Controlled-Release Systems for Biologics

It is evident by the progress in new drug delivery technologies that much attention has been devoted toward the way in which biologics are delivered. As shown in this chapter, present efforts in the field of delivery of biologics have accelerated and widened the possibility of their use with therapeutic agents for treatment of various chronic disorders. From the times when achieving a zero-order release profile was just an imaginary concept and controlled release technology was known only to a few scientists, it has now been established widely and has gained significant applications in variety of fields ranging from gene therapy to tissue engineering. Keywords: controlled release technology; biologic delivery; polymeric delivery systems; composite delivery systems

[1]  K. Roy,et al.  Gene delivery with in-situ crosslinking polymer networks generates long-term systemic protein expression. , 2003, Molecular therapy : the journal of the American Society of Gene Therapy.

[2]  K. Letchford,et al.  A review of the formation and classification of amphiphilic block copolymer nanoparticulate structures: micelles, nanospheres, nanocapsules and polymersomes. , 2007, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[3]  U. Banerjee,et al.  Biotechnological applications of cyclodextrins. , 2002, Biotechnology advances.

[4]  Heungsoo Shin,et al.  Development of functional fibrous matrices for the controlled release of basic fibroblast growth factor to improve therapeutic angiogenesis. , 2010, Tissue engineering. Part A.

[5]  Kinam Park,et al.  Controlled Drug Delivery: Present and Future , 2000 .

[6]  J. A. Kessler,et al.  Emerging peptide nanomedicine to regenerate tissues and organs , 2010, Journal of internal medicine.

[7]  Jagdish Singh,et al.  In vivo absorption of steroidal hormones from smart polymer based delivery systems. , 2010, Journal of pharmaceutical sciences.

[8]  K. Lee,et al.  Controlled delivery of heat shock protein using an injectable microsphere/hydrogel combination system for the treatment of myocardial infarction. , 2009, Journal of controlled release : official journal of the Controlled Release Society.

[9]  J. Gottesman,et al.  Evaluation of an implant that delivers leuprolide for 1 year for the palliative treatment of prostate cancer. , 2000, Urology.

[10]  C. Bucana,et al.  Analysis of the fate of systemically administered liposomes and implications for their use in drug delivery. , 1982, Cancer research.

[11]  Bochu Wang,et al.  Preparation and characterization of liposomes-in-alginate (LIA) for protein delivery system. , 2006, Colloids and surfaces. B, Biointerfaces.

[12]  Alexander V Kabanov,et al.  Nanogels for oligonucleotide delivery to the brain. , 2004, Bioconjugate chemistry.

[13]  P. Carmeliet,et al.  3D systems delivering VEGF to promote angiogenesis for tissue engineering. , 2011, Journal of controlled release : official journal of the Controlled Release Society.

[14]  K. Lee,et al.  Injectable microsphere/hydrogel combination systems for localized protein delivery. , 2009, Macromolecular bioscience.

[15]  V. M. Knepp,et al.  Stability of Nonaqueous Suspension Formulations of Plasma Derived Factor IX and Recombinant Human Alpha Interferon at Elevated Temperatures , 1998, Pharmaceutical Research.

[16]  Viness Pillay,et al.  A Review on Composite Liposomal Technologies for Specialized Drug Delivery , 2011, Journal of drug delivery.

[17]  V. Sinha,et al.  Biodegradable microspheres for protein delivery. , 2003, Journal of controlled release : official journal of the Controlled Release Society.

[18]  F. Veiga,et al.  Microencapsulation of hemoglobin in chitosan-coated alginate microspheres prepared by emulsification/internal gelation , 2005, The AAPS Journal.

[19]  G. Betageri,et al.  Comparative Assessment of In Vitro Release Kinetics of Calcitonin Polypeptide from Biodegradable Microspheres , 2002, Drug delivery.

[20]  R. Langer,et al.  Enhancement of poly(orthoester) microspheres for DNA vaccine delivery by blending with poly(ethylenimine). , 2008, Biomaterials.

[21]  Jagdish Singh,et al.  Thermosensitive Drug Delivery System of Salmon Calcitonin: In Vitro Release, In Vivo Absorption, Bioactivity and Therapeutic Efficacies , 2010, Pharmaceutical Research.

[22]  Soriano,et al.  The role of PEG on the stability in digestive fluids and in vivo fate of PEG-PLA nanoparticles following oral administration. , 2000, Colloids and surfaces. B, Biointerfaces.

