Fast dispersing dosage forms free of gelatin

A fast and decentralized technology, applied in pill delivery, medical preparations of non-active ingredients, drug delivery, etc., can solve the problems of non-disclosure

Inactive Publication Date: 2002-02-27
R.P.斯克尔公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This reference does not disclose a fast dispersing solid dosage form containing at least 20% by weight of at least one modified starch and a process for preparing the dosage form by removing the solvent from a mixture containing the active ingredient, modified starch and matrix forming agent

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0115] Perfectagel MPT is hydroxypropyl distarch phosphate, which is commercially available from AVebe U.K., Ltd.

[0116] components

amount (g)

weight%

Paselli MD 10

10

10

Mannitol

3

3

purified water

87

87

[0117] Paselli MD 10 is an enzyme modified starch which is commercially available from Avebe U.K., Ltd.

[0118] Stir the water with an electric mixer with a handle and stir in the starch and mannitol. The starch does not require heating. The solution was stirred for 1.5 hours to equilibrate.

[0119] The dosage form disperses smoothly and quickly in the mouth and has a sweet taste.

Embodiment 4

[0122] Avebe MD20 is an enzyme modified starch which is commercially available from Avebe U.K., Ltd.

[0123]The dosage forms prepared in Examples 1-4 all disintegrated rapidly in the mouth in less than 10 seconds.

Embodiment 5

[0125] Study on Viscosity Curves of Various Modified Starches

[0126] components

[0127] Ingredients

[0128] No significant change in viscosity was observed over the 22 hour period. This is a highly desired property in the preparation of FDDF's. This property improves the potency of the product and reduces losses due to waste.

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PUM

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Abstract

The present invention relates to fast dispersing solid dosage forms that preferably dissolve in the oral cavity within sixty (60), more preferably within thirty (30), most preferably within ten (10) seconds. A novel feature of the solid dosage forms according to the invention reside in the fact that the composition is essentially free or absolutely free of mammalian gelatin. It has been discovered that the use of certain modified starches at concentrations from 20 to 90 % by weight of the solid dosage form prepares dosage forms that are mechanically and chemically stable and are able to deliver higher concentrations of an active ingredient than the heretofore utilized gelatin based fast dispersing solid dosage forms. Further, the solid dosage forms according to the invention are obtainable by removing a solvent, such as water, from a mixture comprising an active ingredient, a modified starch and a matrix forming agent via freeze drying.

Description

[0001] related application [0002] This application claims priority to UK Patent Application No. 9901819.4, filed 27 January 1999, entitled Pharmaceutical Compositions. technical field [0003] The present invention relates to a pharmaceutical composition for oral administration in the form of a rapidly dispersing dosage form. The new dosage form is substantially free of mammalian gelatin and contains at least one matrix forming agent and lactose-modified starch. Background of the invention [0004] The most common dosage form of the drug is a tablet. The main limitations of tablets include poor patient acceptance due to difficulty in swallowing and lack of bioavailability of the active substance due to ineffective dissolution of the tablet. Therefore, there is a need for rapidly dissolving dosage forms in the pharmaceutical field. Various approaches have been used to overcome the deficiencies of tablets, including effervescent tablets, chewable tablets, disintegrants an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/14A61K9/19A61K9/20A61K47/10A61K47/36
CPCA61K9/2018A61K9/2059A61K9/2095A61K9/0056A61K9/14
Inventor L·P·格罗瑟O·J·默里R·格林P·卡尼
Owner R.P.斯克尔公司
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