CN1929825A - 皮肤病学的软凝胶组合物 - Google Patents
皮肤病学的软凝胶组合物 Download PDFInfo
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- CN1929825A CN1929825A CNA2005800072278A CN200580007227A CN1929825A CN 1929825 A CN1929825 A CN 1929825A CN A2005800072278 A CNA2005800072278 A CN A2005800072278A CN 200580007227 A CN200580007227 A CN 200580007227A CN 1929825 A CN1929825 A CN 1929825A
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Abstract
用于治疗多种皮肤病学疾病状态的可口服给药的软凝胶胶囊或软明胶胶囊及其填充组合物。这些组合物还特别地用于治疗儿童或年龄至少为55岁的患者。
Description
本申请要求了2004年1月20日提交的序号为60/537,288号的美国临时专利申请的优先权,本文将其内容全部引入作为参考。
发明领域
本发明主题涉及用于治疗各种皮肤病学疾病状态的可口服给药的软凝胶胶囊(softgels)或软明胶胶囊(soft gelatin capsules)及其填充组合物。这些组合物特别用于治疗儿童、年龄至少为55岁的患者和女性。
发明背景
在本领域内早已公知多种药理学活性剂的局部给药来治疗各种皮肤病学病症。皮肤的可达性及其为局部用药制剂的长期应用提供的机会使得在过去的数年中,局部药物输送系统的应用不断增加。通常,这些局部用药剂型可以为液体、半固体或固体形式。
通常将药物以此方式应用于皮肤,以产生四种一般作用中的一种或多种:在皮肤表面上的作用,在角质层中的作用,需要渗透进表皮和真皮的更深层的作用,或者足够量的药物穿过表皮和真皮输送至脉管系统以产生治疗性全身浓度而产生的全身作用。
但是,当以局部用药剂型应用时,有时难以完成药物渗透进入有活力的表皮和真皮。此外,即使可以完成药物的渗透,该药物仅可能被输送至该组合物应用的局部区域,而非区域性的或是全身性的。因此,局部用药组合物通常在治疗众多表现某些区域性或全身性作用的皮肤病学病症方面不是最佳的。
局部用药药物剂型可能具有其它的在应用中显示副作用的缺点,例如对敏感皮肤区域的刺激。这种刺激经常是由于为了保持局部用药剂型中活性剂的稳定性而加入的防腐剂产生的。有时在局部用药组合物中保持药物的稳定性是非常困难的,使得防腐剂在许多局部用药组合物中都是非常普遍和必要的成分。
此外,有时必须保持局部用药组合物长时间地与皮肤接触,以将足够量的活性剂释放至皮肤,并针对皮肤病学病症产生期望的药理学作用。但是,难以配制在使用者的常规日常活动中不会损耗或擦除而保持长时间地与皮肤接触的局部用药组合物。此外,足够耐用以便长时间地保持在皮肤上的局部用药组合物通常具有缺点,即其可不易被皮肤吸收,其易于封闭皮肤的毛孔,其在性质上可能是多脂的,以及难以从皮肤上洗掉。
为了克服这些与皮肤病学病症的某些局部治疗相关的问题,许多药物可以口服剂型的形式给药。最普通的口服剂型是片剂和胶囊。可从粉末形式或其它形式的固体成分的压制中制备片剂和胶囊。但是诸如通过压制形成的片剂或胶囊的口服剂型经常导致所述活性成分的大量降解。
此外,由于活性剂是以粉状、晶体形式存在,所以给药时固体口服剂型可引起刺激。给药后,这种粉状、晶体形式的活性成分同样可能难以达到该活性剂的最佳的、控制溶出和吸收。由于此粉状晶体形式,因而经常难以获得该活性剂的一致的生物利用度。
大多数片剂还需要使用稀释剂或填充剂,以使片剂制成实用的大小用于压制。类似地,片剂经常包含其它赋形剂,例如粘合剂、润滑剂、助流剂和崩解剂来制备片剂,以及辅助药物输送。但是,这些附加成分的存在可能对患者及活性成分的稳定性均具有不良作用,这依赖于所使用的试剂。
另外,某些硬片剂和硬胶囊对于疏水性药物是不良的输送手段。疏水型药物通常不易溶于水、胃液或肠液中。当其以固体剂型复合时,疏水性药物的溶出速率缓慢、吸收可变化,以及生物利用度不完全。
对于某些患者,特别是某些年轻及老年患者以及女性患者,硬片剂以及硬胶囊还难以吞咽。这是由于其坚硬的、紧密的性质造成其外表粗糙,可能易于卡在嘴里或喉咙里。因此,仍然需要可易于向年轻的、老年的和女性患者给药的、对治疗皮肤病学病症有效的其它剂型。
在本领域内,公知软胶囊(soft gel capsules),或者软凝胶胶囊是上述那些剂型的替代剂型,但是对于皮肤病学病症的治疗不是必要的。例如,美国专利第5,587,149号公开了用于诸如抗坏血酸(维生素C)的水溶性活性成分的软凝胶胶囊制剂,其中填充物质包含乳剂,该乳剂的第一相包括聚乙二醇(该水溶性活性成分溶于其中),以及第二相包括硅酮液体。
同样,美国专利第6,251,426号公开了包含高浓度的布洛芬溶液的软明胶胶囊。但是,此专利未公开软凝胶胶囊输送用于治疗皮肤病学病症的活性剂的能力。
美国专利第5,200,191号公开了包含视黄醇的局部应用于皮肤的软凝胶胶囊组合物。所公开的软凝胶胶囊提供了用于分配产品的单一使用方法,其中该软凝胶胶囊在一端含有用于分配包含于其中的填充物质的拧松或其它可移除的部件。但是,由于打开的软凝胶胶囊中的活性剂是局部应用于皮肤,因此该剂型与先前讨论的局部用药剂型很相似。
本领域内公知的用于治疗皮肤病学病症的一种口服软凝胶胶囊是Accutane(异维甲酸),为得自于新泽西Hoffmann-La Roche的软凝胶胶囊,其包含活性成分异维甲酸(公知为类视黄醇)。因为类视黄醇作为一类必须避免接触氧气以防止氧化的化合物,所以该软凝胶胶囊剂型在制造过程中用于保护异维甲酸。但是,在将所述药物实际输送至患者方面,相对于诸如包含异维甲酸的局部用药组合物,该软凝胶胶囊组合物不具有任何优点。事实上,由于异维甲酸是以液体悬浮剂的形式包含于Accutane软凝胶胶囊中,因此在给药后其具有约90小时的半衰期,导致高可能性的不良副作用。
因此,在本领域内仍然存在着对通过组合物的给药来治疗某些皮肤病学病症的方法的需求,该组合物可有效地将活性剂输送至体内,以治疗皮肤病学病症。这种方法通过有效地将用于治疗皮肤病学病症的药物口服给药,提供了对局部用药剂型和诸如片剂和胶囊的压制的口服剂型的替代。还存在着对通过口服组合物的给药来治疗年轻、老年及女性患者的皮肤病学病症的需求,而口服组合物容易及乐意被这些患者群所接受。本发明关注于这些需求。
发明概述
本发明主题主要涉及治疗哺乳动物的皮肤病学病症的方法。通过将提供治疗有效量的药理学活性剂的软胶囊给予所述哺乳动物来实现该方法。所述软胶囊优选地包含内部的、非水液相和外部的明胶和/或软纤维素层。该内部的、非水液相可包含药理学活性剂的溶液或混悬液,该药理学活性剂具有至少90%的纯度并且降解产物的浓度小于所述药理学活性剂起始浓度的约10%。所述纯度和活性剂的降解产物浓度优选地足以允许安全地治疗所述皮肤病学病症,并提供所述药理学活性剂的改进的生物利用度。
在优选的实施方案中,所述药理学活性剂选自抗生素、抗感染剂、抗真菌剂、类固醇、抗组胺剂、抗寄生虫剂、免疫调节剂、反义剂、抗病毒剂、用于治疗皮下和皮上色素沉着病症的药物、抗牛皮癣剂、角质层分离剂、免疫抑制剂、DNA合成抑制剂、细胞毒素剂、抗甲状腺剂、单克隆抗体调节剂、TNF-α拮抗剂、免疫球蛋白、代谢调节剂、抗血管生成剂、激酶调节剂、激素、光动力剂、蛋白酶抑制剂、抗焦虑剂、细胞生长调控剂、酶、前列腺素、肽、镇痛剂、其盐、其衍生物及其混合物。
在另一优选实施方案中,本发明主题涉及治疗哺乳动物的皮肤病学病症的方法,该方法包括:
将提供药理学活性剂的改进的生物利用度的软胶囊口服给予所述哺乳动物,该软胶囊包括:
内部的、非水的液相,该液相包含单一的、疏水的、对治疗所述皮肤病学病症有效的药理学活性剂的溶液或混悬液,该药理学活性剂具有至少90%的纯度并且降解产物的浓度小于所述疏水性药理学活性剂的起始浓度的约10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述皮肤病学病症;以及
外部的明胶层,该明胶层包含明胶、软纤维素、或其混合物以及另外的组分,该另外的组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物;
其中所述疏水性药理学活性剂选自抗感染剂、类固醇、其盐、其衍生物和其混合物。
在另一优选的实施方案中,本发明主题涉及治疗哺乳动物的皮肤病学病症的方法,该方法包括:
将提供药理学活性剂的改进的生物利用度的软胶囊口服给予所述哺乳动物,该软胶囊包括:
当与水性介质结合时具有pH约3-9的内部的、非水的液相,该液相包含单一的、疏水的、对治疗所述皮肤病学病症有效的药理学活性剂的溶液或混悬液和一种或多种脂肪酸或其衍生物,该脂肪酸或其衍生物选自ω-3脂肪酸、DHA、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸、单不饱和脂肪酸、多不饱和脂肪酸、饱和脂肪酸、反式脂肪酸、其衍生物及其混合物,所述单一的药理学活性剂包含纯度至少90%的疏水性抗感染剂或其盐或其衍生物,并且降解产物的浓度小于所述疏水性抗菌剂起始浓度的约10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述皮肤病学病症;以及
