Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform

E. Lynne Kelley; Andrea Fernandes; Marc Pelletier; Eri A. Takami; Christine Emery; Bobby Dyer; Mary V. Jacoski; Valery Lozko; Bart Burgess; Richard H. Smith

doi:10.5731/pdajpst.2021.012670

References

1.↵
1. Jin J.-F.,
2. Zhu L.-L.,
3. Chen M.,
4. Xu H.-M.,
5. Wang H.-F.,
6. Feng X.-Q.,
7. Zhu X.-P.,
8. Zhou Q.
The Optimal Choice of Medication Administration Route Regarding Intravenous, Intramuscular, and Subcutaneous Injection. Patient Prefer. Adherence 2015, 9, 923–942.
OpenUrl
2.↵
1. Mohammed H. T.,
2. Hyseni L.,
3. Bui V.,
4. Gerritsen B.,
5. Fuller K.,
6. Sung J.,
7. Alarakhia M.
Exploring the Use and Challenges of Implementing Virtual Visits During COVID-19 in Primary Care and Lessons for Sustained Use. PLoS One 2021, 16 (6), e0253665.
OpenUrl
3.↵
1. Bittner B.,
2. Richter W.,
3. Schmidt J.
Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs 2018, 32 (5), 425–440.
OpenUrl
4.↵
1. Bruin G.,
2. Hockey H. ‐U. P.,
3. La Stella P.,
4. Sigurgeirsson B.,
5. Fu R.,
6. Patekar M.,
7. Charef P.,
8. Woessner R.,
9. Boutouyrie‐Dumont B.
Comparison of Pharmacokinetics, Safety and Tolerability of Secukinumab Administered Subcutaneously Using Different Delivery Systems in Healthy Volunteers and in Psoriasis Patients. Br. J. Clin. Pharmacol. 2020, 86 (2), 338–351.
OpenUrl
5.↵
1. Badkar A. V.,
2. Gandhi R. B.,
3. Davis S. P.,
4. LaBarre M. J.
Subcutaneous Delivery of High-Dose/Volume Biologics: Current Status and Prospect for Future Advancements. Drug Des., Dev. Ther. 2021, 15, 159–170.
OpenUrl
6.↵
1. Dias C.,
2. Abosaleem B.,
3. Crispino C.,
4. Gao B.,
5. Shaywitz A.
Tolerability of High-Volume Subcutaneous Injections of a Viscous Placebo Buffer: A Randomized, Crossover Study in Healthy Subjects. AAPS PharmSciTech 2015, 16 (5), 1101–1107.
OpenUrl
7.↵
1. Heise T.,
2. Nosek L.,
3. Dellweg S.,
4. Zijlstra E.,
5. Praestmark K. A.,
6. Kildegaard J.,
7. Nielsen G.,
8. Sparre T.
Impact of Injection Speed and Volume on Perceived Pain During Subcutaneous Injections into the Abdomen and Thigh: A Single-Centre, Randomized Controlled Trial. Diabetes, Obes. Metab. 2014, 16 (10), 971–976.
OpenUrl CrossRef PubMed
8.↵
1. Schneider A.,
2. Mueller P.,
3. Jordi C.,
4. Richard P.,
5. Sneeringer P.,
6. Nayyar R.,
7. Yovanoff M.,
8. Lange J.
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.
OpenUrl
9.↵
1. Devonshire V.,
2. Lapierre Y.,
3. Macdonell R.,
4. Ramo-Tello C.,
5. Patti F.,
6. Fontoura P.,
7. Suchet L.,
8. Hyde R.,
9. Balla I.,
10. Frohman E. M.,
11. Kieseier B. C
, for the GAP Study Group. The Global Adherence Project (GAP): A Multicenter Observational Study on Adherence to Disease-Modifying Therapies in Patients with Relapsing-Remitting Multiple Sclerosis. Eur. J. Neurol. 2011, 18 (1), 69–77.
OpenUrl CrossRef PubMed
10.↵
1. McLenon J.,
2. Rogers M. A. M.
The Fear of Needles: A Systematic Review and Meta-Analysis. J. Adv. Nurs. 2019, 75 (1), 30–42.
OpenUrl CrossRef PubMed
11.↵
1. Kojic N.,
