CN102325522B - 基本不含药物活性成分的可发泡组合物用于治疗人体皮肤的用途 - Google Patents
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Abstract
本发明涉及一种基本不含药物活性成分的药物组合物用于治疗人体皮肤的用途，尤其是治疗酒渣鼻、粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病或神经性皮炎。
Description
技术背景
本申请根据巴黎公约要求欧洲专利申请EP 0802233.2(提交时间：2008年12月23日)的优先权，以及在先美国申请系列号61/140,152(提交时间：2008年12月23日)的所有利益，它们在此通过参考均被纳入。
已知本领域有许多含有药物活性成分的可发泡组合物用来治疗皮肤或体腔的各种医疗状况。现有技术包括WO2005/018530、WO2008/038140、US2008/044444、US2006/275218、US2007/020213、US2002/001599、WO2004/037225、WO2005/011567、US2005/0232869、US2005/0069566及其它，它们在此通过参考均被纳入。开发这些可发泡组合物和泡沫载体，是因为它们能包含许多用于治疗各种皮肤或体腔疾病的药物成分。这些泡沫容易施用于皮肤，并且能避免刺痛和发干——在以前的泡沫组合物中已报道的性质。但是，这些组合物都要求一种或多种药物活性成分的存在，例如抗炎剂(例如COX-1抑制剂、COX-2抑制剂、水杨酸衍生物、二羧酸或二羧酸衍生物、THF-α剂、免疫抑制剂、免疫调节剂、糖皮质激素、类固醇或其它)。不必指明对药物活性剂的需求是不利的，因为这些试剂至少在部分患者身上可能具有不希望的副作用。
发明概述
我们令人惊讶地发现一种基本不含药物活性成分的可发泡组合物与喷射剂一起可用于治疗人体皮肤，尤其是治疗酒渣鼻、粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病或神经性皮炎，所述可发泡组合物由以下组成：
(a)至少一种软化剂，
(b)至少一种稳定剂，
(c)至少一种防腐剂，
(d)至少一种乳化剂，
(e)至少一种泡沫稳定剂，
(f)至少一种保湿剂
本发明的一个优选实施方式是上述基本不含药物活性成分的可发泡组合物与喷射剂一起用于治疗人体皮肤，尤其是治疗酒渣鼻、粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病或神经性皮炎的用途，其中：
(a)至少一种软化剂是辛酸/癸酸甘油三酯，
(b)至少一种稳定剂是鲸蜡/硬脂醇或硬脂酸甘油酯或其混合物，
(c)至少一种防腐剂是苯甲酸，
(d)至少一种乳化剂是PEG-40硬脂酸酯、聚山梨酯80或其混合物，
(e)至少一种泡沫稳定剂是甲基纤维素、黄原酸胶或其混合物，
(f)至少一种保湿剂是异山梨醇二甲醚、丙二醇或其混合物。
本发明一个特别优选的实施方式是上述基本不含药物活性成分的可发泡组合物与喷射剂一起用于治疗人体皮肤，尤其是治疗酒渣鼻、粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病或神经性皮炎的用途，所述的可发泡组合物包含：
(a)用量为约10.87重量百分比的辛酸/癸酸甘油三酯，
(b)约1.09重量百分比的鲸蜡/硬脂醇和约0.54重量百分比的硬脂酸甘油酯的混合物，
(c)在至少一种防腐剂的用量中苯甲酸为约0.1重量百分比，
(d)约2.83重量百分比的PEG-40硬脂酸酯和约0.98重量百分比的聚山梨酯80的混合物，
(e)约0.11重量百分比的甲基纤维素和约0.27重量百分比的黄原酸胶的混合物，
(f)约5.44重量百分比的异山梨醇二甲醚和约10.87重量百分比的丙二醇的混合物。
可作为喷射剂使用的化合物是在室温和常压下为气体并且在室温下加压后能液化。可用的喷射剂有丁烷、丙烷、异丁烯、二甲醚、氟碳气体或其混合物。
