KR101330775B1 - 보툴리눔 독소의 국소 적용 및 경피 전달을 위한 조성물 및 방법 - Google Patents
보툴리눔 독소의 국소 적용 및 경피 전달을 위한 조성물 및 방법 Download PDFInfo
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- KR101330775B1 KR101330775B1 KR1020137011291A KR20137011291A KR101330775B1 KR 101330775 B1 KR101330775 B1 KR 101330775B1 KR 1020137011291 A KR1020137011291 A KR 1020137011291A KR 20137011291 A KR20137011291 A KR 20137011291A KR 101330775 B1 KR101330775 B1 KR 101330775B1
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- pharmaceutical composition
- botulinum toxin
- polylysine
- molecular weight
- positively charged
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Abstract
Description
도 2는 한쪽 다리는 본 발명의 조성물로 처리되고 그 반대쪽의 영역은 본 발명에 따른 담체를 포함하지 않는 또 다른 보툴리눔 독소-함유 조성물로 치료된 마우스의 뒷 다리들(hind limbs)의 상태를 보여주는 사진이다.
도 3은 "Essentia Botox lotion"에 의한 국소적 치료 전 및 후에 대상자의 이마 상의 주름들을 보여주는 사진이다.
도 4는 "Essentia Botox Lotion"에 의한 주름의 국소 치료 후(A) 및 치료 전(B)의 이마의 Mikrosil 캐스트를 보여준다. 실제 대상을 찍는 것으로부터 초래될 수 있는 인위적 결과(artifact)를 최소화하기 때문에 유용한 Mikrosil 캐스트들은 치료되지 않은 면이 보다 깊은 주름들을 갖는다는 것을 명확하게 보여준다.
도 5는 "Essentia Botox Lotion"(A) 및 대조구 로션(B)의 적용 5일 후, 대상자의 이마에 대해 수행된 Minor's 전분/요오드 테스트를 묘사하는 사진을 보여준다. 대조구 로션은 약 21,000의 분자량을 가지며 TAT 분지형 기들을 갖는 양전하로 하전된 폴리라이신 백본을 포함했다. 이 사진들은 적용 2분 후에 찍었다.
도 6은 4분이 경과된 후 찍혔다는 것을 제외하고는 도 5의 경우와 동일하다.
도 7은 액와 다한증 연구들에서 이용된 투여 영역을 보여준다. 투여 영역은 액모(axillary hair)에 의해 뒤덮인 피부의 영역보다 1 센티미터 연장된다.
도 8a는 사람 대상자에서 액와 다한증의 치료를 위해 짧은 펩티드 담체를 이용하여 국소용 작용제로서 완전한 피부(intact skin)를 통해 치료적으로 전달된 보툴리눔 독소의 효율을 보여주는 실험의 결과를 나타낸다. 그래프는 Botox + 짧은 펩티드 담체 또는 담체 단독에 의한 치료 4주 후 중량에 의해 측정된 땀의 양(5분당 mg)의 유의성 있는 감소를 보여준다. 결과들은 동일한 군에 대한 기준값(baseline value) 대비 비율로서 4주차 값들이며, 그 유의성은 P<0.05로 Wilcoxon 분석에 의해 결정했다. N=10명의 환자들이었다. 도 8b는 사람 대상자에서 액와 다한증의 치료를 위해 짧은 펩티드 담체를 이용하여 국소용 작용제로서 완전한 피부를 통해 치료적으로 전달된 보툴리눔 독소의 효율을 보여주는 실험의 결과를 나타낸다. 그래프는 Botox + 짧은 펩티드 담체 또는 담체 단독에 의한 치료 4주 후 중량에 의해 측정된 땀의 양(5분당 mg)의 상당한 감소를 보여준다. 결과들은 양 시점들에 대한 대조구 값에 대한 비율로서 치료군 값들(treatment values)이며, 그 유의성은 P<0.05로 Wilcoxon 분석에 의해 결정했다. N=10명의 환자들이었다.