2. Goyal P.,
3. Lou C. H.,
4. Corwin M. J.
An Innovative Needle-Free Injection System: Comparison to 1 ml Standard Subcutaneous Injection. AAPS PharmSciTech 2017, 18 (8), 2965–2970.
OpenUrl
12.↵
1. Kelley E. L.,
2. Smith R. H.,
3. Corcoran G.,
4. Nygren S.,
5. Jacoski M. V.,
6. Fernandes A.
Advances in Subcutaneous Injections: PRECISE II: A Study of Safety and Subject Preference for an Innovative Needle-Free Injection System. Drug Delivery 2021, 28 (1), 1915–1922.
OpenUrl
13.↵
1. Taberner A.,
2. Hogan N. C.,
3. Hunter I. W.
Needle-Free Jet Injection Using Real-Time Controlled Linear Lorentz-Force Actuators. Med. Eng. Phys. 2012, 34 (9), 1228–1235.
OpenUrl PubMed
14.↵
Center for Biologics Evaluation and Research. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical (accessed April 10, 2021).
15.↵
1. Berteau C.,
2. Filipe-Santos O.,
3. Wang T.,
4. Rojas H. E.,
5. Granger C.,
6. Schwarzenbach F.
Evaluation of the Impact of Viscosity, Injection Volume, and Injection Flow Rate on Subcutaneous Injection Tolerance. Med. Devices (Auckl) 2015, 8, 473–484.
OpenUrl CrossRef
16.↵
1. Jain M.,
2. Doughty D.,
3. Clawson C.,
4. Li X.,
5. White N.,
6. Agoram B.,
7. van der Merwe R.
Tralokinumab Pharmacokinetics and Tolerability When Administered by Different Subcutaneous Injection Methods and Rates. Int. J. Clin. Pharmacol. Ther. 2017, 55 (07), 606–620.
OpenUrl
17.↵
1. Portron A.,
2. Jordan P.,
3. Draper K.,
4. Muenzer C.,
5. Dickerson D.,
6. van Iersel T.,
7. Hofmann C.
A Phase I Study to Assess the Effect of Speed of Injection on Pain, Tolerability, and Pharmacokinetics after High-Volume Subcutaneous Administration of Gantenerumab in Healthy Volunteers. Clin. Ther. 2020, 42 (1), 108–120.
OpenUrl
18.↵
1. Zharkov A.,
2. Barton B.,
3. Heinzmann D.,
4. Bakalos G.,
5. Schreitmüller T.
Development Pathways for Subcutaneous Formulations of Biologics versus Biosimilar Development. Expert Rev. Precis. Med. Drug Devel. 2019, 1–8.
19.↵
1. Perraudin C.,
2. Bourdin A.,
3. Spertini F.,
4. Berger J.,
5. Bugnon O.
Switching Patients to Home-Based Subcutaneous Immunoglobulin: An Economic Evaluation of an Interprofessional Drug Therapy Management Program. J. Clin. Immunol. 2016, 36 (5), 502–510.
OpenUrl
20.↵
1. Shaker M.,
2. Briggs A.,
3. Dbouk A.,
4. Dutille E.,
5. Oppenheimer J.,
6. Greenhawt M.
Estimation of Health and Economic Benefits of Clinic versus Home Administration of Omalizumab and Mepolizumab. J. Allergy Clin. Immunol.: Pract. 2020, 8 (2), 565–572.
OpenUrl
21.↵
1. Markkanen P.,
2. Galligan C.,
3. Laramie A.,
4. Fisher J.,
5. Sama S.,
6. Quinn M.
Understanding Sharps Injuries in Home Healthcare: The Safe Home Care Qualitative Methods Study to Identify Pathways for Injury Prevention. BMC Public Health 2015, 15 (1), 359.
OpenUrl CrossRef PubMed
22.↵
1. Das A. K.,
2. Islam M. N.,
3. Billah M. M.,
4. Sarker A.
COVID-19 Pandemic and Healthcare Solid Waste Management strategy - A Mini-Review. Sci. Total Environ. 2021, 778, 146220.
OpenUrl CrossRef

