Slow control released methylphenidate hydrochloride capsule and its preparing method

A technology of methylphenidate hydrochloride and capsules, which is applied in the field of sustained and controlled release pharmaceutical preparations, sustained and controlled release capsule preparations and their preparation, can solve the problems of obvious side effects, short half-life, poor compliance, etc. The effect of improving compliance

Inactive Publication Date: 2007-06-27
SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, in clinical application, it is found that methylphenidate hydrochloride still has many problems: as, the half-life is short, and it needs to be taken 2-3 times a day; the side effects are obvious, including headache, stomachache, insomnia, loss of appetite; Common, poor compliance; risk of addiction in excess of therapeutic doses

Method used

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  • Slow control released methylphenidate hydrochloride capsule and its preparing method
  • Slow control released methylphenidate hydrochloride capsule and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Prepare drug-loaded pellets according to the following composition ratios

[0036] Blank ball core 100g

[0037] Methylphenidate Hydrochloride 30g

[0038] Polyvinylpyrrolidone 3g

[0039] Polyethylene glycol-4000 0.3g

[0040] Prepare quick-acting pellets according to the following composition ratio

[0041] Drug-loaded pellets 100g

[0042] Hypromellose 2.5g

[0043] Polyethylene glycol-4000 0.5g

[0044] Prepare medium-effect pellets according to the following composition ratio

[0045] Drug-loaded pellets 100g

[0046] Surelease® Solids 6g

[0047] Prepare long-acting pellets according to the following composition ratio

[0048] Drug-loaded pellets 100g

[0049] Surelease® solid content 12g

[0050]Methylphenidate hydrochloride is micronized and dissolved in polyvinylpyrrolidone aqueous solution, polyethylene glycol-4000 is added under stirring, and a coating solution is obtained after ultrasonication. The blank ball core is coated with a fluidized bed, ...

Embodiment 2

[0055] Prepare drug-loaded pellets according to the following composition ratios

[0056] Blank ball core 100g

[0057] Methylphenidate Hydrochloride 10g

[0058] Polyvinylpyrrolidone 3g

[0059] Polyethylene glycol-6000 small amount

[0060] Prepare quick-acting pellets according to the following composition ratio

[0061] Drug-loaded pellets 100g

[0062] Methylcellulose 2g

[0063] Talc Trace

[0064] Prepare medium-effect pellets according to the following composition ratio

[0065] Drug-loaded pellets 100g

[0066] Cellulose acetate 3g

[0067] Triethyl citrate 0.15g

[0068] Prepare long-acting pellets according to the following composition ratio

[0069] Drug-loaded pellets 100g

[0070] Cellulose acetate 5g

[0071] Triethyl citrate 0.25g

[0072] The preparation process was the same as in Example 1. Take 80 g of quick-acting pellets, 100 g of medium-acting pellets, and 80 g of long-acting pellets, mix them uniformly, and pack them into capsule shells at a...

Embodiment 3

[0074] Prepare drug-loaded pellets according to the following composition ratios

[0075] Blank ball core 100g

[0076] Methylphenidate Hydrochloride 80g

[0077] Hypromellose 3.5g

[0078] Glyceryl triacetate small amount

[0079] Prepare quick-acting pellets according to the following composition ratio

[0080] Drug-loaded pellets 100g

[0081] Polyvinylpyrrolidone 2g

[0082] Talc powder 3g

[0083] Prepare medium-effect pellets according to the following composition ratio

[0084] Drug-loaded pellets 100g

[0085] Eudragit E30D 6g

[0086] Triethyl citrate 1.5g

[0087] Talc powder 3g

[0088] Prepare long-acting pellets according to the following composition ratio

[0089] Drug-loaded pellets 100g

[0090] Eudragit E30D 9g

[0091] Triethyl citrate 2.5g

[0092] Talc powder 4g

[0093] The preparation process was the same as in Example 1. Take 20 g of quick-acting pellets, 80 g of medium-acting pellets, and 50 g of long-acting pellets, mix them uniformly, a...

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Abstract

The present invention relates to pharmaceutical technology, and is especially a kind of slow control released methylphenidate hydrochloride capsule and its preparation process. The capsule includes capsule covering and pellets, which includes quick acting pellets in 5-50 %, medium acting pellets in 10-60 % and long acting pellets in 5-40 %. The quick acting pellet consists of vacant core, medicine carrying layer and protecting layer; and each of the medium acting pellet and the long acting pellet consists of vacant core, medicine carrying layer and slow releasing coating layer. The dosage of the slow control released methylphenidate hydrochloride capsule is 10-40 mg. Test shows that the slow control released methylphenidate hydrochloride capsule has quick treating effect and sustained medicine release over 90 % in 12 hr. Compared with common methylphenidate hydrochloride tablet, the present invention has decreased medicine taking times and reduced toxic side effect.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a sustained and controlled release pharmaceutical preparation, in particular to a sustained and controlled release capsule preparation with methylphenidate hydrochloride as the main agent and a preparation method thereof. Background technique [0002] Attention deficit hyperactivity disorder (Attention-deficit / hyperactivity disorder ADHD) is the most common childhood mental development disorder, and the Chinese mental disease diagnostic classification is called ADHD in children. The disorder is characterized by attention deficits, impulsive behavior, easily distracted, and hyperactivity, often accompanied by learning difficulties and conduct disturbances. The domestic investigation found that the prevalence rate is 1.5-10%, because the disease has not been paid enough attention for a long time, the actual incidence rate is higher. [0003] Methylphenidate hydrochloride is currently the firs...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/4458A61K47/38A61P25/14
Inventor 高申吴娟丁雪鹰邹豪高静尹东锋李国栋储藏
Owner SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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