도 9는 액와 다한증의 치료를 위해 국소적으로 적용된 "Essentia Botox Lotion"에 의한 치료의 전 및 후의 Minor's 전분/요오드 테스트를 묘사하는 사진을 보여준다. 대상자 #12에 대해 우측 액와(겨드랑이)는 "Essentia Botox Lotion"로 처리되고(a 및 c), 좌측 액와는 대조구로 처리된 경우(b 및 d)에서 기준값 대비 2주차에서의 전분/요오드 테스트를 보여준다. 이 사진들은 전분 요오드에 담긴 담체+보톡스에 의한 처리 후에 관찰되는 통상적인 효과들을 보여준다. 일부 교차점(crossover)이 대조구 측에서 관찰되나(중량 데이터에서의 25% 감소와 일치됨), 상당한 감소는 치료에 의해 부여된다(치료군에 대한 중량 데이터에서의 65% 감소와 일치됨).
군 | 평균 | 표준 오차 |
JMW-7 | 33 | 5.333334 |
JMW-8 | 8.666667 | 0.333334 |
군 | 평균 | 표준 오차 |
JMW-9 | 3.333 | 0.333 |
JMW-10 | 0.333 | 0.333 |
JMW-11 | 0.793 | 0.300 |
군 | 평균 | 표준 오차 |
BA | 0.833 | 0.307 |
AZ | 3.197 | 0.083 |
군 | 평균 | 표준 오차 |
BA1 | 0.333 | 0.211 |
AZ1 | 3.833 | 0.167 |
Claims (70)
- 보툴리눔 독소의 유효량과 공유결합에 의해 부착된 양전하로 하전된 효능기를 갖는 양전하로 하전된 백본을 포함하는 양전하로 하전된 담체의 유효량을 포함하는, 통증 치료에서 사용하기 위한 약제학적 조성물로서,
상기 보툴리눔 독소는 공유결합에 의해 변형되지 않고,
상기 양전하로 하전된 담체 및 보툴리눔 독소가 직접적으로 접촉하여 비-공유결합성 복합체(non-covalent complex)를 형성하며,
상기 약제학적 조성물을 통증의 치료를 필요로 하는 환자에게 국소 투여하기 위한 피부학적으로 허용가능한 담체, 비히클, 또는 매질을 포함하는 것인 약제학적 조성물. - 청구항 1에 있어서, 상기 통증은 신경병성 통증인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 통증은 편두통인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 통증은 근육-경련 통증인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 조성물은 환자의 피부로의 국소 투여에서 사용하기 위해 제제화된 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 담체는 아래첨자 n1은 0 내지 20의 정수이고 아래첨자 n2는 독립적으로 5 내지 25의 홀수인 것인 -(gly)nl-(arg)n2(서열번호 1), HIV-TAT, 안테나페디아 PTD, 및 HIV-TAT 또는 안테나페디아 PTD의 단편으로부터 선택된 양전하로 하전된 효능기가 부착된 폴리머성 백본을 포함하는 것인 약제학적 조성물.
- 청구항 6에 있어서, 상기 담체는 아래첨자 n1은 0 내지 20의 정수이고 아래첨자 n2는 독립적으로 5 내지 25의 홀수인 것인 -(gly)nl-(arg)n2(서열번호 1)로부터 선택된 양전하로 하전된 효능기를 갖는 폴리펩티드를 포함하는 것인 약제학적 조성물.
- 청구항 7에 있어서, 상기 아래첨자 n1은 0 내지 8의 정수인 것인 약제학적 조성물.
- 청구항 7에 있어서, 상기 아래첨자 n1은 2 내지 5의 정수인 것인 약제학적 조성물.
- 청구항 7에 있어서, 상기 아래첨자 n2는 7 내지 17의 홀수인 것인 약제학적 조성물.