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Keywords

[1] 1.↵
Jin J.-F.,
Zhu L.-L.,
Chen M.,
Xu H.-M.,
Wang H.-F.,
Feng X.-Q.,
Zhu X.-P.,
Zhou Q.
The Optimal Choice of Medication Administration Route Regarding Intravenous, Intramuscular, and Subcutaneous Injection. Patient Prefer. Adherence 2015, 9, 923–942.
OpenUrl

[2] Jin J.-F.,

[3] Zhu L.-L.,

[4] Chen M.,

[5] Xu H.-M.,

[6] Wang H.-F.,

[7] Feng X.-Q.,

[8] Zhu X.-P.,

[9] Zhou Q.

[10] 2.↵
Mohammed H. T.,
Hyseni L.,
Bui V.,
Gerritsen B.,
Fuller K.,
Sung J.,
Alarakhia M.
Exploring the Use and Challenges of Implementing Virtual Visits During COVID-19 in Primary Care and Lessons for Sustained Use. PLoS One 2021, 16 (6), e0253665.
OpenUrl

[11] Mohammed H. T.,

[12] Hyseni L.,

[13] Bui V.,

[14] Gerritsen B.,

[15] Fuller K.,

[16] Sung J.,

[17] Alarakhia M.

[18] 3.↵
Bittner B.,
Richter W.,
Schmidt J.
Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs 2018, 32 (5), 425–440.
OpenUrl

[19] Bittner B.,

[20] Richter W.,

[21] Schmidt J.

[22] 4.↵
Bruin G.,
Hockey H. ‐U. P.,
La Stella P.,
Sigurgeirsson B.,
Fu R.,
Patekar M.,
Charef P.,
Woessner R.,
Boutouyrie‐Dumont B.
Comparison of Pharmacokinetics, Safety and Tolerability of Secukinumab Administered Subcutaneously Using Different Delivery Systems in Healthy Volunteers and in Psoriasis Patients. Br. J. Clin. Pharmacol. 2020, 86 (2), 338–351.
OpenUrl

[23] Bruin G.,

[24] Hockey H. ‐U. P.,

[25] La Stella P.,

[26] Sigurgeirsson B.,

[27] Fu R.,

[28] Patekar M.,

[29] Charef P.,

[30] Woessner R.,

[31] Boutouyrie‐Dumont B.

[32] 5.↵
Badkar A. V.,
Gandhi R. B.,
Davis S. P.,
LaBarre M. J.
Subcutaneous Delivery of High-Dose/Volume Biologics: Current Status and Prospect for Future Advancements. Drug Des., Dev. Ther. 2021, 15, 159–170.
OpenUrl

[33] Badkar A. V.,

[34] Gandhi R. B.,

[35] Davis S. P.,

[36] LaBarre M. J.

[37] 6.↵
Dias C.,
Abosaleem B.,
Crispino C.,
Gao B.,
Shaywitz A.
Tolerability of High-Volume Subcutaneous Injections of a Viscous Placebo Buffer: A Randomized, Crossover Study in Healthy Subjects. AAPS PharmSciTech 2015, 16 (5), 1101–1107.
OpenUrl

[38] Dias C.,

[39] Abosaleem B.,

[40] Crispino C.,

[41] Gao B.,

[42] Shaywitz A.

