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Methylphenidate hydrochloride sustained-release floating micropill in stomach and its preparation method

A technology of methylphenidate hydrochloride and sustained-release pellets, which is applied in the field of medicine, can solve problems such as poor safety, increased tensile strength, and smaller porosity, and achieve high safety in use, reduced side effects, and improved bioavailability Effect

Inactive Publication Date: 2008-10-22
石家庄蒎格医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its disadvantages are: 1. The pressure of tablet pressing also affects the floating performance. Excessive pressure will increase the tensile strength of the tablet and reduce the porosity, which will have a negative impact on the floating performance.
3. The safety is poor. In case the sustained release control fails, the entire dose will pour out and cause the patient’s blood drug concentration to be too high

Method used

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  • Methylphenidate hydrochloride sustained-release floating micropill in stomach and its preparation method
  • Methylphenidate hydrochloride sustained-release floating micropill in stomach and its preparation method
  • Methylphenidate hydrochloride sustained-release floating micropill in stomach and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Ball core preparation:

[0024] Expandable polystyrene beads (particle size 180-300um) are softened when placed in a batch pre-expansion machine and heated by steam to above 92°C. Adjust the pre-expansion temperature, steam pressure and feed amount to volatilize the blowing agent The volume of the escaped particles slowly expands to 20 times, and then the foam particles are allowed to fall freely into the aging chamber made of mesh anti-static gauze for 8 hours. Enter the fluidized bed for drying to obtain pellet cores with a particle size of 500-800um. Then sieve according to the needs, and sieve out the pellet core of 700um-800um; its density is about 0.05g / cm 3 Then it is put into the fluidized bed and sprayed with stomach-dissolving coating liquid, which can further increase the particle diameter and density of the pellet core and make the appearance smoother.

[0025] above core

[0026]

[0027] drug coating solution

[0028]

[0029] protective coating ...

Embodiment 2

[0046] Ball core preparation:

[0047] Expandable polystyrene beads (particle size 180-300um) are softened when placed in a batch pre-expansion machine and heated by steam to above 92°C. Adjust the pre-expansion temperature, steam pressure and feed amount to volatilize the blowing agent The volume of the escaped particles slowly expands to 20 times, and then the foam particles are allowed to fall freely into the aging chamber made of mesh anti-static gauze for 8 hours. Enter the fluidized bed for drying to obtain pellet cores with a particle size of 500-800um. Then sieve according to the needs, and sieve out the pellet core of 700um-800um; its density is about 0.05g / cm 3 Then it is put into the fluidized bed and sprayed with stomach-dissolving coating liquid, which can further increase the particle diameter and density of the pellet core and make the appearance smoother.

[0048] above core

[0049]

[0050] drug coating solution

[0051]

[0052] protective coating ...

Embodiment 3

[0069] Ball core preparation:

[0070] Expandable polystyrene beads (particle size 180-300um) are softened when placed in a batch pre-expansion machine and heated by steam to above 92°C. Adjust the pre-expansion temperature, steam pressure and feed amount to volatilize the blowing agent The volume of the escaped particles slowly expands to 20 times, and then the foam particles are allowed to fall freely into the aging chamber made of mesh anti-static gauze for 8 hours. Enter the fluidized bed for drying to obtain pellet cores with a particle size of 500-800um. Then sieve according to the needs, and sieve out the pellet core of 700um-800um; its density is about 0.05g / cm 3 Then it is put into the fluidized bed and sprayed with stomach-dissolving coating liquid, which can further increase the particle diameter and density of the pellet core and make the appearance smoother.

[0071] above core

[0072]

[0073] drug coating solution

[0074]

[0075] protective coating ...

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Abstract

The invention relates to the technical field of medicine, which discloses an anti-ADHD drug methylphenidate hydrochloride gastric floating sustained-release pellet and a preparation method thereof. The gastric floating sustained-release pellet is composed of a pellet core, a drug layer, an isolation layer and a sustained-release layer, the density thereof is less than 1g / cm<3>, which can be floated in the stomach for the sustained-release of methylphenidate hydrochloride, the pellet can be prepared into a gastric floating sustained-release capsule by being filled in a capsule; compared with the ordinary preparation, the gastric floating sustained-release pellet or the gastric floating sustained-release capsule reduces the times of drug administration, leads the methylphenidate hydrochloride to maintain the comparatively stable plasma-drug concentration in vivo, ensures the long effectiveness of the methylphenidate hydrochloride, relatively reduces the side effects of the methylphenidate hydrochloride compared with the conventional sustained-release preparation, improve the bioavailability and reduces the dosage. The gastric floating sustained-release pellet adopts the conventional process for preparation, which is easy to realize the industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an intragastric floating sustained-release pellet of methylphenidate hydrochloride, an anti-hyperactivity disorder drug for children, and a preparation method thereof. Background technique [0002] Methylphenidate hydrochloride is a central nervous system and respiratory stimulant. In small doses, it reflexively excites the respiratory center through carotid body chemoreceptors, and in large doses directly excites the medullary respiratory center. It is suitable for eliminating drowsiness, fatigue and respiratory depression caused by hypnotics. In recent years, it has been used to treat mild brain dysfunction in children and has received good results. [0003] The methylphenidate hydrochloride sustained-release preparation was first developed and marketed by Novartis in the United States in 1982. The trade name is RITALIN-SR. The dosage form is a sustained-release ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/445A61K47/44A61K47/32A61K47/10A61K47/14A61K47/38A61K9/34A61K9/48A61P25/14
Inventor 王雷波
Owner 石家庄蒎格医药科技有限公司
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