- 청구항 7에 있어서, 상기 아래첨자 n2는 7 내지 13의 홀수인 것인 약제학적 조성물.
- 청구항 6에 있어서, 상기 담체는 HIV-TAT 및 그의 단편으로부터 선택된 양전하로 하전된 효능기가 부착된 폴리펩티드를 포함하는 것인 약제학적 조성물.
- 청구항 12에 있어서, 상기 효능기는 아래첨자 p 및 q는 각각 독립적으로 0 내지 20의 정수인 것인 식 (gly)p-RGRDDRRQRRR-(gly)q (서열번호 2), (gly)p-YGRKKRRQRRR-(gly)q (서열번호 3), 또는 (gly)p-RKKRRQRRR-(gly)q (서열번호 4)를 갖는 양전하로 하전된 HIV-TAT 단편인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 양전하로 하전된 효능기는 총 담체 중량의 0.05 중량% 이상을 구성하는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 양전하로 하전된 효능기는 총 담체 중량의 0.5 중량% 내지 45 중량%를 구성하는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 양전하로 하전된 효능기는 총 담체 중량의 0.1 중량% 내지 30 중량%를 구성하는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 백본은 양전하로 하전된 폴리펩티드를 포함하는 것인 약제학적 조성물.
- 청구항 17에 있어서, 상기 백본은 양전하로 하전된 폴리라이신을 포함하는 것인 약제학적 조성물.
- 청구항 18에 있어서, 상기 폴리라이신은 10,000 내지 1,500,000의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 18에 있어서, 상기 폴리라이신은 25,000 내지 1,200,000의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 18에 있어서, 상기 폴리라이신은 100,000 내지 1,000,000의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 백본은 양전하로 하전된 비-펩티드(nonpeptidyl) 담체를 포함하는 것인 약제학적 조성물.
- 청구항 22에 있어서, 상기 양전하로 하전된 비-펩티드 담체는 폴리알킬렌이민인 것인 약제학적 조성물.
- 청구항 23에 있어서, 상기 폴리알킬렌이민은 폴리에틸렌이민인 것인 약제학적 조성물.
- 청구항 24에 있어서, 상기 폴리에틸렌이민은 10,000 내지 2,500,000의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 24에 있어서, 상기 폴리에틸렌이민은 100,000 내지 1,800,000의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 24에 있어서, 상기 폴리에틸렌이민은 500,000 내지 1,400,000의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 22에 있어서, 상기 보툴리눔 독소는 재조합 보툴리눔 독소를 포함하는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 보툴리눔 독소는 4.5 내지 6.3의 pH를 갖는 조성물로 적용되는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 약제학적 조성물은 제어 방출형(controlled release) 조성물인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 약제학적 조성물은 액체 조성물인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 약제학적 조성물은 겔 조성물인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 약제학적 조성물은 크림, 로션 또는 연고인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 약제학적 조성물은 염수를 더 포함하는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 약제학적 조성물은 염수 및 pH 완충 시스템을 더 포함하는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 약제학적 조성물은 상기 보툴리눔 독소를 분배하기 위한 장치에 담겨 있고, 상기 장치는 개체의 피부 또는 상피에 국소로 적용되는 것인 약제학적 조성물.
- 청구항 36에 있어서, 상기 장치는 피부 패치인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 보툴리눔 독소는 융합 단백질을 포함하는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 보툴리눔 독소는 보툴리눔 독소 F형인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 보툴리눔 독소는 보툴리눔 독소 G형인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 보툴리눔 독소는 보툴리눔 독소 복합체의 형태인 것인 약제학적 조성물.
- 청구항 18에 있어서, 상기 폴리라이신은 75,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 42에 있어서, 상기 폴리라이신은 30,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 43에 있어서, 상기 폴리라이신은 25,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 14에 있어서, 상기 폴리머성 백본은 폴리라이신을 포함하는 것인 약제학적 조성물.