[43] 7.↵
Heise T.,
Nosek L.,
Dellweg S.,
Zijlstra E.,
Praestmark K. A.,
Kildegaard J.,
Nielsen G.,
Sparre T.
Impact of Injection Speed and Volume on Perceived Pain During Subcutaneous Injections into the Abdomen and Thigh: A Single-Centre, Randomized Controlled Trial. Diabetes, Obes. Metab. 2014, 16 (10), 971–976.
OpenUrl CrossRef PubMed

[44] Heise T.,

[45] Nosek L.,

[46] Dellweg S.,

[47] Zijlstra E.,

[48] Praestmark K. A.,

[49] Kildegaard J.,

[50] Nielsen G.,

[51] Sparre T.

[52] 8.↵
Schneider A.,
Mueller P.,
Jordi C.,
Richard P.,
Sneeringer P.,
Nayyar R.,
Yovanoff M.,
Lange J.
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.
OpenUrl

[53] Schneider A.,

[54] Mueller P.,

[55] Jordi C.,

[56] Richard P.,

[57] Sneeringer P.,

[58] Nayyar R.,

[59] Yovanoff M.,

[60] Lange J.

[61] 9.↵
Devonshire V.,
Lapierre Y.,
Macdonell R.,
Ramo-Tello C.,
Patti F.,
Fontoura P.,
Suchet L.,
Hyde R.,
Balla I.,
Frohman E. M.,
Kieseier B. C
, for the GAP Study Group. The Global Adherence Project (GAP): A Multicenter Observational Study on Adherence to Disease-Modifying Therapies in Patients with Relapsing-Remitting Multiple Sclerosis. Eur. J. Neurol. 2011, 18 (1), 69–77.
OpenUrl CrossRef PubMed

[62] Devonshire V.,

[63] Lapierre Y.,

[64] Macdonell R.,

[65] Ramo-Tello C.,

[66] Patti F.,

[67] Fontoura P.,

[68] Suchet L.,

[69] Hyde R.,

[70] Balla I.,

[71] Frohman E. M.,

[72] Kieseier B. C

[73] 10.↵
McLenon J.,
Rogers M. A. M.
The Fear of Needles: A Systematic Review and Meta-Analysis. J. Adv. Nurs. 2019, 75 (1), 30–42.
OpenUrl CrossRef PubMed

[74] McLenon J.,

[75] Rogers M. A. M.

[76] 11.↵
Kojic N.,
Goyal P.,
Lou C. H.,
Corwin M. J.
An Innovative Needle-Free Injection System: Comparison to 1 ml Standard Subcutaneous Injection. AAPS PharmSciTech 2017, 18 (8), 2965–2970.
OpenUrl

[77] Kojic N.,

[78] Goyal P.,

[79] Lou C. H.,

[80] Corwin M. J.

[81] 12.↵
Kelley E. L.,
Smith R. H.,
Corcoran G.,
Nygren S.,
Jacoski M. V.,
Fernandes A.
Advances in Subcutaneous Injections: PRECISE II: A Study of Safety and Subject Preference for an Innovative Needle-Free Injection System. Drug Delivery 2021, 28 (1), 1915–1922.
OpenUrl

[82] Kelley E. L.,

[83] Smith R. H.,

[84] Corcoran G.,

[85] Nygren S.,

[86] Jacoski M. V.,

[87] Fernandes A.

[88] 13.↵
Taberner A.,
Hogan N. C.,
Hunter I. W.
Needle-Free Jet Injection Using Real-Time Controlled Linear Lorentz-Force Actuators. Med. Eng. Phys. 2012, 34 (9), 1228–1235.
OpenUrl PubMed

[89] Taberner A.,

[90] Hogan N. C.,

[91] Hunter I. W.

[92] 14.↵
Center for Biologics Evaluation and Research. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical (accessed April 10, 2021).

[93] 15.↵
Berteau C.,
Filipe-Santos O.,
Wang T.,
Rojas H. E.,
Granger C.,
Schwarzenbach F.
Evaluation of the Impact of Viscosity, Injection Volume, and Injection Flow Rate on Subcutaneous Injection Tolerance. Med. Devices (Auckl) 2015, 8, 473–484.
OpenUrl CrossRef

[94] Berteau C.,

[95] Filipe-Santos O.,

[96] Wang T.,

[97] Rojas H. E.,

[98] Granger C.,

[99] Schwarzenbach F.

