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Drug composition containing sitagliptin and melbine

A technology for metformin and a composition is applied in the field of sustained-release preparations of sitagliptin and metformin, and achieves the effects of simple production process, consistent dissolution and good stability

Active Publication Date: 2018-02-09
HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no production and sales of propyl gallate pharmaceutical excipients in the domestic market

Method used

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  • Drug composition containing sitagliptin and melbine
  • Drug composition containing sitagliptin and melbine
  • Drug composition containing sitagliptin and melbine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1: the preparation of metformin sustained-release tablet core

[0041] prescription:

[0042]

[0043]

[0044] Preparation:

[0045] Weigh the prescription amount of internally added raw and auxiliary materials, wet granulate with ethyl cellulose ethanol solution, dry in a fluidized bed, and granulate with a granulator to obtain internally added granules; mix the internally added granules with the prescription amount of externally added auxiliary materials, and measure After the content of the intermediate, the tablet is compressed to obtain the metformin hydrochloride sustained-release tablet core.

Embodiment 2

[0047] Sitagliptin suspension prescription:

[0048] effect

Name of raw material

Dosage (g)

raw material

Sitagliptin phosphate monohydrate (calculated as phosphate):

64.25

porogenic material

Mannitol

51.40

Film forming material

Hydroxypropyl Cellulose EF

64.25

plasticizer

polyethylene glycol 4000

53.32

Antisticking agent

talcum powder

3.21

solvent

ethanol

1927.50

production

1000 pieces

[0049] Preparation method: Dissolve polyethylene glycol 4000 in ethanol (95% concentration), add hydroxypropyl cellulose EF and stir to dissolve, mannitol, talcum powder, and sitagliptin pass through a 100-mesh sieve, and then add the above solution in sequence to obtain Sitagliptin suspension coating solution.

[0050] Use a high-efficiency coating machine, control the coating parameters as fan frequency 1000kw, air inlet temperature 80°C, material temperature 30°C, adjust t...

Embodiment 3

[0053] Sitagliptin suspension prescription:

[0054] effect

[0055] The method of evenly wrapping the sitagliptin suspension on the metformin tablet core prepared by the method of Example 1 is to use a high-efficiency coating machine to control the coating parameters as fan frequency 1200kw, inlet air temperature 70°C, material temperature 40°C, other preparation methods were the same as in Example 2, and 5000 coated tablets containing sitagliptin and metformin sustained-release layers were prepared.

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PUM

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Abstract

The invention discloses a drug composition containing sitagliptin and melbine. A melbine sustained release tablet core is coated with sitagliptin in a mixed suspension mode. The invention also discloses composition of a sitagliptin suspension. By carefully selecting preparation prescriptions, antioxidants are not used in the prescriptions, a production process is simple, and meanwhile and the technical advantages of uniform preparation content, consistent dissolution, good stability and the like are also achieved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a slow-release preparation of sitagliptin and metformin. Background technique [0002] Sustained-release tablets of sitagliptin phosphate and metformin were developed by Merck & Co. of the United States and were approved by the FDA on February 2, 2012 for the treatment of type 2 diabetes patients to control their blood sugar balance. [0003] Sitagliptin phosphate was approved by the FDA in October 2006. It is the first gliptins drug approved by the FDA, that is, dipeptidyl peptidase IV inhibitors (DPP4 inhibitors), and it is currently occupying the market. The largest share of gliptins. Sitagliptin can be used alone or in combination with metformin and pioglitazone for the treatment of type 2 diabetes. Sitagliptin has a good curative effect, does not cause weight gain in patients, and has a small risk of hypoglycemia. It is an oral effective drug with a good market p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4985A61K9/36A61P3/10A61K31/155
CPCA61K9/209A61K9/2866A61K31/155A61K31/4985A61K2300/00
Inventor 卢良华马丽娜
Owner HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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