CN1658898B - 包含培哚普利的口腔分散药物组合物 - Google Patents
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Abstract
本发明涉及包含培哚普利的口腔分散固体药物组合物，其特征在于：其含有培哚普利或其可药用盐之一以及由共干燥的乳糖和淀粉组成的颗粒。
Description
本发明涉及用于经口服途径施用培哚普利或其可药用盐的固体口腔分散药物形式，其无需同时饮用一杯水也不存在吞咽问题。
培哚普利是抗高血压化合物，其尤其对某些酶如羧多肽酶(carboxypolypeptidase)、脑啡肽酶或激肽酶II具有抑制作用。它通过作用于转化酶而尤其抑制十肽血管紧张素I向八肽血管紧张素II(其在某些情况下引起高血压)的转化。
培哚普利及其可药用盐在治疗学中的用途使得降低或甚至抑制导致高血压疾病或心力衰竭的所述酶的活性成为可能。对激肽酶II的作用导致循环缓激肽增加，并因此导致动脉压下降。
目前，培哚普利的叔丁胺盐以需用半杯水吞服的片剂形式经口服途径施用。这些培哚普利片剂可用于治疗高血压和充血性心力衰竭。
目前所规定的培哚普利叔丁胺盐的剂量为每天1mg至8mg，为即释(immediate-release)片剂形式。
很多人如儿童和老年人在吞咽常规片剂时存在困难，因此其大小常常并非无关紧要。与药物摄入有关的问题(气哽；“进入错误管道”；由于喉部阻塞导致窒息)常造成对用药方案的依从性差或者甚至治疗中断。
本发明的药物组合物不仅使得解决必须吞咽的片剂形式的已知问题成为可能，而且可提供更优的医疗服务，特别可改善患者的生活质量。
培哚普利的口腔分散药物组合物具有如下优势：可迅速获得升高的活性成分血浆水平。
本发明的口腔分散药物组合物具有在其施用过程中既不需要水也无需咀嚼的独特特点。它在口中崩解非常迅速，优选在不到3分钟、甚至更优选在不到1分钟内崩解。
现有技术中描述了多种迅速溶出的药物形式。一般而言，以往所述技术的共同点在于它们使用崩解剂如
CL(交联聚乙烯吡咯烷酮)、(羧甲基淀粉)和AC
(交联羧甲基纤维素钠)。
对于口腔分散片制剂，崩解剂是必不可少的，且必须与直接压片赋形剂联合使用。在制备所述片剂中遇到的困难在于如下事实：要获得具有稳定、可重复且与片剂常规操作要求相适应的物理特性的片剂非常困难。
但是，通常使用的混合物使片剂的硬度非常大，完全不适于在口腔中迅速崩解。
其它口腔分散形式可以通过使用冷冻干燥法制备，得到非常疏松的固体形式，称为“口服冻干剂”。这些形式需要使用高度特异且复杂的生产方法，其操作耗时，得到的药物形式成本价格高昂。此外，利用冷冻干燥的制备方法需要将活性成分溶于水的步骤，其可引起活性成分分解。
本发明使这些问题得以解决。它涉及培哚普利的固体口腔分散形式，包含天然来源的单一赋形剂，使得可迅速崩解，并具有中性味道和适宜的构成。所述赋形剂既作为粘合剂又作为崩解剂发挥作用。它使得可获得简单的培哚普利制剂，在制备过程中无需使用水，极其适于直接压片，得到的片剂脆碎度低且硬度与常规操作方法相适应。
此外，所述赋形剂可获得体积非常小的片剂，可给予非常年幼的儿童。儿科片剂要求使施用更简单、在口中的崩解非常迅速，以确保儿童不会将片剂再次吐出，还要求片剂具有足够的硬度以易于操作和使用简单方法(泡罩包装、适合的单位剂量分样器)包装。
本发明的口腔分散形式使得制备体积非常小的儿科片剂(直径3mm，厚度1mm以上，重量10mg以上)成为可能，其易于操作并在几秒内于口中崩解。
更具体而言，本发明涉及培哚普利的固体口腔分散药物组合物，其特征在于：其包含：
-培哚普利或其可药用盐，和
-由共干燥的乳糖和淀粉组成的颗粒。
出于组合物制备的原因，本发明的组合物还可包含一种或多种常规使用的润滑剂和助流剂，以及矫味剂、着色剂和甜味剂。
在本发明的药物组合物中，培哚普利优选为叔丁胺盐形式。
本发明还涉及由共干燥的乳糖和淀粉组成的颗粒在制备培哚普利固体口腔分散药物组合物中的用途。
术语“口腔分散”应理解为意指在不到3分钟、优选不到1分钟内在口腔中崩解的固体药物组合物。
存在于本发明固体药物组合物中的所述颗粒相当于专利申请EP00/402159.8中所述的组合物。这些颗粒以球形结构和有利的可压性为特征，并以名称
销售。
所述颗粒对于置于大体积搅拌液体中的片剂的崩解性能是公知的。特别令人惊讶的是：当用于制备口腔分散形式时，所述颗粒在口中崩解方面应产生特别令人满意的结果，其原因有二。
第一个原因基于如下发现：水溶性最小的赋形剂最适于配制口腔分散片(溶出造成水的粘度增加，减慢了水向片剂中的渗透)，但是所述颗粒含有大量高度水溶性乳糖。此外，所述颗粒中含有的淀粉不是现有技术口腔分散形式中所使用和描述的“超级崩解”剂。
第二个原因基于如下发现：当用常规方法在水中进行测定时，不能将(片剂中所用的)赋形剂的崩解性能外推为相同片剂在唾液中的体内行为。在水中的崩解速度是(根据欧洲药典)在足够大量但对溶出而言不能达到饱和水平的水中进行测量的，而在体内，由于唾液的体积小，赋形剂处于饱和水平。此外，在常规试验中对片剂进行的搅拌不能反映在口中的崩解情况。因此，申请人在对比试验中发现：某些公知为良好崩解剂的赋形剂并不适合用于制备口腔分散形式。相反，某些在水中显示出平均崩解度的赋形剂可表现出有利的体内性能。
之后，申请人惊讶地发现：所述颗粒使得片剂非常适于在口中崩解，在很宽的片剂硬度范围内均如此，同时保持低水平的脆碎度，这是特别值得注意的。大部分现有技术中在口中迅速崩解的口腔分散形式均高度易碎，这反映在以下方面：需要使用特殊包装以及一旦进行操作并将其从包装中取出就存在崩解危险。
特别值得注意的是：可在宽片剂硬度范围内保持上述口腔分散性和低脆碎度标准，也就是说对于硬度为5至50牛顿(优选10至20牛顿)的片剂均可保持。
本发明药物组合物的特征优选在于：相对于片剂总重量，它们包含：
-以重量计0.1％至10％的培哚普利或其可药用盐，优选0.5％至6％，