术语“药物活性化合物”或“药物活性成分”是指在临床试验中被证实具有药理活性，并且被欧洲药品局(EMEA)或美国食品药品监督管理局(FDA)批准为药物的化合物。术语“基本不含药物活性化合物”或“基本不含药物活性成分”的意思是不意图在组合物中添加“药物活性化合物”或“药物活性成分”。因此，非故意污染导致的药物活性成分的总量远低于0.05％，优选低于0.01％。最优选的是，用药物技术中使用的标准分析方法检测不到组合物中有任何的药物成分。
根据本发明的可发泡组合物通过药物专业人员已知的本领域所记载的方法制备。它们通常被包装在有出口阀的容器中。同样，可能的阀内容器在本领域有记载，在本文中不需要解释。
可发泡组合物实质上不含醇，即没有短链醇(具有1-4个碳原子的链长)。
现有技术中组合物一个已知的缺点是药物活性化合物的溶解度低。因此，不需要溶解(solve)任何药物活性化合物是根据本发明的组合物的优点。
临床试验已表明，根据本文所描述的可发泡组合物具有有益的性质，尤其是在治疗酒渣鼻时。非常令人惊讶的是注意到该治疗效果不使用任何药物活性成分即能实现。根据本发明的组合物可治疗许多其它的医疗状况，例如粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病和神经性皮炎。
此外，这里描述的组合物可用于人体皮肤的预防性治疗(例如对于有发展为该疾病的已知趋势的患者)。
根据这里描述的可发泡组合物还可用于人体皮肤的美容处理。
因此，本发明的另一个方面是提供一种通过对所需患者局部应用这里所述的泡沫来治疗人体皮肤疾病的方法，该皮肤疾病例如粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病和神经性皮炎。
本发明的另一个方面是提供一种通过对人类局部应用这里所述的泡沫来预防性治疗人体皮肤的方法，特别是用于具有发展为皮肤疾病的已知趋势的人类，该皮肤疾病例如粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病和神经性皮炎。
本发明的另一个方面是提供一种通过对人类局部使用这里描述的泡沫来美容处理人体皮肤的方法。
对于这里描述的所有这些应用(治疗、预防或美容)，发现包装于具有出口阀的容器中的下列基本不含活性药物化合物的组合物最有用
| 10.00-12.00 g/100g | 辛酸/癸酸甘油三酯 |
| 0.90-1.20 g/100g | 鲸蜡/硬脂醇 |
| 0.44-0.70 g/100g | 硬脂酸甘油酯 |
| 0.10-0.15 g/100g | 苯甲酸 |
| 2.50-3.00 g/100g | PEG-40硬脂酸酯 |
| 0.08-0.20 g/100g | 甲基纤维素 |
| 0.20-0.32 g/100g | 黄原酸胶 |
| 0.90-1.20 g/100g | 聚山梨酯80 |
| 5.35-6.00 g/100g | 异山梨醇二甲醚 |
| 10.87-12.25 g/100g | 丙二醇 |
| 至pH4.5 | 氢氧化钠 |
| 加至100 | 纯水 |
| 7.00-9.00 g | 喷射剂掺混物 |
实施例
实施例1
下列组合物根据本领域已知的方法制备。
根据实施例1B的组合物表现出最好的有益性质。
实施例2
用实施例1中描述的组合物治疗患有酒渣鼻的患者。将该特定的组合物一天应用几次，优选一天至少三次。在使用两周后，患者表现为酒渣鼻症状明显减少。再如上继续使用一段时间后，症状进一步减少。尤其是有轻型酒渣鼻的患者能受益于该应用。
实施例3
用根据本发明的组合物治疗患有银屑病的患者。将该组合物一天应用几次，优选一天至少三次。在使用两周后，患者表现为银屑病症状明显减少。再如上继续使用一段时间后，症状进一步减少。
实施例4
将根据实施例1的组合物的应用与现有技术所公开的进行比较，收集到以下数据。文献US2008/044444被认为是最接近的现有技术。US2008/044444的实施例9公开了一种能与权利要求1的组合物相比的二羧酸组合物，但是含有15％壬二酸。已知壬二酸对酒渣鼻的治疗有效。它是例如以商品名Finacea
和Skinoren Gel
销售的凝胶制剂的一部分，并且已被各种管理机构批准，包括FDA。因此，壬二酸组合物例如Finacea被看做是酒渣鼻治疗中的标准疗法。US2008/044444描述了许多能用US2008/044444的组合物治疗的疾病(参见[0186]段)。但是，其没有证明这类组合物能治疗任何所提及疾病的具体数据。
