Evonik Operations Gmbh

Evonik Roehm Gmbh

Evonik Rohm Gmbh

Hans Bär

Shraddha Joshi

Ashish Guha

Vinay Jain

Felix Hofmann

Michael Gottschalk

Gerhard Renner

Bettina Hölzer

Thomas Fürst

Marcel Arndt

Julian Blaesy

Isabel Wahl

Miriam Robota

Vishal Kaneria

Silke Schminke

Christian BRUNNENGRÄBER

A process can be used for preparing a polymer coated hard-shell capsule, filled with a fill containing a biologically active ingredient. The hard-shell capsule contains a body and a cap, and in a closed state, the cap overlaps the body in a pre-locked state or a final-locked state. The material of the body and cap contains an ethyl-, methyl-, or propyl-ether of cellulose, starch, or pullulan. The hard-shell capsule is coated with a coating layer, containing one or more anionic cellulose(s), ethyl cellulose, and/or one or more starches comprising at least 35% by weight of amylose, where the coating layer is present in an amount of about 1 to 5.8 mg/cm. The process involves providing the polymer-coated hard-shell capsule in the pre-locked state to a capsule-filling machine, separating the body and the cap, filling the body with the fill, and rejoining the body and the cap in the final-locked state.

Process for preparing filled hard-shell capsules with cellulose or starch-based coatings with a capsule-filling machine

A process prepares a polymer-coated hard shell capsule, suitable as container for pharmaceutical or nutraceutical biologically active ingredients. The hard shell capsule can include a body and a cap. In the closed state, the cap overlaps the body either in a pre-locked state or in a final-locked state. The hard shell capsule can be provided in the pre-locked state and spray-coated with a coating solution, suspension, or dispersion that includes a polymer or a mixture of polymers to create a coating layer which covers the outer surface of the hard shell capsule in the pre-locked state.

Process for preparing a coated hard shell capsule

A process can be used for preparing a polymer coated hard-shell capsule, filled with a fill containing a biologically active ingredient. The hard-shell capsule contains a body and a cap, and in a closed state, the cap overlaps the body either in a pre-locked state or in a final-locked state. The material of the body and the cap contains an ethyl-, methyl-, or propyl-ether of cellulose, starch, or pullulan. The hard-shell capsule is coated with a coating layer that covers the hard-shell capsule in the pre-locked state. The coating layer contains one or more (meth)acrylate copolymers, where the coating layer is present in an amount of about 1 to 5.8 mg/cm. The process involves providing the polymer-coated hard-shell capsule in the pre-locked state to a capsule-filling machine, separating the body and the cap, filling the body with the fill, and rejoining the body and the cap in the final-locked state.

Process for preparing filled hard-shell capsules with (meth)acrylate copolymer based coatings with a capsule-filling machine

The invention relates to a pH-dependent controlled release pharmaceutical composition, comprising a core, and an opioid, wherein the core is coated at least by one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of i) 40-95% by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer, and ii) 5-60% by weight, based on dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0, characterized in that the coating layer further comprises 110 to 250% by weight of a non-porous inert lubricant, 1 to 35% by weight of a neutral cellulosic compound and 1 to 25% by weight of an emulsifier, each calculated on dry weight of the polymer mixture.

PH-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol

The invention relates to a controlled release pharmaceutical composition, comprising a core, comprising a pharmaceutical active ingredient, whereby the core is coated by an ethanol resistance conferring coating layer which has the effect of conferring the release profile of the pharmaceutical active ingredient to be resistant against the influence of ethanol, whereby the ethanol resistance conferring coating layer comprises at least 70% by weight of a mixture of a polymeric portion a) and an excipients portion b), with the polymeric portion a) is consisting of a water insoluble essentially neutral vinyl polymer or vinyl copolymer and the excipients portion b) is consisting of the excipients b1) 100 to 250% by weight of a non-porous inert lubricant, b2) 1 to 35% by weight of a cellulosic compound, b3) 0.1 to 25% by weight of an emulsifier and additionally or alternatively to b3), b4) 0.1 to 30% by weight of a plasticizer whereby the excipients of the excipients portion b) are each calculated on the dry weight of the polymer portion a).

Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients

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Michelstadt, Germany

Hans Bär