Hard-shell capsule with at least one coating layer with a low oxygen permeability
AssigneeEvonik Operations GmbH
InventorsManfred AßMUS, Kathrin NOLLENBERGER, Bettina HÖLZER, Hans BÄR
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Abstract
The present invention refers to a precoated hard-shell capsule with at least one coating layer, suitable as container with an improved protective effect against atmospheric oxygen for pharmaceutical or nutraceutical biologically active ingredients and to a method for preparing a pharmaceutical delivering system comprising a hard-shell capsule and a fill, the fill comprising a pharmaceutically or nutraceutically active ingredient.
Claims14
A precoated hard-shell capsule with at least one coating layer, suitable as container for pharmaceutical or nutraceutical biologically active ingredients,
- wherein the at least one coating layer comprises
- i) at least one (meth)acrylate copolymer with a weight average molar mass from 25,000 to 900,000 g/mol and having a glass transition temperature (Tgm) from 0 to 200° C., wherein the (meth)acrylate copolymer comprises maximally 50% by weight of methacrylic acid monomer units,
- ii) at least one plasticizer with a solubility in water of at least 50 g/l in an amount of maximally 50% by weight relative to the amount of the (meth)acrylate copolymer,
- iii) at least one emulsifier with a melting point higher than 40° C. and having a hydrophilic/lipophilic balance (HLB) of 3 to 6,
- iv) at least one emulsifier with a melting point lower than 40° C. and having a hydrophilic/lipophilic balance (HLB) of 8 to 16,
- and wherein the at least one coating layer has an oxygen permeability of at most 2,500 ml/(m2·d·atm) measured at a thickness of the least one coating layer of 100 μm.
Dependencies are inferred from the claim text.