Methylphenidate hydrochloride instant film and preparation method thereof

Abstract

The invention discloses an instant methylphenidate hydrochloride film and a preparation method thereof. The preparation method comprises the following steps: adding 30 g of a film-forming material, namely hydroxypropyl methylcellulose-E15, into purified water with a temperature being 50 DEG C and a volume being 500 ml, slowly stirring for enabling the material to be uniformly dispersed, standing until the material is fully swelled, and completely cooling and dissolving; adding 30 g of polyethylene glycol 400 and 11 g of methylphenidate hydrochloride in sequence, performing ultrasonic treatment, fully dissolving polyethylene glycol 400 and methylphenidate hydrochloride, finally adding 0.75 g of microcrystalline cellulose and 2.50 g of low-substituted hydroxypropyl cellulose, fully stirring for enabling microcrystalline cellulose and low-substituted hydroxypropyl cellulose to be uniformly dispersed, removing bubbles with a standing method after a system is uniform, and performing coating by a coating machine under a condition that the coating thickness is 100 microns to obtain the instant methylphenidate hydrochloride film. The instant methylphenidate hydrochloride film prepared with the method has the advantages that the film can be absorbed by mouth mucosa, so that an effect is quickly achieved; a first-pass effect of liver caused by oral administration also can be avoided and the influence of a gastrointestinal tract microenvironment is avoided.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a methylphenidate hydrochloride instant film and a preparation method thereof. Background technique [0002] Methylphenidate Hydrochloride (Methylphenidate Hydrochloride) is a central stimulant, which can improve mental activity, promote quick thinking, refresh the mind, relieve fatigue, and have little toxic and side effects. [0003] Methylphenidate hydrochloride currently used clinically is common tablet and powder injection. Slow onset, inconvenient administration, especially under anhydrous conditions, patients cannot take it. [0004] Instant film is a new dosage form that has developed rapidly in recent years. This product not only has the characteristics of being quickly absorbed by the oral mucosa to achieve rapid onset of action, but also avoids the liver first-pass effect caused by oral administration, and at the same time avoids being...

AI Technical Summary

Problems solved by technology

Slow onset, inconvenient administration, especially in anhydrous conditions, patients cannot take

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