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首页> 外文期刊>AAPS PharmSciTech >Preparation of Spherical Crystal Agglomerates of Naproxen Containing Disintegrant for Direct Tablet Making by Spherical Crystallization Technique
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Preparation of Spherical Crystal Agglomerates of Naproxen Containing Disintegrant for Direct Tablet Making by Spherical Crystallization Technique

机译：球形结晶技术制备含崩解剂萘普生球状结晶附聚物

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摘要

The purpose of this research was to obtain directly compressible agglomerates of naproxen containing disintegrant by spherical crystallization technique. Acetone–water containing hydroxypropyl celloluse (HPC) and disintegrant was used as the crystallization system. In this study croscarmellose sodium (Ac–Di–Sol) was employed as disintegrant. The agglomerates were characterized by differential scanning calorimetry (DSC), powder X-ray diffraction (XRPD), and scanning electron microscopy and were evaluated for flow, packing and tableting properties and drug release. The growth of particle size and the spherical form of the agglomerates resulted in formation of products with good flow and packing properties. The improved compaction properties of the agglomerated crystals were due to their fragmentation occurred during compression. DSC and XRPD studies showed that naproxen particles, crystallized in the presence of HPC and Ac–Di–Sol did not undergo structural modifications. The dissolution rate of naproxen from tablets made of naproxen–(Ac–Di–Sol) agglomerates was enhanced significantly because of including the disintegrant in to the particles. This was attributed to an increase in the surface area of the practically water insoluble drug is exposed to the dissolution medium. In conclusion the spherical crystallization technique developed in this study is suitable for obtaining agglomerates of drug with disintegrant.
机译：这项研究的目的是通过球形结晶技术获得含有崩解剂的萘普生可直接压缩的团块。含有羟丙基纤维素（HPC）和崩解剂的丙酮-水用作结晶体系。在这项研究中，交联羧甲基纤维素钠（Ac-Di-Sol）被用作崩解剂。通过差示扫描量热法（DSC），粉末X射线衍射（XRPD）和扫描电子显微镜对附聚物进行表征，并评估其流动性，包装和压片性质以及药物释放。附聚物的粒度和球形形式的增长导致形成具有良好流动性和堆积性质的产物。团聚晶体的改进的压实性能是由于在压缩过程中发生碎裂。 DSC和XRPD研究表明，在HPC和Ac-Di-Sol存在下结晶的萘普生颗粒没有进行结构修饰。由于萘普生-（Ac-Di-Sol）附聚物制成的片剂中萘普生的溶解速率得到显着提高，因为其中包括崩解剂。这归因于几乎不溶于水的药物暴露于溶解介质的表面积的增加。总之，本研究中开发的球形结晶技术适用于获得具有崩解剂的药物附聚物。

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