Evonik Operations Gmbh

Evonik Roehm Gmbh

Shraddha Joshi

Ashish Guha

Vinay Jain

Harsh Shah

Hans Bär

Priyanka Bansilal Haksar

Felix Hofmann

Preeti Patil

Smitha Shetty

Bettina Hölzer

Marcel Arndt

Aditi Poddar

Vishal Kaneria

Miriam Robota

Jean-Luc Herbeaux

Umesh Kapale

Nilam Bharambe

Priyanka Parab

Mitulkumar M Patel

Firouz Asgarzadeh

Sanjay Lanke

Suresh Doke

Christian Mahlmeister

Theresia Kuntz

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 with a core, an inner coating layer, and an outercoating layer, wherein a pharmaceutical or a nutraceutical active ingredient is contained in the core, one or more salts of alginic acid is contained in the inner coating layer, and one or more water-insoluble polymers or copolymers is contained in the outer coating layer. In the composition, the ratio of the amount of the one or more salts of alginic acid in the inner coating layer is at least 2.5:1 by weight to the amount of the one or more water-insoluble polymers or copolymers in the outer coating layer.

Pharmaceutical or nutraceutical composition with sustained release characteristic and with resistance against the influence of ethanol

A pharmaceutical or nutraceutical composition with a core, an inner layer, and an outercoating layer, wherein a pharmaceutical or a nutraceutical active ingredient is contained in the core, at least 30% by weight of a salt of alginic acid is contained in the inner layer, and at least 30% by weight of a polymer or copolymer with anionic side groups is contained in the outer coating layer.

Gastric resistant 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.

The invention refers to a pharmaceutical or nutraceutical composition, comprising a) a core, comprising a pharmaceutical or a nutraceutical active ingredient, b) an inner coating layer comprising one or more salts of alginic acid and c) an outer coating layer comprising one or more water-insoluble polymers or copolymers and one or more water-soluble polymers, selected from the group of water soluble celluloses, polyvinyl pyrrolidones or polyethylene glycols or any combinations thereof. wherein the ratio by weight of the amount of the one or more salts of alginic acid in the inner coating layer to the amount of the one or more water-insoluble polymers or copolymers in outer coating layer is from 0.6 to less than 2.5:1.

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Navi Mumbai, India

Shraddha Joshi