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Development and evaluation of lafutidine solid dispersion via hot melt extrusion:Investigating drug-polymer miscibility with advanced characterisation

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Asian Journal of Pharmaceutical Sciences 2014年第2期9卷 92-106页

作者： Ritesh Fule Purnima Amin Department of Pharmaceutical Sciences and Technology Institute of Chemical TechnologyNathalal Parekh MargMatungaMumbai 400019MaharashtraIndia

In current study,immediate release solid dispersion(SD)formulation of antiulcer drug lafutidine(LAFT)was developed using hot melt extrusion(HME)*** Soluplusused as a primary solubilizing agent,with different concentrations of selected surfactants like PEG 400,Lutrol F127(LF127),Lutrol F68(LF68)were used to investigate their influence on formulations processing via *** amorphous glassy solid dispersion was found to be thermodynamically and physicochemically *** the contrary,traces of crystalline LAFT not observed in the extrudates according to differential scanning calorimetry(DSC),X-ray diffraction(XRD),scanning electron microscopy(SEM)and Raman *** micro spectrometry had the lowest detection limit of LAFT crystals compared with XRD and *** Force microscopy(AFM)studies revealed drugpolymer molecular miscibility and surface interaction at micro level.1HeCOSY NMR spectroscopy confirmed miscibility and interaction between LAFT and Soluplus,with chemical shift drifting and line *** simulation studies using computational modelling showed intermolecular interaction between *** rate and solubility of LAFT was enhanced remarkably in developed SD *** ratio of polymer and surfactants played crucial role in dissolution rate enhancement of LAFT *** obtained results suggested that developed LAFT has promising potential for oral delivery and might be an efficacious approach for enhancing the therapeutic potential of LAFT.

关键词： Lafutidine Solid dispersion hot melt extrusion Dissolution rate Raman spectroscopy Atomic force microscopy

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The rheological, mechanical and microstructural tools to guide the design of novel controlled-release cellulose matrices for felodipine via hot melt extrusion

The rheological, mechanical and microstructural tools to gui...

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2018年第十二届中国药物制剂大会

作者：伊珊 Jiandong Wang Yang Lu Subin Xiong College of Pharmaceutical Sciences Zhejiang University of Technology

HPMC is a widely used hydrophilic retarding-release polymer but with limited application in hot-melt extrusion(HME) due to its high glass transition temperature(Tg 191℃) and melt viscosity. The aim of this study is to design novel controlled-release HPC/HPMC matrices for poorly water-soluble felodipine(FLDP) via hot-melt extrusion(HME) by using the rheological, mechanical and microstructural characterization tools. Results indicated 30% maximum solubility of FLDP in the molten HPC/HPMC. FLDP, as a stronger plasticizer than HPC and their combining plasticization on HPMC, induced the smooth and regularly shaped extrudates loading up to 50% FLDP at 160℃ and torque of 0.1-0.5 N·m. The rheological behavior associated with the mechanic properties was presented by reduced Young’s and flexural modulus in HPC, and reduced Young’s modulus and increased flexural modulus in FLDP. The asymmetric microstructure of the FLDP/HPC/HPMCK15 M extrudates with the dense surface and loose interior were discovered under SEM. EDX, FT-IR and DSC confirmed the homogeneously molecular dispersion of FLDP, hydrogen bonding of FLDP with HPC/HPMCK15 M, and amorphous state with 30% preloaded FLDP. The hot-melt extruded FLDP/HPC/HPMC(10:45:45 and 30:35:35) matrices showed 24 h zero-order controlled release, low moisture absorption, and enhanced stability. These showed that FLDP/HPC/HPMC extruded matrices can be prepared without additional plasticizers. Both HPC and FLDP showed highly plastic efficiency to HPMC, resulted in regular shapes and homogeneous dispersion of FLDP in the HPC/HPMC matrices. The hydrogen bonding, asymmetric structure and mechanical strength achieved the zero-order controlled release profiles, low moisture absorption and stability of amorphous FLDP in the extruded matrices.

