In vitro modeling of intramuscular injection site events

References

• Vinarov Z, Abdallah M, Agundez JAG, et al. Impact of gastrointestinal tract variability on oral drug absorption and pharmacokinetics: An UNGAP review. Eur J Pharm Sci. 2021 Jul 1;162:105812. 10.1016/j.ejps.2021.105812
   PubMed Web of Science ®Google Scholar
• Frayn KN, Karpe F. Regulation of human subcutaneous adipose tissue blood flow. Int J Obesity. 2014;38(8):1019–1026. doi: 10.1038/ijo.2013.200
   PubMed Web of Science ®Google Scholar
• Schneider A, Mueller P, Jordi C, et al. Hold the device against the skin: the impact of injection duration on user’s force for handheld autoinjectors. Expert Opin Drug Delivery. 2020;17(2):225–236.
   PubMed Web of Science ®Google Scholar
• Schneider A, Jost R, Jordi C, et al. Autoinjectors for large-volume subcutaneous drug delivery: a review of current research and future directions. Expert Opin Drug Delivery. 2023:1–16.
   Web of Science ®Google Scholar
• Frontera WR, Ochala J Skeletal muscle: a brief review of structure and function. Calcif Tissue Int. 2015 Mar;96(3):183–195.10.1007/s00223-014-9915-y
   PubMed Web of Science ®Google Scholar
• Evans EF, Proctor JD, Fratkin MJ, et al. Blood flow in muscle groups and drug absorption. Clin Pharmacol Ther. 1975 Jan;17(1):44–47. 10.1002/cpt197517144
   PubMed Web of Science ®Google Scholar
• Rodger MA, King L Drawing up and administering intramuscular injections: a review of the literature. J Adv Nurs. 2000 Mar;31(3):574–582. 10.1046/j.1365-2648.2000.01312.x
   PubMed Web of Science ®Google Scholar
• Diggle L. The WHO technique for intramuscular thigh vaccination in infants and toddlers had fewer adverse reactions than 2 other techniques. Evid Based Nurs. 2006 Jan;9(1):9.
   PubMedGoogle Scholar
• Ogston-Tuck S Intramuscular injection technique: an evidence-based approach. Nurs Stand. 2014 Sep;29(4):52–59. 10.7748/ns.29.4.52.e9183
   PubMedGoogle Scholar
• McCartan AJS, Curran DW, Mrsny RJ Evaluating parameters affecting drug fate at the intramuscular injection site. J Control Release. 2021 Aug 10;336:322–335.10.1016/j.jconrel.2021.06.023
   PubMed Web of Science ®Google Scholar
• Kearns C, Houghton C, Dickinson E, et al. What variables should inform needle length choice for deltoid intramuscular injection? A systematic review. BMJ Open. 2023;13(1):e063530. doi: 10.1136/bmjopen-2022-063530
   PubMed Web of Science ®Google Scholar
• Mishra P, Stringer M. Sciatic nerve injury from intramuscular injection: a persistent and global problem. Int J Clin Pract. 2010;64(11):1573–1579. doi: 10.1111/j.1742-1241.2009.02177.x
   PubMed Web of Science ®Google Scholar
• Larkin TA, Ashcroft E, Hickey BA, et al. Influence of gender, BMI and body shape on theoretical injection outcome at the ventrogluteal and dorsogluteal sites. J Clin Nursing. 2018;27(1–2):e242–e250.
   PubMed Web of Science ®Google Scholar
• Behrens R, Patel V. Avoiding shoulder injury from intramuscular vaccines. The Lancet. 2021;397(10273):471. doi: 10.1016/S0140-6736(21)00192-6
   PubMed Web of Science ®Google Scholar
• Correll CU, Kim E, Sliwa JK, et al. Pharmacokinetic characteristics of long-acting injectable antipsychotics for schizophrenia: an overview. CNS Drugs. 2021;35(1):39–59. doi: 10.1007/s40263-020-00779-5
   PubMed Web of Science ®Google Scholar
• Li W, Tang J, Lee D, et al.. Clinical translation of long-acting drug delivery formulations. Nat Rev Mater. 2022;7(5):406–420. doi: 10.1038/s41578-021-00405-w
   Web of Science ®Google Scholar
• Walling DP, Hassman HA, Anta L, et al. The Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM and Oral Risperidone: An Open-Label, One-Sequence Study. Drug Des Devel Ther. 2021;15:4371–4382. 10.2147/DDDT.S332026
   PubMed Web of Science ®Google Scholar
• Joiner JB, King JL, Shrivastava R, et al. Effects of Injection Volume and Route of Administration on Dolutegravir In Situ Forming Implant Pharmacokinetics. Pharmaceutics. 2022 Mar 11;14(3). 615 10.3390/pharmaceutics14030615
   PubMed Web of Science ®Google Scholar
• Ma Y, Cong Z, Gao P, et al. Nanosuspensions technology as a master key for nature products drug delivery and in vivo fate. Eur J Pharm Sci. 2023:106425. 185 10.1016/j.ejps.2023.106425
   PubMed Web of Science ®Google Scholar
• Pandya A, Vora L, Umeyor C, et al. Polymeric in situ forming depots for long-acting drug delivery systems. Adv Drug Del Rev. 2023:115003.
