG) (60 / 40) with MW 40,000 g / mol obtained from Birmingham Polymers, USA.

[0295] Active substance: MEA-Phlp extract in the form of granules

[0296] Mannitol: Ph. Eur. , No. 281048, from Unikem.

[0297] Sorbitol: Ph. Eur. , No. 340927, from Nomeco.

[0298] Maltodextrin: NF 18, type CPUR01915(18DE) from Cerestar.

[0299] Talc: Ph. Eur. , No. 297911, from Unikem.

[0300] Magnesium Stearate: Ph. Eur. , No. 280560, from Unikem.

[0301] Test methods for compressed tablets

[0302] Stress resistance

[0303] The tablets are placed horizontally on the support against the first vertical plat...

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PUM

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Abstract

The present invention provides a non-compressed fast-dispersing solid dosage form suitable for oromucosal administration of a pharmaceutically active substance comprising (a) a first matrix forming agent in the form of maltodextrin having a dextrose equivalent (DE) of between 1 and 20,(b) a second matrix forming agent in the form of sorbitol, and (c) the active substance.

Description

technical field [0001] The present invention relates to non-compressible fast-dispersing solid dosage forms suitable for the administration of pharmaceutically active substances and for the manufacture of compressed fast-dispersing tablets. Background of the invention [0002] Allergies are a major health problem in countries adapted to a Western lifestyle. Furthermore, the prevalence of allergic diseases is increasing in these countries. Although allergies are generally not considered life-threatening diseases, asthma causes a significant number of deaths each year. The abnormal prevalence of approximately 30% among adolescents results in significant losses in quality of life, working time and money, and secures a classified place among the major health problems in the Western world. [0003] Allergies are complex diseases. Many factors contribute to hypersensitivity events. Among these are individual susceptibilities determined by the interaction of several genes which...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K39/35A61K47/26A61K47/36A61K47/42A61K9/19A61K9/20A61K39/36
CPCA61K2039/542A61K9/2059A61K9/2018A61K39/36A61K9/19A61K9/006A61K39/35
Inventor C·G·赫格顿A·R·伦德迦德
Owner ALK ABELLO SA
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