QBD Approach for Design and Characterization of Pramlintide Microspheres for Controlled Drug Release

SYMLIN® (pramlintide acetate) injection [package insert]. Wilmington, DE 19850: AstraZeneca Pharmaceuticals LP; 2015. USFDA pill.pdf.

Zhang C, Yang L, Wan F, Bera H, Cun D, Rantanen J, et al. Quality by design thinking in the development of long-acting injectable PLGA/PLA-based microspheres for peptide and protein drug delivery. Int J Pharm. 2020;585:119441. https://linkinghub.elsevier.com/retrieve/pii/S0378517320304257.

Xuan J, Lin Y, Huang J, Yuan F, Li X, Lu Y, et al. Exenatide-loaded PLGA microspheres with improved glycemic control: in vitro bioactivity and in vivo pharmacokinetic profiles after subcutaneous administration to SD rats. Peptides. 2013;46:172–9.https://linkinghub.elsevier.com/retrieve/pii/S0196978113002222.

Andhariya JV, Shen J, Choi S, Wang Y, Zou Y, Burgess DJ. Development of in vitro-in vivo correlation of parenteral naltrexone loaded polymeric microspheres. J Control Release. 2017;255:27–35. https://linkinghub.elsevier.com/retrieve/pii/S0168365917305096.

Mitragotri S, Burke PA, Langer R. Overcoming the challenges in administering biopharmaceuticals: formulation and delivery strategies. Nat Rev Drug Discov. 2014;13:655–72. https://www.nature.com/articles/nrd4363.

Wu Z, Zhao M, Zhang W, Yang Z, Xu S, Shang Q. Influence of drying processes on the structures, morphology and in vitro release profiles of risperidone-loaded PLGA microspheres. J Microencapsul. 2019;36:21–31. https://www.tandfonline.com/doi/full/10.1080/02652048.2019.1582723.

Kohno M, Andhariya JV, Wan B, Bao Q, Rothstein S, Hezel M, et al. The effect of PLGA molecular weight differences on risperidone release from microspheres. Int J Pharm. 2020;582:119339. https://linkinghub.elsevier.com/retrieve/pii/S0378517320303239.

Komati S, Swain S, Rao MEB, Jena BR, Unnam S, Dasi V. QBD-based design and characterization of mucoadhesive microspheres of quetiapine fumarate with improved oral bioavailability and brain biodistribution potential. Bull Fac Pharm, Cairo Univ. 2018;56:129–45. https://linkinghub.elsevier.com/retrieve/pii/S1110093118300310.

Hua Y, Su Y, Zhang H, Liu N, Wang Z, Gao X, et al. Poly(lactic-co-glycolic acid) microsphere production based on quality by design: a review. Drug Deliv. 2021;28:1342–55. https://www.tandfonline.com/doi/full/10.1080/10717544.2021.1943056.

Hales D, Vlase L, Porav SA, Bodoki A, Barbu-Tudoran L, Achim M, et al. A quality by design (QBD) study on enoxaparin sodium loaded polymeric microspheres for colon-specific delivery. Euro J Pharm Sci. 2017;100:249–61. https://linkinghub.elsevier.com/retrieve/pii/S0928098717300180.

Dorati R, DeTrizio A, Genta I, Grisoli P, Merelli A, Tomasi C, et al. An experimental design approach to the preparation of pegylated polylactide-co-glicolide gentamicin loaded microparticles for local antibiotic delivery. Mater Sci Eng C. 2016;58:909–17. https://linkinghub.elsevier.com/retrieve/pii/S0928493115303799.

Sunanda Laxmi P, Vidyavathi M, Venkata SKR. DoE approach for development of localized controlled release microspheres of Vancomycin for treatment of septic arthritis. Futur J Pharm Sci. 2021;7:235. https://fjps.springeropen.com/articles/10.1186/s43094-021-00382-5.