   PubMed Web of Science ®Google Scholar
• Zlotnikov ID, Malashkeevich SM, Belogurova NG, et al. Thermoreversible gels based on chitosan copolymers as “intelligent” drug delivery system with prolonged action for intramuscular injection. Pharmaceutics. 2023;15(5):1478. doi: 10.3390/pharmaceutics15051478
   PubMed Web of Science ®Google Scholar
• Shi Y, Lu A, Wang X, et al. A review of existing strategies for designing long-acting parenteral formulations: Focus on underlying mechanisms, and future perspectives. Acta Pharm Sin B. 2021 Aug;11(8):2396–2415.10.1016/j.apsb.2021.05.002
   PubMed Web of Science ®Google Scholar
• Qin M, Ye G, Xin J, et al. Comparison of in vivo behaviors of intramuscularly long-acting celecoxib nanosuspensions with different particle sizes for the postoperative pain treatment. Int J Pharm. 2023 Apr 5;636:122793. 10.1016/j.ijpharm.2023.122793
   PubMedGoogle Scholar
• Li S, Wang Z, Yu J, et al. Intramuscularly injected long-acting testosterone-cholesterol prodrug suspension with three different particle sizes: extended in vitro release and enhanced in vivo safety. Drug Deliv Transl Res. 2024 Apr;14(4):1093–1105. 10.1007/s13346-023-01460-2
   PubMedGoogle Scholar
• Rossier B, Jordan O, Allemann E, et al. Nanocrystals and nanosuspensions: an exploration from classic formulations to advanced drug delivery systems. Drug Deliv Transl Res. 2024 Mar 7. 10.1007/s13346-024-01559-0
   Web of Science ®Google Scholar
• Moutinho S Researchers and regulators plan for a future without lab animals. Nat Med. 2023 Sep;29(9):2151–2154.10.1038/s41591-023-02362-z.
   PubMed Web of Science ®Google Scholar
• ICH: S6(R1): Preclinical safety evaluation of biotechnology - derived pharmaceuticals - Step 5. European Medicines Agency; 2011.
   Google Scholar
• EMA regulatory science to 2025: strategic reflection. European Medicines Agency; 2020.
   Google Scholar
• • Official European documentation detailing the changing European guidelines, and how these were to be implemented in over the five year period of 2020 - 2025
   Google Scholar
• EMA regulatory science to 2025: Mid-point achievements to end 2022. European Medicines Agency; 2023.
   Google Scholar
• Purslow PP The structure and functional significance of variations in the connective tissue within muscle. Comp Biochem Physiol A Mol Integr Physiol. 2002 Dec;133(4):947–966. 10.1016/S1095-6433(02)00141-1
   PubMed Web of Science ®Google Scholar
• Daugherty AL, Mrsny RJ Local tissue distribution and cellular fate of vascular endothelial growth factor (VEGF) following intramuscular injection. J Drug Target. 2010 Jan;18(1):27–35. 10.3109/10611860903134317
   PubMed Web of Science ®Google Scholar
• Korthuis RJ. Anatomy of Skeletal Muscle and Its Vascular Supply. 2011. In: Skeletal Muscle Circulation [Internet]. San Rafael (CA): Morgan & Claypool Life Sciences.
   Google Scholar
• Probst M, Kühn JP, Scheuch E, et al. Simultaneous magnetic resonance imaging and pharmacokinetic analysis of intramuscular depots. J Control Release. 2016 Apr;227:1–12.10.1016/j.jconrel.2016.02.029
   PubMed Web of Science ®Google Scholar
• Kalicharan RW, Oussoren C, Schot P, et al. The contribution of the in-vivo fate of an oil depot to drug absorption. Int J Pharm. 2017 Aug 7;528(1–2):595–601. 10.1016/j.ijpharm.2017.06.055
   PubMedGoogle Scholar
• Groseclose MR, Castellino S. Intramuscular and subcutaneous drug depot characterization of a long-acting cabotegravir nanoformulation by MALDI IMS. Int J Mass Spectrom. 2019 Mar;437:92–98..
   Web of Science ®Google Scholar
• Piehl-Aulin K, Laurent C, Engström-Laurent A, et al. Hyaluronan in human skeletal muscle of lower extremity: concentration, distribution, and effect of exercise. J Appl Physiol 1985. 1991;71(6):2493.
