KR20230087187A - 치주질환의 예방 또는 개선에 효과를 나타내는 조성물 - Google Patents
치주질환의 예방 또는 개선에 효과를 나타내는 조성물 Download PDFInfo
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- KR20230087187A KR20230087187A KR1020210175917A KR20210175917A KR20230087187A KR 20230087187 A KR20230087187 A KR 20230087187A KR 1020210175917 A KR1020210175917 A KR 1020210175917A KR 20210175917 A KR20210175917 A KR 20210175917A KR 20230087187 A KR20230087187 A KR 20230087187A
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- periodontal disease
- preventing
- effective
- sustained
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Abstract
본 발명은 치주 질환의 예방 또는 치료에 효과를 나타내는 조성물에 관한 것으로, 보다 상세하게는 유산균(락토바실러스)를 포함하여 충치와 치주질환의 주 원인균(뮤탄스,진지발리스,칸디다균) 및 염증 유발 요소와 플라그를 억제시키고 리포좀을 포함하여 치은 표면에 부착력이 높고, 이에 의한 지속적 서방적 효과로 치주 질환의 예방 또는 치료에 효과적인 서방형 조성물에 관한 것이다.
Description
본 발명은 치주 질환의 예방 또는 치료에 효과를 나타내는 조성물에 관한 것으로, 보다 상세하게는 유산균(락토바실러스)를 포함하여 충치와 치주질환의 주 원인균(뮤탄스,진지발리스,칸디다균) 및 염증 유발 요소와 플라그를 억제시키고 리포좀을 포함하여 치은 표면에 부착력이 높고, 이에 의한 지속적 서방적 효과로 치주 질환의 예방 또는 치료에 효과적인 서방형 조성물에 관한 것이다.
치주질환의 경우 스케일링이나 치주처치 이후 지속적인 관리가 중요하며 원인균 제거가 질환이나 증상 개선에 매우 중요한 부분이다. 원인균 제거는 물리적인 방법과 화락적인 방법이 병행되어야 더욱 효과가 극대화 된다. 치주질환이 있는 경우 치주낭은 현실적으로 매일 양치로 플라그제거 또는 원인균 제거가 불가능 하기 때문에 원인균을 제거하고 항염효과을 줄 수 있는 보조제가 필요하다. 현재 가장 보편적으로 환자들이 보조제로 섭취하고 있는 일반의약품인 인사돌,이가탄 같은 제품들의 경우 잇몸치료제에서 보조치료제로 강등되었으며 식약처에서도 보조치료제로 장기 연속복용을 하지 않도록 주의사항을 추가 하기도 하였다. 치주질환 환자에게 부작용 부담 없이 장기적으로 보조요법으로 섭취할 수 있는 식품 또는 보조제에 대한 수요가 있다.
한국 등록특허 제10-2014-0086980호는 항염 및 살균력이 증진된 치주질환 예방 또는 개선용 조성물에 관한 것으로, 글리시리진산 또는 그의 염, 판테놀 및 초산토코페롤을 포함하는 치주질환 예방 또는 치료용 의약 조성물을 제공하는 조성물에 관한 것이다.
본 발명이 해결하고자 하는 기술적 과제는 치주 질환의 예방 또는 치료에 지속적 효과를 나타내는 조성물을 제공함에 있다.
상술한 기술적 과제를 해결하기 위하여 유산균(락토바실러스 루테리), 리포좀 및 항바이러스제 또는 구강 질환의 예방 또는 치료 효과 물질을 포함하는, 서방형 조성물을 제공한다.
본 발명에 따른 서방형 조성물을 통해 치주 질환의 예방 또는 치료 효과 물질을 효과적으로 전달할 수 있는 구강용 제어방출형 제제를 제공할 수 있다.
본 발명의 기술적 효과들은 이상에서 언급한 것들로 제한되지 않으며, 언급되지 않은 또 다른 기술적 효과들은 아래의 기재로부터 당업자에게 명확하게 이해될 수 있을 것이다.