-以重量计85％至99％的
它们可任选地包含以重量计0.1％至3％的润滑剂如硬脂酰富马酸钠或硬脂酸镁(优选0.5％至1.5％)、以重量计0.1％至3％的助流剂如胶态二氧化硅(优选0.5％至1.5％)以及以重量计0.1％至1％的甜味剂如阿司帕坦和/或乙酰舒泛(优选0.2％至0.5％)。
以下实施例用于阐述本发明，但不以任何方式限制本发明：
培哚普利口腔分散片
实施例1：
制剂：100mg制成片剂
实施例2：
制剂：200mg制成片剂
通过将各成分混合、然后直接压片制备片剂。实施例1和2的片剂的硬度为约20牛顿。
为测定在口中的崩解时间，将实施例1和2中所述的培哚普利口腔分散片置于口中。在这些试验中发现：对于所试验的每种制剂，在口中的崩解时间均小于1分钟。
实施例3：
制剂：10mg制成片剂
片剂的硬度为5至10牛顿。
实施例4：
制剂：20mg制成片剂
片剂的硬度为10至15牛顿。
实施例5：
制剂：20mg制成片剂
片剂的硬度为10至15牛顿。
实施例6：
制剂：20mg制成片剂
片剂的硬度为10至15牛顿。
实施例7：
制剂：20mg制成片剂(包含甜味剂)
片剂的硬度为10至15牛顿。
Claims (9)
1.培哚普利或其可药用盐的固体口腔分散药物组合物，其特征在于：相对于组合物总重量，其包含：
-以重量计0.1％至10％的培哚普利或其可药用盐，
-以重量计85％至99％的由共干燥的85∶15重量比的乳糖和淀粉组成的颗粒。
2.根据权利要求1的药物组合物，其特征在于：其包含以重量计0.5％至6％的培哚普利或其可药用盐。
3.根据权利要求1的药物组合物，其特征在于：其还包含一种或多种润滑剂、助流剂以及任选地甜味剂。
4.根据权利要求1的药物组合物，其特征在于：其为片剂形式。
5.根据权利要求4的片剂，其特征在于：其通过直接压片获得。
6.根据权利要求5的片剂，其特征在于：其硬度为5至50牛顿。
7.根据权利要求6的片剂，其特征在于：其硬度为10至20牛顿。
8.由共干燥的85∶15重量比的乳糖和淀粉组成的颗粒在制备培哚普利或其可药用盐的固体口腔分散组合物中的用途，该组合物在口中于不到3分钟内崩解。
9.根据权利要求8的用途，该组合物在口中于不到1分钟内崩解。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0200790 | 2002-01-23 | ||
| FR0200790A FR2834893B1 (fr) | 2002-01-23 | 2002-01-23 | Composition pharmaceutique orodispersible de perindopril |
| PCT/FR2003/000200 WO2003061691A1 (fr) | 2002-01-23 | 2003-01-22 | Composition pharmaceutique orodispersible de perindopril |
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| CN1658898A CN1658898A (zh) | 2005-08-24 |
| CN1658898B true CN1658898B (zh) | 2012-10-03 |
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| US (3) | US20050106237A1 (zh) |
| EP (1) | EP1467750B1 (zh) |
| JP (1) | JP4090997B2 (zh) |
| KR (1) | KR100588224B1 (zh) |
| CN (1) | CN1658898B (zh) |
| AR (1) | AR038305A1 (zh) |
| AT (1) | ATE332690T1 (zh) |
| AU (1) | AU2003215708B2 (zh) |
| BR (1) | BRPI0307048B1 (zh) |
| CA (1) | CA2473205C (zh) |
| CY (1) | CY1105655T1 (zh) |
| DE (1) | DE60306747T2 (zh) |
| DK (1) | DK1467750T3 (zh) |
| EA (1) | EA007181B1 (zh) |
| ES (1) | ES2268372T3 (zh) |
| FR (1) | FR2834893B1 (zh) |
| GE (1) | GEP20063821B (zh) |
| HK (1) | HK1076743A1 (zh) |
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| NO (1) | NO333723B1 (zh) |
| NZ (1) | NZ533821A (zh) |
| PL (1) | PL205473B1 (zh) |
| PT (1) | PT1467750E (zh) |
| UA (1) | UA78279C2 (zh) |
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| US20080234353A1 (en) * | 2004-03-24 | 2008-09-25 | Reynir Eyjolfsson | Formulations of Ramipril |
| DE102004019845A1 (de) * | 2004-03-29 | 2005-10-20 | Krka Tovarna Zdravil D D | Verfahren zur Herstellung einer festen pharmazeutischen Zusammensetzung |
