KR20170109039A - 첩부제 - Google Patents
첩부제 Download PDFInfo
- Publication number
- KR20170109039A KR20170109039A KR1020177024402A KR20177024402A KR20170109039A KR 20170109039 A KR20170109039 A KR 20170109039A KR 1020177024402 A KR1020177024402 A KR 1020177024402A KR 20177024402 A KR20177024402 A KR 20177024402A KR 20170109039 A KR20170109039 A KR 20170109039A
- Authority
- KR
- South Korea
- Prior art keywords
- pressure
- sensitive adhesive
- adhesive layer
- mass
- patch
- Prior art date
Links
- 239000000853 adhesive Substances 0.000 title claims description 28
- 230000001070 adhesive effect Effects 0.000 title claims description 13
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims abstract description 80
- 239000010410 layer Substances 0.000 claims abstract description 73
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- 238000010030 laminating Methods 0.000 claims abstract description 12
- 238000000034 method Methods 0.000 claims description 21
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- OSWPMRLSEDHDFF-UHFFFAOYSA-N methyl salicylate Chemical compound COC(=O)C1=CC=CC=C1O OSWPMRLSEDHDFF-UHFFFAOYSA-N 0.000 claims description 16
- 229920002367 Polyisobutene Polymers 0.000 claims description 10
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- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 8
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- 229960001047 methyl salicylate Drugs 0.000 claims description 8
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- 235000007586 terpenes Nutrition 0.000 claims description 8
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- 238000002360 preparation method Methods 0.000 claims description 2
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims 3
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- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 23
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Classifications
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- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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Abstract
지지체와, 지지체 상에 적층된 점착제층을 갖는 첩부제로서, 지지체는 스펀레이스 부직포로 이루어지고, 점착제층은 SIS 블록 공중합체 및 유동 파라핀을 포함하고, 첩부제는 소정의 기준 축 방향인 제 1 방향과, 제 1 방향에 직각인 제 2 방향을 갖고, 첩부제의 제 1 방향의 강연도는 18 ∼ 30 ㎜ 인 첩부제를 개시한다.
Description
본 발명은, 첩부제에 관한 것이다.
어깨, 팔꿈치, 무릎 및 허리의 통증을 완화시키기 위하여, 소염 진통제 등의 약물을 배합한 점착제층이 지지체에 적층된 경고 (硬膏) 첩부제 (플라스터제) 가 시판되고 있다. 이와 같은 첩부제 중 지지체에 직포를 사용한 첩부제는, 신축성이 우수하여, 피부의 신축에 추종하기 쉽기 때문에, 부착성이 우수하다. 그러나, 지지체에 직포를 사용한 첩부제는, 이른바 「탄력」(firmness) 이 약한 경향이 있다. 따라서, 첩부제를 환부에 첩부할 때에 갑자기 절곡됨으로써 점착면끼리가 들러붙는 경우가 있어, 첩부제를 첩부하기 어려운 경향이 있다.
한편, 지지체에 부직포를 사용한 첩부제도 개발되고 있다. 지지체에 직포를 사용한 첩부제와 비교하여, 지지체에 부직포를 사용한 첩부제는 「탄력」의 문제가 개선되는 경향이 있긴 하지만, 이른바 콜드 플로가 발생하여 지지체로부터 점착제층의 성분이 스며나오기 쉬워지는 경향이 있다.
본 발명은, 첩부 용이함이 우수하고, 또한, 점착제층의 성분이 지지체로부터 스며나오지 않는 첩부제를 제공하는 것을 목적으로 한다.
본 발명자들은, 상기 사정을 감안하여 예의 검토를 실시하였다. 그 결과, 스펀레이스 부직포로 이루어지는 지지체와, 스티렌-이소프렌-스티렌 블록 공중합체 및 유동 파라핀을 포함하는 점착제층을 조합하고, 또한, 첩부제의 강연도를 18 ∼ 30 ㎜ 로 함으로써, 상기 과제가 해결되는 것을 본 발명자들은 알아냈다.
즉, 본 발명은, 지지체와, 지지체 상에 적층된 점착제층을 갖는 첩부제로서, 지지체는 스펀레이스 부직포로 이루어지고, 점착제층은 스티렌-이소프렌-스티렌 블록 공중합체 및 유동 파라핀을 포함하고, 첩부제는 소정의 기준 축 방향인 제 1 방향과, 제 1 방향에 직각인 제 2 방향을 갖고, JIS L 1085 : 1998 에 규정되는 45 °캔틸레버법으로 측정한 첩부제의 제 1 방향의 강연도는 18 ∼ 30 ㎜ 인 첩부제를 제공한다.
