The goal of the current investigation was to formulate, evaluate co-crystal, and further design of solid unit dosage form of antihyperlipidemic BCS class II drug fenofibrate (FNO). Co-crystals composed of a structurally homogeneous crystalline material that contains two or more components in a definite stoichiometric amount helps in increasing yield, the capability to regulator polymorph fabrication, enhanced invention crystallinity. Ball milling method is used for co-crystal formulation, optimized via 32 full factorial design and characterized by saturation solubility, particle size analysis, Fourier transform infrared spectroscopy (FT-IR) study analysis, powder X-ray diffraction (PXRD) study analysis, surface morphology by scanning electron microscopy (SEM) study, flow properties, and ex vivo intestinal permeation study via non-everted rat intestinal sac model. Furthermore, optimized batch compressed into tablets is evaluated for disintegration time, hardness, friability, in vitro drug release study and stability study. It demonstrated that co-crystal formulation FNOCC7 shows higher saturation solubility 0.3874 ± 2.82 g/ml with less particle size 221.231 ± 0.456 nm, FT-IR spectra confirmed significant structural alterations in the formulation indicating the hetero-molecular interaction, the presence of hydrogen bonding had occurred in the co-crystals, PXRD spectra of formulation determined by the increase in the crystalline nature. FNO co-crystals show flux (F) and permeability coefficient (Papp) 0.322 ± 0.068 μg/min, 5.38 ± 0.093 cm/min respectively increased compared to the pure drug makes in an enhancement of solubility as well as the bioavailability of BCS class II drug. The solubility and dissolution percentage of FNO can be improved by the utilization of Co-crystal of FNO with PEG 4000. The solubilization impact of PEG 4000 might be contributed because of the decrease of molecule conglomeration of the drug presence of crystallinity, expanded wettability, and dispersibility; pharmaceutical co-crystals speak to a beneficial class of crystal form with regard of pharmaceuticals.

中文翻译：

---

非诺贝特的颗粒工程用于先进的药物输送系统

当前研究的目的是配制，评估共晶体，以及进一步设计抗高血脂BCS II类非诺贝特（FNO）固体单位剂型。由结构上均一的晶体材料组成的共晶体，以一定的化学计量量包含两种或多种组分，有助于提高产量，调节多晶型物制造的能力，提高发明的结晶度。球磨法用于共晶配方，通过32个全因子设计进行了优化，并具有饱和溶解度，粒度分析，傅立叶变换红外光谱（FT-IR）研究分析，粉末X射线衍射（PXRD）研究分析，通过扫描电子显微镜（SEM）研究表面形态，流动特性，和非体外大鼠肠囊模型进行离体肠渗透研究。此外，评估了压制成片剂的优化批料的崩解时间，硬度，易碎性，体外药物释放研究和稳定性研究。结果表明，共晶配方FNOCC7的饱和溶解度较高，为0.3874±2.82 g / ml，而粒径较小，为221.231±0.456 nm，FT-IR光谱证实了配方中的重大结构变化，表明存在异分子相互作用，存在氢键在共晶体中已经发生了，配方的PXRD光谱由晶体性质的增加确定。FNO共晶体的通量（F）和磁导率（Papp）为0.322±0.068μg/ min，5.38±0。与纯药物相比，分别增加了093 cm / min，从而提高了BCS II类药物的溶解度和生物利用度。通过与PEG 4000一起使用FNO的共晶体，可以提高FNO的溶解度和溶解度。PEG 4000的增溶作用可能是由于降低了药物结晶度，扩大的润湿性和分散性 药物共晶体在药物方面是有益的晶体形式。PEG 4000的增溶作用可能是由于药物结晶性，扩展的润湿性和分散性的分子团聚减少所致；药物共晶体在药物方面是有益的晶体形式。PEG 4000的增溶作用可能是由于药物结晶性，扩展的润湿性和分散性的分子团聚减少所致；药物共晶体在药物方面是有益的晶体形式。