首页> 外国专利> Pellet, useful to prepare pharmaceutical preparations and administer therapeutically and/or prophylactically active substances e.g. antirheumatic-, antidiabetic- or antiallergic- drug, comprises a water-soluble carrier e.g. mannitol

Pellet, useful to prepare pharmaceutical preparations and administer therapeutically and/or prophylactically active substances e.g. antirheumatic-, antidiabetic- or antiallergic- drug, comprises a water-soluble carrier e.g. mannitol

机译:颗粒,用于制备药物制剂和施用治疗和/或预防活性物质,例如抗风湿药,抗糖尿病药或抗过敏药包括水溶性载体,例如甘露醇

摘要

Pellet (A) (with length-width-ratio of less than 1.4) comprises a water-soluble carrier, where (A) disintegrates under visually detectable loss of pellet structure into smaller fragments in a test carried out by: adding a pellet with demineralized water into a petri dish; subsequently fixing the petri dish directly on the measuring cylinder of a stampf volumeter; and subsequently the pellets are directly photographed. Pellet (A) (with length-width-ratio of less than 1.4) comprises a water-soluble carrier, where (A) disintegrates under visually detectable loss of pellet structure into smaller fragments in a test carried out by: (a) adding a pellet (200-800 mg) with demineralized water (0.5 ml) to a petri dish; (b) subsequently fixing the petri dish directly on the measuring cylinder of a stampf volumeter; (c) after 10 seconds, 30 stampf pitching is carried out; and (d) subsequently the pellets are directly photographed. Independent claims are also included for: (1) a pellet product (B), where at least 90% of it is similar to (A); (2) a pellet product comprising a majority of pellets, which comprise a core containing a water-soluble carrier and where at least 90% of the pellets show a length-width-ratio of less than about 1.4, where the decay time of the pellet product measured in a decay tester with sieve base amounts to less than 1:30 minutes; (3) a pellet product comprising majority of pellets, where the pellet core contains the water-soluble carrier and where 90% of the pellets show a length-width-ratio of less than about 1.4, where the pellet product in a sensory test is classified into 0 (that is equal to no foreign body feeling), 1 (that is equal to pulpy and soft), 2 (that is equal to sandy), 3 (that is equal to granular), where the second classification forms the majority after estimation at 5 seconds in at least 10 test persons; (4) the preparations of (A) and (B); (5) a pharmaceutical pellet (C) comprising (A) as a core and one or more layers of core, which contains at least an active agent; and a pharmaceutical pellet product comprising (C).
机译:粒料(A)(长宽比小于1.4)包含水溶性载体,其中(A)在视觉上可检测到的粒料结构损失下崩解成较小的碎片,该测试通过以下方式进行:通过添加脱矿物质的粒料将水倒入培养皿中;随后将培养皿直接固定在stampf定量器的量筒上;然后直接拍摄颗粒。粒料(A)(长宽比小于1.4)包含水溶性载体,其中(A)在视觉上可检测到的粒料结构损失下分解成较小的碎片,该试验通过以下方式进行:(a)加入用去离子水(0.5 ml)将沉淀(200-800 mg)沉淀到培养皿中; (b)随后将皮氏培养皿直接固定在stampf定量器的量筒上; (c)在10秒后,进行30次击打; (d)随后直接将颗粒照相。还包括以下方面的独立权利要求:(1)颗粒产品(B),其中至少90%与(A)类似; (2)包含多数丸粒的丸粒产品,其丸粒包含含有水溶性载体的核芯,其中至少90%的丸粒的长宽比小于约1.4,其中在具有筛底的衰变测试仪中测量的颗粒产物少于1:30分钟; (3)包含大部分丸粒的丸粒产品,其中丸粒芯包含水溶性载体,其中90%的丸粒的长宽比小于约1.4,其中感官测试中的丸粒产品为分为0(等于没有异物感),1(等于浆状和柔软),2(等于沙质),3(等于粒状),其中第二个分类占多数在至少10位测试人员的5秒估算后; (4)(A)和(B)的制剂; (5)一种药物丸剂(C),其包含(A)作为芯和一层或多层芯,其至少包含活性剂;以及包含(C)的药物颗粒产品。

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