[100] 16.↵
Jain M.,
Doughty D.,
Clawson C.,
Li X.,
White N.,
Agoram B.,
van der Merwe R.
Tralokinumab Pharmacokinetics and Tolerability When Administered by Different Subcutaneous Injection Methods and Rates. Int. J. Clin. Pharmacol. Ther. 2017, 55 (07), 606–620.
OpenUrl

[101] Jain M.,

[102] Doughty D.,

[103] Clawson C.,

[104] Li X.,

[105] White N.,

[106] Agoram B.,

[107] van der Merwe R.

[108] 17.↵
Portron A.,
Jordan P.,
Draper K.,
Muenzer C.,
Dickerson D.,
van Iersel T.,
Hofmann C.
A Phase I Study to Assess the Effect of Speed of Injection on Pain, Tolerability, and Pharmacokinetics after High-Volume Subcutaneous Administration of Gantenerumab in Healthy Volunteers. Clin. Ther. 2020, 42 (1), 108–120.
OpenUrl

[109] Portron A.,

[110] Jordan P.,

[111] Draper K.,

[112] Muenzer C.,

[113] Dickerson D.,

[114] van Iersel T.,

[115] Hofmann C.

[116] 18.↵
Zharkov A.,
Barton B.,
Heinzmann D.,
Bakalos G.,
Schreitmüller T.
Development Pathways for Subcutaneous Formulations of Biologics versus Biosimilar Development. Expert Rev. Precis. Med. Drug Devel. 2019, 1–8.

[117] Zharkov A.,

[118] Barton B.,

[119] Heinzmann D.,

[120] Bakalos G.,

[121] Schreitmüller T.

[122] 19.↵
Perraudin C.,
Bourdin A.,
Spertini F.,
Berger J.,
Bugnon O.
Switching Patients to Home-Based Subcutaneous Immunoglobulin: An Economic Evaluation of an Interprofessional Drug Therapy Management Program. J. Clin. Immunol. 2016, 36 (5), 502–510.
OpenUrl

[123] Perraudin C.,

[124] Bourdin A.,

[125] Spertini F.,

[126] Berger J.,

[127] Bugnon O.

[128] 20.↵
Shaker M.,
Briggs A.,
Dbouk A.,
Dutille E.,
Oppenheimer J.,
Greenhawt M.
Estimation of Health and Economic Benefits of Clinic versus Home Administration of Omalizumab and Mepolizumab. J. Allergy Clin. Immunol.: Pract. 2020, 8 (2), 565–572.
OpenUrl

[129] Shaker M.,

[130] Briggs A.,

[131] Dbouk A.,

[132] Dutille E.,

[133] Oppenheimer J.,

[134] Greenhawt M.

[135] 21.↵
Markkanen P.,
Galligan C.,
Laramie A.,
Fisher J.,
Sama S.,
Quinn M.
Understanding Sharps Injuries in Home Healthcare: The Safe Home Care Qualitative Methods Study to Identify Pathways for Injury Prevention. BMC Public Health 2015, 15 (1), 359.
OpenUrl CrossRef PubMed

[136] Markkanen P.,

[137] Galligan C.,

[138] Laramie A.,

[139] Fisher J.,

[140] Sama S.,

[141] Quinn M.

[142] 22.↵
Das A. K.,
Islam M. N.,
Billah M. M.,
Sarker A.
COVID-19 Pandemic and Healthcare Solid Waste Management strategy - A Mini-Review. Sci. Total Environ. 2021, 778, 146220.
OpenUrl CrossRef

[143] Das A. K.,

[144] Islam M. N.,

[145] Billah M. M.,

[146] Sarker A.

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Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform

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Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform

References

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Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.