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Articles in press
약물전달용 나노플랫폼 NLC, MOF 및 OMV의 제조기술과 산업화 전망
Manufacturing Strategies and Industrial Perspectives of NLC, MOF, and OMV Nanoplatforms for Drug Delivery
이현일(Hyeon Il Lee)1
김채현(Chae Hyeon Kim)1
박재현(Jae Hyeon Park)1
이가영(Ga Yeong Lee)1
이유빈(Yu Been Lee)1
김홍기(Hong Ki Kim)1
유하영1†
1상명대학교 생명공학과
In Press, Journal Pre-proof, Available online 1 November 2026
Abstract
약물전달용 나노플랫폼은 약물의 안정성, 생체이용률, 표적 전달성 및 방출 제어성을 향상시키기 위한 핵심 제형 기술로 발전해 왔다. 본 총설에서는 차세대 약물전달용 나노플랫폼으로서 나노구조 지질 운반체(nanostructured lipid carriers, NLC), 금속-유기 골격체(metal-organic frameworks, MOF) 및 외막소포체(outer membrane vesicles, OMV)의 구조적 특성, 약물 적재 및 방출 기전, 제조기술, 품질평가 지표 및 산업화 고려사항을 검토하였다. NLC는 지질 매트릭스를 기반으로 난용성 약물 적재와 제조공정 확장성에 장점을 가지며, MOF는 다공성 골격 구조를 통해 고용량 적재와 자극 반응성 방출이 가능하다. OMV는 생물유래 막 구조를 기반으로 cargo 전달과 면역조절 기능을 동시에 나타낼 수 있으나, 내독성 및 배치 간 변동성 관리가 중요하다. 이들 플랫폼의 실용화를 위해서는 설계기반 품질고도화(QbD), 공정분석기술(PAT), 장기 안정성 평가 및 규제 대응형 품질관리 체계의 통합적 구축이 요구된다.
Drug delivery nanoplatforms have been developed to improve drug stability, bioavailability, target delivery, and controlled release. This review summarizes the structural features, drug loading and release mechanisms, manufacturing technologies, quality attributes, and industrial considerations of nanostructured lipid carriers (NLCs), metal-organic frameworks (MOFs), and outer membrane vesicles (OMVs) as next-generation drug delivery nanoplatforms. NLCs provide advantages in loading poorly water-soluble drugs and scalable formulation development based on lipid matrices. MOFs enable high-capacity drug loading and stimuli-responsive release through tunable porous frameworks. OMVs offer bio-derived membrane functions for cargo delivery and immunomodulation, although endotoxin control and batch-to-batch variability remain critical issues. Thus, the translation of these platforms should be discussed not only as a formulation issue but also as a process-driven quality-control problem involving QbD, PAT, long-term stability, and regulatory-oriented safety assessment.
