Medicine and Health Sciences Commons^™

Hot-Melt Extrusion Based Fused Deposition Modeling 3d Printing Of Atorvastatin Calcium Tablets: Impact Of Shape And Infill Density On Printability And Performance, Preethi Mandati

Electronic Theses and Dissertations

The main objective of the current research is to investigate the effect of shapes (heart and round shape tablets) and infill densities (50% and 100%) on drug release profiles of tablets prepared by hot melt extrusion (HME) coupled fused deposition modeling (FDM) technique. Two different commercial FDM 3D printers with different filament feeding mechanisms were evaluated for suitability of printing. Drug-loaded filaments of 1.5 mm and 2.5 mm diameters were extruded using Process 11 mm HME, using atorvastatin as a model drug and Kollicoat® IR, Kollidon® VA64, Kollidon®12PF, and Kolliphor® P407 as hydrophilic polymers. Filaments of Kollicoat® IR in combination …

Development Of Site - Specific Drug Delivery Systems Using Hot Melt Extrusion And Fused Deposition Modeling 3d Printing, Nagireddy Reddy Dumpa

Electronic Theses and Dissertations

Due to preferential site of drug absorption and the need for increased concentration of medication at the required tissues, dosage forms should be designed or formulated in such a way that medication is released at a specific site or after a specific time in the gastrointestinal tract (GIT). Knowledge of transit times of dosage forms in each part of GIT, by use of particular polymers or employing specific delivery systems such as floating systems, delivery of medication to specific sites in the GIT can be achieved. HME coupled FDM 3D printing has the capability to create customized dosage forms for …

Novel Application Of Melt Extrusion And Additive Manufacturing On Developing Diverse Dosages, Jiaxiang Zhang

Electronic Theses and Dissertations

New drug product development is a time consuming and costly process. One of the significant challenges is the poor aqueous solubility of many active pharmaceutical ingredients (APIs). Among those techniques, hot-melt extrusion(HME) is optimal for pharmaceutical solid dispersion development because of it free of using an organic solvent, easy scale up, and suitable for continuous processing with ensured optimal quality control.

Investigation Of Theophylline Nicotinamide Pharmaceutical Co-Crystals Utilizing Hot Melt Extrusion, Priyanka Srinivasan

Electronic Theses and Dissertations

The objective of the current study was to investigate the feasibility of Theophylline and Nicotinamide pharmaceutical co-crystals by hot melt extrusion technology and to evaluate the processability by using HPMCAS-MG and PEO as polymer carriers. Theophylline, a BCS class I was chosen as a model drug and Nicotinamide, a vitamin B family was selected as a suitable co-former for the co-crystals study. HPMCAS-MG, a synthetic polymer and PEO, water-soluble polymer were chosen as polymer carriers for the study. To optimize the process parameters and formulations, a physical mixture of 1:1 molar ratio of theophylline and nicotinamide were prepared. Physical mixture …

Patient Friendly Formulations Utilizing Hot Melt Extrusion Technology, Manjeet Bhagwan Pimparade

Electronic Theses and Dissertations

This research work exhibited the new outlook of hot melt extrusion technology for orally disintegrating tablet, fast disintegration films and fixed dose combinations. Previous research demonstrated these applications by conventional formulation techniques which has inherent shortcoming of use of large amount of solvent and batch size manufacturing. This present work addressed some of the unique challenges which could provide patients ease of administration and reduce dosing frequencies, and moreover, mitigate the manufacturing challenges. For orally disintegrating tablet study, ethylcellulose, along with a suitable plasticizer, was used as a polymeric carrier. Pore forming agents were incorporated into the extruded matrix to …

Evaluation And Enhancement Of Physical Stability Of Amorphous Solid Dispersions, Xin Feng

Electronic Theses and Dissertations

A major concern during formulation development has been to enhance the dissolution rate and bioavailability of poorly water-soluble drugs.[1],[2] The amorphous forms of APIs have attracted considerable attention as the amorphous forms tend to exhibit significantly higher levels of supersaturation in aqueous media when compared to the crystalline forms.[3],[4] For drugs which bioavailability is limited by aqueous solubility (biopharmaceutical classification system (BCS) class II drugs), which is a significant number of recently discovered drug candidates, the improved solubility may lead to enhanced bioavailability.[5-7] Oral absorption of APIs depends on two broad, but crucial, events, namely drug solubilization and gastrointestinal permeation.[8] …

Influence Of Hot Melt Extrusion Processing Parameters On The Properties Of A Pharmaceutical Formulation, Saad M. Alshahrani

Electronic Theses and Dissertations

Hot melt extrusion (HME) is an old technology that has been recently adapted to be used in the pharmaceutical industry. HME is a continuous process that is widely used to produce a solid dispersion matrix. The aim of this dissertation is to evaluate different factors that will affect the pharmaceutical formulation properties that are produced using HME. For HME, there are different variables that will affect the product quality such as processing parameters, material selection, material ratio, and the presence of gas or moisture. One aim of this study is to find the most significant factor that affects the product …

Solubility Enhancement And Precipitation Inhibition Of Poorly Water Soluble Compounds Utilizing Hot Melt Extrusion Technology, Jiannan Lu

Electronic Theses and Dissertations

Soluplus® (SOL), a graft amorphous copolymer, composed of polyethylene glycol, vinyl acetate and vinylcaprolactam in a ratio of 13: 30: 57, was utilized to prepare solid dispersions containing felodipine (FEL) or ketoconazole (KTZ) using hot-melt extrusion technology. The melting point depression approach was utilized to determine the miscibility and solubility of the model compounds within Soluplus® , of which felodipine demonstrated higher solubility when compared to ketoconazole (14% vs 4.3% w/w) at room temperature (298K). Moreover, the solubility parameters of FEL, KTZ and SOL were calculated as 21.76, 26.51 and 21.64, respectively.

Polarized light microscopy, Fourier transform infrared spectroscopy (FT-IR), …

Design And Development Of Drug Delivery Systems For Immediate And Sustained Release Utilizing Hot Melt Extrusion, Abhilasha Singh

Electronic Theses and Dissertations

Polymers have indispensable role in pharmaceutical formulation development. Polymer choice is a critical factor to obtain the desired drug-release profile during formulation development for HME (Hot melt extrusion). Many commercially available, pharmaceutical-grade polymers can be used in HME formulations. The suitable polymer choice facilitates processing in the extruder. When choosing a polymer to use in a formulation, processing conditions and processing attributes of the active pharmaceutical ingredients (APIs) should be considered. The physicochemical and the mechanisms of drug release from drug delivery systems prepared by utilizing HME with various polymeric carriers were investigated. Amorphous forms of API can have as …

Pharmaceutical Formulation Development Utilizing Hot Melt Extrusion And Other Techniques For Development Of Immediate And Controlled Release Dosage Forms, Noorullah Naqvi Mohammed

Electronic Theses and Dissertations

Hot melt extrusion (HME) was evaluated as a processing technology for the manufacture of immediate as well as controlled release formulations for oral delivery of two model compounds. For immediate release applications lower molecular weight grades of Hydroxypropyl cellulose polymers, EF and ELF, were utilized as carrier matrices to form solid solutions of a poorly soluble compound, Ketoprofen (KPR). Thermal characterization techniques were used to confirm thermal stability, miscibility and setting up processing conditions for extrusion. Extruded matrices were pelletized to be filled into pellets or further milled and compressed into tablets. Pellets exhibited a carrier dependent release with ELF …