Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System

Reference

1. 1.↵
   1. Shire S. J.,
   2. Shahrokh Z.,
   3. Li J.

   Challenges in the Development of High Protein Concentration Formulations. J. Pharm. Sci. 2004, 93 (6), 1390–1402.

   OpenUrlCrossRefPubMedWeb of Science
2. 2.↵
   1. Schoenknecht T.,
   2. Romacker M.

   Prefilled Syringes: Why New Developments Are Important in Injectable Delivery Today. In Prefilled Syringe: Innovations that Meet the Growing Demand; ONDrugDelivery Ltd.: East Sussex, UK, 2005, pp 9–11.
3. 3.↵
   1. Overcashier D. E.,
   2. Chan E. K.,
   3. Hsu C. C.

   Technical Considerations in the Development of Prefilled Syringes for Protein Products. Am. Pharm. Rev. 2004, 9 (7), 77–83.

   OpenUrl
4. 4.↵
   1. Jezek J.,
   2. Darton N. J.,
   3. Derham B. K.,
   4. Royle N.,
   5. Simpson I.

   Biopharmaceutical Formulations for Prefilled Delivery Devices. Expert Opin. Drug Deliv. 2013, 10 (6), 811–828.

   OpenUrlPubMed
5. 5.↵
   1. Berteau C.,
   2. Schwzenbach F.,
   3. Donazzalo M.,
   4. Berube J.,
   5. Abry H.,
   6. Cotton J.

   Evaluation of Performance, Safety, Subject Acceptance and Compliance of a Disposable Auto-Injector for Subcutaneous Injections in Healthy Volunteers. J. Patient Preference and Adherence 2004, 4, 379–388.

   OpenUrl
6. 6.↵
   1. Bee J. S.,
   2. Frey V. V.,
   3. Javed U. J.,
   4. Corcoran M. L.,
   5. Roussel P. S.,
   6. Krause S. O.,
   7. Cash P. W.,
   8. Bishop S. M.,
   9. Dimitrova M. N.

   Characterization of the Initial Level and Migration of Silicone Oil Lubricant in Empty Prefilled Syringes for Biologics Using Infrared Spectroscopy. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 494–503.

   OpenUrlAbstract/FREE Full Text
7. 7.↵
   1. Dixit N.,
   2. Maloney K. M.,
   3. Kalonia D. S.

   Effect of Processing Parameters on the Physical Stability of Silicone Coatings. AAPS PharmSciTech, 2012, 13 (4), 1116–1119.

   OpenUrlPubMed
8. 8.↵
   1. Bee J. S.,
   2. Randolph T. W.,
   3. Carpenter J. F.,
   4. Bishop S. M.,
   5. Dimitrova M. N.

   Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals. J. Pharm. Sci. 2011, 100 (10), 4158–4170.

   OpenUrl
9. 9.↵
   1. Gerhardt A.,
   2. Mcgraw N. R.,
   3. Schwartz D. K.,
   4. Bee J. S.,
   5. Carpenter J. F.,
   6. Randolph T. W.

   Protein Aggregation and Particle Formation in Prefilled Glass Syringes. J. Pharm. Sci. 2014, 103 (6), 1601–1612.

   OpenUrl
10. 10.↵
    1. Mehta S. B.,
    2. Lewus R.,
    3. Bee J. S.,
    4. Randolph T. W.,
    5. Carpenter J. F.

    Gelation of a Monoclonal Antibody at the Silicone Oil–Water Interface and Subsequent Rupture of the Interfacial Gel Results in Aggregation and Particle Formation. J. Pharm. Sci. 2015, 104 (4), 1282–1290.

    OpenUrl
11. 11.↵
    1. Wen Z. Q.,
    2. Vance A.,
    3. Vega F.,
    4. Cao X.,
    5. Eu B.,
    6. Schulthesis R.

    Distribution of Silicone Oil in Prefilled Glass Syringes Probed with Optical and Spectroscopic Methods. PDA J. Pharm. Sci. Technol. 2009, 63 (2), 149–158.

    OpenUrlAbstract/FREE Full Text
12. 12.↵
    https://permselect.com/files/Silicone_Chemical_Compatibility_Chart.pdf.
13. 13.↵
    1. Thirumangalathu R.,
    2. Krishnan S.,
    3. Ricci M. S.,
    4. Brems D. N.,
    5. Randolph T. W.,
    6. