Characterization of a Novel Particle in a Pharmaceutical Drug Product

Stephanie Moore; Peter Masatani; Yasser Nashed-Samuel; Gianpiero Torraca; Michael Akers; Jeremy Gastwirt; Chakradhar Padala; David Semin

doi:10.5731/pdajpst.2021.012686

References

1.↵
1. Sloey C.,
2. Gleason C.,
3. Phillips J.
Determining the Delamination Propensity of Pharmaceutical Glass Vials Using a Direct Stress Method. PDA J. Pharm. Sci. Technol. 2013, 67 (1), 35–42.
OpenUrl Abstract/FREE Full Text
2.↵
1. Ditter D.,
2. Mahler H.-C.,
3. Roehl H.,
4. Wahl M.,
5. Huwyler J.,
6. Nieto A.,
7. Allmendinger A.
Characterization of Surface Properties of Glass Vials Used as Primary Packaging Material for Parenterals. Eur. J. Pharm. Biopharm. 2018, 125, 58–67.
OpenUrl
3.↵
1. Mathonet S.,
2. Mahler H.-C.,
3. Esswein S. T.,
4. Mazaheri M.,
5. Cash P. W.,
6. Wuchner K.,
7. Kallmeyer G.,
8. Das T. K.,
9. Finkler C.,
10. Lennard A.
A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2016, 70 (4), 392–408.
OpenUrl Abstract/FREE Full Text
4.↵
1. Rupertus V.,
2. Hladik B.,
3. Rothhaar U.,
4. Scheumann V.
A Quick Test to Monitor the Delamination Propensity of Glass Containers. PDA J. Pharm. Sci. Technol. 2014, 68 (4), 373–380.
OpenUrl Abstract/FREE Full Text
5.↵
1. Rothaar U.,
2. Klause M.,
3. Hladik B.
Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System. PDA J. Pharm. Sci. Technol. 2016, 70 (6), 560–567.
OpenUrl Abstract/FREE Full Text
6.↵
1. Iacocca R. G.,
2. Toltl N.,
3. Allgeier M.,
4. Bustard B.,
5. Dong X.,
6. Foubert M.,
7. Hofer J.,
8. Peoples S.,
9. Shelbourn T.
Factors Affecting the Chemical Durability of Glass Used in the Pharmaceutical Industry. AAPS PharmSciTech 2010, 11 (3), 1340–1349.
OpenUrl PubMed
7.↵
1. Haines D.,
2. Scheumann V.,
3. Rothhaar U.
Glass Flakes: Pre-Testing Stops a Big Problem Before It Even Starts. Contract Pharma 2013, 92–98.
8.↵
1. Bacon F. R.,
2. Raggon F. C.
Promotion of Attack on Glass and Silica by Citrate and Other Anions in Neutral Solution. J. Am. Ceram. Soc. 1959, 42 (4), 199–205.
OpenUrl
9.↵
1. Guadagnino E.,
2. Zuccato D.
Delamination Propensity of Pharmaceutical Glass Containers by Accelerated Testing with Different Extraction Media. PDA J. Pharm. Sci. Technol. 2012, 66 (2), 116–125.
OpenUrl Abstract/FREE Full Text
10.↵
1. Pillai S. A.,
2. Chobisa D.,
3. Urimi D.,
4. Ravindra N.
Pharmaceutical Glass Interactions: A Review of Possibilities. J. Pharm. Sci. Res. 2016, 8 (2), 103–111.
OpenUrl
11.↵
1. Zhao J.,
2. Lavalley V.,
3. Mangiagalli P.,
4. Wright J. M.,
5. Bankston T. E.
Glass Delamination: A Comparison of the Inner Surface Performance of Vials and Pre-Filled Syringes. AAPS PharmSciTech 2014, 15 (6), 1398–1409.
OpenUrl
12.↵
1. Ogawa T.,
2. Miyajima M.,
3. Nishimoto N.,
4. Minami H.,
5. Terada K.