- 청구항 45에 있어서, 상기 폴리라이신은 75,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 46에 있어서, 상기 폴리라이신은 30,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 47에 있어서, 상기 폴리라이신은 25,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 효능기 중 하나 이상은 아래첨자 p 및 q는 각각 독립적으로 0 내지 8의 정수인 것인 식 (gly)p-RGRDDRRQRRR-(gly)q (서열번호 2)의 식을 갖는 것인 약제학적 조성물.
- 청구항 49에 있어서, 상기 폴리머성 백본은 폴리라이신을 포함하는 것인 약제학적 조성물.
- 청구항 50에 있어서, 상기 폴리라이신은 75,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 51에 있어서, 상기 폴리라이신은 30,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 52에 있어서, 상기 폴리라이신은 25,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 50 내지 53 중 어느 한 항에 있어서, 상기 보툴리눔 독소는 보툴리눔 신경독소 A, B, C, D, E, F 또는 G형을 포함하는 것인 약제학적 조성물.
- 청구항 54에 있어서, 상기 보툴리눔 독소는 150,000의 분자량을 갖는 보툴리눔 신경독소 A형인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 효능기 중 하나 이상은 아래첨자 p 및 q는 각각 독립적으로 0 내지 8의 정수인 것인 식 (gly)p-YGRKKRRQRRR-(gly)q (서열번호 3)의 식을 갖는 것인 약제학적 조성물.
- 청구항 56에 있어서, 상기 폴리머성 백본은 폴리라이신을 포함하는 것인 약제학적 조성물.
- 청구항 57에 있어서, 상기 폴리라이신은 75,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 58에 있어서, 상기 폴리라이신은 30,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 59에 있어서, 상기 폴리라이신은 25,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 57 내지 60 중 어느 한 항에 있어서, 상기 보툴리눔 독소는 보툴리눔 신경독소 A, B, C, D, E, F 또는 G형을 포함하는 것인 약제학적 조성물.
- 청구항 61에 있어서, 상기 보툴리눔 독소는 150,000의 분자량을 갖는 보툴리눔 신경독소 A형인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 효능기 중 하나 이상은 아래첨자 p 및 q는 각각 독립적으로 0 내지 8의 정수인 것인 식 (gly)p-RKKRRQRRR-(gly)q (서열번호 4)의 식을 갖는 것인 약제학적 조성물.
- 청구항 63에 있어서, 상기 폴리머성 백본은 폴리라이신을 포함하는 것인 약제학적 조성물.
- 청구항 64에 있어서, 상기 폴리라이신은 75,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 65에 있어서, 상기 폴리라이신은 30,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 66에 있어서, 상기 폴리라이신은 25,000 미만의 분자량을 갖는 것인 약제학적 조성물.
- 청구항 64 내지 67 중 어느 한 항에 있어서, 상기 보툴리눔 독소는 보툴리눔 신경독소 A, B, C, D, E, F 또는 G형을 포함하는 것인 약제학적 조성물.
- 청구항 68에 있어서, 상기 보툴리눔 독소는 150,000의 분자량을 갖는 보툴리눔 신경독소 A형인 것인 약제학적 조성물.
- 청구항 1에 있어서, 상기 폴리머성 백본에 부착된 효능기는 부착된 효능기를 갖지 않는 것을 제외하고는 동일한 폴리머성 백본을 이용한 보툴리눔 독소의 경피 전달에 비해 보툴리눔 독소의 경피 전달을 증가시키기에 충분한 양으로 존재하는 것인 약제학적 조성물.
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KR1020137011291A KR101330775B1 (ko) | 2004-03-03 | 2005-03-03 | 보툴리눔 독소의 국소 적용 및 경피 전달을 위한 조성물 및 방법 |
KR1020127012049A KR101322433B1 (ko) | 2004-03-03 | 2005-03-03 | 보툴리눔 독소의 국소 적용 및 경피 전달을 위한 조성물 및 방법 |
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