상기 점착제층에 있어서의 스티렌-이소프렌-스티렌 블록 공중합체와 유동 파라핀의 질량비가 1 ∼ 1.65 : 1 이면 된다. 상기 점착제층은, 살리실산메틸 및 멘톨을 포함하면 된다. 상기 점착제층은, 폴리이소부틸렌을 포함하면 된다. 상기 점착제층은, 테르펜 수지를 포함하면 된다. 상기 점착제층은, 점착제층의 전체 질량 기준으로, 9 ∼ 11 질량% 의 살리실산메틸 및 2.5 ∼ 6.5 질량% 의 멘톨을 포함하면 되고, 또 점착제층의 전체 질량 기준으로, 23.7 ∼ 32.5 질량% 의 스티렌-이소프렌-스티렌 블록 공중합체, 17.9 ∼ 27.5 질량% 의 유동 파라핀, 9 ∼ 11 질량% 의 살리실산메틸, 3 ∼ 6 질량% 의 멘톨, 3 ∼ 12 질량% 의 폴리이소부틸렌 및 17 ∼ 25 질량% 의 테르펜 수지를 포함하면 된다.
또, 상기 부직포의 겉보기 중량은 90 ∼ 110 g/㎡ 이면 된다. 상기 부직포의 폭 방향의 20 % 모듈러스가 3 ∼ 5 N/50 ㎜ 이면 된다. 상기 부직포의 폭 방향의 50 % 모듈러스가 8 ∼ 15 N/50 ㎜ 이면 된다. 상기 부직포는 폴리에스테르로 이루어지면 된다. JIS L 1085 : 1998 에 규정되는 45 °캔틸레버법으로 측정한 첩부제의 제 1 방향의 강연도는 18 ∼ 27 ㎜ 이면 된다.
본 발명에 관련된 첩부제는 「탄력」이 있기 때문에 첩부하기 쉽다. 또, 점착제층의 성분의 콜드 플로가 잘 발생하지 않는다.
본 실시형태에 관련된 첩부제는, 지지체와, 지지체 상에 적층된 점착제층을 갖는다. 지지체는, 스펀레이스 부직포로 이루어지고, 점착제층은, 스티렌-이소프렌-스티렌 블록 공중합체 및 유동 파라핀을 포함한다. 첩부제는 소정의 기준 축 방향인 제 1 방향과, 제 1 방향에 직각인 제 2 방향을 갖고, 첩부제의 제 1 방향의 강연도는 18 ∼ 30 ㎜ 이다.
본 명세서에 있어서, 강연도란, JIS L 1085 : 1998 에 규정되는 45 °캔틸레버법으로 측정한 강연도를 의미한다. 즉, 강연도란, 45 °의 사면 (斜面) 을 갖고 또한 상면에 스케일을 구비하는, 표면이 매끄러운 수평대 상에, 폭 2 ㎝ 의 시험편 (첩부제 또는 지지체) 을, 그 단변과 스케일의 기선 (基線) 이 일치하도록 배치하고, 시험편을 상기 사면의 방향으로 완만하게 미끄러뜨렸을 때, 시험편의 일방의 단변의 중앙점이 상기 사면과 접할 때까지 시험편이 이동한 거리 (㎜) 를 의미한다. 첩부제의 제 1 방향의 강연도는, 시험편을 제 1 방향을 따라 사면을 완만하게 미끄러뜨렸을 때의 강연도를 의미한다.
스펀레이스 부직포란, 섬유에 고압의 수류를 분사하여 얽히게 하는, 이른바 수류 낙합법으로 형성된 부직포를 의미한다. 스펀레이스 부직포의 원료는, 폴리에틸렌테레프탈레이트 (PET) 등의 폴리에스테르, 에틸렌-아세트산비닐 공중합체 (EVA), 염화비닐, 폴리에틸렌 및 폴리프로필렌 등의 폴리올레핀, 부타디엔-스티렌-메타크릴산메틸 공중합 수지, 나일론, 폴리우레탄, 알콕시알킬(메트)아크릴레이트 공중합체, 폴리비닐아세탈, 폴리아미드 및 레이온 등의 합성 수지, 무명, 울, 실크 등의 천연 소재를 들 수 있다. 첩부제의 첩부 용이함의 관점에서, 스펀레이스 부직포는, 폴리에스테르로 이루어지는 스펀레이스 부직포가 바람직하다. 섬유의 직경은 5 ∼ 15 ㎛ 인 것이 바람직하다.
스펀레이스 부직포의 겉보기 중량은, 예를 들어 50 g/㎡ 이상이며, 70 g/㎡ 이상인 것이 바람직하고, 90 g/㎡ 이상인 것이 보다 바람직하다. 스펀레이스 부직포의 겉보기 중량이 상기 하한값 이상이면, 점착제층의 성분의 스며나옴이 잘 발생하지 않게 된다. 스펀레이스 부직포의 겉보기 중량은, 예를 들어 200 g/㎡ 이하이며, 150 g/㎡ 이하인 것이 바람직하고, 125 g/㎡ 이하인 것이 보다 바람직하다. 상기 상한값 이하이면, 첩부제의 첩부시에 위화감이 잘 발생하지 않게 된다. 첩부제의 첩부 용이함의 관점에서, 스펀레이스 부직포의 겉보기 중량은, 90 ∼ 110 g/㎡ 또는 100 ∼ 110 g/㎡ 인 것이 특히 바람직하다.
