Discussion on the development and evaluation of new drugs of oral soluble film
Films refer to the film-like preparation made by processing the raw material and the appropriate film-form-ing material.Oral soluble film refers to the film that dissolves rapidly in the mouth.The characteristics of the oral soluble film include accurate dose,easy to carry,and improving the compliance of patients with specific indications.Based on the require-ments of registration regulations and approval of oral soluble films at home and abroad in recent years,the evaluation of oral soluble films were put forward in terms of development,formulation,manufacturing process and quality research and control.The application strategy and path should be rationally selected after comprehensive evaluation.During formulation and process development,focus on the key factors affecting product quality according to the characteristics of dosage forms,and conduct targeted quality research and control.These discussions are expected to guide the development and evaluation of oral soluble films,and promote the approval and marketing of high-quality oral soluble film new drugs with clinical needs.
Oral soluble filmOrodispersible filmsInnovative drugsFormulation and manufacturing processQuality controlDevelopment and evaluation
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