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Preparation method and products of morphine osmotic pump tablets

A technology for osmotic pump tablets and morphine, which is applied in the field of preparation of morphine osmotic pump tablets, can solve the problems of unsuitability for large-scale commercial production, complex preparation process, and difficulty in controlling the robustness of the process, so as to improve social function rehabilitation and quality of life , long-lasting analgesic effect, and the effect of reducing individual differences and adverse reactions

Active Publication Date: 2018-07-24
XINAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation process is complicated, and it is difficult to control the robustness of the process, so it is not suitable for commercial production

Method used

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  • Preparation method and products of morphine osmotic pump tablets
  • Preparation method and products of morphine osmotic pump tablets
  • Preparation method and products of morphine osmotic pump tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] The prescription composition of morphine osmotic pump sustained release (controlled release) tablets is as follows (calculated in 1000 tablets):

[0060] Chip:

[0061]

[0062] Semi-permeable membrane coating solution:

[0063]

[0064] Gastric shading coating solution:

[0065] Opadry (stomach-soluble type) 9.0g;

[0066] Ethanol: water 0:100(m / m) 70g;

[0067] In the tablet core, lactose is not only used as a filler, but also used as a penetration enhancer together with polyethylene glycol 6000, edetate disodium is used as an antioxidant, and magnesium stearate is used as a lubricant;

[0068] In the translucent coating solution, cellulose acetate is the semipermeable membrane coating material, polyethylene glycol and polysorbate 80 are plasticizers and porogens, and acetone and aqueous solution are solvents;

[0069] In the stomach-soluble light-shielding coating solution, Opadry is the stomach-soluble light-shielding coating film, which contains polyethyl...

Embodiment 2

[0077] The prescription composition of morphine osmotic pump sustained release (controlled release) tablets is as follows (calculated in 1000 tablets):

[0078] Chip:

[0079]

[0080] Semi-permeable membrane coating solution:

[0081]

[0082] Gastric shading coating solution:

[0083] Opadry (stomach-soluble type) 2g;

[0084] Ethanol: water 0:100 (m / m) 18g.

[0085] Its preparation method is as follows:

[0086] (1) Dissolve the edetate disodium of the tablet core prescription amount in the tablet core prescription water, pass the morphine hydrochloride, lactose and polyethylene glycol 6000 of the tablet core prescription amount respectively through an 80-mesh sieve, and place them in a high-efficiency wet process. The granulator is mixed for 6 minutes, then the above solution is made into a soft material, dried in a drying oven at 50°C, sieved with a 20-mesh sieve, and the dry granules are sized, and finally magnesium stearate is added to compress into tablet cor...

Embodiment 3

[0092] The prescription composition of morphine osmotic pump sustained release (controlled release) tablets is as follows (calculated in 1000 tablets):

[0093] Chip:

[0094]

[0095] Semi-permeable membrane coating solution:

[0096]

[0097] Gastric shading coating solution:

[0098] Opadry (stomach-soluble type) 7.2g;

[0099] Ethanol: water 0:100(m / m) 52.8g;

[0100] Its preparation method is as follows:

[0101] (1) Dissolve edetate disodium in the tablet core prescription amount in water, pass the morphine hydrochloride, lactose, and polyethylene glycol 6000 in the tablet core prescription amount respectively through a 60-mesh sieve, and place in a high-efficiency wet granulator for mixing 7min, then make soft material with aqueous solution, dry in a drying oven at 50°C, sieve the dry granules with a 20-mesh sieve, and finally add magnesium stearate to compress into tablet cores;

[0102] (2) Dissolve the cellulose acetate, polyethylene glycol 4000 and polyso...

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Abstract

The invention relates to a preparation method and products of morphine osmotic pump tablets. According to the preparation method, morphine or pharmaceutically acceptable salts of morphine are taken asbulk drugs, pharmaceutically acceptable osmotic pressure active substances and other filling accessory ingredients, and semipermeable coating film accessory ingredients and gastric dissolvable coating film accessory ingredients are added so as to obtain the morphine osmotic pump tablets. Long lasting stable drug release is realized, drug release time period is as long as 24h, release ratio is 90%or higher, drug eating time of each day can be reduced. The osmotic pressure difference across the membrane is taken as the drug release power, drug release is stable, blood concentration fluctuationis reduced, toxic and side effect is reduced, treatment safety and security are increased, and obvious clinical advantages are achieved.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a method for preparing morphine osmotic pump tablets, and also relates to a product prepared by the method. Background technique [0002] According to the estimates of the International Center for Cancer Research, the number of cancer cases in the world will increase at an average annual rate of 3% to 5% in the future. It is estimated that there will be 20 million new cases in the world in 2020, and there will be about 2 million new cancer patients in China every year. Pain is one of the most common clinical symptoms of cancer patients, which seriously affects the quality of life of patients. According to the survey by the World Health Organization, 70% of cancer patients will suffer from different degrees of pain. Therefore, WHO regards cancer pain control as one of the four key projects of cancer control. There are many methods for the treatment of cancer pain, and drug therapy based on ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/38A61K47/10A61K47/26A61K31/485A61P25/04
CPCA61K9/0004A61K9/2031A61K9/2853A61K9/2866A61K31/485
Inventor 蒲道俊赵强李标郑小锋余春梅徐洁张玲玲罗宏杨宇林尤敏
Owner XINAN PHARMA