스펀레이스 부직포는, machine direction (흐름 방향 또는 세로 방향) 및 cross direction (폭 방향 또는 가로 방향) 을 갖는다. 스펀레이스 부직포의 신축성은, 예를 들어, 흐름 방향의 50 % 모듈러스가 200 ∼ 400 N/50 ㎜ 이고, 폭 방향의 50 % 모듈러스가 5 ∼ 15 N/50 ㎜ 이다. 신축성의 측정은, JIS L 1096 : 2010 에 규정되는 정신장 (定伸長) 시 신장력에 기초한다. 스펀레이스 부직포의 신축성이 상기 범위 내이면, 첩부제의 첩부 부위의 피부의 신축에 추종하기 쉬워진다. 첩부제의 첩부 용이함의 관점에서, 스펀레이스 부직포의 신축성은, 흐름 방향의 20 % 모듈러스가 40 ∼ 90 N/50 ㎜ 인 것이 바람직하고, 55 ∼ 75 N/50 ㎜ 인 것이 보다 바람직하고, 폭 방향의 20 % 모듈러스가 3 ∼ 5 N/50 ㎜ 인 것이 바람직하고, 3.6 ∼ 4.4 N/50 ㎜ 인 것이 보다 바람직하고, 흐름 방향의 50 % 모듈러스가 150 ∼ 350 N/50 ㎜ 인 것이 바람직하고, 220 ∼ 300 N/50 ㎜ 인 것이 보다 바람직하고, 폭 방향의 50 % 모듈러스가 8 ∼ 15 N/50 ㎜ 인 것이 바람직하고, 11.2 ∼ 11.7 N/50 ㎜ 인 것이 바람직하다. 스펀레이스 부직포의 폭 방향 및 흐름 방향은, 각각 첩부제의 제 1 방향 및 제 2 방향에 일치하는 것이 바람직하다.
스펀레이스 부직포의 폭 방향의 강연도는, 18 ∼ 30 ㎜ 인 것이 바람직하다. 스펀레이스 부직포의 폭 방향의 강연도가 상기 범위 내이면, 스펀레이스 부직포로 이루어지는 지지체에 점착제층을 적층한 첩부제를 제조한 경우에, 첩부제의 제 1 방향의 강연도를 용이하게 원하는 범위로 할 수 있다. 첩부제의 제 1 방향의 강연도는 18 ∼ 30 ㎜ 이며, 첩부제의 첩부 용이함의 관점에서 18 ∼ 27 ㎜ 또는 21 ∼ 27 ㎜ 인 것이 바람직하다.
지지체는, 스펀레이스 부직포로서 시판되고 있는 제품을 사용할 수 있고, 그러한 제품은, 예를 들어, 유니티카 주식회사, 쿠라레 쿠라플렉스 주식회사, 주식회사 유호, 다이와보 폴리텍 주식회사 및 니혼 바이린 주식회사 등에서 판매되고 있다.
점착제층은, 스티렌-이소프렌-스티렌 블록 공중합체 (이하, SIS 또는 SIS 블록 공중합체라고 하는 경우가 있다) 및 유동 파라핀을 포함한다. 이들 성분을 포함하는 점착제층을 스펀레이스 부직포와 조합함으로써, 첩부제의 「탄력」을 강하게 하는 것이 가능해져, 첩부제가 첩부하기 쉬워진다.
SIS 블록 공중합체로서 시판되고 있는 제품을 사용할 수 있고, 그러한 제품으로서, 카리플렉스 TR-1107, 카리플렉스 TR-1111, 카리플렉스 TR-1112, 카리플렉스 TR-1117 (이상, 쉘 화학 주식회사 제조), JSR5000, JSR5002, JSR5100 (이상, JSR 주식회사 제조) 및 퀸탁 3570C (닛폰 제온 주식회사 제조) 를 들 수 있다.
점착제층에 있어서의 SIS 블록 공중합체의 함유량은, 점착제층 전체 질량에 대하여, 예를 들어 10 질량% 이상, 바람직하게는 15 질량% 이상, 보다 바람직하게는 20 질량% 이상이다. 상기 하한값 이상의 SIS 블록 공중합체를 포함하는 점착제층을 구비하는 첩부제는, 필요한 첩부 기간 중에 피부로부터 첩부제가 박리되지 않고, 또한 충분한 「탄력」을 갖는다. 점착제층에 있어서의 SIS 블록 공중합체의 함유량은, 점착제층 전체 질량에 대하여, 예를 들어 50 질량% 이하, 바람직하게는 40 질량% 이하, 보다 바람직하게는 30 질량% 이하이다. 상기 상한값 이하의 SIS 블록 공중합체를 포함하는 점착제층을 구비하는 첩부제는, 첩부제를 박리할 때에 통증을 수반하지 않는 것 등의 사용성이 우수하다. 첩부제의 첩부 용이함의 관점에서, 점착제층에 있어서의 SIS 블록 공중합체의 함유량은, 23.7 ∼ 32.5 질량% 인 것이 특히 바람직하다.
