Formulation design and in vivo evaluation of dry powder inhalation system of new vasoactive intestinal peptide derivative ([R(15, 20, 21), L(17), A(24,25), des-N(28)]-VIP-GRR) in experimental asthma/COPD model rats

Int J Pharm. 2011 May 30;410(1-2):54-60. doi: 10.1016/j.ijpharm.2011.03.021. Epub 2011 Mar 16.

Abstract

Vasoactive intestinal peptide (VIP) has been considered as a promising drug candidate for asthma and COPD because of its potent immunomodulating and anti-inflammatory activities. Recently, our group developed a new VIP derivative, [R(15, 20, 21), L(17), A(24,25), des-N(28)]-VIP-GRR (IK312548), with improved chemical and metabolic stability. In the present study, a dry powder inhaler system of IK312548 was designed for inhalation therapy with minimal systemic side effects, the physicochemical properties of which were also evaluated with a focus on morphology, particle size distribution, inhalation performance, and peptide stability. Laser diffraction and cascade impactor analysis suggested high dispersion and deposition in the respiratory organs with a fine particle fraction of 31.2%. According to UPLC/ESI-MS and circular dichroic spectral analyses, no significant changes in the purity and structure of VIP derivative were observed during preparation of respirable formulation. Anti-inflammatory properties of IK312548 respirable powder (RP) were characterized in antigen-sensitized asthma/COPD-model rats. There were marked inflammatory cells infiltrated into the lung tissues of experimental asthma/COPD-model rats; however, intratracheal administration of IK312548-RP led to significant reductions of recruited inflammatory cells in lung tissues and BALF by 72 and 78%, respectively. Thus, respirable powder formulation of IK312548 might be a promising medication for asthma, COPD, and other airway inflammatory diseases.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Animals
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / pharmacokinetics
  • Anti-Inflammatory Agents / pharmacology*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Disease Models, Animal
  • Drug Stability
  • Dry Powder Inhalers
  • Inflammation / drug therapy
  • Inflammation / physiopathology
  • Lung / drug effects
  • Lung / physiopathology
  • Male
  • Particle Size
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / physiopathology
  • Rats
  • Rats, Sprague-Dawley
  • Tissue Distribution
  • Vasoactive Intestinal Peptide / administration & dosage
  • Vasoactive Intestinal Peptide / analogs & derivatives*
  • Vasoactive Intestinal Peptide / pharmacokinetics
  • Vasoactive Intestinal Peptide / pharmacology

Substances

  • Anti-Inflammatory Agents
  • vasoactive intestinal peptide-glycyl-arginyl-arginine, arginyl(15,20,21)-leucyl(17)-alanyl(24,25)-desasparagyl(28)-
  • Vasoactive Intestinal Peptide