Comparisons of Aluminum and Silica Elution from Various Glass Vials. Chem. Pharm. Bull. 2016, 64 (2), 150–160.
OpenUrl
13.↵
1. Ogawa T.,
2. Miyajima M.,
3. Wakiyama N.,
4. Terada K.
Aluminum Elution and Precipitation in Glass Vials: Effect of pH and Buffer Species. Drug Dev. Ind. Pharm. 2015, 41 (2), 315–321.
OpenUrl
14.↵
1. Ogawa T.,
2. Miyajima M.,
3. Wakiyama N.,
4. Terada K.
Effects of Phosphate Buffer in Parenteral Drugs on Particle Formation from Glass Vials. Chem. Pharm. Bull. 2013, 61 (5), 539–545.
OpenUrl
15.↵
1. Adams P. B.
Spicule Formation in Solutions Stored in Glass Containers. Ceram. Bull. 1973, 52 (3), 250–254.
OpenUrl
16.↵
1. Ratnaswamy G.,
2. Hair A.,
3. Li G.,
4. Thirumangalathu R.,
5. Nashed-Samuel Y.,
6. Brych L.,
7. Dharmavaram V.,
8. Wen Z.-Q.,
9. Fujimori K.,
10. Jing W.,
11. Sethuraman A.,
12. Swift R.,
13. Ricci M. S.,
14. Piedmonte D. M.
A Case Study of Nondelamination Glass Dissolution Resulting in Visible Particles: Implications for Neutral pH Formulations. J. Pharm. Sci. 2014, 103 (4), 1104–1114.
OpenUrl PubMed
17.↵
1. Li G. G.,
2. Cao S.,
3. Jiao N.,
4. Wen Z.-Q.
Classification of Glass Particles in Parenteral Product Vials by Visual, Microscopic, and Spectroscopic Methods. PDA J. Pharm. Sci. Technol. 2014, 68 (4), 362–372.
OpenUrl Abstract/FREE Full Text
18.↵
1. Cao X.,
2. Matthew Fesinmeyer R.,
3. Pierini C. J.,
4. Siska C. C.,
5. Litowski J. R.,
6. Brych S.,
7. Wen Z.-Q.,
8. Kleemann G. R.
Free Fatty Acid Particles in Protein Formulations, Part 1: Microscpectroscopic Identification. J. Pharm. Sci. 2015, 104 (2), 433–446.
OpenUrl PubMed
19.↵
1. Hampl V.,
2. Guo X.,
3. Ehrenstrasser C.,
4. Viertler M.,
5. Rayner L.,
6. Campanelli G.,
7. Schipflinger R.,
8. Thewes K.,
9. Cerreti A.,
10. Boehm S.,
11. Sonderegger C.
A Newly Identified Impurity in Polysorbate 80, the Long-Chain Ketone 12-Tricosanone, Forms Visible Particles in a Biopharmaceutical Drug Product. J. Pharm. Sci. 2018, 107 (6), 1552–1561.
OpenUrl
20.↵
1. Couston R. G.,
2. Skoda M. W.,
3. Uddin S.,
4. van der Walle C. F.
Adsorption Behavior of a Human Monoclonal Antibody at Hydrophilic and Hydrophobic Surfaces. mAbs 2013, 5 (1), 126–139.
OpenUrl
21.↵
1. Joshi O.,
2. McGuire J.
Adsorption Behavior of Lysozyme and Tween 80 at Hydrophilic and Hydrophobic Silica-Water Interfaces. Appl. Biochem. Biotechnol. 2009, 152 (2), 235–248.
OpenUrl PubMed
22.↵
1. Fujimori K.,
2. Lee H.,
3. Sloey C.,
4. Ricci M. S.,
5. Wen Z.-Q.,
6. Phillips J.,
7. Nashed-Samuel Y.
Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality. PDA J. Pharm. Sci. Technol. 2016, 70 (3), 248–255.
OpenUrl Abstract/FREE Full Text
23.↵
1. Iacocca R. G.,
2. Allgeier M.
Corrosive Attack of Glass by a Pharmaceutical Compound. J. Mater. Sci. 2007, 42 (3), 801–811.
OpenUrl

In This Issue

Download PDF

Article Alerts

Email Article

Citation Tools

Cited By...