   Google Scholar
• Fraser JRE, Laurent TC, Laurent UBG. Hyaluronan: its nature, distribution, functions and turnover. J Intern Med. 1997;242(1):27–33. doi: 10.1046/j.1365-2796.1997.00170.x
   PubMed Web of Science ®Google Scholar
• Loukas M, Shoja MM, Thurston T, et al. Anatomy and biomechanics of the vertebral aponeurosis part of the posterior layer of the thoracolumbar fascia. Surg Radiol Anat. 2008 Mar;30(2):125–129.10.1007/s00276-007-0291-4
   PubMed Web of Science ®Google Scholar
• Gordon MK, Hahn RA Collagens. Cell Tissue Res. 2010 Jan;339(1):247–257.10.1007/s00441-009-0844-4
   PubMed Web of Science ®Google Scholar
• Sloop CH, Dory L, Roheim PS Interstitial fluid lipoproteins. J Lipid Res. 1987 Mar;28(3):225–237. 10.1016/S0022-2275(20)38701-0
   PubMed Web of Science ®Google Scholar
• Fogh-Andersen N, Altura BM, Altura BT, et al. Composition of interstitial fluid. Clin Chem. 1995 Oct;41(10):1522–1525. 10.1093/clinchem/41.10.1522
   PubMed Web of Science ®Google Scholar
• Reed RK, Rubin K Transcapillary exchange: role and importance of the interstitial fluid pressure and the extracellular matrix. Cardiovasc Res. 2010 Jul;87(2):211–217. 10.1093/cvr/cvq143
   PubMed Web of Science ®Google Scholar
• Waterhouse BR, Farmery AD. The organization and composition of body fluids. Anaesth Intensive Care Med. 2012 Dec;13(12):603–608.
   Google Scholar
• Wiig H, Swartz MA Interstitial fluid and lymph formation and transport: physiological regulation and roles in inflammation and cancer. Physiol Rev. 2012 Jul;92(3):1005–1060. 10.1152/physrev.00037.2011
   PubMed Web of Science ®Google Scholar
• Turkina MV, Ghafouri N, Gerdle B, et al. Evaluation of dynamic changes in interstitial fluid proteome following microdialysis probe insertion trauma in trapezius muscle of healthy women. Sci Rep. 2017 03;7:43512. 1 10.1038/srep43512
   PubMedGoogle Scholar
• Roumelioti ME, Glew RH, Khitan ZJ, et al. Fluid balance concepts in medicine: Principles and practice. World J Nephrol. 2018 Jan;7(1):1–28. 10.5527/wjn.v7.i1.1
   PubMedGoogle Scholar
• Kumar V, Karon BS. Comparison of measured and calculated bicarbonate values. Clin Chem. 2008;54(9):1586–1587. doi: 10.1373/clinchem.2008.107441
   PubMed Web of Science ®Google Scholar
• Markhus CE, Wiig H Isolation of interstitial fluid from skeletal muscle and subcutis in mice using a wick method. Am J Physiol Heart Circ Physiol. 2004 Nov;287(5):H2085–90. 10.1152/ajpheart.00379.2004
   PubMed Web of Science ®Google Scholar
• Wang Z, Luan J, Seth A, et al.. Microneedle patch for the ultrasensitive quantification of protein biomarkers in interstitial fluid. Nat Biomed Eng. 2021;5(1):64–76. doi: 10.1038/s41551-020-00672-y
   PubMed Web of Science ®Google Scholar
• Samant PP, Prausnitz MR. Mechanisms of sampling interstitial fluid from skin using a microneedle patch. Proc Natl Acad Sci USA. 2018;115(18):4583–4588.
   PubMed Web of Science ®Google Scholar
• Zhivkova ZD. Studies on drug-human serum albumin binding: the current state of the matter. Curr Pharm Des. 2015;21(14):1817–30.
   PubMed Web of Science ®Google Scholar
• Kragh-Hansen U. Human Serum Albumin: A Multifunctional Protein. In: Otagiri M, Chuang VTG, editors. Albumin in Medicine: Pathological and Clinical Applications. Singapore: Springer Singapore; 2016. p. 1–24.
   Google Scholar
• Lännergren J, Bruton JD, Westerblad H. Vacuole formation in fatigued skeletal muscle fibres from frog and mouse: effects of extracellular lactate. J Physiol. 2000 Aug 01;526 Pt 3:597–611.
   PubMed Web of Science ®Google Scholar
• Oyane A, Kim HM, Furuya T, et al. Preparation and assessment of revised simulated body fluids. J Biomed Mater Res A. 2003 May 01;65(2):188–95.
   PubMedGoogle Scholar
• Marques M, Loebenberg R, Almukainzi M. Simulated Biological Fluids with Possible Application in Dissolution Testing. Dissolut Technol. 2011 AUG 2011;18(3):15–28.
   Web of Science ®Google Scholar
• Simon A, de Almeida Borges VR, Cabral LM, et al. Development and validation of a discriminative dissolution test for betamethasone sodium phosphate and betamethasone dipropionate intramuscular injectable suspension. AAPS PharmSciTech. 2013 Mar;14(1):425–434.10.1208/s12249-012-9920-2
   PubMed Web of Science ®Google Scholar
• Kinnunen HM, Sharma V, Contreras-Rojas LR, et al. A novel in vitro method to model the fate of subcutaneously administered biopharmaceuticals and associated formulation components. J Control Release. 2015 Sep;214:94–102.10.1016/j.jconrel.2015.07.016
   PubMed Web of Science ®Google Scholar
• Fountain WA, Naruse M, Claiborne A, et al. Low-dose aspirin and COX inhibition in human skeletal muscle. J Appl Physiol (1985). 202012 01;129(6):1477–1482.