점착제층에 있어서의 유동 파라핀의 함유량은, 점착제층 전체 질량에 대하여, 예를 들어 5 질량% 이상, 바람직하게는 10 질량% 이상, 보다 바람직하게는 15 질량% 이상이다. 상기 하한값 이상의 유동 파라핀을 포함하는 점착제층을 구비하는 첩부제는, 충분한 점착성을 갖는다. 점착제층에 있어서의 유동 파라핀의 함유량은, 점착제층 전체 질량에 대하여, 예를 들어 50 질량% 이하, 바람직하게는 40 질량% 이하, 보다 바람직하게는 30 질량% 이하이다. 상기 상한값 이하의 유동 파라핀을 포함하는 점착제층을 구비하는 첩부제는, 적당한 유연성을 구비하기 때문에, 첩부하기 쉬워진다. 첩부제의 첩부 용이함의 관점에서, 점착제층에 있어서의 유동 파라핀의 함유량은, 17.9 ∼ 27.5 질량% 인 것이 특히 바람직하다.
또, 점착제층에 있어서의 SIS 블록 공중합체와 유동 파라핀의 질량비는, 1 ∼ 1.65 : 1 이 바람직하다. 이러한 비율로 양자를 배합하면, 첩부제의 「탄력」을 강하게 하는 것이 가능해져, 첩부제가 첩부하기 쉬워진다. 또, 이러한 비율로 양자를 배합하면, 점착제층을 적당한 경도로 조정할 수 있고, 제조시에, 점착제층에 기포가 잘 발생하지 않게 되어, 제조 적성이 우수하다. 또한, 이러한 비율로 양자를 배합하면, 콜드 플로도 방지하기 쉬워진다.
점착제층은, 필요에 따라 SIS 블록 공중합체 이외의 점착제, 유동 파라핀 이외의 가소제를 포함해도 되고, 점착 부여제, 흡수 촉진제, 항산화제, 충전제, 가교제, 방부제, 자외선 흡수제, 계면 활성제, pH 조정제, 색소 및 향료 등의 첨가제를 포함해도 된다.
SIS 블록 공중합체 이외의 점착제로서, 천연 고무, 합성 이소프렌 고무, 폴리이소부틸렌, 폴리비닐에테르, 폴리우레탄, 폴리이소프렌, 폴리부타디엔, 스티렌-부타디엔 공중합체 및 스티렌-이소프렌 공중합체를 들 수 있다. 점착제층은, 바람직하게는 폴리이소부틸렌을 포함한다. 폴리이소부틸렌의 사용에 의해, 점착력을 향상시키는 것이 가능해진다. 점착제층에 있어서의 폴리이소부틸렌의 함유량은, 예를 들어 1 ∼ 20 질량% 이며, 바람직하게는 2 ∼ 15 질량% 이다. 첩부제의 첩부 용이함의 관점에서, 점착제층에 있어서의 폴리이소부틸렌의 함유량은, 3 ∼ 12 질량% 인 것이 특히 바람직하다.
유동 파라핀 이외의 가소제로서, 폴리부텐, 액상 폴리이소부틸렌 및 동식물유를 들 수 있다.
점착 부여제로서, 지환족 포화 탄화수소 수지 (아라카와 화학공업사 제조, 상품명 : 아르콘 P-100 등), 수소 첨가 로진에스테르 (아라카와 화학공업사 제조, 상품명 : KE-311, KE-100 ; 허큘리스사 제조, 상품명 : 포랄 105, 포랄 85 등), 수소화 지환족계 탄화수소 (엑슨 화학사 제조, 상품명 : 에스코레츠 5300 등), 테르펜 수지, 석유 수지 및 페놀 수지를 들 수 있다. 점착 부여제 중, α-피넨 및 β-피넨 등으로 이루어지는 테르펜 수지는, 점착력을 높이는 작용이 우수하기 때문에 바람직하다. SIS 블록 공중합체 및 유동 파라핀을 1 ∼ 1.65 : 1 의 비율로 점착제층에 배합하는 경우, 점착제층의 점착력이 저하되는 경향이 있다. 이와 같은 경우에는, 테르펜 수지의 사용에 의해, 점착력을 향상시킬 수 있다. 점착력 향상의 관점에서, 점착제층에 있어서의 테르펜 수지의 함유량은, 17 ∼ 25 질량% 인 것이 특히 바람직하다.
흡수 촉진제로서, 미리스트산이소프로필, 세바크산디에틸, 소르비탄모노라우레이트, 올레일인산나트륨, 라우릴황산나트륨, 옥틸페닐에테르, 라우릴에테르, 소르비탄모노라우레이트, 라우로일디에탄올아미드, 라우로일사르코신, 올레오일사르코신슈가에스테르, 레시틴, 글리시르레틴산, 우레아, 살리실산, 티오글리콜산칼슘, 락트산, 락트산에스테르, 올리브유, 스쿠알렌, 라놀린 및 글리세린을 들 수 있다.
