PMID- 30141117
OWN - NLM
STAT- MEDLINE
DCOM- 20190626
LR  - 20190626
IS  - 1573-904X (Electronic)
IS  - 0724-8741 (Linking)
VI  - 35
IP  - 10
DP  - 2018 Aug 23
TI  - Formulation of High-Performance Dry Powder Aerosols for Pulmonary Protein 
      Delivery.
PG  - 195
LID - 10.1007/s11095-018-2452-z [doi]
AB  - PURPOSE: Pulmonary delivery of biologics is of great interest, as it can be used 
      for the local treatment of respiratory diseases or as a route to systemic drug 
      delivery. To reach the full potential of inhaled biologics, a formulation 
      platform capable of producing high performance aerosols without altering protein 
      native structure is required. METHODS: A formulation strategy using Particle 
      Replication in Non-wetting Templates (PRINT) was developed to produce protein dry 
      powders with precisely engineered particle morphology. Stability of the 
      incorporated proteins was characterized and the aerosol properties of the protein 
      dry powders was evaluated in vitro with an Andersen Cascade Impactor (ACI). 
      RESULTS: Model proteins bovine serum albumin (BSA) and lysozyme were micromolded 
      into 1 mum cylinders composed of more than 80% protein, by mass. Extensive 
      characterization of the incorporated proteins found no evidence of alteration of 
      native structures. The BSA formulation produced a mass median aerodynamic 
      diameter (MMAD) of 1.77 mum +/- 0.06 and a geometric standard deviation (GSD) of 
      1.51 +/- 0.06 while the lysozyme formulation had an MMAD of 1.83 mum +/- 0.12 and a 
      GSD of 1.44 +/- 0.03. CONCLUSION: Protein dry powders manufactured with PRINT could 
      enable high-performance delivery of protein therapeutics to the lungs.
FAU - Wilson, Erin M
AU  - Wilson EM
AD  - Division of Pharmacoengineering and Molecular Pharmaceutics Eshelman School of 
      Pharmacy, University of North Carolina at Chapel Hill,, Chapel Hill, North 
      Carolina, USA.
FAU - Luft, J Christopher
AU  - Luft JC
AD  - Division of Pharmacoengineering and Molecular Pharmaceutics Eshelman School of 
      Pharmacy, University of North Carolina at Chapel Hill,, Chapel Hill, North 
      Carolina, USA.
FAU - DeSimone, Joseph M
AU  - DeSimone JM
AD  - Division of Pharmacoengineering and Molecular Pharmaceutics Eshelman School of 
      Pharmacy, University of North Carolina at Chapel Hill,, Chapel Hill, North 
      Carolina, USA. desimone@unc.edu.
AD  - Department of Chemistry, University of North Carolina at Chapel Hill, Chapel 
      Hill, North Carolina, USA. desimone@unc.edu.
AD  - Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel 
      Hill,, Chapel Hill, North Carolina, USA. desimone@unc.edu.
AD  - Department of Chemical and Biomolecular Engineering, North Carolina State 
      University,, Raleigh, North Carolina, USA. desimone@unc.edu.
LA  - eng
GR  - HDTRA1-13-1-0045/Defense Threat Reduction Agency/
PT  - Journal Article
DEP - 20180823
PL  - United States
TA  - Pharm Res
JT  - Pharmaceutical research
JID - 8406521
RN  - 0 (Aerosols)
RN  - 0 (Powders)
RN  - 27432CM55Q (Serum Albumin, Bovine)
SB  - IM
MH  - Administration, Inhalation
MH  - Aerosols/*chemistry
MH  - Chemistry, Pharmaceutical
MH  - Drug Delivery Systems/methods
MH  - Dry Powder Inhalers
MH  - Humans
MH  - *Lung
MH  - Particle Size
MH  - Powders/*chemistry
MH  - Serum Albumin, Bovine/*chemistry
OTO - NOTNLM
OT  - aerosols
OT  - dry powder inhalers
OT  - particle engineering
OT  - pulmonary protein delivery
EDAT- 2018/08/25 06:00
MHDA- 2019/06/27 06:00
CRDT- 2018/08/25 06:00
PHST- 2018/05/04 00:00 [received]
PHST- 2018/06/20 00:00 [accepted]
PHST- 2018/08/25 06:00 [entrez]
PHST- 2018/08/25 06:00 [pubmed]
PHST- 2019/06/27 06:00 [medline]
AID - 10.1007/s11095-018-2452-z [pii]
AID - 10.1007/s11095-018-2452-z [doi]
PST - epublish
SO  - Pharm Res. 2018 Aug 23;35(10):195. doi: 10.1007/s11095-018-2452-z.