Determining method for drug loading in preparation process of solid dispersion

A technology of solid dispersion and determination method, which is applied in the field of biomedicine to achieve the effect of cost reduction

Pending Publication Date: 2019-10-25
聊城高新生物技术有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there is no tablet with the specification (200mg) corresponding to the US FDA on sale in the Chinese market, and the products on sale in the international market are prepared by hot-melt extrusion technology, so the development of 200mg tablet can improve the choice of clinical medication and fill the gap in the market

Method used

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  • Determining method for drug loading in preparation process of solid dispersion
  • Determining method for drug loading in preparation process of solid dispersion
  • Determining method for drug loading in preparation process of solid dispersion

Examples

Experimental program
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Effect test

preparation example Construction

[0034] Preparation of Itraconazole Solid Dispersion and Selection of Excipients

[0035] Test materials and equipment

[0036] Itraconazole (batch number: A-10511611011, Shouguang Fukang Pharmaceutical); hydroxypropyl methylcellulose (batch number: PD441808, Dow Chemical); propylene glycol (PG, Guangzhou Meiyi Biotechnology Co., Ltd.); hot melt extrusion machine (Hake Minilab, Thermo Fisher Co., Ltd.); thermogravimetric analyzer (Discovery TGA, Waters Corporation, USA); differential scanning calorimeter (Discovery DSC, Waters Corporation, USA); intelligent dissolution apparatus (Distek 7100, Xinghe Instrument Co., Ltd.); automatic sampler (Distek 4300, Xinghe Instrument Co., Ltd.); ultraviolet spectrophotometer (Distek S-3100, Xinghe Instrument Co., Ltd.); X-ray powder diffractometer (D8 Advance , American Bruker Dalton Company); other reagents were of analytical grade.

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Abstract

The invention provides a determining method for the drug loading in the preparation process of a solid dispersion. Phase transition peaks of different proportions of drug loading disperse phases within the temperature range serve as a criterion for the optimal drug loading in the preparation process of the solid dispersion by means of a differential scanning calorimetric method. When the phase transition phase is obviously changed with increase of the drug loading, it is shown that too much drugs cannot realize uniform solid dispersion with an accessory. Thus, when the phase transition peak appears, the drug loading proportion of the accessory at the corresponding temperature is optimal for the accessory combination. The method has the advantages that the drug loading can be known rapidlyand conveniently, and compared with a present method, the method is convenient, the test period is shortened, the frequency is greatly reduced, and the test cost and time can be reduced effectively.

Description

technical field [0001] The invention relates to a method for determining drug loading in a solid dispersion by using a phase transition peak, and belongs to the technical field of biomedicine. Background technique [0002] At present, about 70% of new drugs under research and 40% of marketed drugs belong to the biopharmaceutical classification system (BCS) class or In the preparation process, there are problems of water solubility, permeability and bioavailability that cannot meet the demand [1-2] . The properties of poorly soluble drugs determine the characteristics of difficult dissolution and low bioavailability of such substances in vivo and in vitro. Currently, pharmaceutical preparations often use technical means such as solvent method, nano-dispersion method, melting method, and hot-melt extrusion to dissolve them. Processing and forming a solid dispersion to ensure that such drugs can meet the requirements for dissolution and bioavailability. Hot-melt extrusion...

Claims

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Application Information

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IPC IPC(8): G01N33/15A61K9/14A61K31/496
CPCG01N33/15A61K9/14A61K31/496
Inventor 韩军高岩王正平
Owner 聊城高新生物技术有限公司
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