Ethypharm, Inc.

Laboratoires Prographarm

Societe Laboratoires Des Products Ethiques - Ethypharm

Prographarm Laboratories

Etienne Bruna

Edouard Gendrot

Charles Chauveau

Gerard Cousin

Jean-Marc Zuccarelli

Noureddine Nouri

Gérard Cousin

Alain-Gilles Demichelis

Francis Philippon

Marie-Sylvie Boutin

The invention concerns a microgranule consisting of a core coated with at least a coating layer, said coated core comprising at least an active principle. The invention is characterised in that the core and said coating layer contain each between 80 and 95 wt. % of active principle, the complement to 100% consisting of at least a binding agent, and the coated core has a substantially spherical shape. The invention also concerns the method for making such microgranules.

Microgranules based on active principle and method for making same

The invention concerns a method for making coated granules with masked taste and instant release of the active principle which consists in: first, mixing the constituents of a powder comprising at least the active principle and a granular disintegrating agent; then, granulating the resulting powder, in the presence of a mixture of carriers comprising at least a binding agent capable of binding the particles together to obtain grains; coating the grains formed by spraying a suspension comprising at least a coating agent and a membrane disintegrating agent; finally drying the resulting coated granules.

Process for manufacturing coated granules with masked taste and immediate release of the active principle

A process for manufacturing coated particles of &ggr;-aminobutyric acid analogue, whose lactam content by weight relative to the weight of &ggr;-aminobutyric acid analogue is less than 0.5% is disclosed. The process is characterized in that a coating solution of at least one polymer in an organic solvent is sprayed onto the particles of &ggr;-aminobutyric acid analogue.

Process for manufacturing coated gabapentin or pregabalin particles

Rapidly disintegratable multiparticulate tablet the excipient mixture of which is suitable for imparting a disintegration rate such that the tablet disintegrates in the mouth in an extremely short time, notably in less than sixty seconds, characterized by the fact that the active substance is present in the form of coated microcrystals or coated or uncoated microgranules.

Rapidly disintegratable multiparticular tablet

A sustained release diltiazem formulation for oral administration comprising a pellet having a central sugar sphere a plurality of alternating first and second layers surrounding the sphere to form a core, the first layer comprising a water soluble pharmaceutically acceptable polymeric material and the second layer comprising diltiazem or a pharmaceutically acceptable salt thereof and an outer membrane surrounding the plurality of layers. The outer membrane comprises first inner membrane layers of ethylcellulose. The outer membrane also comprises an outer membrane coating of a water insoluble pharmaceutically acceptable polymeric material, a plasticizer and a lubricant, in from one to five or more layers. The number of layers and the coating of the two outer membrane layers are effective to permit the release of the diltiazem from the pellet at a rate allowing controlled absorption thereof over a twelve or twenty four hour period following oral administration, the rate being measured in vitro as a dissolution rate of the pellet, which when measured in an aqueous solution in a paddle apparatus according to U.S. Pharmacopeia XXII, substantially corresponds to the following dissolution pattern: from 15 to 40% of the total diltiazem is released after 4 hours of measurement; from 40 to 70% of the total diltiazem is released after 8 hours of measurement; from 50 to 85% of the total diltiazem is released after 12 hours of measurement; and from 70 to 100% of the total diltiazem is released after 24 hours of measurement.

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Jouy, France

Etienne Bruna