外部的包含明胶和另外的组分的明胶层,所述另外的组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物。
在另一优选的实施方案中,本发明主题涉及治疗哺乳动物的皮肤病学病症的方法,该方法包括:
将提供多西霉素或其盐或其衍生物的改进的生物利用度的软胶囊口服给予所述哺乳动物,该软胶囊包括:
当与水性介质结合时具有pH约3-9的内部的、非水的液相,该液相包含作为对治疗所述皮肤病学病症有效的唯一活性成分的强力霉素或其盐或其衍生物的溶液或混悬液和一种或多种脂肪酸或其衍生物,该脂肪酸或其衍生物选自ω-3脂肪酸、DHA、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸、单不饱和脂肪酸、多不饱和脂肪酸、饱和脂肪酸、反式脂肪酸、其衍生物及其混合物,所述强力霉素具有至少95%的纯度,并且降解产物的浓度小于所述强力霉素的起始浓度的约5%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述皮肤病学病症;以及
外部的包含明胶和另外组分的明胶层,所述另外组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物。
在可选择的优选实施方案中,本发明主题涉及治疗哺乳动物的皮肤病学病症的方法,该方法包括:
将提供疏水性药理学活性剂的改进的生物利用度的软胶囊口服给予所述哺乳动物,该软胶囊包括:
内部的、非水的液相,该液相包含单一的、对治疗所述皮肤病学病症有效的疏水性药理学活性剂或其盐或其衍生物的溶液或混悬液和一种或多种脂肪酸或其衍生物,该脂肪酸或其衍生物选自ω-3脂肪酸、二十二碳六烯酸(DHA)、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸、单不饱和脂肪酸、多不饱和脂肪酸、饱和脂肪酸、反式脂肪酸、其衍生物和及其混合物,所述疏水性药理学活性剂具有至少90%的纯度,并且降解产物的浓度小于所述疏水性药理学活性剂的起始浓度的约10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述皮肤病学病症;以及
外部的包含明胶和另外组分的明胶层,所述另外组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物。
在另一可选择的实施方案中,本发明主题涉及治疗年龄超过至少55岁的人类患者的方法,该方法包括:
将提供药理学活性剂的改进的生物利用度的软胶囊口服给予所述需要该软胶囊的人类患者,该软胶囊包括:
内部的、非水的液相,该液相包含药理学活性剂的溶液或混悬液和一种或多种脂肪酸或其衍生物,该药理学活性剂具有至少90%的纯度,并且降解产物的浓度小于所述药理学活性剂的起始浓度的约10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述人类患者并提供所述药理学活性剂的改进的生物利用度;以及
外部的明胶和/或软纤维素层;
其中所述药理学活性剂选自抗生素、抗感染剂、抗真菌剂、类固醇、抗组胺剂、抗寄生虫剂、免疫调节剂、反义剂、抗病毒剂、用于治疗皮下和皮上色素沉着病症的药物、抗牛皮癣剂、角质层分离剂、免疫抑制剂、DNA合成抑制剂、细胞毒素剂、抗甲状腺剂、单克隆抗体调控剂、TNF-α拮抗剂、免疫球蛋白、代谢调节剂、抗血管生成剂、激酶调节剂、激素、光动力剂、蛋白酶抑制剂、抗焦虑剂、细胞生长调节剂、酶、前列腺素、肽、镇痛剂、其盐、其衍生物及其混合物。
在另一可选择的实施方案中,本发明主题涉及治疗年龄超过至少55岁的人类患者的皮肤病学病症的方法,该方法包括:
将提供四环素的改进的生物利用度的软胶囊口服给予所述需要该软胶囊的人类患者,该软胶囊包括:
当与水性介质结合时具有pH约3-9的内部的、非水的液相,该液相包含作为对治疗所述皮肤病学病症有效的唯一活性成分的四环素或其盐或其衍生物的溶液或混悬液和一种或多种脂肪酸或其衍生物,该脂肪酸或其衍生物选自ω-3脂肪酸、二十二碳六烯酸(DHA)、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸、单不饱和脂肪酸、多不饱和脂肪酸、饱和脂肪酸、反式脂肪酸、其衍生物和及其混合物,所述四环素具有至少90%的纯度,并且降解产物的浓度小于所述四环素的起始浓度的约10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述人类患者;以及
外部的包含明胶和另外组分的明胶层,该另外组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物。
在另一优选的实施方案中,本发明主题涉及适用于向人类口服给药的,并且提供皮肤病学有效活性剂的改进的生物利用度的软胶囊,该软胶囊包括:
当与水性介质结合时具有pH约3-9的内部的、非水的液相,该液相包含皮肤病学有效的活性剂或其盐或其衍生物的溶液或混悬液和一种或多种脂肪酸或其衍生物,该脂肪酸或其衍生物选自ω-3脂肪酸、DHA、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸、单不饱和脂肪酸、多不饱和脂肪酸、饱和脂肪酸、反式脂肪酸、其衍生物和及其混合物,所述皮肤病学活性剂具有至少90%的纯度,并且降解产物的浓度小于约所述肤病学活性剂的起始浓度的10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述人类患者;以及
外部的包含明胶和另外组分的明胶层,该另外组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物。
在另一优选的实施方案中,本发明主题涉及适用于向人类口服给药的,并且提供四环素的改进的生物利用度的软胶囊,该软胶囊包括:
当与水性介质结合时具有pH约3-9的内部的、非水的液相,该液相包含作为对治疗皮肤病学病症有效的唯一活性成分的四环素或其盐或其衍生物的溶液或混悬液和一种或多种脂肪酸或其衍生物,该脂肪酸或其衍生物选自ω-3脂肪酸、二十二碳六烯酸(DHA)、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸、单不饱和脂肪酸、多不饱和脂肪酸、饱和脂肪酸、反式脂肪酸、其衍生物和及其混合物,所述四环素具有至少90%的纯度,并且降解产物的浓度小于所述四环素的起始浓度的约10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述人类患者;以及
外部的包含明胶和另外组分的明胶层,该另外组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物。
发明的详细说明
定义
本发明所用的“给药”是指口服地或者向治疗的患者的体孔提供组合物。本发明所用的术语给药不包括静脉内地或经吸入地向患者提供组合物。
本发明所用的“控制释放”是指释放的速率不同于所述药理学活性剂的正常释放速率。因此,该术语表明已改变了所述药理学活性剂的释放速率,获得了与该剂的正常释放速率相比,更加延缓、持久或延长的释放。
本发明所用的“降解产物”是指由本发明所述组合物中的一种或多种活性成分的分解作用产生的产物。
本发明所用的短语“有效量”意为组合物或其组分的量足够充分以积极改变欲治疗的所述病症,但是足够低以避免续发性感染,该续发性感染引起了对除那些本发明所关注的治疗之外的另外治疗的需求。有效量随进行治疗的特定病症或数种病症、病症的严重性、治疗的持续时间、所用组合物的特定组分、进行治疗的患者的体重、耐受性和其它身体属性,以及包括医师的卫生保健提供者所公知的相似因素而改变。
本发明所用的“硬的”口服剂型是指例如通过压制、直接的或相反的,制粒、和/或喷雾干燥形成的固体口服药物输送系统。例如,可通过压制一种或多种粉末状的物质形成这种硬的口服剂型。硬片剂、囊片(caplets)和胶囊中包括的小丸剂是这种固体口服剂型的非限制性例子。
本发明所用的“药物可接受的盐”是指所述活性化合物的盐,其与该活性化合物具有相同的药理学活性,并且其既不在生物学方面也不在其它方面不适合。例如,可用有机酸或无机酸形成盐。适合的酸的非限制性例子包括醋酸、乙酰水杨酸、己二酸、藻酸、抗坏血酸、天冬氨酸、苯甲酸、苯磺酸、二硫酸(bisulfic acid)、硼酸、丁酸、樟脑酸、樟脑磺酸、碳酸、枸橼酸、环戊烷丙酸、二葡糖酸、十二烷基硫酸(dodecyl sulfic acid)、乙磺酸、甲酸、富马酸、甘油酸、甘油磷酸、甘氨酸、葡庚糖酸、葡糖酸、谷氨酸、戊二酸、乙醇酸、半硫酸(hemisulficacid)、庚酸、己酸、马尿酸、氢溴酸、盐酸、氢碘酸、羟基甲磺酸、乳酸、马来酸、苹果酸、丙二酸、扁桃酸、甲磺酸、粘酸、萘烷磺酸(naphthylanesulfonic acid)、naphthylic acid、烟酸、亚硝酸、草酸、壬酸、磷酸、丙酸、糖精、水杨酸、山梨酸、琥珀酸、硫酸、酒石酸、硫氰酸、巯基乙醇酸、硫代硫酸、对甲苯磺酸、十一烯酸、天然地和合成来源的氨基酸。
