Quality by Design Approach in Liposomal Formulations: Robust Product Development

被引：32

作者：

Alshaer, Walhan ^{[1
]}

Nsairat, Hamdi ^{[2
]}

Lafi, Zainab ^{[2
]}

Hourani, Omar M. ^{[3
]}

Al-Kadash, Abdulfattah ^{[1
]}

Esawi, Ezaldeen ^{[1
]}

Alkilany, Alaaldin M. ^{[4
]}

机构：

[1] Univ Jordan, Cell Therapy Ctr, Amman 11942, Jordan

[2] Al Ahliyya Amman Univ, Fac Pharm, Pharmacol & Diagnost Res Ctr, Amman 19328, Jordan

[3] Univ Jordan, Sch Pharm, Dept Pharmaceut & Pharmaceut Technol, Amman 11942, Jordan

[4] Qatar Univ, Coll Pharm, QU Hlth, Doha 2713, Qatar

来源：

MOLECULES | 2023年 / 28卷 / 01期

关键词：

drug delivery; nanomedicine; liposomes; quality by Design (QbD); nano-pharmaceuticals; pharmaceutical industry; PERFORMANCE LIQUID-CHROMATOGRAPHY; LONG-CIRCULATING LIPOSOMES; DIFFERENTIAL SCANNING CALORIMETRY; TRANSMISSION ELECTRON-MICROSCOPY; NANOSTRUCTURED LIPID CARRIERS; DRUG-DELIVERY SYSTEMS; PARTICLE-SIZE; PHARMACEUTICAL QUALITY; CATIONIC LIPIDS; HIGH-THROUGHPUT;

D O I：

10.3390/molecules28010010

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

Nanomedicine is an emerging field with continuous growth and differentiation. Liposomal formulations are a major platform in nanomedicine, with more than fifteen FDA-approved liposomal products in the market. However, as is the case for other types of nanoparticle-based delivery systems, liposomal formulations and manufacturing is intrinsically complex and associated with a set of dependent and independent variables, rendering experiential optimization a tedious process in general. Quality by design (QbD) is a powerful approach that can be applied in such complex systems to facilitate product development and ensure reproducible manufacturing processes, which are an essential pre-requisite for efficient and safe therapeutics. Input variables (related to materials, processes and experiment design) and the quality attributes for the final liposomal product should follow a systematic and planned experimental design to identify critical variables and optimal formulations/processes, where these elements are subjected to risk assessment. This review discusses the current practices that employ QbD in developing liposomal-based nano-pharmaceuticals.

引用

页数：19

共 156 条

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