본 발명이 여러 가지 수정 및 변형을 허용하면서도, 그 특정 실시예들이 도면들로 예시되어 나타내어지며, 이하에서 상세히 설명될 것이다. 그러나 본 발명을 개시된 특별한 형태로 한정하려는 의도는 아니며, 오히려 본 발명은 청구항들에 의해 정의된 본 발명의 사상과 합치되는 모든 수정, 균등 및 대용을 포함한다.
비록 제1, 제2 등의 용어가 여러 가지 요소들, 성분들, 영역들, 층들 및/또는 지역들을 설명하기 위해 사용될 수 있지만, 이러한 요소들, 성분들, 영역들, 층들 및/또는 지역들은 이러한 용어에 의해 한정되어서는 안 된다는 것을 이해할 것이다.
본 발명은 리포좀 및 치주 질환의 예방 또는 치료 효과 물질을 포함하는, 서방형 조성물에 관한 것이다. 본 발명을 통해 치주 질환의 예방 또는 치료 효과 물질을 효과적으로 전달할 수 있는 구강용 제어방출형 제제를 제공할 수 있다.
이러한 기술적 배경하에서, 본 출원의 발명자들은 치주 질환의 예방 또는 치료 효과를 나타내는 물질을 리포좀에 포함시킨 형태로 제형화하여, 치주조직 또는 구강막 표면에 부착력이 높고, 이에 의한 지속적 서방적 효과로 치주 질환의 예방 또는 치료에 효과적인 조성물을 제공할 수 있음을 확인하고, 본 발명을 완성하였다.
상기 리포좀 (Liposome)은 양친매성의 인지질이 수상에서 소수성의 힘에 의해 자가배열되어 있는 구조체로, 인지질막은 세포의 구조와 동일하여, 세포이입이 쉽고, 다른 구조체에 비해 내부에 수용성 물질을 담지할 수 있는 공간이 커서 수용성 물질의 전달체 및 담지체로 사용될 수 있다.
상기 리포좀은 인지질로 구성된 전달 및 매개체로써 나노 크기(1μm 이하)의 캡슐형상이며, 리포좀 내부에는 친유성과 친수성의 기능성 물질을 모두 함유시킬 수 있어 인체의 피부 세포와 유사한 생체에 적합성 물질이며 친수성 제형에 첨가하면 부유상태로 존재하게 되어 표면 안정성을 지닌다.
지질막의 구성 성분은 두개의 소수성 지방산 그룹과 친수성의 인산기 그룹으로 이루어진 양친매성 인지질이며, 수용액에서 이중막을 형성하고 이것은 인공적인 세포처럼 닫힌 구조의 소포를 형성하기도 한다. 이중막 구조에서 비극성인 지방산 꼬리부분은 막의 안쪽을 향하고 극성인 머리 부분은 바깥쪽을 향하게 된다.
상기 리포좀은 예를 들면, 유기 용매 중에 현탁된 지질 분자를 감압하에 증발시켜 용기 내에 건조 필름을 형성하고, 적절한 양의 수성상을 상기 용기에 첨가한 후 혼합물을 교반한다. 그후, 상기 혼합물을 멀티라멜라 소포가 형성되기에 충분한 시간 동안 정치시켜 제조될 수 있다.
