A smart approach to enable preclinical studies in pharmaceutical industry: PLGA-based extended release formulation platform for subcutaneous applications

References

• Amidon GL, Lennernäs H, Shah VP, et al. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12(3):413–420.
   PubMed Web of Science ®Google Scholar
• Sánchez-Serrano I. Success in translational research: lessons from the development of bortezomib. Nat Rev Drug Discov. 2006;5(2):107–114.
   PubMed Web of Science ®Google Scholar
• Gullapalli R, Wong A, Brigham E, et al. Development of ALZET® osmotic pump compatible solvent compositions to solubilize poorly soluble compounds for preclinical studies. Drug Deliv. 2012;19(5):239–246.
   PubMed Web of Science ®Google Scholar
• Tan T, Watts SW, Davis RP. Drug delivery: enabling technology for drug discovery and development. iPRECIO® micro infusion pump: programmable, refillable, and implantable. Front Pharmacol. 2011;2:44.
   PubMed Web of Science ®Google Scholar
• Makadia HK, Siegel SJ. Poly lactic-co-glycolic acid (PLGA) as biodegradable controlled drug delivery carrier. Polymers. 2011;3(3):1377–1397.
   PubMed Web of Science ®Google Scholar
• Vilos C, Velasquez LA. Therapeutic strategies based on polymeric microparticles. J Biomed Biotechnol. 2012;2012:672760.
   PubMedGoogle Scholar
• Wang Y. FDA’s regulatory science program for generic PLA/PLGA-based drug products. Am Pharm Rev. 2016;19:5–9.
   Google Scholar
• Shen J, Choi S, Qu W, et al. In vitro–in vivo correlation of parenteral risperidone polymeric microspheres. J Control Release. 2015;218:2–12.
   PubMed Web of Science ®Google Scholar
• Wischke C, Schwendeman SP. Principles of encapsulating hydrophobic drugs in PLA/PLGA microparticles. Int J Pharm. 2008;364(2):298–327.
   PubMed Web of Science ®Google Scholar
• Kobayashi H, Watanabe R, Choyke PL. Improving conventional enhanced permeability and retention (EPR) effects; what is the appropriate target? Theranostics. 2014;4(1):81–89.
   Web of Science ®Google Scholar
• Dannenfelser RM, Yalkowsky SH. Data base of aqueous solubility for organic non-electrolytes. Sci Total Environ. 1991;109–110(C):625–628.
   Google Scholar
• Jain RA. The manufacturing techniques of various drug loaded biodegradable poly(lactide-co-glycolide) (PLGA) devices. Biomaterials. 2000;21(23):2475–2490.
   PubMed Web of Science ®Google Scholar
• Hamoudeh M, Diab R, Fessi H, et al. Paclitaxel-loaded microparticles for intratumoral administration via the TMT technique: preparation, characterization, and preliminary antitumoral evaluation. Drug Dev Ind Pharm. 2008;34(7):698–707.
   PubMed Web of Science ®Google Scholar
• Wang X, Yang L, Zhang H, et al. Fluorescent magnetic PEI-PLGA nanoparticles loaded with paclitaxel for concurrent cell imaging, enhanced apoptosis and autophagy in human brain cancer. Colloids Surf B Biointerfaces. 2018;172:708–717.
   PubMed Web of Science ®Google Scholar
• Yang C, Plackett D, Needham D, et al. PLGA and PHBV microsphere formulations and solid-state characterization: possible implications for local delivery of fusidic acid for the treatment and prevention of orthopaedic infections. Pharm Res. 2009;26(7):1644–1656.
   PubMed Web of Science ®Google Scholar
• Zaghloul AA, Mustafa F, Siddiqu A, et al. Biodegradable microparticulates of beta-estradiol: preparation and in vitro characterization. Drug Dev Ind Pharm. 2005;31(8):803–811.
   PubMed Web of Science ®Google Scholar
• Thote AJ, Chappell JT Jr., Gupta RB, et al. Reduction in the initial-burst release by surface crosslinking of PLGA microparticles containing hydrophilic or hydrophobic drugs. Drug Dev Ind Pharm. 2005;31(1):43–57.
