Controlled agglomeration

利用受控制的凝聚方法、即能够使颗粒大小受控制生长的方法制备颗粒物的方法。该方法特别适用于制备包含水溶性较低和/或易于化学分解的治疗性和/或预防性活性物质的药物组合物。该方法包含i)将包含载体的第一组合物喷在包含固体物质的第二组合物上，其中载体以液体形式存在于第一组合物中，熔点约为5℃或更高，而第二组合物的温度最高为对应于该载体和/或载体组合物熔点的温度，以及ii)利用混合或其它机械方法处理其上喷有第一组合物的第二组合物，从而获得颗粒物。 A process for the preparation of a particulate material by a controlled agglomeration method, i.e. a method that enables a controlled growth in particle size. The method is especially suitable for use in the preparation of pharmaceutical compositions containing a therapeutically and/or prophylactically active substance which has a relatively low aqueous solubility and/or which is subject to chemical decomposition. By employment of the novel process, compositions can be prepared that have improved properties with respect to release of the active substance from the composition as evidenced by in vitro dissolution test and/or with respect to improved shelf life of the compositions upon storage. The process comprising i) spraying a first composition comprising a carrier, which has a melting point of about 5 °C or more such as, e.g., about 10 °C or more, about 20°C or more or about 25 °C or more and which is present in the first composition in liquid form, on a second composition comprising a material in solid form, the second composition having a temperature of at the most a temperature corresponding to the melting point of the carrier and/or of the carrier composition such as, e.g., a temperature of at least about 2 °C, at least about 5 °C or at least about 10°C lower than the melting point of the carrier and/or of the carrier composition, and ii) mixing or other means of mechanical working the second composition onto which the first composition is sprayed to obtain the particulate material. The invention also relates to a particulate material obtained by the novel process and to pharmaceutical compositions containing such particulate material. The particulate material obtained exhibits excellent flowability and compactability and possess excellent tabletting properties.