[23]  Jagdish Singh,et al.  Phase-sensitive polymer-based controlled delivery systems of leuprolide acetate: in vitro release, biocompatibility, and in vivo absorption in rabbits. , 2007, International journal of pharmaceutics.

[24]  U. Gietz,et al.  Sustained release of injectable zinc-recombinant hirudin suspensions: development and validation of in vitro release model. , 1998, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[25]  Tsuyoshi Shimoboji,et al.  Hybrid hyaluronan hydrogel encapsulating nanogel as a protein nanocarrier: new system for sustained delivery of protein with a chaperone-like function. , 2010, Journal of controlled release : official journal of the Controlled Release Society.

[26]  T. Park,et al.  Controlled release of plasmid DNA from photo-cross-linked pluronic hydrogels. , 2005, Biomaterials.

[27]  N. Mishra,et al.  Biodegradable Polymer Based Particulate Carrier(s) for the Delivery of Proteins and Peptides , 2008 .

[28]  Jagdish Singh,et al.  Basal level insulin delivery: in vitro release, stability, biocompatibility, and in vivo absorption from thermosensitive triblock copolymers. , 2011, Journal of pharmaceutical sciences.

[29]  H. Ravivarapu,et al.  Sustained suppression of pituitary-gonadal axis with an injectable, in situ forming implant of leuprolide acetate. , 2000, Journal of pharmaceutical sciences.

[30]  Cato T Laurencin,et al.  Biomedical Applications of Biodegradable Polymers. , 2011, Journal of polymer science. Part B, Polymer physics.

[31]  D. Mooney,et al.  Hydrogels for tissue engineering. , 2001, Chemical Reviews.

[32]  Q. Ye,et al.  DepoFoam technology: a vehicle for controlled delivery of protein and peptide drugs. , 2000, Journal of controlled release : official journal of the Controlled Release Society.

[33]  M. Akashi,et al.  Influenza hemagglutinin vaccine with poly(gamma-glutamic acid) nanoparticles enhances the protection against influenza virus infection through both humoral and cell-mediated immunity. , 2007, Vaccine.

[34]  V. Zecchi,et al.  Chitosan microcapsules as controlled release systems for insulin. , 1997, Journal of microencapsulation.

[35]  Z. Dai,et al.  Novel iron-polysaccharide multilayered microcapsules for controlled insulin release. , 2009, Acta biomaterialia.

[36]  D. Putnam,et al.  Poly(lactic acid)-poly(ethylene glycol) nanoparticles as new carriers for the delivery of plasmid DNA. , 2001, Journal of controlled release : official journal of the Controlled Release Society.

[37]  M. Brandl.  Vesicular Phospholipid Gels: A Technology Platform , 2007, Journal of liposome research.

[38]  R Langer,et al.  Responsive polymeric delivery systems. , 2001, Advanced drug delivery reviews.

[39]  R. Gelberman,et al.  Controlled-release kinetics and biologic activity of platelet-derived growth factor-BB for use in flexor tendon repair. , 2008, The Journal of hand surgery.

[40]  E. Mathiowitz,et al.  Nanosphere based oral insulin delivery. , 2000, Journal of controlled release : official journal of the Controlled Release Society.

[41]  S. Bhaskaran,et al.  Recent trends in vaccine delivery systems: A review , 2011, International journal of pharmaceutical investigation.

[42]  Jagdish Singh,et al.  Evaluation of polyanhydride microspheres for basal insulin delivery: Effect of copolymer composition and zinc salt on encapsulation, in vitro release, stability, in vivo absorption and bioactivity in diabetic rats. , 2009, Journal of pharmaceutical sciences.

[43]  M. Hamori,et al.  Controlled release of insulin from self-assembling nanofiber hydrogel, PuraMatrix™: application for the subcutaneous injection in rats. , 2012, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[44]  M. Brandl.  Vesicular phospholipid gels. , 2010, Methods in molecular biology.

[45]  Antonios G Mikos,et al.  In vitro release of plasmid DNA from oligo(poly(ethylene glycol) fumarate) hydrogels. , 2005, Journal of controlled release : official journal of the Controlled Release Society.

[46]  Lonnie D Shea,et al.  Non-viral vector delivery from PEG-hyaluronic acid hydrogels. , 2007, Journal of controlled release : official journal of the Controlled Release Society.

[47]  Philip H Long,et al.  Medical Devices in Orthopedic Applications , 2008, Toxicologic pathology.

[48]  A. Oliva,et al.  A mathematical model for interpreting in vitro rhGH release from laminar implants. , 2006, International journal of pharmaceutics.

