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Nitroglycerin high-flux transdermal drug delivery system

A technology of transdermal drug delivery system and nitroglycerin, applied in the field of transdermal drug delivery system, can solve problems such as not being accepted by patients

Pending Publication Date: 2021-05-18
江苏集萃新型药物制剂技术研究所有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to obtain the required daily dose greater than 40 mg, multiple existing systems must be used simultaneously, or a system with a significantly increased area of ​​administration must be developed, neither of which is well received by patients

Method used

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  • Nitroglycerin high-flux transdermal drug delivery system
  • Nitroglycerin high-flux transdermal drug delivery system
  • Nitroglycerin high-flux transdermal drug delivery system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The NG / ethanol depot composition comprises a medical grade silicone oil matrix gelled with silica, NG homogeneously dispersed on lactose, and ethanol adsorbed on a particulate carrier. 5 kg of medical silicone oil with a viscosity of about 100 centistokes and 175 grams of colloidal silicon dioxide were put into a high-energy mixer to form a gel-like silicone oil. 200 grams of porous polypropylene was poured into a separate container and approximately 600 grams of USP ethanol (95% ethanol) was added with stirring to produce a substantially dry flowable powder, which was visually observed to absorb substantially all of the ethanol . 5 kg of nitroglycerin-lactose (10 wt% nitroglycerin) and porous polypropylene loaded with ethanol were put into the above high energy mixer and mixed until a homogeneous blend was obtained. The formed NG-ethanol gel was filled using a form-fill-seal machine into a reservoir between an impermeable backing and a controlled-release membrane load...

Embodiment 2

[0023] A transdermal therapeutic system was manufactured according to the process of Example 1, except that ethanol was adsorbed on 200 g of silicon dioxide. The release rate is substantially the same as that of Example 1.

Embodiment 3

[0025] Similar to the system described in Example 1, the difference is that EVA (18% VA) film is used instead of EVA (12% VA) film, per cm 2 loaded with 5 mg of nitroglycerin and per cm 2 Load 20 mg of 70% ethanol. The system starts with figure 2 A similar behavior is shown in releasing nitroglycerin, except that they have about 80% higher flux.

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Abstract

The invention relates to a transdermal drug delivery system for treating angina pectoris and congestive heart failure by controlling the transdermal delivery of nitroglycerin at a transdermal rate of at least 40 [mu] g / cm<2> / hr, preferably higher, and belongs to the technical field of pharmaceutical preparations. A nitroglycerin high-flux transdermal drug delivery system capable of delivering the nitroglycerin on intact human skin at a rate of up to 40 [mu] g / cm<2> / hr or more, and preferably in the range of 50-150 [mu] g / cm <2> / hr. In addition, ethanol is delivered as a penetration enhancer for the nitroglycerin at a rate of 250-500 [mu] g / cm <2> / hr. A controlled release film formed from an ethylene vinyl acetate material controls the delivery rate of a drug and a penetration enhancer, and the content of the vinyl acetate in the material is greater than 11%, preferably between 12% and 18%. The system is suitable for treating angina pectoris and congestive heart failure.

Description

technical field [0001] The present invention relates to a transdermal drug delivery system controlled at least 40 μg / cm 2 / hr, preferably a higher transdermal rate, for the transdermal delivery of nitroglycerin for the treatment of angina pectoris and congestive heart failure, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Nitroglycerin (NG) has long been recognized as a vasodilator for the treatment of angina and congestive heart failure. NG initially studied oral or oral administration, and more recently transdermal administration. NG transdermal drug delivery can be applied to the skin by gel or ointment, such as Nitrobid® ointment, the NG transdermal drug delivery system, at about 0.5 to 0.625 mg / cm 2 / 24 hrs average rate of delivery of NG into the body, equivalent to about 20 to 26 μg / cm 2 / hr. Another system, Deponit, already approved in Europe, uses approximately 15 μg / cm 2 / hr rate to deliver NG. [0003] Alth...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K47/32A61K47/04A61K47/34A61K31/21A61K31/045A61P9/04A61P9/10
CPCA61K9/7023A61K31/045A61K31/21A61K47/02A61K47/32A61K47/34A61P9/04A61P9/10A61K2300/00
Inventor 全丹毅
Owner 江苏集萃新型药物制剂技术研究所有限公司
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