the first approval of an oro-dispersible film dosage form in China

Qilu Pharmaceutical’s risperidone oro-dispersible film has been formally approved for market launch by the National Medical Products Administration (NMPA), marking the first approval of an oro-dispersible film dosage form in China. This product is indicated for the treatment of bipolar disorder and schizophrenia.

Risperidone remains a first-line recommended therapy in current schizophrenia treatment guidelines. It modulates neurotransmitter balance by antagonizing dopamine D₂ and 5-HT₂A receptors, thereby regulating neuronal signaling in the brain to influence emotion, behavior, and cognition. This mechanism effectively alleviates symptoms and reduces relapse rates in schizophrenia. Currently approved risperidone formulations in China include tablets, orodispersible tablets, dispersible tablets, oral solutions, injectables, and capsules.

Compared to conventional dosage forms, the oro-dispersible film employs precise integration of film-forming polymers with drug molecules to enable "stamp-sized" administration. This innovation eliminates the need for water ingestion, enhances portability, and facilitates rapid absorption and onset of action, significantly improving patient compliance.

Drug impurities—unavoidable byproducts of manufacturing—may compromise efficacy or introduce toxicity risks. Given risperidone’s complex chemical structure, its synthesis typically generates impurities such as risperidone N-oxide (CAS 832747-55-4), dehydrogenation products, and isomerization or ring-opened degradation products under light, acidic, or alkaline conditions. Different formulations introduce additional impurity profiles. Per the Technical Guidelines for Studying Impurities in Chemical Drugs, new drug applications must rigorously characterize impurity structures and control threshold limits (typically ≤0.1%). As an emerging dosage form in China, oro-dispersible films necessitate more comprehensive impurity profiling databases during development.

The launch of Qilu’s risperidone film signifies a milestone in China’s advanced dosage form R&D. Behind every safe and effective medication, drug impurity reference standards serve as the indispensable "gold standard" for quality control throughout the R&D chain.

​​Supply Declaration​​

As a partner in pharmaceutical R&D, ​SZEB  provides complete suites of risperidone impurity references (including Risperidone Impurities A-H, N-oxide, etc.) alongside reference materials for psychiatric drugs such as aripiprazole and olanzapine. All materials are supported by full certification packages (COA, HPLC, HNMR, and MS spectra), accelerating R&D and regulatory processes for industry partners.More information about drug impurity at the offical website:www.ex-biotech.com , contact us by e-mail: sales@ex-biotech.com .