No citing articles found.

Google Scholar

More in this TOC Section

Show more Research

Keywords

[1] 1.↵
Sloey C.,
Gleason C.,
Phillips J.
Determining the Delamination Propensity of Pharmaceutical Glass Vials Using a Direct Stress Method. PDA J. Pharm. Sci. Technol. 2013, 67 (1), 35–42.
OpenUrl Abstract/FREE Full Text

[2] Sloey C.,

[3] Gleason C.,

[4] Phillips J.

[5] 2.↵
Ditter D.,
Mahler H.-C.,
Roehl H.,
Wahl M.,
Huwyler J.,
Nieto A.,
Allmendinger A.
Characterization of Surface Properties of Glass Vials Used as Primary Packaging Material for Parenterals. Eur. J. Pharm. Biopharm. 2018, 125, 58–67.
OpenUrl

[6] Ditter D.,

[7] Mahler H.-C.,

[8] Roehl H.,

[9] Wahl M.,

[10] Huwyler J.,

[11] Nieto A.,

[12] Allmendinger A.

[13] 3.↵
Mathonet S.,
Mahler H.-C.,
Esswein S. T.,
Mazaheri M.,
Cash P. W.,
Wuchner K.,
Kallmeyer G.,
Das T. K.,
Finkler C.,
Lennard A.
A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products. PDA J. Pharm. Sci. Technol. 2016, 70 (4), 392–408.
OpenUrl Abstract/FREE Full Text

[14] Mathonet S.,

[15] Mahler H.-C.,

[16] Esswein S. T.,

[17] Mazaheri M.,

[18] Cash P. W.,

[19] Wuchner K.,

[20] Kallmeyer G.,

[21] Das T. K.,

[22] Finkler C.,

[23] Lennard A.

[24] 4.↵
Rupertus V.,
Hladik B.,
Rothhaar U.,
Scheumann V.
A Quick Test to Monitor the Delamination Propensity of Glass Containers. PDA J. Pharm. Sci. Technol. 2014, 68 (4), 373–380.
OpenUrl Abstract/FREE Full Text

[25] Rupertus V.,

[26] Hladik B.,

[27] Rothhaar U.,

[28] Scheumann V.

[29] 5.↵
Rothaar U.,
Klause M.,
Hladik B.
Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System. PDA J. Pharm. Sci. Technol. 2016, 70 (6), 560–567.
OpenUrl Abstract/FREE Full Text

[30] Rothaar U.,

[31] Klause M.,

[32] Hladik B.

[33] 6.↵
Iacocca R. G.,
Toltl N.,
Allgeier M.,
Bustard B.,
Dong X.,
Foubert M.,
Hofer J.,
Peoples S.,
Shelbourn T.
Factors Affecting the Chemical Durability of Glass Used in the Pharmaceutical Industry. AAPS PharmSciTech 2010, 11 (3), 1340–1349.
OpenUrl PubMed

[34] Iacocca R. G.,

[35] Toltl N.,

[36] Allgeier M.,

[37] Bustard B.,

[38] Dong X.,

[39] Foubert M.,

[40] Hofer J.,

[41] Peoples S.,

[42] Shelbourn T.

[43] 7.↵
Haines D.,
Scheumann V.,
Rothhaar U.
Glass Flakes: Pre-Testing Stops a Big Problem Before It Even Starts. Contract Pharma 2013, 92–98.

[44] Haines D.,

[45] Scheumann V.,

[46] Rothhaar U.

[47] 8.↵
Bacon F. R.,
Raggon F. C.
Promotion of Attack on Glass and Silica by Citrate and Other Anions in Neutral Solution. J. Am. Ceram. Soc. 1959, 42 (4), 199–205.
OpenUrl

[48] Bacon F. R.,

[49] Raggon F. C.