如果使用有机碱,则优选地使用挥发性差的碱,例如低分子量的链烷醇胺,例如乙醇胺、二乙醇胺、N-乙基乙醇胺、N-甲基二乙醇胺、三乙醇胺、二乙氨基乙醇、2-氨基-2-甲基-正丙醇、二甲氨基丙醇、2-氨基-2-甲基丙二醇和三异丙醇胺。可提及的挥发性差的碱还例如为乙二胺、氨基葡萄糖、己撑二胺、吗啉、哌啶、哌嗪、环己胺、三丁胺、十二烷胺、N,N-二甲基十二烷胺、硬脂胺、油胺、苄胺、二苄胺、N-乙基苄胺、二甲基硬脂胺、N-甲基吗啉、N-甲基哌嗪、4-甲基环己胺和N-羟乙基吗啉。
还可使用诸如氢氧化三甲基苄基铵、氢氧化四甲铵、或氢氧化四乙铵的氢氧化季铵的盐,也可使用胍及其衍生物,特别是其烷化产物。但是,也可能将诸如甲胺、乙胺或三乙胺的低分子量的烷基胺用作成盐剂。根据本发明,用于所述化合物的适合的盐也可是那些具有无机阳离子的盐,例如碱金属盐,特别是钠盐、钾盐或铵盐;碱土金属盐,例如,特别是镁盐或钙盐;以及具有二价或四价阳离子的盐,例如锌盐、铝盐或锆盐。也关注含有有机碱的盐,例如二环己胺盐;甲基-D-葡萄糖胺;以及含有诸如精氨酸、赖氨酸的氨基酸的盐,等等。所述碱性含氮基团也可用诸如低级烷基卤,例如氯代甲烷、乙基氯、丙基氯和丁基氯,溴代甲烷、乙基溴、丙基溴和丁基溴,碘代甲烷、乙基碘、丙基碘和丁基碘;二烷基硫酸盐,例如,二甲基硫酸盐、二乙基硫酸盐、二丁基硫酸盐和二戊基硫酸盐;长链的卤化物,例如癸基氯、月桂基氯、肉豆蔻酰氯和硬脂酰氯,癸基溴、月桂基溴、肉豆蔻酰溴和硬脂酰溴,癸基碘、月桂基碘、肉豆蔻酰碘和硬脂酰碘;诸如苄基溴和苯乙基溴的芳基卤(asthma halides);和其它的试剂季铵化。因此获得水溶性或油溶性或可分散的产物。
本发明所用的“软凝胶胶囊”、“软凝胶(soft gel)”和“软明胶”可互换地使用,并且均指的是胶囊,该胶囊具有一层的、密封的壳壁或外层,以溶液或其它形式充满油和/或其它水成液或非水液体,并且固体分散在其中。
本发明所用的“进行治疗”或“治疗”意为预防或减少皮肤病学病症、疾病、感染、过敏症、反应或其它皮肤病学疾病状态的症状或影响的严重性。
本发明所用的其它术语的含义由本领域内其公知的意义所定义。
软胶囊
根据本发明所述的优选方法和组合物,为了治疗所述哺乳动物的皮肤病学病症,将软凝胶胶囊或软明胶胶囊给予哺乳动物,以提供治疗有效量的药理学活性剂。在这点上,优选的方法涉及哺乳动物的皮肤病学病症的治疗方法,该方法包括将提供治疗有效量的药理学活性剂的软胶囊给予所述哺乳动物。
在优选的实施方案中,所述软胶囊包括内相和外相。所述内相优选为包含药理学活性剂或其盐或其衍生物的溶液或混悬液的内部的、非水液相,该药理学活性剂或其盐或其衍生物至少为90%的纯度,并且降解产物的浓度小于该药理学活性剂的起始浓度的约10%。该纯度水平和降解产物的浓度足以允许安全地治疗所述皮肤病学病症并且提供所述药理学活性剂的改善的生物利用度。
在另一优选实施方案中,所述外相为外部的明胶和/或软纤维素层。
在另一优选实施方案中,所述软胶囊使用的药理学活性剂选自抗生素、抗感染剂、抗真菌剂、类固醇、抗组胺剂、抗寄生虫剂、免疫调节剂、反义剂、抗病毒剂、用于治疗皮下和皮上色素沉着病症的药物、抗牛皮癣剂、角质层分离剂、免疫抑制剂、DNA合成抑制剂、细胞毒素剂、抗甲状腺剂、单克隆抗体调节剂、TNF-α拮抗剂、免疫球蛋白、代谢调节剂、抗血管生成剂、激酶调节剂、激素、光动力剂、蛋白酶抑制剂、抗焦虑剂、细胞生长调控剂、酶、前列腺素、肽、镇痛剂、其盐、其衍生物及其混合物。
在特别的优选实施方案中,将所述软胶囊口服给药给予所述患者。
相对于公知的用于口服治疗皮肤病学病症的现有技术的硬口服剂型,本发明所用的软胶囊提供了显著的优势。例如,尽管需要在相对高温下形成所述软胶囊,但是由于在该软凝胶的形成过程中使用较低的压制压力,所以与可比较的硬片剂或硬胶囊相比,本发明所述软胶囊时常含有较少的所述药理学活性剂的降解物。
此外,因为用液体而不是粉末状的成分形成所述软胶囊,所以向患者给药时,相对于相应的硬片剂或硬胶囊,所述软凝胶剂型出乎意料地提供了较少的刺激和更好的活性稳定性。与硬片剂或硬胶囊相比,液体成分在软凝胶形成中的应用也可提供增强的吸收和溶解特性以及更一致的生物利用度。
这些区别使得本发明所述软胶囊在药物剂型的形成过程中以及长期的贮存期中,保持所述皮肤病学活性成分的高纯度水平和低浓度的降解产物。因此,与硬片剂和硬胶囊相比,本发明所述软胶囊可经常含有更高纯度水平的皮肤病学活性成分,使得改善了对各种皮肤病学病症、尤其是区域性的或全身性的皮肤病学病症的治疗。
在优选的实施方案中,本发明所述软胶囊将降解产物的浓度维持在小于约7%,更优选为小于约5%,最优选为小于约3%的包含于其中的所述药理学活性剂的起始浓度。在这点上,本发明所述软胶囊将包含于其中的所述活性成分的降解产物浓度充分地保持在由诸如美国食品药品管理局(FDA)的政府管理机构提出的对此特定活性成分的限度内。
同样地,本发明所述软胶囊使包含于其中的所述药理学活性剂维持在至少为90%,优选为至少95%的纯度水平。这些优势特性使得应用可口服给药的药物剂型时,增强了对皮肤病学病症的治疗。
此外,当将硬片剂和硬胶囊有时所需要的另外的赋形剂的量最小化时,本发明所述软胶囊表现的治疗皮肤病学效果的能力代表了相对于本领域内先前公知的典型硬口服组合物的明显改进。因为较少的成分存在于组合物中,所以减少了患者对该组合物具有副作用的可能性。于是,预料本发明所述软胶囊在少数的患者中产生副作用。
另外,本发明所述软凝胶胶囊在提供固体剂型时以溶液的形式输送药物。因此,这些软胶囊是适于疏水性药物的有效输送系统,该疏水性药物可溶于亲水性溶剂中,当该胶囊被压碎、咀嚼或溶解时,可立即释放该疏水性药物,在胃液中产生该药物的溶液,以预备从胃肠道吸收入血液中。这可能导致迅速启动所需要的治疗效果。
因此,本发明所述软胶囊有效地治疗患者的皮肤病学病症,而不显示某些有时与硬片剂和硬胶囊相关的缺点。
本发明所述软胶囊同样地克服了使用本领域内先前公知的、用于治疗皮肤病学病症的典型的局部用药剂型的缺点。例如,使用本发明所述软凝胶胶囊促进了包含于其中的皮肤病学活性剂的增强的吸收和溶解特性、更一致的生物利用度以及局部的或全身的效力。相反,某些局部用药剂型可能有时候提供有限的药物渗透,可能只将该药物输送至所述组合物所应用的局部区域处,而不是区域性或全身性输送。此外,通过许多先前公知的局部用药剂型,有时难以调控和/或最大化所给予的活性剂的吸收、溶解和生物利用度特性。
此外,有时候可能难以产生对治疗各种皮肤病学病症有效的稳定的局部用药组合物。因此,这些特定的局部用药组合物具有有限的贮存期限,并且不能长期的保存在市场上或者长期使用。相反,本发明所述软胶囊是非常稳定的组合物,具有长期的贮存稳定性。
在这点上,局部用药剂型通常含有诸如防腐剂的另外的成分以维持该局部用药剂型中的活性剂的稳定性。但是,当向患者给药时,这种另外成分有时候可能具有诸如刺激敏感皮肤的不良影响。相反,本发明所述软胶囊具有增强的所述药理学活性剂的稳定性,无需使用作为必要组分的防腐剂。与相应的局部用药药物剂型相比,这出乎意料地减少了刺激的发生率。
本发明所述软胶囊易于向患有多种皮肤病学病症中任意一种病症的患者口服给药。事实上,这些组合物外层的光滑特性使得年轻患者,即5-20岁的儿童,有时指老年患者的55-90岁或更年长患者以及不同于男性患者的女性患者顺利地吞咽该组合物。在优选的实施方案中,8-18岁的儿童可顺利地吞咽本发明所述组合物。相反,先前的硬口服剂型往往不易被这些同样的患者吞咽。
此外,许多先前的局部用药组合物有时必须保持长时间地接触皮肤,以将足够量的所述活性剂释放至该皮肤处,并针对皮肤病学病症产生期望的药理学作用。这可能需要令人不舒服的组合物足够耐用以长期地保持在皮肤上,或者需要每天多次使用,导致不太适宜的患者依从性。因此,因为本发明所述软胶囊是口服而不是局部给药,所以其可导致患者对必要的用药法的依从性增加,以有效地治疗皮肤病学病症。
本发明所述软胶囊可制成各种颜色,或者可在形成后在外表印有标记,以提供货品名称或指示该胶囊的来源或包囊于其中的所述药理学活性剂。所述印刷的材料可以是任何适合的染料或色素,以及可通过任何公知的用于在软凝胶胶囊上应用某类标识的方法或机器来应用所述标识,该公知的方法或机器例如为那些显示于美国专利第2,449,139;2,623,494;2,703,047;2,688,775;3,124,840;3,203,347和3,333,031号中的方法或机器,在此将所述专利的全部内容引入作为参考。
外层
本发明所述软胶囊包括作为必要组分的光滑的外层。该外层的光滑性使得年轻患者,即5-20岁的儿童,优选为8-18岁的儿童,有时指老年患者的年龄超过55岁的患者以及女性患者容易吞咽所述组合物。在这点上,所述外层可以是外部的明胶层或外部的软纤维素层。此外,所述外层允许该软凝胶胶囊包装为便利的单一使用的容器。
