Development of extemporal suspensions for oral administration

Introduction. In the context of the development of a personalized approach in medicine, extemporaneous medicines are of particular importance, in the creation of which the most convenient type of dosage form and acceptable excipients can be selected taking into account the age, allergy status, the presence of concomitant diseases and other individual characteristics of the patient. Pharmaceutical development of an extemporaneous medicines is usually the responsibility of a pharmacist-technologist of a production pharmacy. To optimize this process, it is important to develop methodological approaches to the pharmaceutical development of extemporaneous medicines. Objective: substantiation of the methodological scheme for the pharmaceutical development of extemporaneous suspensions for oral administration for children within the framework of the Quality by Design (QbD) concept using the example of furazidin suspension. Material and methods. The study used content analysis of scientific literature and regulatory documents and systems analysis based on the QbD concept. Results. Based on the quality target product profile, the optimal extemporaneous dosage form of furazidin for children is powder for preparation of oral suspension. Critical quality indicators for pharmaceutical development of bulk powder are description (taste), particle size, sedimentation stability, viscosity, dosing uniformity; for dosed powder – description (taste), dosing uniformity. Bulk powder should contain a stabilizer and a sweetener, while dosed powder must contain only a sweetener. Critical parameters of the manufacturing process of powders for preparation of oral suspension include grinding time of furazidin tablets and mixing time of ingredients. Conclusion. In the course of the conducted study, a methodological scheme for the pharmaceutical development of extemporaneous suspensions for oral administration for children was developed, which can be introduced into the routine practice of production pharmacies to optimize the process of manufacturing and dispensing children's extemporaneous dosage forms.