상기 리포좀은 예를 들어, 포스파티딜콜린(PC), 포스파티딜글리세롤(PG), 포스파티딜에탄올아민(PE), 포스파티딜세린(PS), 포스파티드산(PA), 포스파티딜이노시톨(PI), 달걀 포스파티딜콜린(EPC), 달걀 포스파티딜글리세롤(EPG), 달걀 포스파티딜에탄올아민(EPE), 달걀 포스파티딜세린(EPS), 달걀 포스파티드산(EPA), 달걀 포스파티딜이노시톨(EPI), 콩 포스파티딜콜린(SPC), 콩 포스파티딜글리세롤(SPG), 콩 포스파티딜에탄올아민(SPE), 콩 포스파티딜세린(SPS), 콩 포스파티드산(SPA), 콩 포스파티딜이노시톨(SPI), 다이팔미토일포스파티딜콜린(DPPC), 1,2-다이올레오일-sn-글리세로-3-포스파티딜콜린(DOPC), 다이미리스토일포스파티딜콜린(DMPC), 다이팔미토일포스파티딜글리세롤(DPPG), 다이올렐포스파티딜글리세롤(DOPG), 다이미리스토일포스파티딜글리세롤(DMPG), 헥사데실포스포콜린(HEPC), 수소화된 콩 포스파티딜콜린(HSPC), 다이스테아로일포스파티딜콜린(DSPC), 다이스테아로일포스파티딜글리세롤(DSPG), 다이올레일포스파티딜에탄올아민(DOPE), 팔미토일스테아로일포스파티딜콜린(PSPC), 팔미토일스테아로일포스파티딜글리세롤(PSPG), 모노올레오일포스파티딜에탄올아민(MOPE), 1-팔미토일-2-올레오일-sn-글리세로-3-포스파티딜콜린(POPC), 폴리에틸렌글리콜 다이스테아로일포스파티딜에탄올아민(PEG-DSPE), 다이팔미토일포스파티딜세린(DPPS), 1,2-다이올레오일-sn-글리세로-3-포스파티딜세린(DOPS), 다이미리스토일포스파티딜세린(DMPS), 다이스테아로일포스파티딜세린(DSPS), 다이팔미토일포스파티드산(DPPA), 1,2-다이올레오일-sn-글리세로-3-포스파티드산(DOPA), 다이미리스토일포스파티드산(DMPA), 다이스테아로일포스파티드산(DSPA), 다이팔미토일포스파티딜이노시톨(DPPI), 1,2-다이올레오일-sn-글리세로-3-포스파티딜이노시톨(DOPI), 다이미리스토일포스파티딜이노시톨(DMPI), 다이스테아로일포스파티딜이노시톨(DSPI), POPE(1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoethanolamine), POPG(1-palmitoyl-2-oleoyl-sn-glycero-3-phospho-(1'-rac-glycero) 및 이들의 조합으로 이루어진 군에서 선택된 1종 이상을 포함할 수 있으나, 이에 제한되는 것은 아니다. 구체적으로, 상기 리포좀은 포스파티딜에탄올아민(PE) 및 포스파티딜세린(PS)을 포함할 수 있다.
본 발명에 따른 조성물은 리포좀을 포함하는 마이크로캡슐, 마이크로스피어, 나노캡슐 또는 나노스피어 형태를 가질 수 있다. 이러한 마이크로캡슐, 마이크로스피어, 나노캡슐 또는 나노스피어 형태로 제조하기 위해, 중합체, 가소제와 유화제를 추가로 포함할 수 있다. 예를 들어, 폴리알킬 메타크릴레이트, 폴리알킬시아노아크릴레이트, 폴리락트산, 폴리에스테르, 에틸셀룰로스, 셀룰로스 유도체, 알부민, 젤라틴, 소듐 알기네이트, 펙틴, 키토산, 구아검 또는 크산탄검과 같은 다당류를 포함할 수 있다.
바이러스가 체내 진입하는 경로의 첫 단계는 구강 점막을 통과해 잇몸 혈관으로 진입하는 것이다. 본 발명을 통해 항바이러스제를 구강 점막에 잔류하면서 지속적으로 바이러스 차단 물질이 방출되도록 할 수 있다.
상기 항바이러스제는 예를 들어, 비뉴클레오시드 역전사 효소 억제제(NNRTIs; Non-nucleoside reverse-transcriptase inhibitors), 뉴클레오시드 역전사 효소 저해제(NRTIs; Nucleoside reverse-transcriptase inhibitors), 단백분해효소 억제제(PIs; Protease inhibitors), 통합효소억제제(INSTI; Integrase Strand Transfer Inhibitor), 융합 억제제, CCR 5(Chemokine (C-C motif) ligand 5) 억제제, 독감 치료제 또는 코로나바이러스 치료제일 수 있으나, 이에 제한되는 것은 아니다.
