KR950031051A - 활성물질 및 케탈화 폴리타르트라미드산을 함유하는 나노입자, 이의 제조방법 및 용도 - Google Patents

활성물질 및 케탈화 폴리타르트라미드산을 함유하는 나노입자, 이의 제조방법 및 용도 Download PDF

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KR950031051A
KR950031051A KR1019950004748A KR19950004748A KR950031051A KR 950031051 A KR950031051 A KR 950031051A KR 1019950004748 A KR1019950004748 A KR 1019950004748A KR 19950004748 A KR19950004748 A KR 19950004748A KR 950031051 A KR950031051 A KR 950031051A
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nanoparticles
acid
ketalized
active substance
polytartramide
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아레르스 미하엘
발히 악쎌
자이프케 게르하르트
러쎌-존스 그레고리
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엥겔하르트, 루츠
훽스트 아크티엔게젤샤프트
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5146—Organic macromolecular compounds; Dendrimers obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyamines, polyanhydrides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/23—Calcitonins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6921—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere
    • A61K47/6927—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere the form being a solid microparticle having no hollow or gas-filled cores
    • A61K47/6929—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere the form being a solid microparticle having no hollow or gas-filled cores the form being a nanoparticle, e.g. an immuno-nanoparticle
    • A61K47/6931—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere the form being a solid microparticle having no hollow or gas-filled cores the form being a nanoparticle, e.g. an immuno-nanoparticle the material constituting the nanoparticle being a polymer
    • A61K47/6933—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere the form being a solid microparticle having no hollow or gas-filled cores the form being a nanoparticle, e.g. an immuno-nanoparticle the material constituting the nanoparticle being a polymer the polymer being obtained by reactions only involving carbon to carbon, e.g. poly(meth)acrylate, polystyrene, polyvinylpyrrolidone or polyvinylalcohol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/70—Nanostructure
    • Y10S977/773—Nanoparticle, i.e. structure having three dimensions of 100 nm or less
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/84—Manufacture, treatment, or detection of nanostructure
    • Y10S977/90—Manufacture, treatment, or detection of nanostructure having step or means utilizing mechanical or thermal property, e.g. pressure, heat
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/902—Specified use of nanostructure
    • Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
    • Y10S977/915—Therapeutic or pharmaceutical composition

Abstract

활성물질 및 케탈화 폴리타르트라미드산을 함유하는 나노입자는 활성물질, 특히 펩티드 및 단백질용 부형제로서 적당하다. 나노입자의 제조방법은 본 명세서에 상술되어 있다.

Description

활성물질 및 케탈화 폴리타르트라미드산을 함유하는 나노입자, 이의 제조방법 및 용도
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (10)