所述外层将独特的强度和持久性赋予本发明所述软胶囊。此外,该外层保护所述内部液相或填充的材料不受空气氧化,该空气氧化损害了诸如硬片剂和硬胶囊的其它口服剂型的效力和贮存期限。此外,所述外层可使存在于所述内部液相中的所述成分控制释放。
本发明所用的优选的外部明胶层包含明胶和另外的组分,该另外的组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物。同样地,本发明所用的优选的外部软纤维素层包含纤维素和另外的组分,该纤维素选自羟丙基甲基纤维素、羟丙基纤维素、羟乙基纤维素、羟甲基纤维素、乙基纤维素、微晶纤维素及其混合物,该另外的组分选自胶凝剂、盐、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物。在这点上,优选的胶凝剂为角叉菜胶。在此还可考虑本领域内技术人员所公知的、用于形成明胶层或软纤维素层的其它组分。
本发明所述软胶囊的外层还可包含任何其它的适合于这种剂型的成分,该成分列于美国食品与药品管理局(FDA)药品评价和研究中心(CDER)管理办公室于1996年1月出版的“Inactive Ingredient Guide(非活性成分指南)”,在此将其全部内容引入作为参考。
由于本发明所述的光滑的外层是从液体中形成的,因此其含有具有弯曲边缘的圆形。因此,所述外层可优选呈各种各样的圆形尺寸和形状,其包括但不限于卵形的、球形的、椭圆形的、管状的,和其它特殊类型的形状。在特别优选的实施方案中,所述外层具有卵形或球形形状。与硬胶囊相比,该外层的弯曲边缘及圆形形状使得本发明所述软胶囊更容易吞咽。此外,可配制所述外层,以提供控制释放并改善所述药理学活性剂的适口性。例如,所述外层可结合磷脂或聚合物或天然树胶以将所述药理学活性剂包封于其中,以赋予希望的延缓/控制释放效果。当用本发明所述软胶囊给予药理学活性剂时,这些特征促使患者的依从性改善并减少副作用的发生。
内部液相
本发明所述软胶囊还另外包含必要的内部液相。该内部液相优选为非水液相。当于水性介质结合时,该内部液相优选地具有约3-9的pH值。
所述内部液相可以是单相或者可混溶液体的混合物。在优选的实施方案中,本发明所述软胶囊的内部液相包含药理学活性剂的溶液、混悬液或糊状物和一种或多种脂肪酸或其衍生物。优选地,这种脂肪酸的非限制性例子选自脂肪酸、脂肪酸酯、脂肪酸醚、脂肪酸醇及其混合物。
优选地,用于本发明所述软胶囊的内部液相的特异性脂肪酸的非限制性例子选自ω-3脂肪酸、二十二碳六烯酸(DHA)、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸、单不饱和脂肪酸、多不饱和脂肪酸、饱和脂肪酸、反式脂肪酸、其衍生物及其混合物。
本发明所述软胶囊的内部液相还可任选地包含另外的成分,该另外的成分选自花生油、氢化花生油、蓖麻油、氢化蓖麻油、玉米油、橄榄油、氢化植物油、硅油、大豆油、液体石蜡、鲸蜡醇、十六醇十八醇化合物、硬脂醇、硬脂酸、蜂蜡、二氧化硅、聚乙二醇、甘油一酯、甘油二酯、甘油三酯、泊洛沙姆、硅酮油及其混合物。本发明还可考虑其它适合作为载体用于药理学活性剂的水成液或非水液体,优选使用非水液体。
本发明所述软胶囊的内部液相还可包含任何其它的适合用于这种剂型的成分,该成分列于美国食品与药品管理局(FDA)药品评价和研究中心(CDER)管理办公室于1996年1月出版的“非活性成分指南”,在此将其全部内容引入作为参考。
药理学活性剂
本发明所述软胶囊中的内部液相中的必要组分是对治疗患者皮肤病学病症有效的药理学活性剂。所述药理学活性剂优选地以其离子化的形式、非离子化的形式或其混合物形式加入所述内部液相中。
在优选的实施方案中,所述药理学活性剂以溶液的形式存在于所述内部液相中。在可选择的优选实施方案中,所述药理学活性剂不以溶液的形式存在于所述内部液相中。在这点上,所述药理学活性剂可以混悬液或糊状物的形式存在于所述内部液相中。
所述药理学活性剂优选地以至少为90%的纯度存在于本发明所述组合物中,并且降解产物的浓度小于所述药理学活性剂的起始浓度的约10%。该纯度和降解产物的浓度允许安全地治疗皮肤病学病症,并提供所述药理学活性剂的改善的生物利用度。
在优选的实施方案中,本发明所述软胶囊将降解产物的浓度维持在小于约7%,更优选地小于约5%,最优选地小于约3%的包含于其中的所述药理学活性剂的起始浓度。在这点上,本发明所述软胶囊将包含于其中的所述药理学活性剂的降解产物的浓度充分地维持在由诸如美国FDA的政府管理机构提供的对特定活性成分的限度内。
同样地,本发明所述软胶囊优选地将包含于其中的所述药理学活性剂维持在至少为95%的纯度水平。这些优势特性使得应用可口服给药的药物剂型时,增强了对皮肤病学病症的治疗。
本发明方法所用的治疗皮肤病学病症的药理学活性剂优选的、非限制性例子包括抗生素、抗感染剂、抗真菌剂、类固醇、抗组胺剂、抗寄生虫剂、免疫调节剂、反义剂、抗病毒剂、用于治疗皮下和皮上色素沉着病症的药物、抗牛皮癣剂、角质层分离剂、免疫抑制剂、DNA合成抑制剂、细胞毒素剂、抗甲状腺剂、单克隆抗体调节剂、TNF-α拮抗剂、免疫球蛋白、代谢调节剂、抗血管生成剂、激酶调节剂、激素、光动力剂、蛋白酶抑制剂、抗焦虑剂、细胞生长调节剂、酶、前列腺素、肽、镇痛剂、其盐、其衍生物及其混合物。在特别优选的实施方案中,所述药理学活性剂或其盐或其衍生物为疏水的。
在特别优选的实施方案中,所述药理学活性剂为抗感染剂。本发明所述软胶囊中使用的抗感染剂的优选的、非限制性例子选自四环素类、头孢菌素类、β-内酰胺类、多肽、磺胺类药剂、氨基糖甙类、大环内酯类、青霉素类、喹诺酮类、酰胺醇类(amphenicols)、林可酰胺类、安莎霉素类、硝基呋喃类、碳青霉烯类、头霉素类、单菌霉素类、酮内酯类、其盐、其衍生物及其混合物。
在尤其优选的实施方案中,所述抗感染剂为四环素类。本发明所用的四环素类的优选的、非限制性例子选自氯四环素(chlortetracycline)、氯莫环素(clomocycline)、去甲金霉素(demeclocycline)、demnocycline、多西霉素(doxycycline)、胍甲四环素(guamecycline)、赖甲环素(lymecycline)、氯甲烯土霉素(meclocycline)、甲烯土霉素(methacycline)、二甲胺四环素(minocycline)、土霉素(oxytetracycline)、penirnepicycline、羟哌四环素(pipacycline)、吡甲四环素(rolitetracycline)、sanicycline、senocicline、spicycline、四环素(tetracycline)、其盐、其衍生物及其混合物。在这点上特别优选地使用多西霉素、其盐或其衍生物。
在可选择的优选实施方案中,所述抗感染剂为头孢菌素。在这点上,使用的头孢菌素类的优选的、非限制性例子选自1-卡巴(dethia)头孢菌素(1-carba(dethia)cephalosporin)、头孢克洛(cefaclor)、cefactor、头孢羟氨苄(cefadroxil)、头孢孟多(cefamandole)、头孢曲秦(cefatrizine)、头孢西酮(cefazedone)、头孢唑啉(cefazolin)、头孢吡肟(cefepime)、头孢克肟(cefixime)、头孢甲肟(cefmenoxime)、头孢美唑(cefmetazole)、头孢地嗪(cefodizime)、头孢尼西(cefonicid)、头孢哌酮(cefoperazone)、头孢胺甲苯唑(ceforanide)、头孢噻肟(cefotaxime)、头孢替坦(cefotetan)、头孢替安(cefotiam)、头孢西丁(cefoxitin)、cefpirnizole、cefpirimide、头孢泊肟酯(cefpodoxime proxetil)、头孢丙烯(cefprozil)、头孢沙定(cefroxadine)、头孢磺啶(cefsulodin)、头孢他啶(ceftazidime)、头孢特仑新戊酰甲氧酯(cefteram)、头孢替唑(ceftezole)、头孢布坦(ceftibuten)、头孢唑肟(ceftizoxime)、头孢曲松(ceftriaxone)、头孢呋辛(cefuroxime)、头孢唑喃(cefuzonam)、头孢乙氰(cephacetrile)、头孢氨苄(cephalexin)、头孢来星(cephaloglycin)、头孢噻啶(cephaloridine)、头孢菌素(cephalosporin)、头孢噻酚(cephalothin)、头孢匹林(cephapirin),头孢拉定(cephradine)、loracabef、pivcefalexin,及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂为β-内酰胺。在这点上,使用的β-内酰胺类的优选的、非限制性例子选自亚胺培南(imipenem)、美洛培南(meropenem)、氨曲南(aztreonam)、克拉维酸(clavulanic acid)、舒巴坦(sulbactam)、他佐巴坦(tazobactam),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂为多肽。