항산화제로서, 토코페롤 및 그 에스테르 유도체, 아스코르브산, 아스코르브산스테아르산에스테르, 노르디하이드로구아이아레트산, 디부틸하이드록시톨루엔 및 부틸하이드록시아니솔을 들 수 있다.
충전제로서, 탄산칼슘, 탄산마그네슘, 규산염 (예를 들어, 규산알루미늄, 규산마그네슘 등), 규산, 황산바륨, 황산칼슘, 아연산칼슘, 산화아연, 산화티탄 및 스테아르산아연을 들 수 있다.
가교제로서, 열경화성 수지 (아미노 수지, 페놀 수지, 에폭시 수지, 알키드 수지 및 불포화 폴리에스테르 등), 이소시아네이트 화합물 및 블록 이소시아네이트 화합물 등의 유기계 가교제, 금속 및 금속 화합물 등의 무기계 가교제를 들 수 있다.
방부제로서, 파라옥시벤조산에틸, 파라옥시벤조산프로필 및 파라옥시벤조산부틸을 들 수 있다.
자외선 흡수제로서, p-아미노벤조산 유도체, 안트라닐산 유도체, 살리실산 유도체, 쿠마린 유도체, 아민산계 화합물, 이미다졸린 유도체, 피리딘 유도체 및 디옥산 유도체를 들 수 있다.
점착제층에 함유되는 약물은 특별히 한정되지 않고, 예를 들어, 아세트아미노페논, 페나세틴, 메페남산, 디클로페낙나트륨, 플루페남산, 아스피린, 살리실산나트륨, 살리실산메틸, 살리실산글리콜, 아미노피린, 알클로페나크, 이부프로펜, 나프록센, 플루르비프로펜, 케토프로펜, 암페낙나트륨, 메피리졸, 인도메타신, 피록시캄 및 펠비낙 등의 소염 진통제 ; 하이드로코르티손, 트리암시놀론, 덱사메타손 및 프레드니솔론 등의 스테로이드계 항염증제 ; 염산딜티아젬, 사질산펜타에리트리톨, 질산이소소르비드, 트라피질, 니코란딜, 니트로글리세린, 락트산프레닐라민, 몰시도민, 아질산알루미늄, 염산톨라졸린 및 니페디핀 등의 혈관 확장제 ; 염산프로카인아미드, 염산리도카인, 염산프로프라놀롤, 염산알프레놀롤, 아테놀롤, 나돌롤, 타르타르산메토프로롤, 애즈멀린, 디소피라미드 및 염산멕실레틴 등의 부정맥용제 ; 염산에카라진, 인다파미드, 염산클로니딘, 염산부니트롤롤, 염산라베타롤, 캅토프릴, 아세트산구아나벤즈, 메부타메이트 및 황산베타니딘 등의 혈압 강하제 ; 시트르산카르베타펜탄, 클로페라스틴, 탄닌산옥세라딘, 염산클로부티놀, 염산클로페다놀, 염산노스카핀, 염산에페드린, 염산이소프로테레놀, 염산클로르프레날린, 염산메톡시페나민, 염산프로카테롤, 염산툴로부테롤, 염산클렌부테롤 및 푸말산케토티펜 등의 진해거담제 ; 시클로포스파미드, 플루오로우라실, 테가푸르, 마이토마이신 C, 염산프로카르바진, 독시플루리딘 및 라니무스틴 등의 항악성 종양제 ; 아미노벤조산에틸, 염산테트라카인, 염산프로카인, 염산디부카인, 염산옥시부프로카인 및 염산프로피토카인 등의 국소 마취제 ; 프로필티오우라실, 티아마졸, 아세트산메테놀론, 에스트라디올, 에스트리올 및 프로게스테론 등의 호르몬제 ; 염산디펜히드라민, 말레산클로르페니라민, 프로메타진, 염산사이프로헵타딘 및 염산디페닐피랄린 등의 항히스타민제 ; 와파린칼륨 및 염산티클로피딘 등의 혈액 응고 저지제 ; 브롬화메틸아트로핀 및 스코폴라민 등의 진경제 ; 티오펜탈나트륨 및 펜토바르비탈나트륨 등의 전신 마취제 ; 브롬발레릴우레아, 아모바비탈 및 페노바비탈 등의 최면·진통제 ; 페니토인나트륨 등의 항전간제 ; 염산메탐페타민 등의 흥분제·각성제 ; 염산디페니돌 및 메실산베타히스틴 등의 진운제 (鎭暈劑) ; 염산클로르프로마진, 티오리다진, 메프로바메이트, 염산이미프라민, 클로르디아제폭시드 및 디아제팜 등의 정신 신경용제 ; 염산숙사메토늄 및 염산에페리손 등의 골격 근이완제 ; 브롬화네오스티그민 및 염화베타네콜 등의 자율신경용제 ; 염산아만타딘 등의 항파킨슨제 ; 하이드로플루메타이아자이드, 이소소르비드 및 푸로세미드 등의 이뇨제 ; 염산페닐레프린 등의 혈관 수축제 ; 브롬화로벨린, 디모르폴라민 및 염산날록손 등의 호흡 촉진제 ; 브롬화글리코피로늄, 프로글루미드, 염산세트락세이트, 시메티딘 및 스피조푸론 등의 소화성 궤양 치료제 ; 우르소디스옥시콜산 및 오살미드 등의 이담제 ; 헥사민, 스파르테인, 디노프로스트 및 염산리토드린 등의 비뇨 생식기 및 항문용제 ; 살리실산, 시클로피록스올아민 및 염산크로코나졸 등의 기생성 피부 질환용제 ; 우레아 등의 피부 연화제 ; 칼시트리올, 염산티아민, 인산리보플라빈나트륨, 염산피리독신, 니코틴산아미드, 판테놀 및 아스코르브산 등의 비타민제 ; 염화칼슘, 요오드화칼륨 및 요오드화나트륨 등의 무기질 제제 ; 에탐실레이트 등의 지혈제 ; 티오프로닌 등의 간장 질환용제 ; 시안아미드 등의 습관성 중독용제 ; 콜히친, 프로베네시드 및 술핀피라존 등의 통풍 치료제 ; 톨부타미드, 클로르프로파미드, 글리미딘나트륨, 글리부졸, 염산부포르민 및 인슐린 등의 당뇨병용제 ; 벤질페니실린칼륨, 프로피실린칼륨, 클록사실린나트륨, 암피실린나트륨, 염산바캄피실린, 카르베니실린나트륨, 세팔로리딘, 세폭시틴나트륨, 에리트로마이신, 클로람페니콜, 테트라사이클린, 황산카나마이신 및 사이클로세린 등의 항생 물질 ; 이소시아니드, 피라진아마이드 및 에티오나미드 등의 화학 요법제 ; 염산모르핀, 인산코데인, 염산코카인, 염산페티딘 및 시트르산펜타닐 등의 마약을 들 수 있다.
고농도의 살리실산메틸 및 멘톨 (예를 들어, l-멘톨) 을 점착제층에 함유시키면, 이들 약물의 작용에 의해, 점착제층이 가소화되기 쉬워지는 경향이 강해지고, 첩부제의 「탄력」이 약해져, 첩부제가 첩부하기 어려워진다. 그러나, 본 실시형태에 관련된 첩부제는, 상기 서술한 바와 같이 「탄력」이 강하기 때문에, 점착제층에 이들 약물이 고농도로 포함되어 있어도, 첩부제가 첩부하기 쉬워진다. 특히, 점착제층의 전체 질량 기준으로, 9 ∼ 11 질량% 의 살리실산메틸 및 2.5 ∼ 6.5 질량% 또는 3 ∼ 6 질량% 의 멘톨을 점착제층이 포함하는 경우에, 본 실시형태에 관련된 첩부제의 적용이 적합하다.
점착제층의 두께는 50 ∼ 3000 ㎛ 인 것이 바람직하다. 점착제층의 두께가 3000 ㎛ 이하이면 점착제층에 포함되는 약제의 방출성이 양호해지고, 50 ㎛ 이상이면, 피부 접착성이 양호해져, 첩부제가 잘 박리되지 않게 된다.
지지체의 두께는, 예를 들어 300 ㎛ 이상이며, 400 ㎛ 이상인 것이 바람직하다. 지지체의 두께가 상기 하한값 이상이면, 점착제층의 성분의 스며나옴이 잘 발생하지 않게 된다. 또, 지지체의 두께는, 예를 들어 1200 ㎛ 이하이며, 700 ㎛ 이하인 것이 바람직하다. 지지체의 두께가 상기 상한값 이하이면, 첩부제가 잘 박리되지 않게 된다.
지지체의 두께 및 점착제층의 두께의 합계, 즉 첩부제의 두께는, 300 ∼ 5000 ㎛ 인 것이 바람직하다. 첩부제의 두께가 5000 ㎛ 이하이면, 첩부제의 단 (端) 이 의류 등에 잘 걸리지 않게 되고, 첩부제가 잘 박리되지 않게 된다. 첩부제의 두께가 300 ㎛ 이상이면 첩부제의 지지성이 충분해지고, 첩부제를 확실하게 첩부할 수 있게 되고, 또 첩부 후의 첩부제에 주름이 잘 발생하지 않게 된다.
본 실시형태에 관련된 첩부제는, 단변이 4 ∼ 10 ㎝ 이고 장변이 6 ∼ 15 ㎝ 인 장방형 또는 모서리가 둥근 장방형의 형상이면 된다. 본 실시형태에 관련된 첩부제의 형상이 장방형 또는 모서리가 둥근 장방형인 경우, 장변 방향 및 단변 방향이 각각, 스펀레이스 부직포의 폭 방향 및 흐름 방향에 일치하고, 또한, 첩부제의 제 1 방향 및 제 2 방향에 일치하는 것이 바람직하다.