[49]  Shuguang Zhang,et al.  Controlled release of functional proteins through designer self-assembling peptide nanofiber hydrogel scaffold , 2009, Proceedings of the National Academy of Sciences.

[50]  V V Ranade,et al.  Drug Delivery Systems 4. Implants in Drug Delivery , 1990, Journal of clinical pharmacology.

[51]  S. W. Kim,et al.  Polyethylene Glycol-Conjugated Copolymers for Plasmid DNA Delivery , 2004, Pharmaceutical Research.

[52]  H. Sah,et al.  The influence of biodegradable microcapsule formulations on the controlled release of a protein , 1994 .

[53]  Kinam Park,et al.  Biodegradable Polymers for Microencapsulation of Drugs , 2005, Molecules.

[54]  Mehrdad Hamidi,et al.  Applications of carrier erythrocytes in delivery of biopharmaceuticals. , 2007, Journal of controlled release : official journal of the Controlled Release Society.

[55]  Ronald A Rader,et al.  (Re)defining biopharmaceutical , 2008, Nature Biotechnology.

[56]  M. Brandl,et al.  Development and in vitro evaluation of a liposome based implant formulation for the decapeptide cetrorelix. , 2005, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[57]  Guangdong Zhou,et al.  A novel method for the direct fabrication of growth factor-loaded microspheres within porous nondegradable hydrogels: controlled release for cartilage tissue engineering. , 2012, Journal of controlled release : official journal of the Controlled Release Society.

[58]  J. Benoit,et al.  Protein-loaded PLGA-PEG-PLGA microspheres: a tool for cell therapy. , 2012, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[59]  Ge Jiang,et al.  Preparation and characterization of poly(D,L-lactide-co-glycolide) microspheres for controlled release of human growth hormone , 2008, AAPS PharmSciTech.

[60]  M. Danquah,et al.  Synthesis of biodegradable polymer-mesoporous silica composite microspheres for DNA prime-protein boost vaccination. , 2010, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[61]  Jagdish Singh,et al.  Smart polymer based delivery systems for peptides and proteins. , 2007, Recent patents on drug delivery & formulation.

[62]  F. Andreopoulos,et al.  Delivery of basic fibroblast growth factor (bFGF) from photoresponsive hydrogel scaffolds. , 2006, Biomaterials.

[63]  S. Bulut,et al.  Slow release and delivery of antisense oligonucleotide drug by self-assembled peptide amphiphile nanofibers. , 2011, Biomacromolecules.

[64]  P. de Vos,et al.  Alginate-based microcapsules for immunoisolation of pancreatic islets. , 2006, Biomaterials.

[65]  F. Hsu,et al.  The Collagen-Containing Alginate/Poly(L-Lysine)/Alginate Microcapsules , 2000, Artificial cells, blood substitutes, and immobilization biotechnology.

[66]  Kristi S Anseth,et al.  DNA delivery from photocrosslinked PEG hydrogels: encapsulation efficiency, release profiles, and DNA quality. , 2004, Journal of controlled release : official journal of the Controlled Release Society.

[67]  H. Yoo,et al.  DNA nanogels composed of chitosan and Pluronic with thermo-sensitive and photo-crosslinking properties. , 2009, International journal of pharmaceutics.

[68]  B. Gander,et al.  Ultrasonic atomisation into reduced pressure atmosphere--envisaging aseptic spray-drying for microencapsulation. , 2004, Journal of controlled release : official journal of the Controlled Release Society.

[69]  V. Jain,et al.  Comparison of humoral and cell-mediated immune responses to cationic PLGA microspheres containing recombinant hepatitis B antigen. , 2011, International journal of pharmaceutics.

[70]  Yi Shi,et al.  Current advances in sustained-release systems for parenteral drug delivery , 2005, Expert opinion on drug delivery.

[71]  Jagdish Singh,et al.  Controlled release of growth hormone from thermosensitive triblock copolymer systems: In vitro and in vivo evaluation. , 2008, International journal of pharmaceutics.

[72]  P. Anderson,et al.  Cytokines in liposomes: preliminary studies with IL-1, IL-2, IL-6, GM-CSF and interferon-gamma. , 1994, Cytokine.

[73]  Xianghui Yu,et al.  Controlled release of PEI/DNA complexes from mannose-bearing chitosan microspheres as a potent delivery system to enhance immune response to HBV DNA vaccine , 2007, Journal of Controlled Release.

[74]  J. Fariña,et al.  Biodegradable laminar implants for sustained release of recombinant human growth hormone. , 2002, Biomaterials.

