Boehringer Mannheim Gmbh

Kali-chemie Pharma Gmbh

Boehringer Mannhelm Gmbh

Berthold Stemmle

Fritz Demmer

Alexander Wirl

Alwin Sobe

Bernd Boedecker

Guenter-Josef Peschke

Manfred Rehburg

Friederike Henninges

Klaus Budde

Klaus-Juergen Koelln

Guenther Kuhnow

Process for the preparation of shaped, compressed controlled-release unit-dosage forms from a therapeutic active substance exhibiting a self-retarding release that depends on the magnitude of the force used for the compression. The process gives unit-dosage forms for which the release of the active substance is highly uniform, reproducibly identical and largely linear. To achieve this, the active substance and an additive charge that inhibits or compensates for the self-retardation of its release are processed into particles in the first stage of production, so that the preliminary compressed objects made from these particles without any further additives exhibit a rapid release (in comparison with the required controlled release) over the range of the force of compression envisaged for the production of the unit-dosage form in question, after which the particles are compressed in the second stage of production with a release-retarding agent to obtain the unit-dosage forms. The invention also relates to the unit-dosage forms thus obtained.

Process for the preparation of shaped, compressed controlled-release

Pancreatin-containing micropellet cores which can be coated with a gastric juice-resistant film are prepared by extruding a mixture containing pancreatin, polyethylene glycol 4000 and a lower alcohol such as propan-2-ol to produce extrudates which break by themselves into fragments, rounding the fragments with the addition of highly liquid paraffin and drying. Propan-2-ol may be present with the paraffin during rounding. The micropellet cores contain 65-85% pancreatin, and have a bulk density of 0.6 g/ml to 0.85 g/ml, a spherical to ellipsoidal shape with a minor axis in the range of 0.7-1.4 mm and a particle size distribution in which at least 80% of the micropellet cores have a minor axis to major axis ratio in the range from 1:1 to 1:2.

Pancreatin micropellets prepared with polyethylene glycol 4000, paraffin

The present invention provides a medicament containing 80 to 95% clodronate, 2 to 10% filling material and 1 to 10% lubricant. The present invention also provides a process for the production of a clodronate-containing medicament containing 80 to 95% clodronate, 2 to 10% filling material and 1 to 10% lubricant, wherein the dry components are mixed, moist granulated with an aqueous binding agent and the granulate obtained subsequently dried, a lubricant being additionally admixed with the final granulate in an amount of from 1 to 5% and the mixture thus obtained pressed into tablets or filled into capsules which have a rate of dissolving of &gt;90% after 30 minutes.

Clodronate-containing medicaments and a process for the preparation

The present invention provides a composition containing guar flour in the form of tablets for oral administration, said tablets having been produced by dry pressing guar flour with a particle size of 60 to 500 .mu.m. in admixture with 5 to 30% of highly dispersed silica gel.

Method for making a guar flour chewable dosage unit

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Burgdorf, Germany

Berthold Stemmle