상기 항바이러스제는 예를 들어, 에파비렌즈(efavirenz), 에트라비린(etravirine), 네비라핀(nevirapine), 도라비린(doravirine), 릴피비린(rilpivirine), 델라비르딘(delavirdine), 지도부딘(zidovudine), 디다노신(didanosine), 잘시타빈(zalcitabine), 스타부딘(stavudine), 라미부딘(lamivudine), 아바카비어(abacavir), 테노포비르 디소프록시 푸마레이트(tenofovir disoproxil fumarate), 엠트리시타빈(emtricitabine), 테노포비르 알라페나미드 푸마레이트(tenofovir alafenamide fumarate), 사퀴나비르(saquinavir), 리토나비르(ritonavir), 인디나비르(indinavir), 넬피나비르(nelfinavir), 암프레나비르(amprenavir), 로비나비르(lopinavir), 아타자나비르(atazanavir), 포삼프레나비르(fosamprenavir), 티프라나비르(tipranavir), 다루나비르(darunavir), 코비시스타트(cobicistat), 돌루테그라비르(dolutegravir), 랄테그라비르(raltegravir), 엔푸버타이드(enfuvirtide), 마라비록(maraviroc), 엘비테그라비르(elvitegravir), 테노포비르 알라페나미드(tenofovir alafenamide), 테노포비르 디소프록실(tenofovir disoproxil), 아만타딘(amantadine), 리만타딘(rimantadine), 오셀타미비르(oseltamivir), 자나미비르(zanamivir), 페라미비르(peramivir), 발록사비르(baloxavir), 라니나미비어(laninamivir), 아시클로비르(aciclovir), 발라시클로비르(valaciclovir), 이독스우리딘(idoxuridine), 비다라빈(vidarabine), 펜시클로비르(penciclovir), 팜시클로비르(famciclovir), 트리플루리딘(trifluridine), 시도포비어(cidofovir), 포스카넷(foscarnet), 클레부딘(clevudine), 텔비부딘(telbivudine), 엔테카비르(entecavir), 아데포비르(adefovir), 베시포비르(besifovir), 페그인터페론 알파 2a(peginterferon-α-2a), 페그인터페론 알파 2b(peginterferon-α-2b), 리바비린(ribavirin), 보세프레비르(boceprevir), 다사부비르(dasabuvir), 다클라타스비르(daclatasvir), 아수나프레비르(asunaprevir), 소포스부비르(sofosbuvir), 엘바스비르(elbasvir), 그라조프레비르(grazoprevir), 글레카프레비르(glecaprevir), 피브렌타스비르(pibrentasvir), 옴비타스비르(ombitasvir), 파리타프레비르(paritaprevir), 인터페론알파 2a(interferon alfa-2a), 인터페론알파 2b(interferon alfa-2b) 또는 이미퀴모드(imiquimod)일 수 있으나, 이에 제한되는 것은 아니다.
상기 구강 질환의 예방 또는 치료 효과 물질은 바람직하지 않은 생리학적 상태를 예방하거나, 치유하거나, 호전시킬 수 있는 화합물, 천연물 또는 생화합물을 포함할 수 있다. 예를 들어, 상기 구강 질환의 예방 또는 치료 효과 물질은 충치균 살균물질, 베타 글루칸 생성 억제 물질, 구강 면역 물질, 구강 검 출혈억제물질, 항염 물질, 골 재생 물질로 구성된 군에서 선택되는 하나 이상일 수 있다.
구체적으로, 다음을 포함할 수 있다:
(1) 충치균 살균 물질 : Lactobacillus reuteri 균주, 균주의 박테리오신 (bacteriosin), 프로폴리스, 니신 (nisin);
(2) 바이오필름인 베타 글루칸의 생성 억제 : 니신;
(3) 구강 면역 물질 : 비타민 C, 비타민 B12;
(4) 구강 검 출혈억제 물질: 엽산 (비타민 B9);
(5) 항염 물질 : 니파야자(Nypa fruticans Wurmb), 유백피 (Ulmi Cortex);및
(6) 골재생 물질: 산사자 등일 수 있으나, 이에 제한되는 것은 아니다.
