Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana 500037, India.
College of Pharmacy and Pharmaceutical Sciences, Florida A&M University, Tallahassee, FL 32307, USA.
Int J Pharm. 2022 Aug 25;624:122022. doi: 10.1016/j.ijpharm.2022.122022. Epub 2022 Jul 15.
Liposomes have several advantages, such as the ability to be employed as a carrier/vehicle for a variety of drug molecules and at the same time they are safe and biodegradable. In the recent times, compared to other delivery systems, liposomes have been one of the most well-established and commercializing drug products of new drug delivery methods for majority of therapeutic applications. On the other hand, it has several limitations, particularly in terms of stability, which impedes product development and performance. In this review, we reviewed all the potential instabilities (physical, chemical, and biological) that a formulation development scientist confronts throughout the development of liposomal formulations as along with the ways to overcome these challenges. We have also discussed the effect of microbiological contamination on liposomal formulations with a focus on the use of sterilization methods used to improve the stability. Finally, we have reviewed quality control techniques and regulatory considerations recommended by the agencies (USFDA and MHLW) for liposome drug product development.
脂质体有几个优点，如能够作为载体/载体来携带各种药物分子，同时它们是安全和可生物降解的。在最近的一段时间里，与其他给药系统相比，脂质体已经成为新的药物输送方法中最成熟和商业化的药物产品之一，适用于大多数治疗应用。另一方面，它有几个局限性，特别是在稳定性方面，这阻碍了产品的开发和性能。在这篇综述中，我们回顾了制剂开发科学家在开发脂质体制剂时所面临的所有潜在不稳定性（物理、化学和生物），以及克服这些挑战的方法。我们还讨论了微生物污染对脂质体制剂的影响，重点是使用灭菌方法来提高稳定性。最后，我们回顾了机构（美国 FDA 和 MHLW）推荐的脂质体药物产品开发的质量控制技术和监管注意事项。