在这点上,使用的多肽类的优选的、非限制性例子选自安福霉素(amphomycin)、杆菌肽(bacitracin)、卷曲霉素(capreomycin)、粘菌素(colistin)、持久杀菌素(enduracidin)、恩维霉素(enviomycin)、夫沙芬净(fusafungine)、短杆菌肽(gramicidin)、短杆菌肽S(gramicidin S)、米卡霉素(mikamycin)、多粘菌素(polymyxin)、甲磺酸多粘菌素(polymyxin-methanesulfonic acid)、普那霉素(pristinamycin)、利托菌素(ristocetin)、替考拉宁(teicoplanin)、硫链丝菌素(thiostrepton)、结核放线菌素(tuberactinomycin)、短杆菌酪素(tyrocidine)、短杆菌素(tyrothricin)、万古霉素(vancomycin)、紫霉素(viomycin)、维吉尼霉素(virginiamycin)、杆菌肽锌(zinc bacitracin),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂为磺胺剂。在这点上,使用的磺胺剂的优选的、非限制性例子选自乙酰磺胺甲氧吡嗪(acetyl sulfamethoxypyrazine)、乙酰磺胺异噁唑(acetyl sulfisoxazole)、偶氮磺酰胺(azosulfamide)、苄磺胺(benzylsulfamide)、氯胺-β(chloramine-β)、氯胺-T(chloramine-T)、双氯胺T(dichloramine-T)、甲醛磺胺噻唑(formosulfathiazole)、N2-甲酰基-磺胺二甲异嘧啶(N2-formyl-sulfisomidine)、N4-β-D-葡萄糖基磺胺(N4-β-D-glucosylsulfanilamide)、磺胺米隆(mafenide)、4′-(甲基-氨磺酰基)对氨基苯磺酰苯胺(4′-(methyl-sulfamoyl)sufanilanilide)、对硝基磺胺噻唑(p-nitrosulfathiazole)、诺丙磺胺(noprylsulfamide)、酞磺醋胺(phthalylsulfacetamide)、酞磺胺噻唑(phthalylsulfathiazole)、柳氮磺嘧啶(salazosulfadimidine)、琥珀磺胺噻唑(succinylsulfathiazole)、苯酰磺胺(sulfabenzamide)、磺胺醋酰(sulfacetamide)、磺胺氯达嗪(sulfachlorpyridazine)、磺胺柯定(sulfachrysoidine)、磺胺西汀(sulfacytine)、磺胺嘧啶(sulfadiazine)、磺胺戊烯(sulfadicramide)、磺胺二甲氧嘧啶(sulfadimethoxine)、磺胺多辛(sulfadoxine)、磺胺乙二唑(sulfaethidole)、磺胺脒(sulfaguanidine)、磺胺二甲哑唑脒(sulfaguanol)、磺胺林(sulfalene)、磺胺洛西酸(sulfaloxic acid)、磺胺甲基嘧啶(sulfamerazine)、磺胺对甲氧嘧啶(sulfameter)、磺胺二甲基嘧啶(sulfainethazine)、磺胺甲噻二唑(sulfamethizole)、磺胺甲氧甲嘧啶(sulfamethomidine)、磺胺甲基异唑(sulfamethoxazole)、磺胺甲氧嗪(sulfamethoxypyridazine)、磺胺曲罗(sulfametrole)、磺胺米柯定(sulfamnidochrysoidine)、磺胺二甲噁唑(sulfamoxole)、磺胺(sulfanilamide)、磺胺甲磺酸三乙醇胺盐(sulfanilamidomethanesulfonicacid triethanolamine salt)、4-磺胺水杨酸(4-sulfanilamidosalicyclic acid)、N4-磺胺酰磺胺(N4-sulfanilylsulfanilamide)、磺胺酰脲(sulfanilylurea)、N-磺胺酰-3,4-丙谷胺(N-sulfanilyl-3,4-xylamide)、磺胺硝苯(sulfanitran)、磺胺异甲基嘧啶(sulfaperine)、磺胺苯吡唑(sulfaphenazole)、磺胺普罗林(sulfaproxyline)、磺胺吡嗪(sulfapyrazine)、磺胺吡啶(sulfapyridine)、磺胺异噻唑(sulfasomizole)、sulfasyrnazine、磺胺噻唑(sulfathiazole)、磺胺硫脲(sulfathiourea)、磺胺托拉米(sulfatolamide)、磺胺二甲异嘧啶(sulfisomidine)、磺胺异噁唑(sulfisoxazole)、醋氨苯砜(acedapsone)、醋地砜(acediasulfone)、磺胺苯砜(acetosulfone)、氨苯砜(dapsone)、地百里砜(diathymosulfone)、葡胺苯砜(glucosulfone)、苯丙砜(solasulfone)、琥珀氨苯砜(succisulfone)、对氨基苯磺酸(sulfanilic acid)、对氨苯磺酰苄氨(p-sulfanilylbenzylamine)、p,p′-磺酰二苯胺-N,N′-二半乳糖苷(p,p′-sulfonyldianiline-N,N′-digalactoside)、阿地砜(sulfoxone)、噻唑砜(thiazolsulfone),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是氨基糖甙。在这点上,所用的氨基糖甙类的优选的、非限制性例子选自阿米卡星(amikacin)、安普霉素(apramycin)、阿贝卡星(arbekacin)、bambeimycins、布替罗星(butirosin)、地贝卡星(dibekacin)、双氢链霉素(dihydrostreptomycin)、阿司米星(fortimicin)、新霉素(fradiomycin)、庆大霉素(gentamicin)、ispamicin、卡那霉素(kanamycin)、小诺霉素(micronomicin)、新霉素(neomycin)、奈替米星(netilmicin)、巴龙霉素(paromomycin)、核糖霉素(ribostamycin)、西索米星(sisomicin)、大观霉素(spectinomycin)、链霉素(streptomycin)、链霉素异烟肼(streptonicozid)、妥布霉素(tobramycin),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是大环内酯。在这点上,所用的大环内酯类的优选的、非限制性例子选自阿奇霉素(azithromycin)、卡波霉素(carbomycin)、克拉霉素(clarithromycin)、红霉素(erythromycin)、交沙霉素(josamycin)、柱晶白霉素(leucomycins)、麦迪霉素(midecamycins)、米卡霉素(miokamycin)、竹桃霉素(oleandomycin)、普利霉素(primycin)、雷帕霉素(rapamycin)、罗他霉素(rokitamycin)、罗沙米星(rosaramicin)、罗红霉素(roxithromycin)、螺旋霉素(spiramycin)、醋竹桃霉素(troleandomycin),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是青霉素。在这点上,所用的青霉素类的优选的、非限制性例子选自美西林(amidinocillin)、氮卓脒青霉素(amdinocillin)、pivoxil、阿莫西林(amoxicillin)、氨苄西林(ampicillan)、阿帕西林(apalcillin)、阿扑西林(aspoxicillin)、阿度西林(azidocillan)、阿洛西林(azlocillan)、巴氨西林(bacampicillin)、benzylpenicillic acid、苄青霉素(benzylpenicillin)、羧苄西林(carbenicillin)、卡非西林(carfecillin)、卡茚西林(carindacillin)、氯甲西林(clometocillin)、氯唑西林(cloxacillin)、环己西林(cyclacillin)、双氯西林(dicloxacillin)、联苯西林(diphenicillin)、依匹西林(epicillin)、芬贝西林(fenbenicillin)、floxicillin、海他西林(hetacillin)、仑氨西林(lenampicillin)、美坦西林(metampicillin)、甲氧西林(methicillin)、美洛西林(mezlocillin)、萘夫西林(nafcillin)、苯唑西林(oxacillin)、培那西林(penamecillin)、氢碘酸喷沙西林(penethamate hydriodide)、青霉素G(penicillin G)、青霉素N(penicillin N)、青霉素O(penicillin O)、青霉素V(penicillin V)、青哌环素(penimepicycline)、非奈西林(phenethicillin)、哌拉西林(piperacillin)、pivapicillin、丙匹西林(propicillin)、喹那西林(quinacillin)、suilbenicillin、酞氨西林(talampicillin)、替莫西林(temocillin)、替卡西林(ticarcillin),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是喹诺酮。