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Pravastatin transdermal administration preparation and preparation method thereof

A technology for pravastatin and drug administration, which is applied in the field of transdermal drug delivery preparations containing pravastatin and its preparation, and can solve the problem of reducing drug penetration rate, limiting the migration rate of drugs and transdermal penetration enhancers, and drug storage. Low laminar fluidity and other problems, to achieve the effect of maintaining effective blood drug concentration, small side effects, and ensuring safety

Active Publication Date: 2010-10-13
HANGZHOU MINSHENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although it is also a reservoir-type transdermal drug delivery preparation, due to the low fluidity of the drug reservoir layer, the migration rate of the drug and the transdermal penetration enhancer is limited, thereby reducing the transdermal rate of the drug

Method used

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  • Pravastatin transdermal administration preparation and preparation method thereof
  • Pravastatin transdermal administration preparation and preparation method thereof
  • Pravastatin transdermal administration preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The transdermal preparation described in this example is a filled and closed transdermal preparation, which consists of a five-layer structure of a protective layer, an adhesive layer, a release-controlling film layer, a drug reservoir, and a backing layer. The materials used in each layer and the components are as follows:

[0047] Backing layer: composite aluminum foil

[0048] Protective layer: PTFE film

[0049] Controlled release film layer: polyacetate cellulose film

[0050] Adhesive layer:

[0051] Pravastatin: 5%

[0052] Silicone PSA: 85%

[0053] Azone: 5%

[0054] Propylene Glycol: 5%

[0055] Drug storage:

[0056] Pravastatin sodium: 10%

[0057] Polyvinylpyrrolidone K30: 30%

[0058] Azone: 5%

[0059] Propylene Glycol: 30%

[0060] Macrogol 400: 25%

[0061] Preparation of transdermal formulations

[0062] 1. Preparation of drug storage:

[0063] Take different proportions of Azone, propylene glycol and polyethylene glycol 400, stir to mix ...

Embodiment 2

[0069] The structure and composition of the transdermal preparation described in this example is the same as that in Example 1, consisting of five layers, and the materials and components used in each layer are as follows:

[0070] Backing layer: polyethylene film

[0071] Protective layer: polyester film

[0072] Controlled Release Membrane: Ethylene-vinyl acetate copolymer membrane

[0073] Adhesive layer: blank silicone pressure sensitive adhesive

[0074] Drug storage:

[0075] Pravastatin sodium: 20%

[0076] Carbomer: 10%

[0077] Macrogol 400: 25%

[0078] Azone: 5%

[0079] 95% ethanol: 20%

[0080] Tween 80 20%

[0081] Preparation of transdermal formulations

[0082] 1. Preparation of drug storage:

[0083] Take an appropriate amount of water to fully swell the carbomer. After the carbomer swells, add different proportions of Azone, 95% ethanol, Tween 80 and polyethylene glycol 400, dissolve and stir to fully disperse and dissolve, and then add Pravastatin...

Embodiment 3

[0088] The structural composition of the transdermal preparation described in this example is the same as in Example 1, consisting of five layers, and the materials and components used in each layer are as follows:

[0089] Backing layer: polyester film

[0090] Protective layer: Polypropylene film

[0091] Controlled Release Membrane: Polysiloxane Membrane

[0092] Adhesive layer: blank polyisobutylene pressure sensitive adhesive

[0093] Drug storage:

[0094] Pravastatin sodium: 5%

[0095] Cellulose acetate: 20%

[0096] Polyvinylpyrrolidone K30: 20%

[0097] Macrogol 400: 10%

[0098] Azone: 10%

[0099] 95% ethanol: 35%

[0100] Preparation of transdermal formulations

[0101] 1. Preparation of drug storage: Take different proportions of Azone, 95% ethanol, cellulose acetate and polyethylene glycol 400, stir to make them evenly mixed, and then add a certain amount of pravastatin sodium to the above mixed solution , Stir to fully disperse and dissolve, then add a ...

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Abstract

The invention relates to a pravastatin transdermal administration preparation and a preparation method thereof. In the invention, pravastatin or a pharmaceutically acceptable salt of the pravastatin serves as a medicament active ingredient, and the medicament active ingredient is a filling closed transdermal preparation which consists of a protective layer, an adhesive layer, a controlled-release membrane layer, a medicament reservoir and a backing layer; the medicament reservoir comprises 1 to 20 percent of pravastatin, and the balance of reservoir substrate; the adhesive layer comprises 0 to 10 percent of pravastatin, and the balance of pressure-sensitive adhesive; the reservoir substrate comprises 5 to 50 percent of transdermal enhancer, while the adhesive layer comprises 0 to 20 percent of transdermal enhancer; and the medicament release area of the preparation is 1 to 100 cm<2>. The pravastatin transdermal administration preparation is convenient to use and carry; the first pass effect of a liver and a gastrointestinal tract is avoided; and an in-vivo experiment of an animal proves that the preparation has no irritation or sensitization to skin. The pravastatin transdermal administration preparation can keep stable and persistent blood concentration, the continuous medicament releasing time is 1 to 7 days, so that the preparation provides the more convenient and safer treatment method for a patient.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a transdermal preparation containing pravastatin and a preparation method thereof. Background technique [0002] Pravastatin (pravastatin), molecular formula C 23 h 35 NaO 7 , molecular weight 446.52, pravastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-COA reductase), which is the rate-limiting enzyme in the initial stage of cholesterol biosynthesis enzyme. Because the open part of its chemical structure is very similar to HMG-CoA, it can inhibit the formation of cholesterol and reduce the content of cholesterol in cells. It is used to reduce total cholesterol, triglyceride, and high-density lipoprotein, and is suitable for hyperlipidemia and Familial hypercholesterolemia. It is clinically used to reduce total cholesterol and low-density lipoprotein in patients with type II hyperlipidemia. Pravastatin can selectively inhibit the biosynthesis ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/22A61P3/06
Inventor 王向军郭殿武叶妙华沈慈敏吴耀东张旭文高渊
Owner HANGZHOU MINSHENG PHARM CO LTD
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