摘要:
A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
摘要:
A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
摘要:
A controlled release dosage form comprising: (i) a tablet core comprising a pharmaceutically active ingredient and one or more pharmaceutically acceptable matrix forming polymers, (ii) a substantially insoluble casing extended over the tablet core covering between 25 to 99% of the surface area of the tablet core, like for example covering only the major surfaces like in FIG. 1 or on major surface and the sidewells like in FIG. 2, the casing resulting from electrostatic deposition of a powder comprising fusible particles onto the tablet core and fusing the particles to form a thin film such that the said electrostatic coated tablet releases the active ingredient with a release profile of active ingredient for 0 to at least 50% by weight release of active ingredient defined by the equations y=k*tn in which y is the fraction of active ingredient released, k is the kinetic constant, t is time, n is the release exponent and n is the range 0.70 to 1.0 i.e. an approximately zero order release profile.
摘要翻译:控制释放剂型,其包含:(i)片芯,其包含药物活性成分和一种或多种药学上可接受的形成基质的聚合物,(ii)在所述片芯上延伸的基本不溶性外壳,覆盖所述表面积的25至99% 片状芯,例如仅覆盖如图1所示的主表面。 1或在主表面和侧壁上,如图1所示。 2,由将可熔颗粒的粉末静电沉积到片芯上并将该颗粒融合以形成薄膜的外壳,使得所述静电包衣片剂以活性成分的释放曲线将活性成分释放至0至少至少 50重量%的由式y = k * t 定义的活性成分的释放,其中y是释放的活性成分的分数,k是动力学常数,t是时间,n是释放 指数,n是0.70到1.0的范围,即约为零阶释放曲线。
摘要:
A fast disintegrating tablet comprising an active ingredient and one or more disintegrants characterised in that the tablet comprises agglomerates having an agglomerated particle size of at least 50 μm, said agglomerates comprising at least 10% by weight of a superdisintegrant selected from croscarmellose cellulose, crospovidone and sodium starch glycollate and being free of active ingredient.
摘要:
A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
摘要:
A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.
摘要:
A fast dissolving and taste masked sildenafil solid dosage form comprising: (i) sildenafil granules which granules comprise at least 45% by weight of a salt of sildenafil, a solubilisation inhibitor for said salt of sildenafil and optionally a sweetening agent and (ii) one or more disintegrants wherein the disintegrants or combination of disintegrants are present in the form of agglomerates having an average agglomerated particle size of at least 50 μm, said agglomerates comprising at least 10% by weight of disintegrant.
摘要:
A pharmaceutical dosage form comprising: a) a tablet core comprising a pharmaceutically active ingredient and one or more pharmaceutically active ingredient and one or more pharmaceutically acceptable adjuvants, the tablet core having a tensile strength of less than 38 N/cm2 before coating and fusion and b) a coating extending over at least 25% of the surface area of the tablet core, the coating resulting from deposition of a powder comprising fusible particles and fusing the particles to form a coating film, thereby providing the pharmaceutical dosage form with a greater hardness/crush strength than the tablet core. The tablet core may be formed by light compression with enables coated components and fragile components, such as capsules, to be used within the compression blend with little or no damage.
摘要:
A sustained release ranolazine formulation contains an intimate mixture of ranolazine and a partially neutralized pH-dependent binder to form a film that is mostly insoluble in aqueous media below pH 4.5 and soluble in aqueous media above pH 4.5. The formulation is suitable for twice daily administration of ranolazine and is useful for controlling the rate of dissolution of ranolazine, and to maintain human plasma ranolazine levels at between 550 and 7500 ng base/mL.