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DP-IV inhibitor drug composition

A technology of 1. DP-IV, composition, applied in the direction of drug combination, pharmaceutical formula, medical preparation of non-active ingredients, etc., can solve the problems of difficulty in localization, large fluctuation of sustained release, non-equivalence, etc.

Pending Publication Date: 2019-05-21
HENAN MEDICAL COLLEGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Ologliptin is a long-acting preparation, which is difficult to localize, and is prone to problems such as large fluctuations in sustained release, inequalities, and unstable preparations
The price of accessories is also a problem

Method used

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  • DP-IV inhibitor drug composition
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1: Compatibility of raw and auxiliary materials

[0018] Mix alogliptin with cornstarch and maltodextrin respectively, and examine their compatibility. Under the accelerated condition of 50°C / 75%RH, after 2 weeks, it is found that the content of total degradation impurities does not exceed 0.5%. Meet the pharmaceutical requirements.

Embodiment 2

[0019] Embodiment 2: prescription screening

[0020] Compress the material amount of 100 tablets as shown in the table below (each tablet contains 25mg of API):

[0021] Table 1 Prescription Screening

[0022]

[0023]

[0024] Preparation Process:

[0025] (1) Pass the above-mentioned excipients and API through 80 and 100 mesh sieves respectively, and set aside.

[0026] (2) Mix the API and all the excipients except magnesium stearate uniformly by equal addition method.

[0027] (3) continue to add magnesium stearate, fully mix.

[0028] (4) Press into plain tablets, investigate the disintegration time limit of the obtained samples, the results are shown in Table 2.

[0029] Table 2

[0030]

[0031] Obviously, the disintegration of formulation 1 is too slow, which is not conducive to dissolution.

Embodiment 3

[0032] Example 3: Prescription scaling up

[0033] Carry out scale-up research according to preparation 2, 3 prescription, each batch of each prescription is pressed 1000 tablets, and process is with reference to embodiment 2, the result finds:

[0034] Formulation 3 has poor fluidity, and the problem of compressibility is more obvious, and its friability is as high as 5%, while the friability of formulation 2 is only 8‰.

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Abstract

The invention provides a DP-IV inhibitor drug composition which comprises Omarigliptin and reducing sugar. According to the DP-IV inhibitor drug composition, the prejudice is overcome, an Omarigliptindomestic preparation is provided, the cost is low, the digestion is consistent with that of the original drug, and the stability is higher than that of the original drug.

Description

technical field [0001] The invention relates to a pharmaceutical composition of DP-IV inhibitor. Background technique [0002] Alogliptin is a novel dipeptidyl peptidase-IV (DP-IV) inhibitor that can be used to treat type 2 diabetes and even obesity and hypertension. [0003] Studies have found that alogliptin is more sensitive to acid and alkali, and is also prone to Maillard reaction. WO2015031228 clearly states in the description and claim 1 that for alogliptin, non-reducing sugar should be used as an auxiliary material. WO2015031228 also pointed out that CC-Na (croscarmellose Na salt) is an excipient with a high risk of degradation. After investigation, the original research preparation finally used neutral, non-reducing D-mannitol as auxiliary materials, and the original research also adopted a special preparation process. [0004] Ologliptin is a long-acting preparation, which is difficult to localize, and is prone to problems such as large fluctuations in sustained...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/36A61K31/4162A61P3/10A61P3/04A61P9/12
Inventor 李苏颖刘岩李倩
Owner HENAN MEDICAL COLLEGE
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