Qilu Pharmaceutical's Risperidone Oral Soluble Film, China's First, Gains NMPA Approval

On July 28, the NMPA official website announced that Qilu Pharmaceutical Co., Ltd. submitted a new drug application under Category 2.2.Risperidone Oral Soluble FilmApproved for marketing. Based on the progress of the drug's clinical trials, the indication approved this time is speculated to beSchizophrenia. According to the Insight database, this is also the first approved in China.Risperidone Oral Soluble Film.

Risperidone is a drug developed for schizophrenia or bipolar disorder. In 2013, Qilu Pharmaceutical Co., Ltd. initiated the development of risperidone oral soluble film. The oral soluble film formulation has multiple advantages, including:

• 1. Convenient to take, not easy to spit out, no risk of choking; the drug can rapidly disintegrate upon contact with a small amount of saliva in the mouth, and does not require chewing or water for swallowing. This greatly improves compliance among patients, especially the elderly, children, those with swallowing difficulties, bedridden patients, those lacking access to water outdoors, and patients who are uncooperative with medication.

• 2. Easy to carry, compact in appearance, generally the size of thin-film chewing gum, with a good taste, and higher user acceptance.

• 3. Rapid absorption, quick onset of action.

According to the Insight database,As of now,Qilu Pharmaceutical has submitted marketing applications for 7 oral soluble film formulations in China., including brexpiprazole orally disintegrating film, risperidone orally disintegrating film, aripiprazole orally disintegrating film, olanzapine orally disintegrating film, memantine hydrochloride orally disintegrating film, montelukast sodium orally disintegrating film, tadalafil orally disintegrating film, etc. Except for brexpiprazole orally disintegrating film, all other products have been approved.

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Editor: Xinyao

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