   Google Scholar
• McCartan A, Mackay J, Curran D, et al. Modelling intramuscular drug fate in vitro with tissue-relevant biomimetic hydrogels. Int J Pharm X. 2022 Dec;4:100125.
   PubMedGoogle Scholar
• Li S, Wang R, Zhang M, et al. Proteomic analysis of non-small cell lung cancer tissue interstitial fluids. World J Surg Oncol. 2013 Aug 5;11:173. 1 10.1186/1477-7819-11-173
   PubMedGoogle Scholar
• Marunaka Y Roles of interstitial fluid pH in diabetes mellitus: Glycolysis and mitochondrial function. World J Diabetes. 2015 Feb;6(1):125–135. 10.4239/wjd.v6.i1.125
   PubMed Web of Science ®Google Scholar
• Reid MB, Shoji T, Moody MR, et al. Reactive oxygen in skeletal muscle. II. Extracellular release of free radicals. J Appl Physiol (1985). 1992Nov;73(5):1805–9.
   Google Scholar
• McCartan A. Modelling critical parameters of the intramuscular injection site. The University of Bath.2022.
   Google Scholar
• Henderson MA, Gillon S, Al-Haddad M. Organization and composition of body fluids. Anaesth Intensive Care Med. 2018 Oct;19(10):568–574.
   Google Scholar
• Torres-Terán I, Venczel M, Klein S Prediction of subcutaneous drug absorption-do we have reliable data to design a simulated interstitial fluid? Int J Pharm. 2021;610:121257. 10.1016/j.ijpharm.2021.121257
   PubMedGoogle Scholar
• Korte I, Brenner KP, Pollmann KP. A comparison of two buffering systems for lens organ culture. Ophthalmic Res. 1982;14(4):265–268. doi: 10.1159/000265201
   PubMed Web of Science ®Google Scholar
• Shyam R, Reddy LVK, Palaniappan A. Fabrication and characterization techniques of in vitro 3D tissue models. Int J Mol Sci. 2023;24(3):1912. doi: 10.3390/ijms24031912
   PubMed Web of Science ®Google Scholar
• Pamies D, Hartung T. 21st Century Cell Culture for 21st Century Toxicology. Chem Res Toxicol. 2017 Jan 17;30(1):43–52.
   PubMed Web of Science ®Google Scholar
• Choi JW, Bae S-H, Kim IY, et al. Testing in vitro toxicity of nanoparticles in 3D cell culture with various extracellular matrix scaffold. bioRxiv. 2021:2021.03. 18.436024.
   Google Scholar
• Juarez-Moreno K, Chávez-García D, Hirata G, et al. Monolayer (2D) or spheroids (3D) cell cultures for nanotoxicological studies? Comparison of cytotoxicity and cell internalization of nanoparticles. Toxicol In Vitro. 2022;85:105461.10.1016/j.tiv.2022.105461
   PubMed Web of Science ®Google Scholar
• Rubashkin MG, Ou G, Weaver VM. Deconstructing signaling in three dimensions. Biochemistry. 2014;53(13):2078–2090. doi: 10.1021/bi401710d
   PubMed Web of Science ®Google Scholar
• Antoni D, Burckel H, Josset E, et al. Three-dimensional cell culture: a breakthrough in vivo. Int J Mol Sci. 2015;16(3):5517–5527. doi: 10.3390/ijms16035517
   PubMed Web of Science ®Google Scholar
• Duval K, Grover H, Han L-H, et al.. Modeling physiological events in 2D vs. 3D cell culture. Physiology. 2017;32(4):266–277. doi: 10.1152/physiol.00036.2016
   PubMed Web of Science ®Google Scholar
• Lelièvre SA, Kwok T, Chittiboyina S Architecture in 3D cell culture: An essential feature for in vitro toxicology. Toxicol In Vitro. 2017;45:287–295.10.1016/j.tiv.2017.03.012
   PubMed Web of Science ®Google Scholar
• Fang Y, Eglen RM. Three-dimensional cell cultures in drug discovery and development. SLAS Discov. 2017;22(5):456–472. doi: 10.1177/1087057117696795
   PubMed Web of Science ®Google Scholar
• Borah A, Kumar DS. Overcoming the barriers of two-dimensional cell culture systems with three-dimensional cell culture systems: techniques, drug discovery, and biomedical applications. Biomedical Product and Materials Evaluation: Elsevier; 2022. p. 179–229.
   Google Scholar
• Dhaliwal A. 3D cell culture: A review. Mater Methods. 2012;2:162.
   Google Scholar
• Mastrullo V, Cathery W, Velliou E, et al. Angiogenesis in tissue engineering: as nature intended? Front Bioeng Biotechnol. 2020;8:188. 10.3389/fbioe.2020.00188
   PubMed Web of Science ®Google Scholar
• Filippi M, Yasa O, Giachino J, et al. Perfusable Biohybrid Designs for Bioprinted Skeletal Muscle Tissue. Adv Healthc Mater. 2023 Jul;12(18):e2300151. 10.1002/adhm.202300151
   PubMed Web of Science ®Google Scholar
• Ostrovidov S, Ramalingam M, Bae H, et al. Latest developments in engineered skeletal muscle tissues for drug discovery and development. Expert Opin Drug Discov. 20232023/01 /02;18(1):47–63..