[50] 9.↵
Guadagnino E.,
Zuccato D.
Delamination Propensity of Pharmaceutical Glass Containers by Accelerated Testing with Different Extraction Media. PDA J. Pharm. Sci. Technol. 2012, 66 (2), 116–125.
OpenUrl Abstract/FREE Full Text

[51] Guadagnino E.,

[52] Zuccato D.

[53] 10.↵
Pillai S. A.,
Chobisa D.,
Urimi D.,
Ravindra N.
Pharmaceutical Glass Interactions: A Review of Possibilities. J. Pharm. Sci. Res. 2016, 8 (2), 103–111.
OpenUrl

[54] Pillai S. A.,

[55] Chobisa D.,

[56] Urimi D.,

[57] Ravindra N.

[58] 11.↵
Zhao J.,
Lavalley V.,
Mangiagalli P.,
Wright J. M.,
Bankston T. E.
Glass Delamination: A Comparison of the Inner Surface Performance of Vials and Pre-Filled Syringes. AAPS PharmSciTech 2014, 15 (6), 1398–1409.
OpenUrl

[59] Zhao J.,

[60] Lavalley V.,

[61] Mangiagalli P.,

[62] Wright J. M.,

[63] Bankston T. E.

[64] 12.↵
Ogawa T.,
Miyajima M.,
Nishimoto N.,
Minami H.,
Terada K.
Comparisons of Aluminum and Silica Elution from Various Glass Vials. Chem. Pharm. Bull. 2016, 64 (2), 150–160.
OpenUrl

[65] Ogawa T.,

[66] Miyajima M.,

[67] Nishimoto N.,

[68] Minami H.,

[69] Terada K.

[70] 13.↵
Ogawa T.,
Miyajima M.,
Wakiyama N.,
Terada K.
Aluminum Elution and Precipitation in Glass Vials: Effect of pH and Buffer Species. Drug Dev. Ind. Pharm. 2015, 41 (2), 315–321.
OpenUrl

[71] Ogawa T.,

[72] Miyajima M.,

[73] Wakiyama N.,

[74] Terada K.

[75] 14.↵
Ogawa T.,
Miyajima M.,
Wakiyama N.,
Terada K.
Effects of Phosphate Buffer in Parenteral Drugs on Particle Formation from Glass Vials. Chem. Pharm. Bull. 2013, 61 (5), 539–545.
OpenUrl

[76] Ogawa T.,

[77] Miyajima M.,

[78] Wakiyama N.,

[79] Terada K.

[80] 15.↵
Adams P. B.
Spicule Formation in Solutions Stored in Glass Containers. Ceram. Bull. 1973, 52 (3), 250–254.
OpenUrl

[81] Adams P. B.

[82] 16.↵
Ratnaswamy G.,
Hair A.,
Li G.,
Thirumangalathu R.,
Nashed-Samuel Y.,
Brych L.,
Dharmavaram V.,
Wen Z.-Q.,
Fujimori K.,
Jing W.,
Sethuraman A.,
Swift R.,
Ricci M. S.,
Piedmonte D. M.
A Case Study of Nondelamination Glass Dissolution Resulting in Visible Particles: Implications for Neutral pH Formulations. J. Pharm. Sci. 2014, 103 (4), 1104–1114.
OpenUrl PubMed

[83] Ratnaswamy G.,

[84] Hair A.,

[85] Li G.,

[86] Thirumangalathu R.,

[87] Nashed-Samuel Y.,

[88] Brych L.,

[89] Dharmavaram V.,

[90] Wen Z.-Q.,

[91] Fujimori K.,

[92] Jing W.,

[93] Sethuraman A.,

[94] Swift R.,

[95] Ricci M. S.,

[96] Piedmonte D. M.

[97] 17.↵
Li G. G.,
Cao S.,
Jiao N.,
Wen Z.-Q.
Classification of Glass Particles in Parenteral Product Vials by Visual, Microscopic, and Spectroscopic Methods. PDA J. Pharm. Sci. Technol. 2014, 68 (4), 362–372.
OpenUrl Abstract/FREE Full Text

[98] Li G. G.,

[99] Cao S.,

[100] Jiao N.,

[101] Wen Z.-Q.