본 발명에 따른 조성물 중 포함된 리포좀은 세포 피부막과 유사하여 구강막 표면에 부착률이 높다. 시간이 지나면서 리포좀 막이 터지면서 내부의 성분들이 방출될 수 있다. 이런 리포좀에 의한 지속적 서방적 효과로 바이러스 감염 경로의 차단, 구강 질환의 예방 또는 치료, 치아와 잇몸의 건강을 유지할 수 있다.
본 발명에 따른 조성물의 작용 부위는 입, 인후 및 식도의 구강 점막 또는 치아로의 국부 전달을 포함한다.
본 발명에 따른 조성물은 정제(tablet), 필름제, 현탁제(suspension), 과립제(granule), 겔제(gel), 환제(pill), 틴크제(tincture), 전제(decoction), 침제(infusion), 주정제(spirit), 유동엑스제(fluidextract), 엘릭서제(elixir), 엑스제(extract), 시럽제(syrup), 산제(powder), 방향수제(aromatic water), 레모네이드제(lemonade) 등의 다양한 형태로 제제화될 수 있다. 또한, 상기 정제(tablet)는 예컨대, 구강붕해정(orally disintegrating tablet), 부착정(mucoadhesive tablet), 분산정(dispersible tablet), 설하정(sublingual tablet), 바칼정(buccal tablet), 저작정(chewable tablet), 조제정(dispensing tablet), 다층정(mulitilayered tablet), 유핵정(press-coated tablet), 비등정(발포정-effervescent tablet), 용해정(solution tablet)등의 다양한 형태로 제제화될 수 있다.
경우에 따라서, 본 발명에 따른 조성물은 액상형이나 구강 내에서 붕해되는 제형(즉, 구강 내 붕해성)과 같이, 구강내 분산성 제형, 예컨대 구강용해필름, 구강붕해정, 현탁액, 현탁정, 속효성붕해정, 구강붕해과립, 구강붕해트로키제, 설하정, 산제 및/또는 츄어블정과 같은 제형일 수 있다.
본 발명에 따른 조성물을 구강 투여용 약학 제제로 제조시에는 통상적으로 약학 제제에 첨가할 수 있는 약학적으로 허용가능한 담체를 더 포함할 수 있다. 상기 약학적으로 허용가능한 담체는 약제학 분야에서 통상적으로 사용되는 부형제, 붕해제, 결합제, 활택제, 유화제, 현탁화제, 안정화제 등의 첨가제를 포함하며, 필요할 경우 감미제, 향료 및/또는 착색제 등을 추가로 첨가할 수 있다.
이상으로 본 발명의 내용의 특정한 부분을 상세히 기술하였는바, 당업계의 통상의 지식을 가진 자에게 있어서, 이러한 구체적 기술은 단지 바람직한 실시양태일 뿐이며, 이에 의해 본 발명의 범위가 제한되는 것이 아닌 점은 명백할 것이다. 따라서, 본 발명의 실질적인 범위는 첨부된 청구항들과 그것들의 등가물에 의하여 정의된다고 할 것이다.
Claims (3)
- 리포좀; 및
항바이러스제 또는 구강 질환의 예방 또는 치료 효과 물질을 포함하는, 서방형 조성물.
- 제1항에 있어서,
상기 리포좀은 포스파티딜에탄올아민(PE) 및 포스파티딜세린(PS)을 포함하는 조성물.
- 제1항에 있어서,
상기 구강 질환의 예방 또는 치료 효과 물질은 치주조직 재생을 위한 콜라겐펜타이드, 단백질, 충치균 살균물질, 베타 글루칸 생성 억제 물질, 구강 면역 물질, 구강 잇몸 출혈 억제 물질, 항염 물질, 골 재생 물질, 유산균(락토바실러스)로 구성된 군에서 선택되는 하나 이상인 조성물.
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