| SK50252005A3 (sk) * | 2005-03-22 | 2006-10-05 | Vúlm, A.S. | Farmaceutický prípravok obsahujúci perindopril erbumín, spôsob jeho prípravy a stabilizácie |
| GB0518129D0 (en) * | 2005-09-06 | 2005-10-12 | Arrow Int Ltd | Ramipril formulation |
| US20070098782A1 (en) * | 2005-10-28 | 2007-05-03 | Selamine Limited | Ramipril Formulation |
| GB2431579A (en) * | 2005-10-28 | 2007-05-02 | Arrow Int Ltd | Ramipril formulations |
| GB0624084D0 (en) * | 2006-12-01 | 2007-01-10 | Selamine Ltd | Ramipril amino acid salts |
| GB0624087D0 (en) * | 2006-12-01 | 2007-01-10 | Selamine Ltd | Ramipril combination salt |
| GB0624090D0 (en) * | 2006-12-01 | 2007-01-10 | Selamine Ltd | Ramipril amine salts |
| DK2886108T4 (da) | 2013-12-23 | 2023-01-30 | Dr Falk Pharma Gmbh | Optimeret farmaceutisk formulering til behandling af inflammatoriske ændringer af øsofagus |
| EP3288556A4 (en) | 2015-04-29 | 2018-09-19 | Dexcel Pharma Technologies Ltd. | Orally disintegrating compositions |
| US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000078292A1 (fr) * | 1999-06-18 | 2000-12-28 | Takeda Chemical Industries, Ltd. | Preparations solides a desintegration rapide |
| WO2001083439A2 (fr) * | 2000-07-06 | 2001-11-08 | Les Laboratoires Serviers | NOUVELLE FORME CRISTALLINE η DU SEL DE TERT-BUTYLAMINE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3506276C1 (de) * | 1985-02-22 | 1986-04-24 | Meggle Milchindustrie Gmbh & Co Kg, 8094 Reitmehring | Direkttablettiermittel |
| CA2179382C (en) * | 1994-01-31 | 2009-11-10 | Takao Mizumoto | Intrabuccally dissolving compressed moldings and production process thereof |
| AU741992B2 (en) * | 1998-03-06 | 2001-12-13 | Adare Pharmaceuticals S.R.L. | Fast disintegrating tablets |
| ATE371439T1 (de) * | 2000-07-27 | 2007-09-15 | Roquette Freres | Granulat bestehend aus stärke und laktose |
| US6651768B2 (en) * | 2000-11-06 | 2003-11-25 | Bombardier Inc. | Snowmobile engine mount |
| FR2834889B1 (fr) * | 2002-01-18 | 2004-04-02 | Roquette Freres | Forme pharmaceutique solide orodispersible |
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2002
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000078292A1 (fr) * | 1999-06-18 | 2000-12-28 | Takeda Chemical Industries, Ltd. | Preparations solides a desintegration rapide |
| WO2001083439A2 (fr) * | 2000-07-06 | 2001-11-08 | Les Laboratoires Serviers | NOUVELLE FORME CRISTALLINE η DU SEL DE TERT-BUTYLAMINE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT |
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