Oral complex preparation comprising fat-soluble drug and solid preparation coated with oil-proof material
Inventors
CHOI, Yun Woong • Ha, Dae Chul • KWON, In Ho • Kim, Byung Jin • Song, Hee Yong • Kwon, Min-seok • Min, Byung Gu • Cho, Sang Min • JANG, Jae Sang
Assignees
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Publication Number
US-11033505-B2
Publication Date
2021-06-15
Expiration Date
Abstract
The present invention relates to an oral complex preparation comprising: a capsule containing a fat-soluble first drug; and a solid preparation containing a second drug, the solid preparation being embedded into the capsule and including an oil-proof material coating layer on the surface thereofThe oral complex preparation of the present invention prepared by embedding the solid preparation including the oil-proof material coating layer on the surface thereof and containing the second drug into the capsule containing the fat-soluble first drug enables two types of drug ingredients to be simultaneously administered. At this time, the oral complex preparation of the present invention can independently transfer each of two types of the active ingredients to a desired region without loss of the active ingredients since the oral complex preparation by enabling the oil-proof material coating layer on the surface of the solid preparation to block elution of the active ingredients of the solid preparation by the fat-soluble first drug or occurrence of side effects with the fat-soluble first drug.
Core Innovation
The invention relates to an oral complex preparation in which a capsule contains a fat-soluble first drug and an embedded solid preparation contains a second drug. The solid preparation includes an oil-proof material coating layer on its surface, so that the solid preparation is embedded into the capsule. The oil-proof material coating layer is included on the solid preparation in an amount of 3% to 6% by weight based on the total weight of the solid preparation, and the oil-proof material comprises polyvinyl alcohol (PVA).
The solid preparation further includes an additional coating layer comprising OPADRY® OY-C-7000A formed inside the oil-proof material coating layer. The OPADRY® OY-C-7000A is composed of 54.85 weight % of hydroxypropylmethyl cellulose, 13.72 weight % of ethylcellulose, 22.86 weight % of titanium oxide, and 8.57 weight % of diethylphthalate.
The document also discloses producing the oral complex preparation by first coating the solid preparation with a first coating solution including OPADRY® OY-C-7000A and then coating with a second coating solution including the oil-proof material. The coated solid preparation is embedded in a capsule sheath, after which the fat-soluble first drug is injected and the capsule is sealed.
Claims Coverage
The document provides two independent claims covering an oral complex preparation and a sequential production method. The coverage centers on the specified oil-proof PVA coating amount of 3% to 6% by weight and the inner OPADRY® OY-C-7000A coating defined by its weight-percent components.
Oil-proof coated embedded solid within a capsule for oral delivery
An oral complex preparation comprising a capsule containing a fat-soluble first drug and a solid preparation containing a second drug, the solid preparation being embedded into the capsule and including an oil-proof material coating layer on the surface thereof in an amount of 3% to 6% by weight based on the total weight of the solid preparation, wherein the oil-proof material comprises polyvinyl alcohol (PVA).
Inner OPADRY® OY-C-7000A coating formed inside the oil-proof layer
The solid preparation further includes an additional coating layer comprising OPADRY® OY-C-7000A formed inside the oil-proof material coating layer, wherein the OPADRY® OY-C-7000A is composed of 54.85 weight % of hydroxypropylmethyl cellulose, 13.72 weight % of ethylcellulose, 22.86 weight % of titanium oxide, and 8.57 weight % of diethylphthalate.
Sequential coating of a solid with OPADRY® then oil-proof material followed by capsule embedding and sealing
A method of producing an oral complex preparation comprising coating a first coating solution including OPADRY® OY-C-7000A on the solid preparation, coating a second coating solution including the oil-proof material on the solid preparation, embedding the solid preparation coated with the oil-proof material into a capsule sheath containing a fat-soluble first drug, and sealing the capsule, wherein the oil-proof material coating layer is included on the solid preparation in an amount of 3% to 6% by weight based on the total weight of the solid preparation, wherein the oil-proof material comprises polyvinyl alcohol (PVA), and wherein the OPADRY® OY-C-7000A is composed of 54.85 weight % of hydroxypropylmethyl cellulose, 13.72 weight % of ethylcellulose, 22.86 weight % of titanium oxide, and 8.57 weight % of diethylphthalate.
Overall, the claims cover an oral complex preparation with a capsule containing a fat-soluble first drug and an embedded second-drug solid protected by a PVA oil-proof coating at 3% to 6% by weight, with an inner OPADRY® OY-C-7000A coating defined by specific weight-percent components. The coverage also extends to a sequential production method that coats the solid with OPADRY® OY-C-7000A and then with the oil-proof material, followed by embedding into a capsule sheath and sealing.
Stated Advantages
Prevents penetration/elution interactions between the fat-soluble first drug and the solid second-drug preparation by using the oil-proof material coating layer and the inner OPADRY® OY-C-7000A coating.
Maintains stability/disintegration performance, including preventing delayed disintegration and hardness loss observed in comparative uncoated or partially coated controls.
Documented Applications
Oral complex preparation for delivering a fat-soluble first drug together with a second drug in an embedded solid preparation within a capsule.
Use of the oral complex preparation for combinations in which the fat-soluble first drug is an omega-3 fatty acid or an alkyl ester and the second drug is a statin-based drug (e.g., atorvastatin or rosuvastatin).
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