Tadalafil oral soluble film agent and preparation method

Abstract

The invention provides a Tadalafil oral soluble film and a preparation method. The Tadalafil oral soluble film is prepared from a Tadalafil oral soluble film containing specific components through a conventional technology and particularly prepared from Tadalafil, a film-forming material, a plasticizer, an optionally existing corrective, an optionally existing coloring agent and an optionally existing aromatic agent. The Tadalafil oral soluble film is characterized in that the film-forming material is prepared from one or more than two components in polysaccharide, one or more than two components in organic acid and one or more than two components in hydroxyalkyl cellulose. Compared with the prior art, the Tadalafil oral soluble film has the advantages that the preparation technology is simple, no special requirement is needed on production equipment, the preparation stability is high, reproduction is easy, the requirements on storing conditions are low, and packaging, transporting and storing are easy.

Description

[0001] Technical field: [0002] The invention provides a new drug preparation of tadalafil, specifically, a tadalafil oral film-soluble agent and a preparation method thereof. It belongs to the field of pharmaceutical preparations. [0003] Background technique: [0004] Erectile dysfunction (erectile dysfunction, ED) is a common clinical disease, there are about 150 million ED patients in the world, which seriously threatens the physical and mental health of the majority of men. What's more serious is that the incidence of ED is increasing year by year, and it is estimated that ED patients will reach 300 million by 2020. There are many influencing factors of ED, which are closely related to age, mental psychology, cardiovascular, endocrine, lifestyle, medicine, injury and surgery, and have obvious relationship with age growth. ED is not only often accompanied by chronic diseases such as diabetes, vascular disease, and obesity, but also an early "alarm" symptom of cardiovasc...

AI Technical Summary

Problems solved by technology

[0011] Tablets are widely accepted by patients as oral solid routine preparations, but tadalafil is very poor in water solubility, and the requirements for making tablets are very high on the raw materials themselves, such as the fluidity of the particles, the size of the particle size, especially for small specifications ( 5mg) tablets, a small deviation in the preparation process will lead to problems with content uniformity, due to the role of mechanical stirring in the process of granulation and mixing, the local temperature is very high, which is also a great test for the stability of raw materials, and Tablets have a process of disintegration in the body. The length of this process is not only affected by the prescription process itself, but also varies greatly from individual to individual.

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