Linagliptin composition and preparation method thereof

A technology of linagliptin and wet granulation, which is applied in the field of linagliptin pharmaceutical composition and its preparation, can solve the problems of bitter taste of the drug, inconvenient taking of the patient, and reduced compliance of taking the drug, so as to achieve rapid disintegration, fast dissolving effect

Inactive Publication Date: 2015-05-27
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, clinically, for some patients, especially children, the elderly, or other patients with dysphagia, tablets greatly reduce the patient's compliance with medication
In addition, because the tablet does not contain correctives, and the medicine has a bitter taste, it also causes a lot of inconvenience for patients to take

Method used

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  • Linagliptin composition and preparation method thereof
  • Linagliptin composition and preparation method thereof
  • Linagliptin composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Table 1

[0038]

[0039] Preparation Process:

[0040] 1. Linagliptin, lactose, and crospovidone are mixed in a wet granulation pot,

[0041] 2. Dissolve and disperse povidone and aspartame into 95% ethanol solution, add to granulation pot for granulation to prepare granules,

[0042] 3. Dry the granules obtained in step "2", granulate,

[0043] 4. Mix the particles with silica,

[0044] 5. Fill the mixed material into the bag.

[0045] The granules prepared in Examples 1 and 2, and the original research tablet were tested for dissolution curves. The detection method was: dissolution medium volume: 1000ml, dissolution medium was hydrochloric acid solution of pH 1.0, rotating speed was 50rpm, paddle method. The dissolution profile results are shown in Table 2.

[0046] Table 2

[0047]

Embodiment 2

[0049] table 3

[0050]

[0051] Preparation Process:

[0052] 1. Mix linagliptin, mannitol, lactose, crospovidone, menthol, magnesium stearate,

[0053] 2. The mixed material is rolled and pressed by a dry granulator to obtain a tablet.

[0054] 3. Pulverize the flakes obtained in step "2" to obtain granules,

[0055] 4. Add silicon dioxide and mix it.

[0056] 5. Fill the mixed material into the bag.

[0057] For the preparation prepared in Examples 3 and 4, the detection of the dissolution curve is carried out, and the detection method is: the volume of the dissolution medium:

[0058] 1000ml, the dissolution medium is hydrochloric acid solution with pH 1.0, the rotation speed is 50rpm, paddle method.

[0059] Table 4

[0060]

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Abstract

The invention discloses linagliptin particles and a preparation method thereof. Linagliptin is used for treating type 2 diebetes. At present, only linagliptin tablets are sold on the market. Aiming at dysphagia patients, compared with the above two dosage forms, the linagliptin particles have obvious advantages and can improve drug compliance of patients.

Description

technical field [0001] The invention relates to a linagliptin pharmaceutical composition and a preparation method thereof. Background technique [0002] Diabetes is not an unfamiliar disease in human history. There is a description in ancient books thousands of years ago that "every time you urinate when you are thirsty, it will be sweet". However, the ancients had no effective treatment for diabetes until the first application of insulin in 1922. A breakthrough has been made in the treatment of diabetes. [0003] In the decades after insulin application. Drugs for diabetes have exploded and there are oral drugs for type 2 diabetes. This frees patients with partial β-cell function from the pain of insulin injections. These include sulfonylureas (eg, gliquidone) and glinides (eg, repaglinide), which stimulate insulin secretion, biguanides, which reduce glycogen output, and alpha-glucosidases, which delay carbohydrate absorption inhibitors and thiazolidinediones that incr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/522A61K47/10A61K47/18A61K47/22A61P3/10
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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