在这点上,所用的喹诺酮类的优选的、非限制性例子选自氨氟沙星(amifloxacin)、西诺沙星(cinoxacin)、环丙沙星(ciprofloxacin)、二氟沙星(difloxacin)、依诺沙星(enoxacin)、氟罗沙星(fleroxacin)、氟甲喹(flumequine)、格帕沙星(grepafloxacin)、左氧氟沙星(levofloxacin)、洛美沙星(lomefloxacin)、米洛沙星(miloxacin)、萘啶酸(nalidixic acid)、诺氟沙星(norfloxacin)、氧氟沙星(ofloxacin)、噁喹酸(oxolinic acid)、培氟沙星(perfloxacin)、吡哌酸(pipemidic acid)、吡咯米酸(piromidicacid)、罗索沙星(rosoxacin)、司帕沙星(sparfloxacin)、tremafloxacin、曲伐沙星(trovafloxacin)、托氟沙星(tosufloxacin),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是酰胺醇。在这点上,所用的酰胺醇类的优选的、非限制性例子选自叠氮氯霉素(azidamfenicol)、氯霉素(chloramphenicol)、chloramphenicol palmirate、氯霉素泛酸酯(chloramphenicol pantothenate)、氟甲砜霉素(florfenicol)、甲砜霉素(thiamphenicol),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是林可酰胺。在这点上,所用的林可酰胺类的优选的、非限制性例子选自克林霉素(clindamycin)、林可霉素(lincomycin),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是安沙霉素(ansamycin)。在这点上,所用的安沙霉素类的优选的、非限制性例子选自利福米特(rifamide)、利福平(rifampin)、利福霉素(rifamycin)、利福昔明(rifaximin),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是硝基呋喃。在这点上,所用的硝基呋喃类的优选的、非限制性例子选自呋喃他酮(furaltadone)、呋唑氯胺(furazolium)、硝呋拉定(nifuradene)、硝呋太尔(nifuratel)、硝呋复林(nifurfoline)、硝呋吡醇(nifurpirinol)、硝呋拉嗪(nifurprazine)、硝呋妥因醇(nifurtoinol)、硝呋妥因(nitrofurantoin),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是头孢霉素。在这点上,所用的头霉素类的优选的、非限制性例子选自头孢拉宗(cefbuperazone)、头孢美唑(cefmetazole)、cefmninox、cefetan、头孢西丁(cefoxitin),及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是单菌霉素类。在这点上,所用的单菌霉素类的优选的、非限制性例子选自氨曲南(aztreonam)、卡芦莫南(carumonam)、tigemonan,及其盐类、衍生物及混合物。
在另一可选择的优选实施方案中,所述抗感染剂是酮内酯。在这点上,所用的酮内酯类的优选的、非限制性例子选自泰利霉素(telithromycin),及其盐类、衍生物及混合物。
在另一优选实施方案中,所述药理学活性剂是类固醇。在本发明所述软胶囊中使用的类固醇类的优选的、非限制性例子选自双丙酸阿氯米松(alclometasone dipropionate)、安西奈德(amcinonide)、双丙酸倍氯米松(beclomethasone dipropionate)、苯甲酸倍他米松(betamethasonebenzoate)、双丙酸倍他米松(betamethasone dipropionate)、戊酸倍他米松(betamethasone valerate)、布地奈德(budesonide)、丙酸氯倍他索(clobetasol propionate)、丁氯倍他松(clobetasone butyrate)、醋酸可的松(cortisone acetate)、地索奈德(desonide)、去羟米松(desoximetasone)、双醋二氟拉松(diflorasone diacetate)、双氟可龙戊酸酯(diflucortolonevalerate)、氟氯奈德(fluclorolone acetonide)、氟米松新戊酸酯(flumethasone pivalate)、氟轻松(fluocinolone acetonide)、醋酸氟轻松(fluocinonide)、丁酸氟可丁(fluocortin butyl)、氟可龙制剂(fluocortolonepreparations)、醋酸氟泊尼定(fluprednidene acetate)、氟氢缩松(flurandrenolide)、氟羟可舒松(flurandrenolone)、氟替卡松丙酸酯(fluticosone propionate)、哈西奈德(halcinonide)、卤倍他索丙酸酯(halobetasol propionate)、氢化可的松(hydrocortisone)、醋酸氢化可的松(hydrocortisone acetate)、丁酸氢化可的松(hydrocortisone butyrate)、丙酸氢化可的松(hydrocortisone propionate)、戊酸氢化可的松(hydrocortisone valerate)、醋酸甲基氢化泼尼松(methylprednisoloneacetate)、糠酸莫米松(mometasone furoate)、盐酸普莫卡因(pramoxinehydrochloride)、醋酸泼尼松(prednisone acetate)、戊酸泼尼松(prednisonevalerate)、曲安奈德(triamcinolone acetonide),及其盐类、衍生物及混合物。
在另一优选实施方案中,药理学上的活性成分是抗组胺剂。在本发明所述软胶囊中,使用的抗组胺剂的优选的、非限制性例子选自阿伐斯汀(acrivastine)、AHR 11325、安他唑啉(antazoline)、阿司咪唑(astemizole)、阿扎他啶(azatadine)、氮卓斯汀(azelastine)、溴苯海拉明(bromodiphenhydramine)、溴苯那敏(bromopheniramine)、卡比沙明(carbinoxamine)、西替利嗪(cetirizine)、氯苯那敏(chlorpheneramine)、氯马斯汀(clemastine)、赛庚啶(cyproheptadine)、脱溴非尼拉敏(debrompheniramine)、去羧乙氧基氯雷他定(descarboethoxyloratadine)、去甲基阿司咪唑(desmethylastemizole)、右氯苯那敏(dexchlorpheniramine)、茶苯海明(dimenhydramine)、苯海拉明(diphenhydramine)、二苯拉林(diphenylpyraline)、多西拉敏(doxylamine)、依巴斯汀(ebastine)、非索非那定(fexofenadine)、羟嗪(hydroxyzine)、酮替芬(ketotifen)、左卡巴斯汀(levocabastine)、洛度沙胺(lodoxamide)、氯雷他定(loratadine)、氯苯甲嗪(meclizine)、美喹他嗪(mequitazine)、甲地嗪(methdilazine)、去甲阿斯米唑(norastemizole)、奥沙米特(oxatomide)、苯茚胺(phenindamine)、非尼拉敏(pheniramine)、异丙嗪(promethazine)、伪麻黄碱(pseudoephedrine)、吡拉明(pyrilamine)、司他斯汀(setastine)、他齐茶碱(tazifylline)、替美斯汀(temelastine)、特非那定(terfenadine)、异丁嗪(trimeprazine)、曲吡那敏(tripelennamine)、曲普利啶(triprolidine),及其盐类、衍生物及混合物。
控制释放