   PubMed Web of Science ®Google Scholar
• Hosseinkhani H. 3‐D culture systems for cell culture technology. J Cell Res. 2018;1:1–4.
   Google Scholar
• Huch M, Knoblich JA, Lutolf MP, et al. The hope and the hype of organoid research. Development. 2017;144(6):938–941. doi: 10.1242/dev.150201
   PubMed Web of Science ®Google Scholar
• Velasco V, Shariati SA, Esfandyarpour R. Microtechnology-based methods for organoid models. Microsyst Nanoeng. 2020;6(1):76. doi: 10.1038/s41378-020-00185-3
   PubMed Web of Science ®Google Scholar
• Sun M, Liu A, Yang X, et al. 3D cell culture—can it be as popular as 2d cell culture? Adv Nanobiomed Res. 2021;1(5):2000066.
   Google Scholar
• Tebon PJ, Wang B, Markowitz AL, et al. Drug screening at single-organoid resolution via bioprinting and interferometry. Nat Commun. 20232023/06 /06;14(1):3168.
   PubMed Web of Science ®Google Scholar
• Tang J, Shi J, Liu J. Editorial: Advances in 3D cell culture for drug screening and toxicology evaluation. Front Bioeng Biotechnol. 2023;11:1266506.
   PubMed Web of Science ®Google Scholar
• Napaporn J, Thomas M, Svetic KA, et al. Assessment of the myotoxicity of pharmaceutical buffers using an in vitro muscle model: effect of pH, capacity, tonicity, and buffer type [article]. Pharm Dev Technol. 2000;5(1):123–130. doi: 10.1081/PDT-100100527
   PubMed Web of Science ®Google Scholar
• Dan-Jumbo SO. Development and validation of an in vitro porcine skeletal muscle model. 2023.
   Google Scholar
• Ricard-Blum S The collagen family. Cold Spring Harb Perspect Biol. 2011 Jan;3(1):a004978. 10.1101/cshperspect.a004978
   PubMed Web of Science ®Google Scholar
• Ricklefs M, Korossis S, Haverich A, et al. Polymeric scaffolds for bioartificial cardiovascular prostheses. Scaffolds in Tissue Engineering-Materials, Technologies and Clinical Applications; IntechOpen: London, UK. 2017:267–291.
   Google Scholar
• Gilbert-Honick J, Iyer SR, Somers SM, et al. Engineering functional and histological regeneration of vascularized skeletal muscle. Biomaterials. 2018 May;164:70–79.10.1016/j.biomaterials.2018.02.006
   PubMed Web of Science ®Google Scholar
• Shi M, Dong R, Hu J, et al. Conductive self-healing biodegradable hydrogel based on hyaluronic acid-grafted-polyaniline as cell recruitment niches and cell delivery carrier for myogenic differentiation and skeletal muscle regeneration. Chem Eng J. 2023;457:141110.
   Web of Science ®Google Scholar
• Narayanan N, Lengemann P, Kim KH, et al. Harnessing nerve-muscle cell interactions for biomaterials-based skeletal muscle regeneration. J Biomed Mater Res A. 2021 Mar;109(3):289–299.
   PubMed Web of Science ®Google Scholar
• Liu D, Nikoo M, Boran G, et al. Collagen and gelatin. Annu Rev Food Sci Technol. 2015;6(1):527–557. doi: 10.1146/annurev-food-031414-111800
   PubMed Web of Science ®Google Scholar
• Shoulders MD, Raines RT. Collagen structure and stability. Annu Rev Biochem. 2009;78(1):929–958. doi: 10.1146/annurev.biochem.77.032207.120833
   PubMed Web of Science ®Google Scholar
• Li P, Wu G. Roles of dietary glycine, proline, and hydroxyproline in collagen synthesis and animal growth. Amino Acids. 2018;50(1):29–38. doi: 10.1007/s00726-017-2490-6
   PubMed Web of Science ®Google Scholar
• Handbook of Food Proteins. Phillips G, Williams P, editors. 2011. English. (Woodhead Publishing in Food Science Technology and Nutrition; 222).
   Google Scholar
• Zhang Z, Li G, Shi B. Physicochemical properties of collagen, gelatin and collagen hydrolysate derived from bovine limed split wastes. J Soc Leath Tech Ch. 2006;90(1):23.
   Web of Science ®Google Scholar
• Djagny VB, Wang Z, Xu S. Gelatin: a valuable protein for food and pharmaceutical industries: review. Crit Rev Food Sci Nutr. 2001 Sep;41(6):481–92.
   PubMed Web of Science ®Google Scholar
• Andrade ÂL, Ferreira JMF, Domingues RZ. Zeta potential measurement in bioactive collagen. Mater Res. 2004;7(4):631–634.