Rapalli VK, Banerjee S, Khan S, Jha PN, Gupta G, Dua K, et al. QBD-driven formulation development and evaluation of topical hydrogel containing ketoconazole loaded cubosomes. Materials Science and Engineering: C. 2021;119:111548. https://linkinghub.elsevier.com/retrieve/pii/S0928493120334664.

Costantino SGWCYYERMHKR, Christenson T, Yeah TY, Rickey ME, Hotz JM, Kumar R, et al. Polymer-based sustained release device. https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/7456254.

Kumskova N, Ermolenko Y, Osipova N, Semyonkin A, Kildeeva N, Gorshkova M, et al. How subtle differences in polymer molecular weight affect doxorubicin-loaded PLGA nanoparticles degradation and drug release. J Microencapsul. 2020;37:283–95.https://www.tandfonline.com/doi/full/10.1080/02652048.2020.1729885.

Ochi M, Wan B, Bao Q, Burgess DJ. Influence of PLGA molecular weight distribution on leuprolide release from microspheres. Int J Pharm. 2021;599:120450. https://linkinghub.elsevier.com/retrieve/pii/S0378517321002556.

Fu X, Ping Q, Gao Y. Effects of formulation factors on encapsulation efficiency and release behaviour in vitro of huperzine A-PLGA microspheres. J Microencapsul. 2005;22:705–14. http://www.tandfonline.com/doi/full/10.1080/02652040500162196.

Park H, Ha E, Kim J, Kim M. Injectable sustained‐release poly(lactic‐co‐glycolic acid) (PLGA) microspheres of exenatide prepared by supercritical fluid extraction of emulsion process based on a design of experiment approach. Bioeng Transl Med. 2023;8:e10485. https://aiche.onlinelibrary.wiley.com/doi/10.1002/btm2.10485.

Gu B, Burgess DJ. Prediction of dexamethasone release from PLGA microspheres prepared with polymer blends using a design of experiment approach. Int J Pharm. 2015;495:393–403. https://linkinghub.elsevier.com/retrieve/pii/S0378517315301873.

Varia U, Patel A, Katariya H, Detholia K. Formulation and optimization of polymeric agglomerates of Bosentan monohydrate by crystallo-co-agglomeration technique. Bull Natl Res Cent. 2022;46:156. https://BNRC.springeropen.com/articles/10.1186/s42269-022-00837-6.

Han J, Fitzpatrick J, Cronin K, Maidannyk V, Miao S. Particle size, powder properties and the breakage behaviour of infant milk formula. J Food Eng. 2021 292:110367. https://linkinghub.elsevier.com/retrieve/pii/S0260877420304532.

Emami J, Haghighi M, Rostami M, Minaiyan M. Development and validation of a new robust RP-HPLC method for simultaneous quantitation of insulin and pramlintide in non-invasive and smart glucose-responsive microparticles. Res Pharma Sci. 2022;17:594. https://journals.lww.com/10.4103/1735-5362.359428.

Lin X, Yang H, Su L, Yang Z, Tang X. Effect of size on the in vitro / in vivo drug release and degradation of exenatide-loaded PLGA microspheres. J Drug Deliv Sci Technol. 2018;45:346–56. https://linkinghub.elsevier.com/retrieve/pii/S1773224717308377.

Shen J, Choi S, Qu W, Wang Y, Burgess DJ. In vitro-in vivo correlation of parenteral risperidone polymeric microspheres. J Control Release. 2015;218:2–12. https://linkinghub.elsevier.com/retrieve/pii/S0168365915301516.

Gavini E, Chetoni P, Cossu M, Alvarez MG, Saettone MF, Giunchedi P. PLGA microspheres for the ocular delivery of a peptide drug, vancomycin using emulsification/spray-drying as the preparation method: in vitro/in vivo studies. Eur J Pharm Biopharm. 2004 ;57:207–12. https://linkinghub.elsevier.com/retrieve/pii/S0939641103002078.

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