Pyridostigmine bromide odor masking orally disintegrating tablets and preparation method thereof

A technology of pyridostigmine bromide and orally disintegrating tablets, which is applied in the field of new preparations, can solve the problems of inconvenient long-term application of injections, inconvenient transportation and carrying of syrups, slow disintegration of sugar-coated tablets, etc., and shorten the disintegration time , The taste is cool and slightly sweet, and the taste is good

Active Publication Date: 2012-01-11
CHONGQING MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] There are some defects in existing pyridostigmine dosage forms: injections are inconvenient for long-term application and cause pain during injection, which reduces patient compliance; syrups are inconvenient to transport and carry; sugar-coated tablets disintegrate slowly, and drug dissolution is slow, requiring Drinking water and using swallowing action to complete the medication process will cause inconvenience...

Method used

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  • Pyridostigmine bromide odor masking orally disintegrating tablets and preparation method thereof
  • Pyridostigmine bromide odor masking orally disintegrating tablets and preparation method thereof
  • Pyridostigmine bromide odor masking orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The weight composition ratio of each component contained in the prescription is:

[0031] 7.5 parts of pyridostigmine bromide

[0032] Eudragit E100 7.5 servings

[0033] Mannitol 50 parts

[0034]15 parts microcrystalline cellulose

[0035] Cross-linked polyvinylpyrrolidone 5 parts

[0036] Aspartame 2.5 parts

[0037] Magnesium stearate 5 parts

[0038] Preparation:

[0039] Pass pyridostigmine bromide through 80-mesh sieve, add to molten Eudragit E100, mix well, rapidly cool the eutectic, pulverize, sieve 80-100-mesh powder, add mannitol and other auxiliary materials, mix evenly, and directly compress the powder into tablets 1000 orally disintegrating tablets with a tablet weight of 200 mg were obtained.

[0040] test results:

[0041]

Embodiment 2

[0043] The weight composition ratio of each component contained in the prescription is:

[0044] 7.5 parts of pyridostigmine bromide

[0045] Eudragit E100 30 servings

[0046] Lactose 17.5 parts

[0047] Sorbitol 20 parts

[0048] Sodium carboxymethyl starch 15 parts

[0049] Low-substituted hydroxypropyl cellulose 5 parts

[0050] Acesulfame K 1.5 parts

[0051] 1.5 parts mint essence

[0052] Talc powder 2 parts

[0053] Preparation:

[0054] Pass pyridostigmine bromide through 80 mesh sieve, add to molten Eudragit E100, mix well, rapidly cool the eutectic, pulverize, screen 80-100 mesh powder, add lactose and other auxiliary materials (except talc powder and mint essence), mix Homogenize, make soft material with distilled water, granulate with 24-mesh sieve, dry at 40°C, granulate with 20-mesh sieve, add peppermint essence and talcum powder, mix and compress to obtain 1000 orally disintegrating tablets with a tablet weight of 200 mg.

[0055] test results:

[005...

Embodiment 3

[0058] The weight composition ratio of each component contained in the prescription is:

[0059] Pyridostigmine bromide 15 parts

[0060] Eudragit E100 25 servings

[0061] Lactose 30 parts

[0062] Mannitol 10 parts

[0063] Sodium carboxymethyl starch 8 parts

[0064] Croscarmellose sodium 12 parts

[0065] Sucralose 1.6 parts

[0066] Magnesium stearate 2.4 parts

[0067] Preparation:

[0068] Take Eudragit E100, dissolve 90 parts of ethanol solution, add pyridostigmine bromide and mix evenly, evaporate most of the solvent, dry under vacuum and reduce pressure, pulverize, screen the 80-100 mesh powder, add lactose and other auxiliary materials, mix evenly, and press the powder directly 1000 orally disintegrating tablets with a tablet weight of 250 mg were obtained.

[0069] test results:

[0070]

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PUM

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Abstract

The invention relates to pyridostigmine bromide odor masking orally disintegrating tablets and a preparation method thereof. The tablets belong to orally disintegrating tablets, and the orally disintegrating tablets consist of pyridostigmine bromide, an odor masking agent, a filling agent, a disintegrating agent and a flavoring agent basically, can be prepared by a direct tablet compressing process or a wet granulation process, have good mouthfeel and are disintegrated for 20 to 45 seconds; and in the dissolution detection process, the average cumulative dissolution quantity in 0.1mol/L of hydrochloric acid medium within 5 minutes is more than 85 percent. The tablets have good mouthfeel and quick response, are quickly disintegrated and convenient to take, and are particularly suitable to be taken by the old, children and patients who suffer from dysphagia and are in special environments (such as an environment in which water is difficult to take). The preparation method does not have special requirements on equipment, and products have controllable quality and low cost, and are easy to produce industrially.

Description

technical field [0001] The invention relates to a novel preparation of pyridostigmine bromide, a drug for treating myasthenia gravis, in particular to an oral disintegrating tablet preparation of pyridostigmine bromide with quick-release effect and good taste and a preparation method thereof. Background technique [0002] Pyridostigmine Bromide (Pyridostigmine Bromide, Pyridostigmine Bromide) is a cholinesterase inhibitor, chemical name: 1-methyl-3-hydroxypyridinium dimethylcarbamate, molecular formula: C 9 h 13 BrN 2 o 2 , molecular weight: 261.12. Pyridostigmine bromide can reversibly combine with cholinesterase, so that endogenous acetylcholine accumulates in the body, and there are muscarinic and nicotinic choline choline receptor excitatory effects. Nicotinic choline receptors have a direct excitatory effect, and can promote the release of acetylcholine from the motor nerve endings, have the effect of exciting smooth muscle, striated muscle and inhibiting cardiovasc...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4425A61K47/36A61K47/38A61K47/42A61P21/04
Inventor 张景勍张梨
Owner CHONGQING MEDICAL UNIVERSITY
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