经口吸入制剂仿制药的药代动力学研究一般考虑

适用于治疗哮喘、慢性阻塞性肺疾病等呼吸系统疾病的经口吸入制剂(OIDPs)药代动力学(PK)行为较复杂,其药物大部分沉积于口腔、鼻咽部、大气道等,仅有少部分药物递送至肺部,沉积的药物可经大气道吸收、吞咽至胃肠道吸收进入体循环,因此与全身作用的药物相比,仅通过PK研究较难评价OIDPs仿制药与参比制剂的生物等效性.近年来...

Considerations about pharmacokinetic study of orally inhaled generic drug products

Orally inhaled drug products(OIDPs),which are used for treating asthma and chronic obstructive pulmonary disease,are characterized with complicated pharmacokinetics(PK).Most of its active pharmaceutical ingredients are deposited in oral cavity,nasopharynx,large airflow track,and so on,while only a few ingredients are delivered to the lung.Deposited ingredients could be absorbed into systemic circulation through swallowing down to gastrointestinal tract and the large airflow track.Therefore,compared to drugs that have systemic effects,it is difficult to evaluate the bioequivalence between OIDPs generic products and reference products only through PK study.In recent years,although domestic OIDPs generic products application is increasing year by year,confusion still exists as regulatory guidelines of international regulatory agencies on PK study have some variations.This article summarizes the PK study technical requirements of OIDPs generic products that the authors have reviewed.Several considerations and suggestions on the assessment are proposed,for the discussion of pharmaceutical enterprises and researchers.