Controlled release of octreotide and assessment of peptide acylation from poly(D,L-lactide-co-hydroxymethyl glycolide) compared to PLGA microspheres

Pharm Res. 2012 Jan;29(1):110-20. doi: 10.1007/s11095-011-0517-3. Epub 2011 Jul 9.

Abstract

Purpose: To investigate the in vitro release of octreotide acetate, a somatostatin agonist, from microspheres based on a hydrophilic polyester, poly(D,L-lactide-co-hydroxymethyl glycolide) (PLHMGA).

Methods: Spherical and non-porous octreotide-loaded PLHMGA microspheres (12 to 16 μm) and loading efficiency of 60-70% were prepared by a solvent evaporation. Octreotide release profiles were compared with commercial PLGA formulation (Sandostatin LAR(®)); possible peptide modification with lactic, glycolic and hydroxymethyl glycolic acid units was monitored.

Results: PLHMGA microspheres showed burst release (~20%) followed by sustained release for 20-60 days, depending on the hydrophilicity of the polymer. Percentage of released loaded peptide was high (70-90%); > 60% of released peptide was native octreotide. PLGA microspheres did not show peptide release for the first 10 days, after which it was released in a sustained manner over the next 90 days; > 75% of released peptides were acylated adducts.

Conclusions: PLHMGA microspheres are promising controlled systems for peptides with excellent control over release kinetics. Moreover, substantially less peptide modification occurred in PLHMGA than in PLGA microspheres.

MeSH terms

  • Acromegaly / drug therapy
  • Acylation
  • Antineoplastic Agents, Hormonal / administration & dosage
  • Antineoplastic Agents, Hormonal / chemistry
  • Antineoplastic Agents, Hormonal / pharmacokinetics*
  • Delayed-Action Preparations / pharmacokinetics
  • Drug Carriers / chemistry*
  • Drug Carriers / pharmacokinetics
  • Glycolates / chemistry
  • Humans
  • Hydrogen-Ion Concentration
  • Lactic Acid / chemistry*
  • Microscopy, Electron, Scanning
  • Microspheres*
  • Neuroendocrine Tumors / drug therapy
  • Octreotide / administration & dosage
  • Octreotide / chemistry
  • Octreotide / pharmacokinetics*
  • Polyesters / chemistry*
  • Polyglycolic Acid / chemistry*
  • Polylactic Acid-Polyglycolic Acid Copolymer
  • Somatostatin / agonists*
  • Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

Substances

  • Antineoplastic Agents, Hormonal
  • Delayed-Action Preparations
  • Drug Carriers
  • Glycolates
  • Polyesters
  • poly(lactic-co-hydroxymethyl glycolic acid)
  • poly(lactide-co-hydroxymethyl glycolide)
  • glycolic acid
  • Polylactic Acid-Polyglycolic Acid Copolymer
  • Polyglycolic Acid
  • Lactic Acid
  • Somatostatin
  • Octreotide