Pyridostigmine bromide odor masking orally disintegrating tablets and preparation method thereof

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...

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 to the elderly, children and patients with dysphagia, and there are potential risks in diabetic patients taking syrup and sugar-coated tablets

[0006] However, the clear taste of pyridostigmine is bitter. To prepare it into orally disintegrating tablets needs to solve the taste problem. Taste masking and taste modification of the main drug is one of the key technologies for developing pyridostigmine orally disintegrating tablets.

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