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Compound pioglitazone hydrochloride/metformin hydrochloride bilayer osmotic pump controlled release preparation and preparation method thereof

A technology of pioglitazone hydrochloride and metformin hydrochloride, which is applied in the field of medicine, can solve the problems of poor thermal stability of polyoxyethylene, poor thermoplasticity of polyoxyethylene, and affecting the release of controlled-release tablets, so as to reduce residual amount, optimize release, and reduce shear force Effect

Inactive Publication Date: 2011-04-13
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] Chinese patents CN1308520A, CN1681496A, CN1852703 and CN101222912A are the patents of Takeda Company on the compound preparation of pioglitazone hydrochloride / metformin hydrochloride. It is mentioned that "the preparation does not substantially have any gel or swelling polymer", which is different from the double-layer osmotic pump controlled release tablet prepared by the present invention
However, simply using high-molecular-weight polyoxyethylene as the main auxiliary material of the booster layer also has some inherent disadvantages: (1) high-molecular-weight polyoxyethylene has poor thermal stability. Polymers are prone to degradation and molecular weight decline, which affects the release of controlled-release tablets to a certain extent, causing greater changes in release and drug release kinetics; (2) high-molecular-weight polyoxyethylene has poor thermoplasticity and is prone to It leads to the phenomenon of "curling" in the process of tablet compression, which leads to weak points in the coating process, which affects the safety of product use

Method used

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  • Compound pioglitazone hydrochloride/metformin hydrochloride bilayer osmotic pump controlled release preparation and preparation method thereof
  • Compound pioglitazone hydrochloride/metformin hydrochloride bilayer osmotic pump controlled release preparation and preparation method thereof
  • Compound pioglitazone hydrochloride/metformin hydrochloride bilayer osmotic pump controlled release preparation and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] 1. Prescription

[0092] (1) Composition of drug-containing layer (for every 1000 tablets)

[0093] Name Dosage

[0094] Metformin Hydrochloride 500g

[0095] Polyoxyethylene (303) 40g

[0096] Povidone K30 10g

[0097] Sodium Lauryl Sulfate 8g

[0098] Magnesium Stearate 2g

[0099] (2) Booster layer composition (for every 1000 pieces)

[0100] Name Dosage

[0101] Polyoxyethylene 50g

[0102] Sodium Alginate 50g

[0103] Sodium chloride 50g

[0104] Povidone K30 20g

[0105] Iron Oxide Black 1g

[0106] Magnesium Stearate 1g

[0107] (3) Composition of isolation coat coating solution (for every 1000 tablets)

[0108] Name Dosage

[0109] Hypromellose (E5) 15g

[0110] Polyethylene glycol 5g

[0111] water 50ml

[0112] 95% ethanol 400ml

[0113] (4) Composition of coating solution for controlled release coating (for every 1000 tablets)

[0114] Name Dosage

[0115] Cellulose acetate 40g

[0116] Povidone K30 20g

[0117] Acetone 1000ml

[0118] ...

Embodiment 2

[0162] prescription:

[0163] (1) Composition of drug-containing layer (for every 1000 tablets)

[0164] Name Dosage

[0165] Metformin Hydrochloride 1000g

[0166] Polyoxyethylene (301) 60g

[0167] Sodium Lauryl Sulfate 16g

[0168] Povidone K30 20g

[0169] Magnesium Stearate 4g

[0170] (2) Booster layer composition (for every 1000 pieces)

[0171] Name Dosage

[0172] Polyoxyethylene 80g

[0173] Sodium Alginate 120g

[0174] Sodium chloride 100g

[0175] Povidone K30 46g

[0176] Iron Oxide Black 2g

[0177] Magnesium Stearate 2g

[0178] (3) Composition of isolation coat coating solution (for every 1000 tablets)

[0179] Name Dosage

[0180] Hypromellose (E5) 30g

[0181] Polyethylene glycol 10g

[0182] water 100ml

[0183] 95% ethanol 800ml

[0184] (4) Composition of coating solution for controlled release coating (for every 1000 tablets)

[0185] Name Dosage

[0186] Cellulose acetate 80g

[0187] Povidone K30 40g

[0188] Acetone 2000ml

[01...

Embodiment 3

[0206] prescription:

[0207] (1) Composition of drug-containing layer (dosage per 1000 tablets)

[0208] Name Dosage

[0209] Metformin Hydrochloride 750g

[0210] Polyoxyethylene (303) 50g

[0211] Povidone (K90) 25g

[0212] Sodium caprate 3g

[0213] Magnesium Stearate 2g

[0214] (2) Booster layer composition (for every 1000 pieces)

[0215] Name Dosage

[0216] Polyoxyethylene 50g

[0217] Sodium Alginate 80g

[0218] Sodium chloride 75g

[0219] Povidone (K90) 26g

[0220] Iron Oxide Black 2g

[0221] Magnesium Stearate 2g

[0222] (3) Composition of isolation coat coating solution (for every 1000 tablets)

[0223] Name Dosage

[0224] Hypromellose (E5) 20g

[0225] Polyethylene glycol 4g

[0226] water 75ml

[0227] 95% ethanol 600ml

[0228] (4) Composition of coating solution for controlled release coating (for every 1000 tablets)

[0229] Name Dosage

[0230] Cellulose acetate 60g

[0231] Povidone (K30) 25g

[0232] Acetone 1500ml

[0233] 95% ...

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Abstract

The invention provides a compound preparation of pioglitazone hydrochloride and metformin hydrochloride bilayer osmotic pump controlled release tablets. The compound preparation structurally comprises the following parts from inside to outside in sequence: a tablet core comprising a drug layer and a digestive layer, an insulation coating layer, a controlled release coating film with drug release holes, a rapid pioglitazone hydrochloride release layer and an unnecessary attractive coating. The invention also provides a preparation method of the compound preparation of pioglitazone hydrochloride and metformin hydrochloride bilayer osmotic pump controlled release tablets. The preparation method comprises the following steps of: (1) preparing the drug layer; (2) preparing the digestive layer; (3) tabletting the tablet core; (4) coating insulation coating layer; (5) coating the controlled release coating; (6) punching the coated tablet: (7) coating the rapid pioglitazone hydrochloride release layer; and (8) coating the attractive coating.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a compound pioglitazone hydrochloride / metformin hydrochloride double-layer osmotic pump controlled-release preparation and a preparation method thereof. Background technique [0002] Diabetes mellitus is a metabolic disease of multiple etiologies characterized by chronic hyperglycemia accompanied by disturbances in carbohydrate, fat and protein metabolism due to defects in insulin secretion and / or action. Diabetes is one of the most common chronic diseases. With the improvement of people's living standards, the aging population and the increase in the incidence of obesity, the incidence of diabetes is increasing year by year. According to the prediction of international authoritative diabetes epidemiology experts, by 2010, there will be 240 million people with diabetes in the world, and the number will increase to 300 million in 2025. [0003] Diabetes can be divided into type 1 diabetes...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K31/155A61K9/28A61P3/10
Inventor 甘勇高义才朱春柳吴立明曹瑞山
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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