[75]  B. Liu,et al.  Controlled release of PEI/DNA complexes from PLGA microspheres as a potent delivery system to enhance immune response to HIV vaccine DNA prime/MVA boost regime. , 2008, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[76]  M. Machluf,et al.  Enhancing the immunogenicity of liposomal hepatitis B surface antigen (HBsAg) by controlling its delivery from polymeric microspheres. , 2000, Journal of pharmaceutical sciences.

[77]  Christophe Egles,et al.  Self-Assembling Peptide Nanofiber Scaffolds Accelerate Wound Healing , 2008, PloS one.

[78]  F. Cui,et al.  Combination of Hyaluronic Acid Hydrogel Scaffold and PLGA Microspheres for Supporting Survival of Neural Stem Cells , 2011, Pharmaceutical Research.

[79]  M. Rafiee-Tehrani,et al.  Peroral delivery systems based on superporous hydrogel polymers: release characteristics for the peptide drugs buserelin, octreotide and insulin. , 2002, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[80]  V. Préat,et al.  Polymeric nanoparticles as delivery system for influenza virus glycoproteins. , 1998, Journal of controlled release : official journal of the Controlled Release Society.

[81]  M. Brandon,et al.  Injectable silicone implants as vaccine delivery vehicles. , 2002, Vaccine.

[82]  Pradeep Tyagi,et al.  Controlled Gene Delivery System Based on Thermosensitive Biodegradable Hydrogel , 2003, Pharmaceutical Research.

[83]  R. Titball,et al.  DNA vaccines for biodefence. , 2005, Advanced drug delivery reviews.

[84]  A. Pavlou,et al.  Monoclonal antibodies market , 2004, Nature Reviews Drug Discovery.

[85]  Jagdish Singh,et al.  Thermosensitive Polymers for Controlled Delivery of Hormones , 2011 .

[86]  Y. Yamaguchi,et al.  Insulin-loaded biodegradable PLGA microcapsules: initial burst release controlled by hydrophilic additives. , 2002, Journal of controlled release : official journal of the Controlled Release Society.

[87]  Raul Machado,et al.  Thermoresponsive self-assembled elastin-based nanoparticles for delivery of BMPs. , 2010, Journal of controlled release : official journal of the Controlled Release Society.

[88]  G. Winter,et al.  Continuous release of rh-interferon α-2a from triglyceride matrices , 2004 .

[89]  Nevin Celebi,et al.  Controlled delivery of peptides and proteins. , 2007, Current pharmaceutical design.

[90]  Hanne Mørck Nielsen,et al.  High loading efficiency and sustained release of siRNA encapsulated in PLGA nanoparticles: quality by design optimization and characterization. , 2011, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[91]  B. Shin,et al.  Poly(L-lactic acid)/polyethylenimine nanoparticles as plasmid DNA carriers , 2008, Archives of pharmacal research.

[92]  Jayanth Panyam,et al.  Rapid endo‐lysosomal escape of poly(DL‐lactide‐coglycolide) nanoparticles: implications for drug and gene delivery , 2002, FASEB journal : official publication of the Federation of American Societies for Experimental Biology.

[93]  S. Schwendeman,et al.  Characterization of the initial burst release of a model peptide from poly(D,L-lactide-co-glycolide) microspheres. , 2002, Journal of controlled release : official journal of the Controlled Release Society.

[94]  P. Kerkhofs,et al.  Delivery of DNA vaccines by agarose hydrogel implants facilitates genetic immunization in cattle. , 2007, Vaccine.

[95]  R. Vandenbroucke,et al.  Polyelectrolyte LbL microcapsules versus PLGA microparticles for immunization with a protein antigen. , 2012, Journal of controlled release : official journal of the Controlled Release Society.

[96]  Jagdish Singh,et al.  Insulin loaded PLGA microspheres: effect of zinc salts on encapsulation, release, and stability. , 2009, Journal of pharmaceutical sciences.

[97]  M. Fonseca,et al.  Coating liposomes with collagen (Mr 50,000) increases uptake into liver. , 1996, Biochimica et biophysica acta.

[98]  A. Gabizon,et al.  Sterically stabilized liposomes: improvements in pharmacokinetics and antitumor therapeutic efficacy. , 1991, Proceedings of the National Academy of Sciences of the United States of America.

[99]  Jagdish Singh,et al.  Controlled delivery of basal level of insulin from chitosan-zinc-insulin-complex-loaded thermosensitive copolymer. , 2012, Journal of pharmaceutical sciences.