본 실시형태에 관련된 첩부제는, 점착제층을 피복하여 보호하기 위한 박리 필름을 추가로 구비하고 있어도 된다. 박리 필름의 재질은, 무연신 폴리프로필렌 (CPP), 연신 폴리프로필렌 (OPP), 폴리에틸렌테레프탈레이트 (PET), 폴리부틸렌테레프탈레이트 (PBT), 폴리에틸렌, 폴리에스테르, 폴리우레탄, 폴리염화비닐 및 폴리스티렌 등의 플라스틱 필름, 합성 수지, 합성지 및 합성 섬유 등의 실리콘 가공한 실리콘 가공지, 알루미늄박, 그래프트지에 폴리에틸렌 등을 라미네이트한 라미네이트 가공지 등을 들 수 있다. 이것들 중에서도 PET 및 가공지가 바람직하게 사용된다. 첩부제가 박리 필름을 구비하는 경우, 첩부제의 강연도는 박리 필름을 벗긴 상태의 첩부제로 측정한 강연도를 의미한다.
박리 필름의 두께는, 예를 들어 10 ∼ 100 ㎛, 바람직하게는 30 ∼ 90 ㎛, 보다 바람직하게는 40 ∼ 85 ㎛ 이다. 박리 필름의 두께가 상기 하한값 이상이면 박리 필름을 쥐기 쉬워지고, 또 박리 필름을 벗길 때에 점착제층에 잘 달라붙지 않게 된다. 한편, 박리 시트의 두께가 상기 상한값 이하이면 제조시의 절단이 용이해지고, 제조 적성이 양호해진다.
본 실시형태에 관련된 첩부제는, 당업자에게 공지된 방법에 의해 제조할 수 있다. 예를 들어, 니더 및 믹서 등의 혼합기를 사용하여, 120 ∼ 160 ℃ 로 가열하면서, 약물 이외의 점착제층의 각 성분을 혼합하고, 이어서, 약물을 열분해하지 않는 온도에서 첨가 혼합하여 점착제층 형성용의 혼합물을 조제한다. 이 혼합물을, 지지체 상에 직접 전연 (展延) 하여 점착제층을 형성하거나, 혹은 박리 필름 상에 전연하여 점착제층을 형성하고, 그 위에 지지체를 얹어, 점착제층을 지지체 상에 압착 전사시켜도 된다.
실시예
첩부제의 평가 실험 (1)
표 1 의 각 성분을 가열 및 반죽하여 점착제 1 을 얻었다. 표 2 에 기재된 폴리에스테르제 부직포 2 ∼ 4 에, 도포량이 210 g/㎡ 가 되도록 점착제 1 을 도포하고, 실시예 1 ∼ 2 및 비교예 1 의 첩부제를 얻었다. 첩부제는, 단변의 길이가 약 5 ㎝, 장변의 길이가 약 7 ㎝ 인 장방형의 형상이다. 또, 부직포의 폭 방향과 첩부제의 장변 방향은 일치한다. 얻어진 첩부제에 대하여, 하기 평가를 실시하였다. 결과를 표 4 에 나타낸다.
첩부제의 평가 항목
(1) 첩부제의 강연도
JIS L 1085 : 1998 에 규정되는 45 °캔틸레버법에 따라, 첩부제의 장변 방향의 강연도를 측정하였다.
(2) 첩부제의 첩부 용이함
건강한 성인 30 명의 숄더부에 첩부제를 첩부하고, 첩부 용이함을 하기 3 단계의 기준으로 스코어화하여, 그 평균값을 구하였다. 평균값이 2 미만인 경우의 평가를 ○ 로 하고, 2 이상인 경우의 평가를 × 로 하였다.
1
첩부하기 쉽다
2
보통
3
첩부하기 어렵다
(3) 첩부제의 부착성
건강한 성인 30 명의 숄더부에 첩부제를 첩부하고, 8 시간 후의 첩부제의 부착 상태를 하기 3 단계의 기준으로 스코어화하여, 그 평균값을 구하였다. 평균값이 2 미만인 경우의 평가를 ○ 로 하고, 2 이상인 경우의 평가를 × 로 하였다.
1
첩부제가 전혀 박리되지 않고, 피부에 밀착된 상태
2
첩부제면의 단부 (端部) 만이 박리된 상태
3
첩부제면의 1/4 이상이 박리된 상태
(4) 점착제의 지지체로의 스며듦 (스며나옴)
점착제의 지지체로의 스며듦 (스며나옴) 의 유무를 육안으로 관찰하여, 스며듦 (스며나옴) 이 확인되지 않는 경우의 평가를 ○, 스며듦 (스며나옴) 이 약간 확인되기는 하지만 첩부제로서의 사용에 문제가 없는 경우의 평가를 △, 스며듦 (스며나옴) 이 확인되고 첩부제로서 사용에 적합하지 않은 경우의 평가를 × 로 하였다.