在优选的实施方案中,本发明所述软胶囊提供了包含于其中的所述药理学活性剂的控制释放。如上所述,该控制释放可以由所述外层的特殊性质所实现。在可选择的实施方案中,可以通过用控制释放物质对所述活性成分进行包被来影响该控制释放。在这点上,所用的控制释放物质的非限制性例子包括合成的或天然的油、蜡、脂肪、树脂或其混合物。
本发明用于提供所述药理学活性剂的控制释放的,优选的药物可接受的油、蜡、脂肪或树脂包括但不限于微晶蜡、石蜡、巴西棕榈蜡、脂肪酸及其盐、甘油一酯盐和甘油二酯盐、甘油一酯的酯和甘油二酯的酯、琼脂、琼脂糖、褐藻胶、低级的甲氧基果胶、胶凝糖或叫结冷胶(gellans)、K-角叉菜胶、t-角叉菜胶、帚叉藻聚糖胶、β-角叉菜胶、凝胶多糖、壳聚糖、魔芋葡甘露聚糖(konjac glucomannan)及其包括热稳定的冷熔化的魔芋葡甘露聚糖的衍生物、纤维素衍生物、淀粉、和两种或多种上述物质的混合物,以及水胶体混合物,例如黄原胶/刺槐豆胶、刺槐豆胶琼脂(locust bean gumlagar)、肉桂/琼脂、肉桂/黄原胶、魔芋/黄原胶、角叉菜胶/刺槐豆胶、魔芋/角叉菜胶、魔芋/淀粉、其它适合的蜡、脂肪、或树脂及其混合物。
另一种产生本发明所述组合物中使用的控制释放的药理学活性剂的非限制性方法是通过首先加热液化所述基质材料,随后用剪切或混合操作分散所述活性剂来将该材料分散在基质内。当所述基质材料凝固或凝结时,所述活性剂保持分散在该基质材料内。
治疗方法
为了治疗哺乳动物的皮肤病学疾病或病症,优选地将本发明所提供的软凝胶胶囊或软明胶胶囊给药于哺乳动物。在优选的实施方案中,通过将所述软胶囊口服给予哺乳动物以有效地治疗皮肤病学疾病或病症来实施所述治疗方法。根据本发明所述方法,可治疗的优选的皮肤病学病症包括初次的和续发性皮肤感染。
在优选的实施方案中,进行治疗的所述哺乳动物是人类。在这点上,在特别优选的实施方案中,进行治疗的人类是5-20岁的儿童,优选为8-18岁的儿童,至少为55岁的人,或女性。
根据本发明所述方法可治疗数种特异性皮肤病学疾病或病症。这些皮肤病学疾病或病症的例子选自皮肤的细菌感染、皮炎、毛囊和皮脂腺的病症、真菌性皮肤感染、寄生虫性皮肤感染、瘙痒症、色素沉着过度疾病、色素减退疾病、细胞过度增殖疾病、鳞屑性丘疹疾病(scaling papular)及其组合。公知的可有效地通过本发明所述的任意药理学活性剂治疗的其他皮肤病学疾病或病症还也考虑利用本发明所述方法来治疗。
在特别优选的实施方案中,本发明所述方法治疗的皮肤病学病症是皮炎。可根据本发明所述方法治疗的优选的、非限制形式的皮炎包括接触性皮炎、过敏性接触皮炎、异位性皮炎、脂溢性皮炎、钱币状皮炎、手和足的慢性皮炎、泛发性表皮脱落性皮炎、停滞性皮炎、苔藓复合性皮炎,及其组合。
在另一特别优选的实施方案中,本发明所述方法治疗的皮肤病学病症是毛囊和皮脂腺病症。可根据本发明所述方法治疗的毛囊和皮脂腺病症的优选的、非限制性例子选自痤疮、红斑痤疮多毛症、脱发、须部假性毛囊炎、角质囊肿及其组合。
在另一可选择的特别优选的实施方案中,本发明所述方法治疗的皮肤病学病症是鳞屑性丘疹疾病。可根据本发明所述方法治疗的鳞屑性丘疹疾病的优选的、非限制性例子选自牛皮癣、玫瑰糠疹、扁平苔藓、毛发红糠疹及其组合。
可根据本发明治疗的特别优选的皮肤病学病症是皮炎、瘙痒症和痤疮。
本发明所述软胶囊可还用于治疗备选的疾病、病症或疾病状态、例如用于各种咳嗽和感冒。
联合治疗
在另一优选实施方案中,本发明所述软胶囊可与另外的药物剂型结合使用,以增强在皮肤病学疾病或病症治疗中的有效性。在这点上,本发明所述软胶囊可作为用药方案的一部分给药,该用药方案另外包括任何其它的本领域内公知的对治疗皮肤病学病症有效的药物和/或药物剂型。同样地,可将不同于本发明所指定的那些活性成分的活性成分加入本发明所述软胶囊中以增强其在治疗皮肤病学疾病或病症中的有效性。相应地,这种另外的活性成分或另外的药物剂型可与本发明所述的软胶囊一起直接或间接地,以及伴随地或顺序地用于患者。
在这点上,在一个实施方案中,可将本发明所述的软胶囊和另外的药物剂型同时给予患者。在另一实施方案中,可将本发明所述的软胶囊和另外的药物剂型中的一种在早晨给药并且可将另一种在晚上给药。
生产方法
可通过本领域内公知的用于制备软胶囊口服剂型的方法生产本发明所述的软胶囊,即当填充材料经过一对模具辊子时,将其包囊在两片明胶间,其中该模具辊子的表面模孔的形状使得到的软凝胶胶囊的形成希望的形状。
根据一种用于制备本发明所述软胶囊的方法,第一步是生产所述的内部液相。可用适当规格的混合、精制和均匀化设备及操作制备该内部液相,有时在真空下进行。将包括在所述的内部液相中的药理学活性剂的粒度以及该内部液相的粘度最优化,以顺利和精确的包囊。必须以避免产品间交叉污染的方式生产所述内部液相。
一旦已制备所述内部液相,下一处理步骤是制备胶囊基质或外层。因为其直接影响着所述软胶囊的形状、外形和缝合强度,所以此步骤是重要的。可根据本领域内通常公知的任何方法制备所述外层。
此方法的最关键步骤是将所述内部液相包囊进所述外层。一种优选的包囊方法是旋转模具法,其是连续的单一操作。优选在低湿度和精确调控的温度下,在单一的步骤中形成并填充所述软凝胶胶囊。
根据一种所考虑的旋转模具法,当熔化的凝胶泵入机器中并在该机器的任一侧形成细带状的凝胶时,所述包囊过程开始。随后这些带状物经过一系列的决定所述胶囊的大小和形状的滚子以及一系列的模具。然后将所述内部液相加料进正排量泵,该正排量泵精确地计量所述内部液相,并在通过应用热和压力将两条明胶带密封一起之前将其注入两条明胶带之间。由于在所述凝胶质内存在水,所以在此阶段形成的胶囊具有惊人的柔韧性。
包囊后,软凝胶胶囊通常经过干燥。可通过转筒式干燥、流化床干燥和托盘干燥,以及任何其它的本领域内公知的干燥操作的任意组合进行这种干燥。例如,所述胶囊可经过转筒式干燥机,在那里除去约25%的水。然后将该胶囊放置在托盘上,将该托盘叠加并转移至干燥室中,在那里使干燥的空气经过该胶囊,以除去任何过量的水分。每隔一定间隔测量所述水分。当将水分限制在约8%时,完成所述干燥处理,所述胶囊已为包装做好准备。P.Tyle,Specialized Drug DeliverySystems(专门的药物输送系统),Marcel Dekker,Inc.(1990);M.S.Patel等人,“Advances in Softgel Formulation Technology”(软凝胶胶囊制剂技术进展),Manufacturing Chemists,1989年七月;William R.Ebert,“Soft Elastic Gelatin Capsules:A Unique Dosage Form”(软弹性胶囊:独特的剂型),Pharmaceutical Technology,1977十月;H.Seager,“Softgelatin capsules:a solution to many tableting problems”(软胶囊:解决众多压片问题的方法),Pharmaceutical Technology,1985年九月;以及第4,067,960,4,198,391,4,744,988,4,780,316和5,200,191号美国专利提供了对此和其它用于制造软凝胶胶囊的方法的一般性讨论,在此将其全部内容引入作为参考。
在本发明所述范围内,还可预料到根据上述方法产生的药物组合物。如果根据此方法产生,这些组合物显示了适于口服给药的化学和物理稳定性。
剂量
本发明所预料到的药理学活性剂的适当剂量水平是本领域内普通技术人员所公知的。已知采用每公斤体重约0.001mg至约5000mg数量级的所述药理学或皮肤病学活性剂的剂量水平治疗本发明所关注的疾病、病症和疾病状态。典型地,所述药理学活性剂的有效量通常包括每天每公斤患者体重约0.1mg至约100mg的药理学活性剂。此外,应理解有效治疗剂的剂量可以单一的或多重的剂量单位形式给药,以提供所需要的治疗效果。
如果需要,可与上文提供的那些治疗剂联合使用其它治疗剂。可与所述载体材料结合以产生单一剂型的活性成分的量随治疗的患者、疾病、病症或疾病状态的性质以及所述活性成分的性质而改变。
本发明所述组合物可每天以单一或多重剂量给药。在优选的实施方案中,本发明所述组合物以每天一至三次给药。以每天两次低剂量开始,逐渐上升至倘若需要的更高剂量是优选的策略。可与所述载体材料结合以产生单一剂型的活性成分的量将随治疗的患者、疾病、病症或疾病状态的性质以及所述活性成分的性质而改变。
但是,应理解,用于任何特定患者的具体剂量水平依赖于本领域内公知的各种因素,包括所用的特异性化合物的活性;所述患者的年龄、体重、一般健康、性别和饮食;给药的时间;排泄速率;联合用药;所治疗的特异病症的严重性;以及给药方式。本领域普通技术人员应理解这样的因素的可变性,并能仅应用常规试验确定具体的剂量水平。
最佳的药物制剂由本领域技术人员根据诸如药物的特异性、或联合用药和所需剂量的考虑因素来确定。参见,例如,“Remington′sPharmaceutical Sciences(雷明顿制药学)”第18版(1990年,Mack出版公司,Easton,PA 18042)和“Harry′s Cosmeticology”第八版(2000年,化学出版有限公司,纽约,NY 10016),本文将其全部公开内容引入本发明中作为参考。这类制剂可影响所述治疗剂的物理状态、稳定性、体内释放速率和体内清除率。
