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Glipizide osmotic pump type controlled release tablet

A technology of glipizide and osmotic pumps, which is applied in medical preparations of non-active ingredients, pill delivery, metabolic diseases, etc., can solve the problems of increased residual drug release at the end, decreased release rate, and decreased membrane weight loss, etc. Achieve the effects of less drug release residue, lower deformability requirements, and lower process costs

Active Publication Date: 2011-08-17
北京天衡药物研究院南阳天衡制药厂
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0005] Our research found that the commercially available glipizide controlled-release tablets Ruiyining were placed under the conditions of 40°C, 60°C, RH75%, and RH92.5% to investigate the influencing factors, and the results showed that the release rate at 60°C was obvious. reduce
After long-term storage at room temperature, the release rate continued to decrease. Although it was still within the release limit specified in the standard, the residual amount of drug released at the end increased greatly; we found through the membrane weight loss experiment that compared with the 0-day sample, the membrane weight loss was significantly reduced. It shows that the permeability of the membrane is reduced, that is, the semipermeable membrane continues to age under the condition of long-term storage at room temperature

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Embodiment 1, commercially available glipizide sustained-release tablet

[0067] Manufacturer: Pfizer Inc. Product Name: Ruiyining

[0068] Batch number: 85807012

[0069] Specification: 5mg

[0070] Release test: According to the import drug standard JX19990091 of the People's Republic of China, the specific method is as follows:

[0071] Get this product, according to the release assay method (Chinese Pharmacopoeia version two appendix XD in 1995, the first method), adopt the second method device of the dissolution assay method, with 900ml of artificial intestinal juice not containing pancreatin as solvent, the rotating speed is per minute 50 turns, operate in accordance with the law, get solution 8ml respectively when 4, 8 and 16 hours, filter, and supplement above-mentioned solvent 8ml in operating container clock immediately; Get continued filtrate, according to spectrophotometry (two appendix IV A ), respectively measure the absorbance at the wavelength of 27...

Embodiment 2

[0098] Embodiment 2 adopts ethyl cellulose and povidone to make the glipizide controlled-release tablet of film-forming material

[0099] 1. Prescription

[0100] 1. Tablet core prescription:

[0101] 1000 pieces, see table 4 below:

[0102] Table 4 embodiment 2 tablet core prescription

[0103]

[0104] 2. Prescription of coating solution: see Table 5 below:

[0105] Table 5 embodiment 2 coating solution prescription

[0106] Ethyl cellulose

30g

povidone k30

14g

ethanol

950ml

water

50ml

[0107] Second, the preparation process:

[0108] 1. Tablet core preparation process:

[0109] (1) Glipizide passes through a 100-mesh sieve;

[0110] (2) Take lactose, sodium chloride, sodium lauryl sulfate, sodium carboxymethylcellulose, povidone K30 and mix according to the prescription amount of the drug-containing layer;

[0111] (3) make soft material with 10% povidone k30 85% ethanol solution;

[0112] (4) Pass throug...

Embodiment 3

[0136] Embodiment 3 adopts ethyl cellulose and polyethylene glycol to make the glipizide controlled-release tablet of film-forming material

[0137] 1. Prescription

[0138] 1. Tablet core prescription: same as Example 2.

[0139] 2. The composition of the coating solution prescription: see Table 9 below:

[0140] Table 9 embodiment 3 coating solution prescription

[0141] Ethylcellulose N-100

30g

Polyethylene glycol-4000

15g

ethanol

800ml

water

200ml

[0142] Second, the preparation process:

[0143] 1, tablet core preparation process: with embodiment 2.

[0144] 2. The preparation process of the semi-permeable membrane coating solution is as follows:

[0145] Weigh the prescribed amount of ethyl cellulose and polyethylene glycol-4000 and disperse in the ethanol-water solution; stir to dissolve completely.

[0146] 3. Weight gain of semi-permeable membrane coating: 13.5%.

[0147] 4. Heat treatment: 40°C for 14 hou...

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Abstract

The invention provides a glipizide osmotic pump type controlled release tablet. The controlled release tablet adopts ethylene cellulose and polyvidone as semi-permeable membrane materials and is unsymmetrical in appearance, not only can overcome the defect that a semi-permeable membrane is aged and reduce the drug release residue, but also can simplify the identification of laser drilling and is stable to place when being conveyed on a conveyor belt; and a hole is easier to be drilled in the middle to facilitate the stable release of the drugs. The invention also provides a method for improving the aging resistance of the glipizide osmotic pump type controlled release tablet, which is characterized in that the ethylene cellulose-the polyvidone is adopted as the semi-permeable membrane material. In addition, the invention further provides an application of an ethylene cellulose-the polyvidone combination for preparing the aging resistance of the glipizide osmotic pump type controlled release tablet.

Description

technical field [0001] The invention relates to a glipizide osmotic pump controlled-release tablet, which uses ethyl cellulose-povidone as a semipermeable membrane material and has an asymmetric shape, belonging to the field of pharmaceutical preparations. Background technique [0002] The chemical name of glipizide is 1-cyclohexyl-3-[p-(2-(5-methylpyrazinecarbonylamide) ethyl) phenyl) sulfonyl] urea, which is a sulfonylurea antidiabetic drug It is effective for most patients with type 2 diabetes. It can lower fasting and postprandial blood sugar, and reduce glycosylated hemoglobin (HbAlc) by 1% to 2%. The main function of this type of drug is to stimulate the secretion of insulin by pancreatic β cells, and its mechanism is to specifically bind to the sulfonylurea receptor on the β cell membrane, so that K + The channel closes, causing a change in membrane potential, Ca 2+ channel opens, intracellular Ca 2+ increase, prompting insulin secretion. In addition, there are ex...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K9/36A61K9/44A61K31/64A61K47/38A61P3/10
Inventor 孟伟张志永
Owner 北京天衡药物研究院南阳天衡制药厂
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