PMID- 37111643
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230501
IS  - 1999-4923 (Print)
IS  - 1999-4923 (Electronic)
IS  - 1999-4923 (Linking)
VI  - 15
IP  - 4
DP  - 2023 Apr 6
TI  - An Overview of the Stability and Delivery Challenges of Commercial Nucleic Acid 
      Therapeutics.
LID - 10.3390/pharmaceutics15041158 [doi]
LID - 1158
AB  - Nucleic acid (NA)-based biopharmaceuticals have emerged as promising therapeutic 
      modalities. NA therapeutics are a diverse class of RNA and DNA and include 
      antisense oligonucleotides, siRNA, miRNA, mRNA, small activating RNA, and gene 
      therapies. Meanwhile, NA therapeutics have posed significant stability and 
      delivery challenges and are expensive. This article discusses the challenges and 
      opportunities for achieving stable formulations of NAs with novel drug delivery 
      systems (DDSs). Here we review the current progress in the stability issues and 
      the significance of novel DDSs associated with NA-based biopharmaceuticals, as 
      well as mRNA vaccines. We also highlight the European Medicines Agency (EMA) and 
      US Food and Drug Administration (FDA)-approved NA-based therapeutics with their 
      formulation profiles. NA therapeutics could impact future markets if the 
      remaining challenges and requirements are addressed. Regardless of the limited 
      information available for NA therapeutics, reviewing and collating the relevant 
      facts and figures generates a precious resource for formulation experts familiar 
      with the NA therapeutics' stability profile, their delivery challenges, and 
      regulatory acceptance.
FAU - Ingle, Rahul G
AU  - Ingle RG
AD  - Institute of Drug Metabolism and Pharmaceutical Analysis, College of 
      Pharmaceutical Sciences, Zhejiang University, Hangzhou 310027, China.
AD  - Dr. Rajendra Gode College of Pharmacy, Amravati 444602, India.
FAU - Fang, Wei-Jie
AU  - Fang WJ
AD  - Institute of Drug Metabolism and Pharmaceutical Analysis, College of 
      Pharmaceutical Sciences, Zhejiang University, Hangzhou 310027, China.
LA  - eng
GR  - 81741144/National Natural Science Foundation of China/
GR  - 2018ZX09J18107-002/Ministry of Science and Technology/
PT  - Journal Article
PT  - Review
DEP - 20230406
PL  - Switzerland
TA  - Pharmaceutics
JT  - Pharmaceutics
JID - 101534003
PMC - PMC10143938
OTO - NOTNLM
OT  - drug delivery
OT  - excipient
OT  - formulation
OT  - mRNA vaccine
OT  - nucleic acid therapeutics
OT  - stability
COIS- The authors declare no conflict of interest.
EDAT- 2023/04/28 06:42
MHDA- 2023/04/28 06:43
PMCR- 2023/04/06
CRDT- 2023/04/28 01:47
PHST- 2023/01/20 00:00 [received]
PHST- 2023/03/21 00:00 [revised]
PHST- 2023/03/24 00:00 [accepted]
PHST- 2023/04/28 06:43 [medline]
PHST- 2023/04/28 06:42 [pubmed]
PHST- 2023/04/28 01:47 [entrez]
PHST- 2023/04/06 00:00 [pmc-release]
AID - pharmaceutics15041158 [pii]
AID - pharmaceutics-15-01158 [pii]
AID - 10.3390/pharmaceutics15041158 [doi]
PST - epublish
SO  - Pharmaceutics. 2023 Apr 6;15(4):1158. doi: 10.3390/pharmaceutics15041158.