   Google Scholar
• Armstrong SE, Bell DR Relationship between lymph and tissue hyaluronan in skin and skeletal muscle. Am J Physiol Heart Circ Physiol. 2002 Dec;283(6):H2485–94. 10.1152/ajpheart.00385.2002
   PubMed Web of Science ®Google Scholar
• Chong BF, Blank LM, McLaughlin R, et al. Microbial hyaluronic acid production. Appl Microbiol Biotechnol. 2005 Jan;66(4):341–351.10.1007/s00253-004-1774-4
   PubMed Web of Science ®Google Scholar
• Bayer IS Hyaluronic Acid and Controlled Release: A Review. Molecules. 2020 Jun 6;25(11). 2649 10.3390/molecules25112649
   PubMed Web of Science ®Google Scholar
• Juncan AM, Moisă DG, Santini A, et al. Advantages of Hyaluronic Acid and Its Combination with Other Bioactive Ingredients in Cosmeceuticals. Molecules. 2021 Jul 22;26(15). 4429 10.3390/molecules26154429
   PubMed Web of Science ®Google Scholar
• Wassenaar JW, Boss GR, Christman KL Decellularized skeletal muscle as an in vitro model for studying drug-extracellular matrix interactions. Biomaterials. 2015 Sep;64:108–114.10.1016/j.biomaterials.2015.06.033.
   PubMed Web of Science ®Google Scholar
• Kapałczyńska M, Kolenda T, Przybyła W, et al. 2D and 3D cell cultures–a comparison of different types of cancer cell cultures. Arch Med Sci. 2018;14(4):910–919.
   PubMed Web of Science ®Google Scholar
• Thati S, McCallum M, Xu Y, et al.. Novel Applications of an In Vitro Injection Model System to Study Bioperformance: Case Studies with Different Drug Modalities. J Pharm Innov. 2020;15(2):268–280. doi: 10.1007/s12247-020-09437-1
   Web of Science ®Google Scholar
• Rawat A, Stipper E, Shah VP, et al. Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal (R) Consta (R). Int J Pharm. 2011 Nov;420(2):198–205.
   PubMedGoogle Scholar
• Park K, Otte A, Sharifi F, et al. Potential roles of the glass transition temperature of PLGA microparticles in drug release kinetics. Mol Pharm. 2020;18(1):18–32.
   PubMedGoogle Scholar
• Yoo J, Won Y-Y. Phenomenology of the initial burst release of drugs from PLGA microparticles. ACS Biomater Sci Eng. 2020;6(11):6053–6062.
   PubMed Web of Science ®Google Scholar
• Ward SR, Davis J, Kaufman KR, et al.. Relationship between muscle stress and intramuscular pressure during dynamic muscle contractions. Muscle and Nerve. 2007;36(3):313–319. doi: 10.1002/mus.20828
   PubMed Web of Science ®Google Scholar
• Kurbel S, Kurbel B, Belovari T, et al. Model of interstitial pressure as a result of cyclical changes in the capillary wall fluid transport. Med Hypotheses. 2001 Aug;57(2):161–166.10.1054/mehy.2001.1288
   PubMed Web of Science ®Google Scholar
• Michel CC, Woodcock TE, Curry FRE. Understanding and extending the Starling principle. Acta Anaesthesiol Scand. 2020;64(8):1032–1037. doi: 10.1111/aas.13603
   PubMed Web of Science ®Google Scholar
• Wilkinson J, Ajulo D, Tamburrini V, et al. Lipid based intramuscular long-acting injectables: Current state of the art. Eur J Pharm Sci. 2022 Nov 1;178:106253. 10.1016/j.ejps.2022.106253
   PubMed Web of Science ®Google Scholar
• Skwierczynski RD, Gray V, De Mutha J. Overview of the Activities of the USP Expert Panel on New Advancements in Product Performance Testing. Dissolut Technol. 2022;29(3):122–127.
   Web of Science ®Google Scholar
• Siepmann J, Siepmann F Sink conditions do not guarantee the absence of saturation effects. Int J Pharm. 2020;577:119009. 10.1016/j.ijpharm.2019.119009
   PubMedGoogle Scholar
• Pavani P, Kumar K, Rani A, et al. The influence of sodium phosphate buffer on the stability of various proteins: Insights into protein-buffer interactions. J Mol Liq. 2021;331:115753.
   Web of Science ®Google Scholar
• Sonntag E, Kolář J, Djukaj S, et al. Accelerated reactive dissolution model of drug release from long-acting injectable formulations. Eur J Pharm Biopharma. 2023.
   PubMed Web of Science ®Google Scholar
• Chen Y-A, Ou S-M, Lin C-C. Influence of dialysis membranes on clinical outcomes: from history to innovation. Membranes (Basel). 2022;12(2):152. doi: 10.3390/membranes12020152
   PubMed Web of Science ®Google Scholar
• Cascone S Modeling and comparison of release profiles: Effect of the dissolution method. Eur J Pharm Sci. 2017;106:352–361. 10.1016/j.ejps.2017.06.021
   PubMed Web of Science ®Google Scholar
• Burke MD, Koetting MC. Development of a Clinically Relevant Dissolution Approach to Simulate Physiological Forces with a USP 2 Apparatus: “Peristaltic Dissolution”. J Pharm Innov. 20202020/08 /22;16(4):699–714.