[102] 18.↵
Cao X.,
Matthew Fesinmeyer R.,
Pierini C. J.,
Siska C. C.,
Litowski J. R.,
Brych S.,
Wen Z.-Q.,
Kleemann G. R.
Free Fatty Acid Particles in Protein Formulations, Part 1: Microscpectroscopic Identification. J. Pharm. Sci. 2015, 104 (2), 433–446.
OpenUrl PubMed

[103] Cao X.,

[104] Matthew Fesinmeyer R.,

[105] Pierini C. J.,

[106] Siska C. C.,

[107] Litowski J. R.,

[108] Brych S.,

[109] Wen Z.-Q.,

[110] Kleemann G. R.

[111] 19.↵
Hampl V.,
Guo X.,
Ehrenstrasser C.,
Viertler M.,
Rayner L.,
Campanelli G.,
Schipflinger R.,
Thewes K.,
Cerreti A.,
Boehm S.,
Sonderegger C.
A Newly Identified Impurity in Polysorbate 80, the Long-Chain Ketone 12-Tricosanone, Forms Visible Particles in a Biopharmaceutical Drug Product. J. Pharm. Sci. 2018, 107 (6), 1552–1561.
OpenUrl

[112] Hampl V.,

[113] Guo X.,

[114] Ehrenstrasser C.,

[115] Viertler M.,

[116] Rayner L.,

[117] Campanelli G.,

[118] Schipflinger R.,

[119] Thewes K.,

[120] Cerreti A.,

[121] Boehm S.,

[122] Sonderegger C.

[123] 20.↵
Couston R. G.,
Skoda M. W.,
Uddin S.,
van der Walle C. F.
Adsorption Behavior of a Human Monoclonal Antibody at Hydrophilic and Hydrophobic Surfaces. mAbs 2013, 5 (1), 126–139.
OpenUrl

[124] Couston R. G.,

[125] Skoda M. W.,

[126] Uddin S.,

[127] van der Walle C. F.

[128] 21.↵
Joshi O.,
McGuire J.
Adsorption Behavior of Lysozyme and Tween 80 at Hydrophilic and Hydrophobic Silica-Water Interfaces. Appl. Biochem. Biotechnol. 2009, 152 (2), 235–248.
OpenUrl PubMed

[129] Joshi O.,

[130] McGuire J.

[131] 22.↵
Fujimori K.,
Lee H.,
Sloey C.,
Ricci M. S.,
Wen Z.-Q.,
Phillips J.,
Nashed-Samuel Y.
Comparison of Acid Titration, Conductivity, Flame Photometry, ICP-MS, and Accelerated Lamellae Formation Techniques in Determining Glass Vial Quality. PDA J. Pharm. Sci. Technol. 2016, 70 (3), 248–255.
OpenUrl Abstract/FREE Full Text

[132] Fujimori K.,

[133] Lee H.,

[134] Sloey C.,

[135] Ricci M. S.,

[136] Wen Z.-Q.,

[137] Phillips J.,

[138] Nashed-Samuel Y.

[139] 23.↵
Iacocca R. G.,
Allgeier M.
Corrosive Attack of Glass by a Pharmaceutical Compound. J. Mater. Sci. 2007, 42 (3), 801–811.
OpenUrl

[140] Iacocca R. G.,

[141] Allgeier M.

Main menu

User menu

Search

Characterization of a Novel Particle in a Pharmaceutical Drug Product

References

In This Issue

Citation Manager Formats

Related Articles

Cited By...

More in this TOC Section

Similar Articles

Keywords

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.

Main menu

User menu

Search

Characterization of a Novel Particle in a Pharmaceutical Drug Product

References

In This Issue

Citation Manager Formats

Jump to section

Related Articles

Cited By...

More in this TOC Section

Similar Articles

Keywords

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.