[100]  Liming Bian,et al.  Enhanced MSC chondrogenesis following delivery of TGF-β3 from alginate microspheres within hyaluronic acid hydrogels in vitro and in vivo. , 2011, Biomaterials.

[101]  Murali M. Yallapu,et al.  Design and engineering of nanogels for cancer treatment. , 2011, Drug discovery today.

[102]  M. Brandl,et al.  Vesicular phospholipid gel-based depot formulations for pharmaceutical proteins: development and in vitro evaluation. , 2010, Journal of controlled release : official journal of the Controlled Release Society.

[103]  Y. Bae,et al.  Role of a novel excipient poly(ethylene glycol)-b-poly(L-histidine) in retention of physical stability of insulin at aqueous/organic interface. , 2007, Molecular pharmaceutics.

[104]  D. Huo,et al.  Fabrication of Degradable Microsphere/PNIPAAm Hydrogel Combination Systems for Protein Delivery , 2010 .

[105]  Marilena Loizidou,et al.  Liposomes and nanoparticles: nanosized vehicles for drug delivery in cancer. , 2009, Trends in pharmacological sciences.

[106]  K. Mäder,et al.  Controlled delivery of nanosuspensions from osmotic pumps: zero order and non-zero order kinetics. , 2012, Journal of controlled release : official journal of the Controlled Release Society.

[107]  H. Merkle,et al.  Microencapsulation of DNA using poly(DL-lactide-co-glycolide): stability issues and release characteristics. , 1999, Journal of controlled release : official journal of the Controlled Release Society.

[108]  N. Wagner,et al.  The effect of protein structure on their controlled release from an injectable peptide hydrogel. , 2010, Biomaterials.

[109]  J L Cleland,et al.  Emerging protein delivery methods. , 2001, Current opinion in biotechnology.

[110]  P. Alexandridis,et al.  Physicochemical aspects of drug delivery and release from polymer-based colloids , 2000 .

[111]  David J. Mooney,et al.  DNA delivery from polymer matrices for tissue engineering , 1999, Nature Biotechnology.

[112]  Sílvia A. Ferreira,et al.  Self‐assembled dextrin nanogel as protein carrier: Controlled release and biological activity of IL‐10 , 2011, Biotechnology and bioengineering.

[113]  T. Thundat,et al.  Degradable thermoresponsive nanogels for protein encapsulation and controlled release. , 2012, Bioconjugate chemistry.

[114]  Jagdish Singh,et al.  Poly (lactide-co-glycolide)-Polymethacrylate Nanoparticles for Intramuscular Delivery of Plasmid Encoding Interleukin-10 to Prevent Autoimmune Diabetes in Mice , 2008, Pharmaceutical Research.

[115]  Mehrdad Hamidi,et al.  Hydrogel nanoparticles in drug delivery. , 2008, Advanced drug delivery reviews.

[116]  V. Nagaraja,et al.  Reversible polyelectrolyte capsules as carriers for protein delivery. , 2010, Colloids and surfaces. B, Biointerfaces.

[117]  D. Mishell,et al.  Norplant: subdermal implant system for long-term contraception. , 1989, American journal of obstetrics and gynecology.

[118]  Craig L Duvall,et al.  Sustained VEGF delivery via PLGA nanoparticles promotes vascular growth. , 2010, American journal of physiology. Heart and circulatory physiology.

[119]  V. Cullins.  Injectable and implantable contraceptives , 1992, Current opinion in obstetrics & gynecology.

[120]  M. Farina,et al.  Microcapsules of alginate/chitosan containing magnetic nanoparticles for controlled release of insulin. , 2010, Colloids and surfaces. B, Biointerfaces.

[121]  A. Grodzinsky,et al.  Growth Factor Delivery Through Self-assembling Peptide Scaffolds , 2011, Clinical orthopaedics and related research.

[122]  M. Patarroyo,et al.  Remarkably high antibody levels and protection against P. falciparum malaria in Aotus monkeys after a single immunisation of SPf66 encapsulated in PLGA microspheres. , 2002, Vaccine.

[123]  R. A. Jain,et al.  The manufacturing techniques of various drug loaded biodegradable poly(lactide-co-glycolide) (PLGA) devices. , 2000, Biomaterials.

[124]  Byung Soo Kim,et al.  BSA-FITC-loaded microcapsules for in vivo delivery. , 2009, Biomaterials.

[125]  V. Kadam,et al.  Nanogel Engineered Polymeric Micelles for Drug Delivery , 2008 .