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Method for evaluating in-vivo and in-vitro correlation of glipizide tablets

A glipizide tablet and a related technology, applied in the field of drug pharmacy, can solve the problems of large resource cost and time cost, difficulty in body absorption, influence on drug absorption and dissolution, etc., and achieve the effect of reducing failure rate and cost

Inactive Publication Date: 2022-02-25
则正(上海)生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Glipizide is a hypoglycemic drug used to treat patients with mild and moderate type II diabetes who are not satisfied with the curative effect of diet control and physical exercise for 2-3 months. The pharmacokinetic characteristics of glipizide are as follows: Absorbed through the small intestine, it takes 30 minutes to take effect, and maintains hypoglycemia for more than 10 hours. However, glipizide is a typical BCSII drug with high permeability and low solubility. Absorption is difficult, resulting in low bioavailability, which is not conducive to the clinical therapeutic effect of Glipizide Tablets. Therefore, it is of great significance to study the dissolution rate of Glipizide Tablets to improve bioavailability
[0003] Since the in vitro release characteristics of the drug will affect the in vivo absorption and dissolution of the drug, and ultimately affect the therapeutic effect and in vivo bioavailability of the drug, the in vivo and in vitro correlation evaluation method has been developed to predict the pharmacokinetic characteristics through the in vitro data of the drug, but The existing evaluation methods cannot evaluate the in vivo and in vitro correlation of glipizide tablets very well. In addition, clinical trials need to consume a lot of resource and time costs, and also have high risks. Therefore, it is necessary to establish a reliable in vivo and in vitro correlation. Correlation evaluation method to ensure drug consistency is critical for pharmaceutical organizations

Method used

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  • Method for evaluating in-vivo and in-vitro correlation of glipizide tablets
  • Method for evaluating in-vivo and in-vitro correlation of glipizide tablets
  • Method for evaluating in-vivo and in-vitro correlation of glipizide tablets

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Embodiment 1

[0036] Embodiment 1, the technological process of a kind of glipizide tablet in the present embodiment comprises the following steps:

[0037] (1) Premixing: Put the prescribed amount of glipizide, microcrystalline cellulose, and lactose into a mixer for mixing, and stir for 5 minutes to obtain a mixed powder.

[0038] (2) Granulation: 1 / 2 of the prescription amount of povidone K30 was configured into a 10% aqueous solution, and the binder was put into the mixer for 30 seconds, continued to run for 30 seconds, and sheared at a low speed for 1 minute to obtain good quality particles.

[0039] (3) Grain sizing: the sizing is carried out by a mobile sizing machine, the sieve aperture is 4mm×4mm, and the rotating speed is 1500rpm.

[0040] (4) Fluidized bed drying: Place the medicine particles on the orifice plate, and the gas is delivered from the lower part, so that the medicine particles move on the gas distribution plate, and the medicine particles are dried. The temperature o...

Embodiment 2

[0043] Example 2, the manufacturing process of glipizide tablets in this example is the same as that of Example 1, the main difference is that the amount of adhesive used in the formulation is different, and the content of the adhesive in Example 1 is 1.50% w / w. 2 Binder content is 3.00% w / w.

Embodiment 3

[0044] Example 3, the manufacturing process of glipizide tablets in this example is different from Example 1 in two places, specifically the granulation step and the mixing step.

[0045] The granulation process in embodiment 3 is to configure the povidone K30 of prescription quantity into 10% aqueous solution, put binder into the mixer, use time 30s, low-speed shear 1min, obtain the granule of good quality; In embodiment 3 The mixing process is to manually mix the dried granules with sodium starch glycolate and magnesium stearate for 3 minutes.

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Abstract

The invention discloses a method for evaluating in-vivo and in-vitro correlation of glipizide tablets, relates to the technical field of pharmaceuticals, and aims to improve in-vivo solubility and dissolution speed of the glipizide tablets, improve bioavailability and ensure consistency of the tablets. According to the method for evaluating the in-vivo and in-vitro correlation of the glipizide tablets, research is mainly carried out according to auxiliary material components in the glipizide tablets, dissolution experiments are carried out in vitro through different adding modes and adding doses of an adhesive and a disintegrating agent, and the corresponding physical characteristics and dissolution curves of the glipizide tablets are obtained, so that the proper in-vivo and in-vitro correlation (In Vitro-In Vivo Correlation) is established, according to the method, the in-vivo absorption degree of the glipizide tablet is better predicted, the failure rate of a subsequent bioequivalence experiment is reduced, and the research and development cost and time are saved.

Description

technical field [0001] The invention relates to the technical field of drug pharmacy, and mainly relates to a method for evaluating the correlation between inside and outside of glipizide tablets. Background technique [0002] Glipizide is a hypoglycemic drug used to treat patients with mild and moderate type II diabetes who are not satisfied with the curative effect of diet control and physical exercise for 2-3 months. The pharmacokinetic characteristics of glipizide are as follows: Absorbed through the small intestine, it takes 30 minutes to take effect, and maintains hypoglycemia for more than 10 hours. However, glipizide is a typical BCSII drug with high permeability and low solubility. Absorption is difficult, resulting in the problem of low bioavailability, which is not conducive to the clinical treatment effect of glipizide tablets. Therefore, it is of great significance to study the dissolution rate of glipizide tablets to improve bioavailability. [0003] Since the...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/32A61K47/36A61K31/64A61P3/10
CPCA61K9/2095A61K9/2027A61K9/2059A61K31/64A61P3/10
Inventor 贺敦伟秦杰子闫敏
Owner 则正(上海)生物科技有限公司