申请人进行了临床研究来比较本文所述的组合物与现有技术US2008/044444中实施例9所述的组合物。在12周探索性多中心双盲实验中，将根据US2008/044444实施例9含有壬二酸的泡沫组合物(下文称为“Aza泡沫”)与根据本申请实施例1b不含任何药物活性成分的组合物进行比较。对超过80名患者进行了治疗：约50％使用含有壬二酸的泡沫(Aza泡沫)，另外的50％使用根据实施例1b的泡沫组合物。所述患者以每天两次局部治疗12周。结果见附图：
图1和2显示了两种组合物治疗前后表示所评价疾病严重性的研究者总体评估(IGA)评分。临床研究者必须对治疗前后的丘疹脓疱性酒渣鼻的严重性进行评分。图1显示了根据本发明的组合物的IGA分数，图2是根据US2008/044444实施例9的组合物的IGA分数。所有数据以治疗患者的百分比提供。图1和2显示了两种组合物的对比功效：发现许多在治疗前患有中至重度丘疹脓疱性酒渣鼻的患者变为痊愈至轻度。在各治疗中未发现统计学显著差异。该发现对于专业人员而言是令人惊讶的，因为壬二酸是熟知的酒渣鼻治疗中的药物和标准疗法。因此，非常令人惊讶的是，根据本申请实施例1的不含壬二酸的可发泡组合物表现出可媲美的结果。
此外，测定了实验过程中的毛细血管扩张评分。在相同的随机双盲实验中，让研究者比较毛细血管扩张强度的严重度。在12周时间最后，让研究者评价患者的毛细血管扩张强度是得到改善、保持不变还是恶化。结果见图3。非常令人惊讶地注意到，毛细血管扩张评分得到改善的患者的数量比用含壬二酸的泡沫治疗的要多得多。
此外，计算了不良反应(例如瘙痒、刺痛和灼烧)的数量。在此临床研究中仅报道了轻度或中度的不良反应，没有报道严重的不良反应。如图4所示，现有技术组合物中的不良反应的总数与根据本发明的组合物相比显著更高。
Claims (7)
1.基本不含药物活性成分的可发泡组合物在制备包装于具有出口阀的容器中的治疗或预防酒渣鼻、粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病或神经性皮炎的药物，或者制备包装于具有出口阀的容器中的美容产品的用途，所述可发泡组合物由以下组成：
。
2.根据权利要求1的基本不含药物活性成分的可发泡组合物在制备包装于具有出口阀的容器中的治疗或预防酒渣鼻、粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病或神经性皮炎的药物，或者制备包装于具有出口阀的容器中的美容产品的用途，所述可发泡组合物由以下组成：
或者由以下组成：
或者由以下组成：
或者由以下组成：
或者由以下组成：
。
3.根据权利要求1的基本不含药物活性成分的可发泡组合物在制备包装于具有出口阀的容器中的治疗或预防酒渣鼻、粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病或神经性皮炎的药物，或者制备包装于具有出口阀的容器中的美容产品的用途，所述可发泡组合物由以下组成：
。
4.根据权利要求1-3中任一项的基本不含药物活性成分的可发泡组合物的用途，其中该喷射剂是丁烷、丙烷、异丁烯、二甲醚、氟碳气体或其混合物。
5.装填有基本不含药物活性成分的可发泡组合物的带有出口阀的容器，用于产生治疗或预防酒渣鼻、粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病或神经性皮炎的泡沫，或者用于人体皮肤美容处理的泡沫，所述可发泡组合物由以下组成：
。
6.装填有基本不含药物活性成分的可发泡组合物的带有出口阀的容器，用于产生治疗或预防酒渣鼻、粉刺、特应性皮炎、接触性皮炎、口周皮炎、银屑病或神经性皮炎的泡沫，或者用于人体皮肤美容处理的泡沫，所述可发泡组合物由以下组成：
或者由以下组成：
或者由以下组成：
或者由以下组成：
或者由以下组成：
。
7.根据权利要求5和6之一的装填有基本不含药物活性成分的可发泡组合物的带有出口阀的容器，其中该喷射剂是丁烷、丙烷、异丁烯、二甲醚、氟碳气体或其混合物。
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