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Preparation of Oral Solid Dosage Forms Based on Homogenized Spot Melting Technique

International journal of pharmaceutics(2022)

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摘要
Given the benefits of high printing precision and capability, the selective laser sintering technique has been used to manufacture medicines and implants with unique engineering and functional properties. Using homogenized beams with a reduced thermal gradient and a larger diameter as an alternative energy source, the thermal stability and production efficiency of powder bed fusion would be improved. Herein, a novel homogenized spot melting (HSM) technology for pharmaceutical preparation was developed in this study. The melting behavior of typical pharmaceutical polymers under a homogenized spot was determined. A crystalline polymer with a low melting point was used as a solid binder, and the HSM printability and formation of drug-loaded formulations were explored. Oral solid dosage forms with different morphological and dissolution designs were prepared and evaluated under optimal formulation and process conditions. It was observed that HSM reduced the surface temperature distribution of the powder bed and improved the printability of drugs and excipients. Crystalline PEG 8000 with suitable flowability and heat conduction efficiency in the molten state was preferable for HSM printing. Incorporating 40% PEG 8000 as a solid binder was an effective strategy for HSM processing of unfused or unstable powders. Solid preparations with different structures and dissolution behaviors were successfully printed, suggesting that HSM is a promisingtechnique for personalized medicine.
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关键词
Homogenized spot melting,Temperature distribution,Melting properties,Solid binder,Printing mechanism,Oral solid dosage forms
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