关键词： felodipine zero-order release amorphous solid dispersions hot melt extrusion hydroxypropylcellulose hypromellose

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Application of Kollidon? VA64 and Sodium Dodecyl Sulfate to Improve the Dissolution of Poorly Water-Soluble Felodipine by hot melt extrusion

Application of Kollidon? VA64 and Sodium Dodecyl Sulfate to ...

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2018年第十二届中国药物制剂大会

作者：陆杨 Subin Xiong College of Pharmaceutical Sciences Zhejiang University of Technology

The objective of this study was to explore sodium dodecyl sulfate（SDS） and VA64 on the crystallization inhibition and dissolution of felodipine（FLDP） extrudates. The rheological results indicated that suitable extrusion temperature of FLDP extrudates with VA64 and/or SDS were 140 ℃. FLDP extrudates were characterized by PLM, DSC and FT-IR. Results indicated that VA64 inhibited FLDP crystallization and the binary FLDP-VA64（1:1 and 1:3） and ternary FLDP/VA64/SDS（1:1:0.02～0.16 and 1:3:0.02～0.32） extrudates were all amorphous solid dispersions（ASDs）. Internal SDS（5%-20%） decreased Tgs of FLDP/VA64/SDS ternary ASDs. The enhanced dissolution rate of binary or ternary VA64-rich ASDs in the non-sink condition of 0.05%SDS was achieved. SDS enhanced the dissolution of VA64-rich ASDs via wettability and complexation with VA64 to accelerate the medium uptake and erosion kinetics of extrudates, but induced FLDP recrystallization and resulted in incomplete dissolution of FLDP-rich extrudates. Interestingly, when the ratio of FLDP/SDS was 1:0.08～0.12, the addition of SDS can significantly promote drug dissolution. To confirm the in vitro relevance of these molecular interaction mechanisms, we prepared two tablet formulations which internal or external added SDS, respectively, the ratio of FLDP/SDS was 1:0.1. The results show that SDS can promote the dissolution of FLDP when only SDS was internal added.

关键词： sodium dodecyl sulfate VA64 amorphous solid dispersions felodipine hot melt extrusion medium uptake erosion molecular interaction

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Development and Characterisation of Natamycin Mini-Matrices Prepared by hot-melt extrusion for Vaginal Delivery

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Journal of Materials Science and Chemical Engineering 2018年第3期6卷 47-54页

作者： Betül Rumeysa Temel Isik Ozgüney Department of Pharmaceutical Technology Faculty of PharmacyEge UniversityIzmirTurkey Department of Pharmaceutical Technology Faculty of PharmacyIzmir Katip Celebi UniversityIzmirTurkey

In this study, bioadhesive mini-matrices of natamycin were prepared for vaginal application by hot-melt extrusion. In addition, melt viscosity measurements, thermogravimetric analysis, in vitro drug release studies and in vitro mucoadhesion test were performed. High molecular weight grades of KlucelTM hydroxypropylcellulose were used as a thermoplastic polymer. TEC and PEG 400 were chosen as plasticizer. According to the obtained results of melt viscosity measurements, the maximum torque of extrudates prepared using PEG 400 increased with increasing drug loading. The thermo-gravimetric analyses showed that natamycin is stable up to 198℃ and this result gives the opportunity to hot melt extrussion process at 90℃. In vitro drug release results showed that the release was extended up to 72 hours and drug release rate increased with increasing drug loading. In respect to the in vitro mucoadhesion test results, the values of work of mucoadhesion were found high as 771,977 ***, 753,199 ***, 686,356 *** for the prepared hot melt extruded mini-matrices. Our results showed that the developed formulations were found worthy of further studies.

关键词： hot melt extrusion Natamycin Controlled Release Bioadhesive Vaginal Delivery

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