实施例
以下实施例为本发明的示例性说明,不应理解为对本发明的限制。所有的聚合物分子量均是平均分子量。除非另有所指,所有的百分比均是基于最终输送系统或制备的制剂的重量百分比,以及总量等于100%重量比。
实施例1
以下实施例示例性地描述了本发明主题的优选的软胶囊的制备。
外相
明胶 168.0mg
甘油 52.0mg
山梨醇/脱水山梨醇 43.0mg
水 137.0mg
内相
聚乙二醇600 459.0mg
甘油 51.0mg
水 38.0mg
一水多西霉素 100.0mg
1.通过将所述聚乙二醇、甘油、水和一水多西霉素混合直至均质来制备内部的液相。
2.在单独的容器中,通过将所述明胶、甘油、山梨醇/脱水山梨醇和水混合直至形成均质的熔融凝胶来产生熔融的凝胶。
3.然后将该熔融的凝胶泵送经过旋转模具机器,在该机器的任一侧形成细的凝胶带。将这些带状物经过一系列的滚子和一组模具以制备椭圆形的胶囊形状。然后将所述内部液相加料至正排量泵,该正排量泵将该内部液相注入两条明胶带之间。随后该明胶带经过热和压力密封在一起。随后将这些胶囊干燥以从该外相中除去水分。
实施例2
以下实施例示例性地描述了本发明主题的另一软胶囊的制备:
%W/W
外相
明胶 38.5
甘油 20.7
AnidrisorbTM35/70 8.8
水
32.0
100.0%
*AnidrisorbTM是得自Roquette Freres所拥有的山梨醇、脱水山梨醇和甘露醇的混合物。
内相
盐酸多西环素 8.00
Labrosol 31.30
PlurolOleique CC497 13.26
LabrafacCC 39.00
水
8.44
100.0%
*Labrosol是所拥有的癸酰基己酰基聚乙二醇-8甘油酯,PlurolOleique CC497是所拥有的聚甘油-6 diolate,以及LabrafacCC是所拥有的中链甘油三酯,均得自Gattefoss Pharmaceuticaldivision(Gattefoss制药部门)。
1.通过将所述Labrosol、PlurolOleique CC497、LabrafacCC、水和盐酸多西环素混合直至均质来制备内部液相。
2.在单独的容器中,通过将所述明胶、甘油、AnidrisorbTM35/70和水混合直至形成均质的熔融凝胶来产生熔融的凝胶。
3.然后将该熔融的凝胶泵入经过旋转模具机器,在该机器的任一侧形成细的凝胶带。将这些带状物经过一系列的滚子和一组模具以制备椭圆形的胶囊形状。然后将所述内部液相加料至正排量泵,该正排量泵将该内部液相注入两条明胶带之间。随后该明胶带经过热和压力密封在一起。随后将这些胶囊干燥以从该外相中除去水分。
实施例3
患者患有皮炎。将本发明所述的软胶囊口服给予该患者。预期该患者改善了他/她的疾病状态或复原。
实施例4
患者患有痤疮。将本发明所述的软胶囊口服给予该患者。预期该患者改善了他/她的疾病状态或复原。
实施例5
患者患有瘙痒症。将本发明所述的软胶囊口服给予该患者。预期该患者改善了他/她的疾病状态或复原。
显而易见的是可以在许多方面修改或改变在此公开的本发明。这样的修改和该变不应视为偏离本发明的精神和范围,并且所有这些修改和变更都包括在所附权利要求范围之内。
Claims (25)
1.治疗哺乳动物的皮肤病学病症的方法,所述方法包括:
将提供药理学活性剂的改进的生物利用度的软胶囊对所述哺乳动物进行口服给药,所述软胶囊包括:
内部的、非水的液相,所述液相包含单一的、疏水的、对治疗所述皮肤病学病症有效的药理学活性剂的溶液或混悬液,所述药理学活性剂至少为90%的纯度并且降解产物的浓度小于所述疏水性药理学活性剂的起始浓度的约10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述皮肤病学病症;以及
外部的明胶层,所述明胶层包含明胶、软纤维素或其混合物以及另外的组分,所述另外的组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂及其混合物;
其中所述疏水性药理学活性剂选自抗感染剂、类固醇、其盐、其衍生物及其混合物。
2.如权利要求1所述的方法,其中所述药理学活性剂至少为95%的纯度。
3.如权利要求1所述的方法,其中所述的内部液相将降解产物的浓度维持在小于所述药理学活性剂的起始浓度的约7%。
4.如权利要求3所述的方法,其中所述的内部液相将降解产物的浓度维持在小于所述药理学活性剂的起始浓度的约5%。
5.如权利要求1所述的方法,其中与硬明胶胶囊相比,所述外层使得所述软胶囊更易吞咽。
6.如权利要求1所述的方法,其中所述哺乳动物为人类。
7.如权利要求6所述的方法,其中所述人类为5至20岁的儿童或55至90岁的或更年老的人。
8.如权利要求7所述的方法,其中所述儿童为8至18岁。
9.如权利要求6所述的方法,其中所述人类为女性。
10.如权利要求1所述的方法,其中所述外层提供了所述药理学活性剂的控制释放。
11.如权利要求1所述的方法,其中所述软胶囊改善了所述药理学活性剂的适口性。
12.如权利要求11所述的方法,其中所述改善的适口性导致对所述药理学活性剂的所述给药的改进的患者依从性。
13.如权利要求1所述的方法,其中向所述哺乳动物给药时,所述软胶囊减少了所述药理学活性剂的副作用的发生率。
14.如权利要求1所述的方法,其中当与水性介质结合时,所述的内部液相具有约3至约9的pH。
15.如权利要求1所述的方法,其中所述内部液相还包含一种或多种脂肪酸或其衍生物,所述脂肪酸或其衍生物选自脂肪酸、脂肪酸酯、脂肪酸醚、脂肪酸醇及其混合物。
16.如权利要求1所述的方法,其中所述内部液相还包含另外的成分,所述另外的成分选自花生油、氢化花生油、蓖麻油、氢化蓖麻油、玉米油、橄榄油、氢化植物油、硅油、大豆油、液体石蜡、鲸蜡醇、十六醇十八醇化合物、硬脂醇、硬脂酸、蜡、二氧化硅、聚乙二醇、甘油一酯、甘油二酯、甘油三酯、泊洛沙姆、硅酮油及其混合物。
17.如权利要求1所述的方法,其中所述皮肤病学病症选自初次的和续发性皮肤感染。
18.如权利要求1所述的方法,其中所述皮肤病学病症选自皮肤的细菌感染、皮炎、毛囊和皮脂腺的病症、真菌性皮肤感染、寄生虫性皮肤感染、瘙痒症、色素沉着过度疾病、色素减退疾病、细胞过度增殖病症、鳞屑性丘疹疾病及其组合。
19.如权利要求1所述的方法,其中所述抗感染剂为四环素或其盐或其衍生物。
20.如权利要求19所述的方法,其中所述四环素为多西霉素或其盐或其衍生物。
21.如权利要求1所述的方法,其中所述软胶囊与另外的对治疗所述皮肤病学病症有效的药物剂型伴随地或顺序地给药。
22.治疗哺乳动物的皮肤病学病症的方法,所述方法包括:
将提供药理学活性剂的改进的生物利用度的软胶囊对所述哺乳动物进行口服给药,所述软胶囊包括:
当与水性介质结合时具有pH约3至约9的内部的、非水的液相,所述液相包含单一的、疏水的、对治疗所述皮肤病学病症有效的药理学活性剂的溶液或混悬液和一种或多种脂肪酸或其衍生物,所述脂肪酸或其衍生物选自ω-3脂肪酸、DHA、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸、单不饱和脂肪酸、多不饱和脂肪酸、饱和脂肪酸、反式脂肪酸、其衍生物及其混合物,所述单一的药理学活性剂包含疏水性抗感染剂或其盐或其衍生物并具有至少90%的纯度以及降解产物的浓度小于所述疏水性抗生素的起始浓度的约10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述皮肤病学病症;以及
外部的明胶层,所述明胶层包含明胶及另外的组分,所述另外的组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂,及其混合物。
23.如权利要求22所述的方法,其中所述疏水性抗感染剂至少为95%的纯度。
24.如权利要求22所述的方法,其中所述的内部液相将降解产物的浓度维持在小于所述疏水性抗感染剂的起始浓度的约7%。
25.治疗哺乳动物的皮肤病学病症的方法,所述方法包括:
将提供多西霉素或其盐或其衍生物的改进的生物利用度的软胶囊对所述哺乳动物进行口服给药,所述软胶囊包括:
当与水性介质结合时具有pH约3至约9的内部的、非水的液相,所述液相包含作为对治疗所述皮肤病学病症有效的唯一活性成分的多西霉素或其盐或其衍生物的溶液或混悬液和一种或多种脂肪酸或其衍生物,所述脂肪酸或其衍生物选自ω-3脂肪酸、DHA、二十二碳五烯酸、二十四碳五烯酸、二十四碳六烯酸、单不饱和脂肪酸、多不饱和脂肪酸、饱和脂肪酸、反式脂肪酸、其衍生物及其混合物,所述多西霉素具有至少90%的纯度并且降解产物的浓度小于所述多西霉素的起始浓度的约10%,其中所述纯度和降解产物的浓度足以允许安全地治疗所述皮肤病学病症;以及
外部的明胶层,所述明胶层包含明胶及另外的组分,所述另外的组分选自另外的胶凝剂、增塑剂、水、着色剂、抗氧化剂、调味剂,及其混合物。
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