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Immediate disintegration polyvalent polymeric matrix for modified release solid oral preparations and method of preparation thereof

a technology of polymer matrix and modified release solid, which is applied in the field of immediate disintegration polymeric polyvalent matrix, can solve the problems of system inability to meet the needs of users, and achieve the effect of avoiding system drawbacks

Inactive Publication Date: 2009-06-25
I P S INT PROD & SERVICES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides an immediate disintegration polyvalent matrix that solves problems of conventional microgranules, pellets, and minipellets. This matrix has the advantage of a higher active substance titer, allowing for higher dosages and better flexibility of unitary dosages. It can be used to make different administration forms of solid oral products, such as high dosage tablets, even fractionable. The matrix can also be used to make extemporaneous suspensions with a great dosage variety. The matrix allows the active substance to reach the gastrointestinal tract quickly and uniformly, starting the modified release."

Problems solved by technology

However these systems inevitably have some drawbacks, mainly due to the necessity of adding inert ingredients (support cores available on the market, known as sugar spheres) to the active substance.

Method used

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Examples

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example

[0021]As a merely illustrative and non limiting example of the general application of the present invention, the method of preparation of a polymeric polyvalent matrix of thioptic acid is given hereinafter, a food supplement which is well adapted to be an illustrative example.

[0022]To obtain a matrix with the mentioned characteristics it is necessary to have at disposal a starting material with a particle size between 200 and 700 μm.

[0023]The method of production to carry out direct application on the active substance of one or more layers of polymeric membrane regulating the release is as follows:

[0024]3.0 kg of a starting material having the above stated particle size is charged in a 10 l revolving pan.

[0025]While the pan is rotating, the active ingredient is covered using a 30% solution of 300 g shellac in ethanol and 300 g talc.

[0026]The covering operation may be effected continuously or in various stages until the required release rate is attained.

[0027]At the end of said opera...

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Abstract

An immediate disintegrating polymeric matrix for oral administration with modified release is disclosed, obtained without using inert supports such as sugar spheres, comprising particles of active substance directly covered with a release regulating membrane. Use of such a matrix to prepare various administration forms for oral use as well as the method of its preparation are also disclosed.

Description

FIELD OF THE INVENTION[0001]The present invention relates to an immediate disintegration polymeric polyvalent matrix, suitable for the oral administration of modified release solid products and the related method of its production.BACKGROUND OF THE INVENTION[0002]The traditional systems to obtain forms of oral administration of medicaments or food supplements with modified release comprise the preparation of tablets, capsules, granulates that once swallowed release the active substance in the gastrointestinal tract according to predeterminated modes.[0003]This release is obtained by application of the active substance on an inert core and then covering the whole with one or more layers of outer membranes comprising substances adapted to provide the desired modified release, that can be a controlled, retarded, extended release according to the substances used for the cover membranes.[0004]In this way the so-called microgranules, pellets or minipellets according to their size are obta...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/20A61K9/10A61K9/48A23L1/48A23L35/00
CPCA23L1/22008A23L1/30A23L1/3008A23V2002/00A61K9/2081A61K9/5015A23V2200/254A23V2200/224A23V2200/16A61K9/0095A61K9/5026A61K9/5042A61K9/5063A61K9/5073A23P10/30A23L27/70A23L33/10A23L33/12A61K9/0002
Inventor PASOTTI, GINOSPALLA, ANDREADE ZANET, EZIO
Owner I P S INT PROD & SERVICES