Preparation and Characterization of Poly(D,L-lactide-co-glycolide) Microspheres for Controlled Release of Human Growth Hormone

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Preparation and Characterization of Poly(D,L-lactide-co-glycolide) Microspheres for Controlled Release of Human Growth Hormone
2003
Yilmaz Capan,1 Ge Jiang,2 Stefano Giovagnoli,3 Kyu-Heum Na,4 and Patrick P. DeLuca5
1Hacettepe University, Ankara, Turkey
2BD Technologies, Research Triangle Park, NC 27709-2016
3Dept of Chemistry and Technology of Drugs, University of Perugia, 06123 Perugia, Italy
4Research Laboratories, Dong-A Pharm Co, Ltd, 47-5, Sanggal-ri, Kiheung-up, Youngin-si, Kyunggi-do 449-905, Korea
5University of Kentucky College of Pharmacy, Faculty of Pharmaceutical Sciences, Lexington, KY 40536-0082
AAPS PharmSciTech. 2003; 4(2): article 28.
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Abstract
The purpose of this research was to assess the physicochemical properties of a controlled release formulation of recombinant human growth hormone (rHGH) encapsulated in poly(D,L-lactide-co-glycolide) (PLGA) composite microspheres. rHGH was loaded in poly(acryloyl hydroxyethyl) starch (acHES) microparticles, and then the protein-containing microparticles were encapsulated in the PLGA matrix by a solvent extraction/evaporation method. rHGH-loaded PLGA microspheres were also prepared using mannitol without the starch hydrogel microparticle microspheres for comparison. The detection of secondary structure changes in protein was investigated by using a Fourier Transfer Infrared (FTIR) technique. The composite microspheres were spherical in shape (44.6 ? 2.47 ?m), and the PLGA-mannitol microspheres were 39.7 ? 2.50 ?m. Drug-loading efficiency varied from 93.2% to 104%. The composite microspheres showed higher overall drug release than the PLGA/mannitol microspheres. FTIR analyses indicated good stability and structural integrity of HGH localized in the microspheres. The PLGA-acHES composite microsphere system could be useful for the controlled delivery of protein drugs.
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