  1. 활성물질 및 하기 일반식(Ⅰ)으 반복구조단위 95mol% 이상을 함유하는 케탈화 폴리타르트라미드산을 함유하는 나노입자.
    상기식에서, R1은 구조식(Ⅱ)
    의 라디칼이고, X는 -NH-이고, R2는 하나 이상의 불활성 라디칼에 의해 치환될 수 있는 직쇄 또는 측쇄 알킬 또는 사이클로알킬이다.
  2. 제1항에 있어서, R1이 구조식(Ⅱ)의 화합물이고, X가 -NH-이고, R2가 a)탄소수 1내지 18의 직쇄 또는 측쇄의 알킬 또는 알케닐 또는 b) 1)카복실 또는 2)2.1 직쇄 또는 측쇄 -O-(C3-C18)-알킬, 2.2-O-(C3-C18)-사이클로알킬, 2.3 (C1-C6)-알킬아미노 또는 2.4 2. 4. 1 하이드록실 또는 2. 4. 2-O-(C2-C4)-알킬로 이루어진 그룹으로부터 선택된 라디칼에 의해 알킬 잔기가 1회 이상 치환된 (C1-C6)-알킬아미노로 이루어진 그룹으로부터의 라디칼에 의해 하이드록실 그룹이 치환된 카복실로 이루어진 그룹으로부터의 라디칼에 의해 1회 이 치환된 탄소수 1내지 18의 직쇄 또는 측쇄 또는 측쇄 알킬 또는 알케닐인 일반식(Ⅰ)의 케탈화 폴리타르트라미드산을 함유하는 나노입자.
  3. 제1항 또는 제2항에 있어서, R1이 구조식(Ⅱ)의 라디칼이고, X가 -NH-이고, R2가 a)탄소수 1내지 18의 알킬, b)(C3-C8)-사이클로알킬 또는 c)일반식
    [여기서, n은 3 또는 4이고 R6은 (C1-C18)-알콕시이다]의 라디칼인 일반식(Ⅰ)의 케탈화 폴리타르트라미드산을 함유하는 나노입자.
  4. 제1항 내지 제3항 중의 어느 한 항에 있어서, 직경이 10내지 1000㎚, 특히 200내지 600㎜인 나노입자.
  5. 제1항 내지 제4항 중의 어느 한 항에 있어서, 케탈화 폴리타르트라미드산에 대한 활성물질의 함량이 1내지 60%인 나노입자.
  6. 제1항 내지 제5항 중의 어느 한 항에 있어서, 활성물질로서 인슐린, 칼시토닌 또는 부셀렐린을 함유하는 나노입자.
  7. 제1항 내지 제5항 중의 어느 한 항에 있어서, 비타민 B12, 비타민 B12유사체 및 렉틴으로 이루어진 그룹으로부터의 리간드가 결합되는 나노입자.
  8. 제7항에 있어서, 리간드가 폴리비닐아민, 폴라아스파르트산, 폴리리신 및 O-(N-석신이미딜)-N,N,N',N'-테트라메틸우로늄 테트라플루오로보레이트로 이루어진 그룹으로부터의 커플링 그룹을 통해 결합되는 나노입자.
  9. a)활성물질 및 제1항에 따른 일반식(Ⅰ)의 케탈화 폴리타르트라미드산을 용해시키고, 임의로는 다른 보조제를 별도로 용해시키고, 수득된 용액을 혼합하고, 혼합물을 외경이 0.2 내지 1.2㎜인 캐뉼러를 통해 침전제에 도입시키거나, b)활성물질 및 제1항에 따른 일반식(Ⅰ)의 케탈화 폴리타르트라미드산을 개별적으로 용해시키고, 임의로는 다른 보조제를 용해시키고, 수득된 용액을 혼합하여 비점도가 0.2 내지 3.5인 용액을 수득하고 이를 분무건조시키고, c)하나 이상의 리간드에 a)또는 b)에 의해 수득된 나노입자를 결합시키고, d)커플링 그룹을 통해 하나 이상의 리간드에 a) 또는 b)에 의해 수득된 나노입자를 연결시키고, e)공극크기가 0.2 내지 0.8㎛인 필터를 통해 a),b),c) 또는 d)에 의해 수득된 나노입자를 여과시킴을 포함하는 제1항에 청구된 나노입자의 제조방법.
  10. 활성물질의 함량을 조절할 수 있고 경구 투여되는 약제학적 제제의 제조를 위한 제1항 내지 제8항 중의 어느 한 항에서 청구된 나노입자의 용도.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950004748A 1994-03-09 1995-03-09 활성물질 및 케탈화 폴리타르트라미드산을 함유하는 나노입자, 이의 제조방법 및 용도 KR950031051A (ko)

Applications Claiming Priority (2)

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DE4407898A DE4407898A1 (de) 1994-03-09 1994-03-09 Nanopartikel, enthaltend einen Wirkstoff und ein Polyketalweinsäureamid, Verfahren zu ihrer Herstellung und Verwendung derselben
DEP4407898.6 1994-03-09

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US (1) US5674531A (ko)
EP (1) EP0671169A1 (ko)
JP (1) JPH07258114A (ko)
KR (1) KR950031051A (ko)
AU (1) AU685577B2 (ko)
CA (1) CA2144216A1 (ko)
DE (1) DE4407898A1 (ko)
FI (1) FI951053A (ko)
HU (1) HUT72033A (ko)
IL (1) IL112905A (ko)
NO (1) NO307422B1 (ko)
NZ (1) NZ270648A (ko)
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ZA951910B (en) 1995-11-13
NO307422B1 (no) 2000-04-03
FI951053A0 (fi) 1995-03-07
NO950889L (no) 1995-09-11
JPH07258114A (ja) 1995-10-09
NO950889D0 (no) 1995-03-08
NZ270648A (en) 1995-09-26
US5674531A (en) 1997-10-07
DE4407898A1 (de) 1995-09-14
IL112905A (en) 2000-08-31
IL112905A0 (en) 1995-06-29
HU9500698D0 (en) 1995-04-28
AU1470195A (en) 1995-09-21
EP0671169A1 (de) 1995-09-13
HUT72033A (en) 1996-03-28

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