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Controlled release complex formulation for oral administration of medicine for diabetes and method for the preparation thereof

An anti-diabetic and preparation technology, applied in the field of oral controlled-release combination preparations, can solve problems such as reducing the effective concentration of drugs

Inactive Publication Date: 2007-12-26
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this combined preparation has a problem of reduced drug effective concentration due to the formation of drug derivatives: cyanoguanidine derivatives of metformin and sulfonamide derivatives of glimepiride

Method used

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  • Controlled release complex formulation for oral administration of medicine for diabetes and method for the preparation thereof
  • Controlled release complex formulation for oral administration of medicine for diabetes and method for the preparation thereof
  • Controlled release complex formulation for oral administration of medicine for diabetes and method for the preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] 500g of metformin·HCl (Hwail Pharm.Co., Ltd), 80g of polyethylene oxide (Polyox  WSR Agglutinant, molecular weight 5,000,000, Union Carbide) and 100 g of xanthan gum (Cpkelco) were each filtered through a No. 30 mesh and mixed together. The mixture was placed in a high-speed mixer (SPG-2, Fujipaudal), and 20 g of polyvinylpyrrolidone (Kollidon  A binder solution composed of K-90, BASF) was added to the mixer, followed by mixing at a speed of 100-1,000 rpm to obtain granules. The granules were dried and filtered through a No. 30 mesh. Among them, 200g of polyvinyl acetate / polyvinylpyrrolidone mixture (Kollidon SR, BASF), 80g of wax (Compritol  888ATO, Gattefosse) and 10 g of silica were added to the granules and mixed for 30 minutes. Finally, 10 g of magnesium stearate powder were added to the mixture, mixed for 3 minutes, and compressed to obtain tablets with the composition of Table 1.

[0067] Table 1

[0068]

Embodiment 2 to 5

[0070] Tablets with the compositions listed in Tables 2 to 5 were prepared by repeating the procedure of Example 1, except that xanthan gum (Cpkelco) was used in the mixture part or polyethylene oxides with different molecular weights were used. Additionally, in these examples, the polyvinylpyrrolidone binder was also partially excluded from particle formation.

[0071] Table 2: Tablet composition of Example 2

[0072]

components

content

(weight%)

particle formation

part

Metformin·HCl

50

polyethylene oxide

(Polyox  WSR, molecular weight 5,000,000)

5

Mixture Department

Minute

Polyvinyl acetate / polyvinylpyrrolidone blend

20

the wax

13

xanthan gum

10

silica

1

Magnesium stearate

1

total

100

[0073] Table 3: Tablet Composition of Example 3

[0074]

components

...

Embodiment 6

[0080] Tablets having the compositions shown in Table 6 were prepared by repeating the procedure of 1 except that no binder-polyvinylpyrrolidone (Kollidon(R) K-90, BASF) binder was used in the granule forming step.

[0081] Table 6

[0082]

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PUM

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Abstract

A controlled release combination formulation for oral administration comprising a) a controlled release portion containing metformin or a pharmaceutically acceptable salt thereof as an active ingredient, and a combination of a polyethylene oxide and a natural gum as a carrier for controlled release; and b) a rapid-release portion containing a sulfonylurea- based medicine for treating diabetes as an active ingredient coated on the controlled release portion is useful for the treatment of diabetes, for it is capable of maintaining an effective concentration of the medicines in blood at a constant level.

Description

technical field [0001] The present invention relates to an oral controlled release combination formulation of two drugs for diabetes and a process for its preparation. Background technique [0002] Metformin is an oral medication designed to help control elevated blood sugar levels in patients by activating glucose receptors in the liver. In diabetic patients, it induces weight loss, lowers blood-triglyceride and low-density lipoprotein (LDL) levels, and increases high-density lipoprotein (HDL). Therefore, it can be used as a first-line drug for non-insulin-dependent diabetes mellitus (NIDDM). [0003] Metformin hydrochloride in tablet form currently sold as GLUCOPHAGE  (Bristol-myers Squibb Company), and its daily dosage is determined based on both potency and tolerability, while not exceeding the maximum recommended dosage of 2,550 mg / day. Side effects of metformin are loss of appetite, bloating, nausea, and diarrhea, along with occasional rashes or hives. These side ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22
CPCA61K31/155A61K9/209A61K31/64A61K45/06A61P43/00A61P3/10A61K2300/00A61K9/20A61K47/34A61K31/55
Inventor 禹钟守李鸿基池文爀金永勋
Owner HANMI PHARMA