   Web of Science ®Google Scholar
• Wolf K, Te Lindert M, Krause M, et al. Physical limits of cell migration: control by ECM space and nuclear deformation and tuning by proteolysis and traction force. J Cell Biol. 2013 Jun 24;201(7):1069–1084. 10.1083/jcb.201210152
   PubMed Web of Science ®Google Scholar
• Haas GJ, Dunn AJ, Marcinczyk M, et al. Biomimetic sponges for regeneration of skeletal muscle following trauma. J Biomed Mater Res A. 2019 Jan;107(1):92–103.10.1002/jbm.a.36535
   PubMed Web of Science ®Google Scholar
• Fischer KM, Scott TE, Browe DP, et al. Hydrogels for Skeletal Muscle Regeneration. Regen Eng Trans Med. 2020:1–9.
   PubMed Web of Science ®Google Scholar
• Purslow PP The Structure and Role of Intramuscular Connective Tissue in Muscle Function. Front Physiol. 2020;11:495. 10.3389/fphys.2020.00495
   PubMed Web of Science ®Google Scholar
• Naomi R, Ridzuan PM, Bahari H. Current Insights into Collagen Type I. Polymers (Basel). 2021 Aug 9;13(16). 2642 10.3390/polym13162642
   PubMed Web of Science ®Google Scholar
• Karpakka J, Virtanen P, Väänänen K, et al. Collagen synthesis in rat skeletal muscle during immobilization and remobilization. J Appl Physiol (1985). 1991Apr;70(4):1775–80.
   Google Scholar
• Wiig H, Reed RK, Tenstad O Interstitial fluid pressure, composition of interstitium, and interstitial exclusion of albumin in hypothyroid rats. Am J Physiol Heart Circ Physiol. 2000 May;278(5):H1627–39. 10.1152/ajpheart.2000.278.5.H1627
   PubMed Web of Science ®Google Scholar
• Byrne MP, Smith TJ, Montgomery VA, et al. Purification, potency, and efficacy of the botulinum neurotoxin type A binding domain from Pichia pastoris as a recombinant vaccine candidate. Infect Immun. 1998 Oct;66(10):4817–4822. 10.1128/IAI.66.10.4817-4822.1998
   PubMed Web of Science ®Google Scholar
• Beyer S, Xie L, Schmidt M, et al. Optimizing novel implant formulations for the prolonged release of biopharmaceuticals using in vitro and in vivo imaging techniques. J Control Release. 2016 Aug 10;235:352–364.10.1016/j.jconrel.2016.06.013
   PubMed Web of Science ®Google Scholar
• Goyon A, Excoffier M, Janin-Bussat MC, et al. Determination of isoelectric points and relative charge variants of 23 therapeutic monoclonal antibodies. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Oct 15;1065-1066:119–128.10.1016/j.jchromb.2017.09.033
   PubMed Web of Science ®Google Scholar
• Safarpour Y, Jabbari B. Botulinum Toxin Treatment of Movement Disorders. Curr Treat Options Neurol. 2018 Feb 24;20(2):4.10.1007/s11940-018-0488-3
   PubMed Web of Science ®Google Scholar
• Veronese FM, Pasut G PEGylation, successful approach to drug delivery. Drug Discov Today. 2005 Nov 1;10(21):1451–1458.10.1016/S1359-6446(05)03575-0
   PubMed Web of Science ®Google Scholar
• Vogel AM, Lennon DR, Broadbent R, et al. Palivizumab prophylaxis of respiratory syncytial virus infection in high-risk infants. J Paediatr Child Health. 2002 Dec;38(6):550–554.10.1046/j.1440-1754.2002.00057.x
   PubMed Web of Science ®Google Scholar
• Markowitz CE. Interferon-beta: mechanism of action and dosing issues. Neurology. 2007 Jun 12;68(24 Suppl 4):S8–11.
   PubMedGoogle Scholar
• Evidente VG, Pappert EJ. Botulinum toxin therapy for cervical dystonia: the science of dosing. Tremor Other Hyperkinet Mov (N Y). 2014;4:273.
   PubMedGoogle Scholar
• Howard JB, Carpenter FH L-asparaginase from Erwinia carotovora. Substrate specificity and enzymatic properties. J Biol Chem. 1972 Feb 25;247(4):1020–1030. 10.1016/S0021-9258(19)45610-X
   PubMed Web of Science ®Google Scholar
• Graham ML Pegaspargase: a review of clinical studies. Adv Drug Deliv Rev. 2003 Sep 26;55(10):1293–1302. 10.1016/S0169-409X(03)00110-8
   PubMed Web of Science ®Google Scholar
• Nicoli S, Santi P, Couvreur P, et al. Design of triptorelin loaded nanospheres for transdermal iontophoretic administration. Int J Pharm. 2001 Feb 19;214(1–2):31–35. 10.1016/S0378-5173(00)00632-3
   PubMedGoogle Scholar
• Park K, Skidmore S, Hadar J, et al. Injectable, long-acting PLGA formulations: Analyzing PLGA and understanding microparticle formation. J Control Release. 2019 Jun 28;304:125–134.10.1016/j.jconrel.2019.05.003
   PubMed Web of Science ®Google Scholar
• Nishiuchi Y, Inui T, Nishio H, et al. Chemical synthesis of the precursor molecule of the Aequorea green fluorescent protein, subsequent folding, and development of fluorescence. Proc Natl Acad Sci USA. 1998 Nov 10;95(23):13549–54.