(5) 제제 적성
점착제층 표면의 기포의 유무를 육안으로 관찰하여, 기포가 없는 경우의 평가를 ○ 로 하고, 기포가 있는 경우의 평가를 × 로 하였다.
표 4 에 나타낸 결과로부터 분명한 바와 같이, 첩부제의 강연도가 18 이상인 실시예 1 및 2 의 첩부제는, 첩부하기 쉽고, 부착성이 우수하고, 또한 지지체로의 점착제의 스며듦이 확인되지 않고, 우수한 첩부제였다. 한편, 첩부제의 강연도가 18 미만인 비교예 1 의 첩부제는, 첩부 용이함의 점에서 열등하였다.
첩부제의 평가 실험 (2)
표 5 의 각 성분을 가열 및 반죽하여 점착제 2 ∼ 6 을 얻었다. 표 2 에 기재된 부직포 1 (폴리에스테르제) 및 3 에, 도포량이 210 g/㎡ 가 되도록 점착제 2 ∼ 6 을 도포하고, 실시예 3 ∼ 7 및 비교예 2 ∼ 6 의 첩부제를 얻었다. 얻어진 첩부제에 대하여, 평가 실험 (1) 과 동일한 평가를 실시하였다. 결과를 표 7 에 나타낸다.
표 7 에 나타낸 결과로부터 분명한 바와 같이, 니들 펀치법에 의해 제조한 부직포 1 을 지지체로서 사용한 비교예 2 ∼ 6 의 첩부제는, 첩부 용이함의 점에서 열등하였다. 한편, 스펀레이스법에 의해 제조한 부직포 3 을 지지체로서 사용한 실시예 3 ∼ 7 의 첩부제는, 첩부 용이함 및 부착성이 우수하였다. 또한, SIS 와 유동 파라핀의 질량비가 1 ∼ 1.65 : 1 의 범위인 실시예 4 ∼ 6 의 첩부제는, 지지체로의 점착제의 스며들기 어려움 및 제조 적성의 점에서도 우수하였다.
Claims (12)
- 지지체와, 지지체 상에 적층된 점착제층을 갖는 첩부제로서,
지지체는, 스펀레이스 부직포로 이루어지고,
점착제층은, 스티렌-이소프렌-스티렌 블록 공중합체 및 유동 파라핀을 포함하고,
첩부제는 소정의 기준 축 방향인 제 1 방향과, 제 1 방향에 직각인 제 2 방향을 갖고,
JIS L 1085 : 1998 에 규정되는 45 °캔틸레버법으로 측정한 첩부제의 제 1 방향의 강연도는 18 ∼ 30 ㎜ 인 첩부제. - 제 1 항에 있어서,
점착제층에 있어서의 스티렌-이소프렌-스티렌 블록 공중합체와 유동 파라핀의 질량비가 1 ∼ 1.65 : 1 인 첩부제. - 제 2 항에 있어서,
점착제층은, 살리실산메틸 및 멘톨을 포함하는 첩부제. - 제 3 항에 있어서,
점착제층은, 폴리이소부틸렌을 포함하는 첩부제. - 제 4 항에 있어서,
점착제층은, 테르펜 수지를 포함하는 첩부제. - 제 5 항에 있어서,
점착제층은, 점착제층의 전체 질량 기준으로, 9 ∼ 11 질량% 의 살리실산메틸 및 2.5 ∼ 6.5 질량% 의 멘톨을 포함하는 첩부제. - 제 5 항에 있어서,
점착제층은, 점착제층의 전체 질량 기준으로, 23.7 ∼ 32.5 질량% 의 스티렌-이소프렌-스티렌 블록 공중합체, 17.9 ∼ 27.5 질량% 의 유동 파라핀, 9 ∼ 11 질량% 의 살리실산메틸, 3 ∼ 6 질량% 의 멘톨, 3 ∼ 12 질량% 의 폴리이소부틸렌 및 17 ∼ 25 질량% 의 테르펜 수지를 포함하는 첩부제. - 제 1 항 내지 제 7 항 중 어느 한 항에 있어서,
부직포의 겉보기 중량은 90 ∼ 110 g/㎡ 인 첩부제. - 제 1 항 내지 제 8 항 중 어느 한 항에 있어서,
부직포의 폭 방향의 20 % 모듈러스가 3 ∼ 5 N/50 ㎜ 인 첩부제. - 제 1 항 내지 제 9 항 중 어느 한 항에 있어서,
부직포의 폭 방향의 50 % 모듈러스가 8 ∼ 15 N/50 ㎜ 인 첩부제. - 제 1 항 내지 제 10 항 중 어느 한 항에 있어서,
부직포는 폴리에스테르로 이루어지는 첩부제. - 제 1 항 내지 제 11 항 중 어느 한 항에 있어서,
JIS L 1085 : 1998 에 규정되는 45 °캔틸레버법으로 측정한 첩부제의 제 1 방향의 강연도는 18 ∼ 27 ㎜ 인 첩부제.
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