   PubMed Web of Science ®Google Scholar
• Park CW, Lee HJ, Oh DW, et al. Preparation and in vitro/in vivo evaluation of PLGA microspheres containing norquetiapine for long-acting injection. Drug Des Dev Ther. 2018;12:711–719.
   PubMed Web of Science ®Google Scholar
• Ayoub MM, Elantouny NG, El-Nahas HM, et al. Injectable PLGA adefovir microspheres; the way for long term therapy of chronic hepatitis-B. Eur J Pharm Sci. 2018;118:24–31.
   PubMed Web of Science ®Google Scholar
• Xie X, Lin W, Xing C, et al. In vitro and in vivo evaluations of PLGA microspheres containing nalmefene. PLoS One. 2015;10(5):e0125953.
   PubMed Web of Science ®Google Scholar
• Gomez C, Blanco MD, Bernardo MV, et al. Cytarabine release from comatrices of albumin microspheres in a poly(lactide-co-glycolide) film: in vitro and in vivo studies. Eur J Pharm Biopharm. 2004;57(2):225–233.
   PubMed Web of Science ®Google Scholar
• Han FY, Thurecht KJ, Whittaker AK, et al. Bioerodable PLGA-based microparticles for producing sustained-release drug formulations and strategies for improving drug loading. Front Pharmacol. 2016;7:185.
   PubMed Web of Science ®Google Scholar
• Park K, Skidmore S, Hadar J, et al. Injectable, long-acting PLGA formulations: analyzing PLGA and understanding microparticle formation. J Control Release. 2019;304:125–134.
   PubMed Web of Science ®Google Scholar
• Jaraswekin S, Prakongpan S, Bodmeier R. Effect of poly(lactide-co-glycolide) molecular weight on the release of dexamethasone sodium phosphate from microparticles. J Microencapsulation. 2007;24(2):117–128.
   PubMed Web of Science ®Google Scholar
• Sun F, Sui C, Teng L, et al. Studies on the preparation, characterization and pharmacological evaluation of tolterodine PLGA microspheres. Int J Pharm. 2010;397(1–2):44–49.
   PubMedGoogle Scholar
• Parumasivam T, Leung SS, Quan DH, et al. Rifapentine-loaded PLGA microparticles for tuberculosis inhaled therapy: preparation and in vitro aerosol characterization. Eur J Pharm Sci. 2016;88:1–11.
   PubMed Web of Science ®Google Scholar
• Yang Q, Owusu-Ababio G. Biodegradable progesterone microsphere delivery system for osteoporosis therapy. Drug Dev Ind Pharm. 2000;26(1):61–70.
   PubMed Web of Science ®Google Scholar
• Ramazani F, Chen W, van Nostrum CF, et al. Strategies for encapsulation of small hydrophilic and amphiphilic drugs in PLGA microspheres: state-of-the-art and challenges. Int J Pharm. 2016;499(1–2):358–367.
   PubMed Web of Science ®Google Scholar
• Ashton S, Song YH, Nolan J, et al. Aurora kinase inhibitor nanoparticles target tumors with favorable therapeutic index in vivo. Sci Transl Med. 2016;8(325):325ra17.
   PubMed Web of Science ®Google Scholar
• Zhang Z, Wang X, Li B, et al. Paclitaxel-loaded PLGA microspheres with a novel morphology to facilitate drug delivery and antitumor efficiency. RSC Adv. 2018;8(6):3274–3285.
   PubMed Web of Science ®Google Scholar
• Qutachi O, Vetsch JR, Gill D, et al. Injectable and porous PLGA microspheres that form highly porous scaffolds at body temperature. Acta Biomater. 2014;10(12):5090–5098.
   PubMed Web of Science ®Google Scholar
• Arpagaus C. PLA/PLGA nanoparticles prepared by nano spray drying. J Pharm Investig. 2019;49(4):405–426.
   Google Scholar
• Yu L. Amorphous pharmaceutical solids: preparation, characterization and stabilization. Adv Drug Deliv Rev. 2001;48(1):27–42.
   PubMed Web of Science ®Google Scholar
• Nežić I, Sander A, Meštrović E, et al. Production of stable amorphous form by means of spray drying. Part Sci Technol. 2019;37(5):632–638.
   Web of Science ®Google Scholar