Evonik Operations Gmbh

Evonik Roehm Gmbh

Ashish Guha

Shraddha Joshi

Vinay Jain

Hans Bär

Felix Hofmann

Bettina Hölzer

Priyanka Bansilal Haksar

Marcel Arndt

Suresh Doke

Vishal Kaneria

Miriam Robota

Jean-Luc Herbeaux

Umesh Kapale

Nilam Bharambe

Mitulkumar M Patel

Firouz Asgarzadeh

Sanjay Lanke

Aditi Poddar

Christian Mahlmeister

Theresia Kuntz

Shraddha Sanjeev Joshi

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 dosage form contains a biologically active ingredient for treating or preventing a disease in the animal or human body, where the treatment or prevention requires release of 50% or more of the biologically active ingredient in the small intestine within the pH range from 3 to 5.5. The dosage form contains: a) a core, containing the biologically active ingredient; b) an intermediate coating layer (ICL) onto or above the core, containing an alkaline agent; and c) an enteric coating layer (ECL) onto or above the intermediate coating layer, containing an enteric polymer. The relation of the alkaline agent to the enteric polymer is 5 to 95% when calculated by the formula:

Dosage form for use in treating or preventing of a disease

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

A pellet contains a core, which contains one or more biologically active ingredients, and a coating layer on the core. The coating layer contains a mixture of a first polymer and a second polymer. The first polymer is a core-shell polymer, containing 50 to 90% by weight of a core, containing polymerized units of 60 to 85% by weight of ethyl acrylate and 20 to 40% by weight of methyl methacrylate; and 10 to 50% by weight of a shell, containing polymerized units of 40 to 60% by weight ethyl acrylate and 40 to 60% by weight methacrylic acid. The second polymer contains polymerized units of 40 to 60% by weight of methacrylic acid and 60 to 40% by weight of ethyl acrylate or methyl methacrylate. A Multi-Unit Pellet System (MUPS), preferably a compressed tablet, contains a multitude of the pellets.

Pellet and multi-unit pellet system (MUPS)

The invention refers to a pharmaceutical or nutraceutical composition comprising a core a) comprising an active ingredient and a water-insoluble polymer, a coating layer b) above the core a) comprising a salt of an alginic acid, and a coating layer c) above the coating layer b) comprising an anionic (meth)acrylate copolymer polymerized from a (meth)acrylate monomer mixture comprising 5-75% by weight in relation to the total weight of the (meth)acrylate monomer mixture of (meth)acrylate monomers with an anionic group, wherein the amount of the water-insoluble polymer in the core a) is 2 to 20% by weight in relation to the weight of the core a) and the amount of the salt of an alginic acid in the coating layer b) is 5 to 85% by weight in relation to the weight of the core a) and the amount of the anionic (meth)acrylate copolymer in the coating layer c) is 10 to 75% by weight in relation to the weight of the core a) and to the coating layer b).

Pharmaceutical or nutraceutical composition with resistance against the influence of ethanol

A pharmaceutical or nutraceutical composition, contains a) a core a), containing a pharmaceutical or a nutraceutical active ingredient and b) a coating layer b), containing a mixture of 80 to 96% by weight of a water-insoluble (meth)acrylate polymer and 4 to 20% by weight of guar gum, wherein the water-insoluble (meth)acrylate polymer contains polymerized units of more than 95 and up to 100% by weight C-C-alkyl esters of acrylic acid or of methacrylic acid and less than 5% by weight of acrylic acid or methacrylic acid.

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Mumbai, India

Ashish Guha