Process for continuous sintering of granules

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...

Patent

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

514567, 424400, 424451, 424464, A61K 3155

Patent

active

059689250

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/EP96/02177 filed May 21, 1996.
EP-B-0 043 254 describes a process for the preparation of medicament formulations with a delayed release of the active compounds which is based on a selective melting process on at least two lipid or lipoid components which have a retarding action for medicament active compounds mixed with these components. In these known processes, high-melting lipid or lipoid component and with a finely divided low-melting lipid or lipoid component, the weight ratio of the two lipid or lipoid components being in the range from 1:5 to 5:1, is brought to a temperature which is above the melting point of the low-melting component but below the melting point of the high-melting component, the active compound and the high-melting lipid or lipoid component being dispersed uniformly in the completely molten low-melting lipid or lipoid component, cooled to below the melting point thereof and
WO-A-93/24110 describes a process for the preparation of sustained release medicament formulations in which the individual components of an extruder, component is melted completely, modifications of these components or fat modifications can form, which can convert back later during storage of tablets which have been prepared using the known granules, such that the release of the active compound is influenced. In the process known from WO-A-93/24110, shearing effects can in turn occur, which can lead to abrasion of material in the extruder tube or on the die plate and therefore to an undesirable introduction of metal into the extrudate.
The object of the present invention is to improve the prior art described.
For this purpose, according to the invention, a process is provided for continuous sintering of granules for the preparation of pellets, in particular medicament formulations in the form of tablets, in which the direction of the open extruder front or the ejector, components being made into a paste or softening (at any rate none of the components melting) and particles of the powder mixture sticking together or sintering to form granules,
The process claimed thus operates under normal pressure, since a die is lacking. The occurrence of shearing forces, as in known extrusion, is largely avoided in this way, so that there is practically no abrasion of the extruder tube or on a die provided in the prior art, and therefore no introduction of metal occurs. Since no single one of the components employed is melted, and since also no strand is extruded, the material emerging from the extruder in the process according to the invention is obtained as granules, so that it does not have to be subjected to a separate granulating stage. Instead, the material emerging from the extruder can be sieved, if necessary, the sieve residue being fed to tablet making, while the material which passes through the sieve can be fed into the process according to the invention again.
A lipid or lipoid component can be used as one of the components for the powder introduced into the extruder.
Components which include an active compound which has a water-solubility of greater than 0.5% can be used as starting substances in the process according to the invention. Examples of active compounds are Diltiazem, Sotalol, Diclofenac or one of their derivatives, such as Diltiazem.HCl, Sotalol.HCl or Diclofenac sodium.
In the process according to the invention, the extruder and/or the screw can be heated in zones, three or more zones following one another (in the conveying direction), the middle zone(s) of which has (have) a higher temperature than the flanking zones.
According to the invention, a screw in which (in the conveying direction), a zone of given thread width and thread pitch is followed by a zone of greater thread width and/or flatter thread pitch. The zones of different thread width and/or thread pitch can be provided here, for example, with the aid of individual elements of the screw connected to one another.
According to the invention, two combing screw bodies arranged parallel to one another and run

REFERENCES:
patent: 4483847 (1984-11-01), Augart

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Process for continuous sintering of granules does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Process for continuous sintering of granules, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Process for continuous sintering of granules will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-2055557

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.