Glipizide osmotic pump controlled release tablet

The technology of osmotic pump controlled release and glipizide is applied in the field of osmotic pump controlled release tablets and their preparation, and can solve the problem that the zero-order drug release characteristics of gel matrix sustained-release tablets are not obvious, the influence of drug stability, and the influence of drugs Release and other issues, to achieve the effect of easy coating control, good drug stability, and good controlled release

Active Publication Date: 2015-03-18
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese Invention Patent No. 200610114125.2 (Glipizide Controlled-release Tablets and Its Preparation Method) discloses a preparation method of Glipizide Controlled-release Tablets with a dose of 5 mg, using copolymer technology, which is the largest The characteristic is that the drug and the excipients form a copolymer, which has a certain solubilization effect on insoluble drugs. During the solubilization effect, some irrelevant impurities may also be produced, and industrialized large-scale production will also be difficult; at the same time, the drug is stored during storage. It will age in the medium, which will affect the release of the drug, and the stability of the drug will be greatly affected
[0005] In addition, Chinese invention patent application No. 038032864 (drug delivery system for sustained release of glipizide) discloses a gel matrix sustained-release tablet with carbomer as the drug release carrier. The zero-order release characteristics of sustained-release tablets ...

Method used

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  • Glipizide osmotic pump controlled release tablet
  • Glipizide osmotic pump controlled release tablet
  • Glipizide osmotic pump controlled release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] The prescription is as follows:

[0055] (1) Drug layer (per tablet):

[0056]

[0057] (2) Push layer (per piece):

[0058]

[0059] (3) Composition of semi-permeable membrane coating solution (for every 1000 tablets)

[0060] Cellulose acetate 70g

[0061] Diethyl phthalate 3.0g

[0062] Acetone: water (95:5) 2000m1

[0063] (4) Moisture-proof coating solution composition:

[0064] OPADRY II White(85668918) Appropriate amount

[0065] Preparation Process:

[0066] 1. Preparation of Drug-Layered Particles:

[0067] Mix the prescribed amount of glipizide, yellow iron oxide, sodium alginate and HPMC (K4M) uniformly by equal volume addition method, mix them in a mixer, add 75% ethanol after mixing uniformly to prepare a soft material, 20 mesh Sieve and granulate, dry at 50°C for more than 4 hours, measure moisture and drug content, then add magnesium stearate, and mix well.

[0068] 2. Preparation of push layer particles:

[0069] After passing through a 6...

Embodiment 2

[0078] (1) Drug layer (per tablet):

[0079]

[0080]

[0081] (2) Push layer (per piece):

[0082]

[0083] (3) Semi-permeable membrane coating

[0084]

[0085] The moisture-proof film coating and preparation process are the same as in Example 1.

Embodiment 3

[0087] (1) Drug layer (per tablet):

[0088]

[0089] (2) Push layer (per piece):

[0090]

[0091]

[0092] (3) Semi-permeable membrane coating

[0093] Ethylcellulose 45g

[0094] Polyethylene glycol (4000) 6g

[0095] Ethanol 1000ml

[0096] The moisture-proof film coating and preparation process are the same as in Example 1.

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Abstract

Disclosed is a glipizide osmotic pump controlled release tablet. The glipizide osmotic pump controlled release tablet comprises, from inside to outside, a double-layer tablet core containing a drug layer and a promoting layer and an insoluble semi-permeable membrane; the drug layer comprises drug release holes and an optional moisture-proof film coating; the drug layer, based on the total weight, contains 1-30 wt.% of glipizide, 30-95 wt.% of a suspending agent, 2-30 wt.% of a retardant, 0-10 wt.% of an adhesive, 0-2 wt.% of a colorant and 0-2 wt.% of a lubricant; the promoting layer, based on the total weight, comprises 30-80 wt.% of an expanding agent, 1-30 wt.% of a retardant, 0-2 wt.% of a colorant, 5-40 wt.% of an osmotic pressure active substance and 0-1 wt.% of a lubricant; and the weight gain of the semi-permeable membrane is 5-20% of the weight of the tablet core. The invention also discloses a preparation method of the glipizide osmotic pump controlled release tablets. The method is convenient for production, and the product is easy to store, and can better achieve the purpose of controlled release.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an osmotic pump controlled-release tablet containing the active drug glipizide and a preparation method thereof. The controlled-release tablet can make the drug enter the gastrointestinal tract at a constant rate, so that the drug with low solubility Glipizide is released at a constant rate. Background technique [0002] Glipizide (Glipizide, chemical name: 5-methyl-N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonphthalein]phenyl]ethyl]-pyrazinecarboxamide ), a second-generation sulfonylurea oral hypoglycemic drug, mainly used for the treatment of patients with mild to moderate non-insulin-dependent diabetes mellitus. In vivo and in vitro experiments have shown that the main mechanism of action of glipizide is to stimulate the β cells of the pancreas to secrete insulin, enhance the effect of insulin on the target tissue, and also stimulate the α cells of the pancreas ...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/64A61K47/36A61P3/10
Inventor 吴宗好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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