   PubMed Web of Science ®Google Scholar
• Rogge MC, Charenkavanich S, DiBiase M, et al. Impaired bioavailability of interferon beta-1a when administered intramuscularly by needle-free injection. Drug Deliv. 1998;5(4):275–280. doi: 10.3109/10717549809065758
   PubMed Web of Science ®Google Scholar
• Probst M, Schmidt M, Weitschies W, et al. In vitro simulation of distribution processes following intramuscular injection. CDBME. 2016;2(1):383–386.
   Google Scholar
• Calderan L, Carton F, Andreana I, et al. An ex vivo experimental system to track fluorescent nanoparticles inside skeletal muscle. Eur J Histochem. 2023 Jan 2;67(1).10.4081/ejh.2023.3596
   PubMed Web of Science ®Google Scholar
• Kanazawa Y, Nagano M, Koinuma S, et al. Effects of aging on basement membrane-related gene expression of the skeletal muscle in rats. Biomed Res. 2021;42(3):115–119. doi: 10.2220/biomedres.42.115
   PubMed Web of Science ®Google Scholar
• Hill RL, Wilmot JG, Belluscio BA, et al. Comparison of drug delivery with autoinjector versus manual prefilled syringe and between three different autoinjector devices administered in pig thigh. Medical Devices: Evidence and Research. 2016:257–266..
   Google Scholar
• Turner PJ, Muraro A, Roberts G Pharmacokinetics of adrenaline autoinjectors. Clin Exp Allergy. 2022 Jan;52(1):18–28.10.1111/cea.14055
   PubMed Web of Science ®Google Scholar
• Dreborg S, Kim H The pharmacokinetics of epinephrine/adrenaline autoinjectors. Allergy Asthma Clin Immunol. 2021 Mar 8;17(1):25.10.1186/s13223-021-00511-y
   PubMed Web of Science ®Google Scholar
• Whyte A, Parker C. A review of the efficacy and tolerability of antipsychotic long-acting injections. Prog Neurol Psychiatry. 2016 Jul-Aug;20(4):22–28.
   Google Scholar
• Khanolkar A, White S, Margerison E. A Novel Method to Optimize Drug Delivery for Parenteral Products Involving New Therapies and Unmet Needs. Pharm Res. 2023:1–13.
   Web of Science ®Google Scholar
• Bettonte S, Berton M, Battegay M, et al. Development of a physiologically‐based pharmacokinetic model to simulate the pharmacokinetics of intramuscular antiretroviral drugs. CPT: Pharmacometrics & Systems Pharmacology. 2024..
   PubMedGoogle Scholar
• Di J, Hou P, Corpstein CD, et al. Multiphysics modeling and simulation of local transport and absorption kinetics of intramuscularly injected lipid nanoparticles. J Control Release. 2023;359:234–243.10.1016/j.jconrel.2023.05.048
   PubMed Web of Science ®Google Scholar
• Atoyebi S, Bunglawala F, Cottura N, et al. Physiologically‐based pharmacokinetic modelling of long‐acting injectable cabotegravir and rilpivirine in pregnancy. Br J Clin Pharmacol. 2024. 10.1111/bcp.16006
   PubMed Web of Science ®Google Scholar
• Siemons M, Schroyen B, Darville N, et al. Role of modeling and simulation in preclinical and clinical long-acting injectable drug development. Aaps J. 2023;25(6):99. doi: 10.1208/s12248-023-00864-9
   PubMed Web of Science ®Google Scholar
• Saldanha L, Langel Ü, Vale N. In silico studies to support vaccine development. Pharmaceutics. 2023;15(2):654.
   PubMed Web of Science ®Google Scholar
• Dubbelboer IR, Sjögren E Physiological based pharmacokinetic and biopharmaceutics modelling of subcutaneously administered compounds–An overview of in silico models. Int J Pharm. 2022;621:121808. 10.1016/j.ijpharm.2022.121808
   PubMedGoogle Scholar
• Micallef J, Arutiunian A, Dubrowski A. The development of an intramuscular injection simulation for nursing students. Cureus. 2020;12(12). doi: 10.7759/cureus.12366
   PubMed Web of Science ®Google Scholar
• Micallef J, Lin AC, Arutiunian A, et al. Design of an Intramuscular Injection Simulator: Accommodating Cultural Differences. Cureus. 2021;13(10).10.7759/cureus.18980
   Web of Science ®Google Scholar
• Tantacharoenrat C, Precharattana M. An Electronic-based Simulator for Intramuscular Injection in Newborns. Int J Nurs Educ. 2023;15(2):1–6.
   Google Scholar
• Mc Crudden MTC, Larraneta E, Clark A, et al. Design, formulation and evaluation of novel dissolving microarray patches containing a long-acting rilpivirine nanosuspension. J Control Release. 2018 Dec 28;292:119–129.10.1016/j.jconrel.2018.11.002
   PubMed Web of Science ®Google Scholar