Establishment of Quality Standard for Loratadine Orodispersible Films
In order to control the product quality of loratadine(1)orodispersible films and provide references for the establishment of specification for similar dosage forms,a quality standard for 1 orodispersible films had been established based on the guidance principles issued by ICH and NMPA,and referring to the pharmacopoeia standards of 1 oral solid dosage forms and the quality information on orodispersible films marketed abroad,in combina-tion with the characteristics of 1 orodispersible films.Quality inspection and stability investigation of three batches of 1 orodispersible films were carried out.The results showed that the appearance,identification,related substances,disso-lution,disintegration time,content,content uniformity and microbial limits of the self-made 1 orodispersible films were in compliance with the quality standard,indicating that the self-made product had good stability.In conclusion,the quality standard provided could adequately control the product quality of 1 orodispersible films.
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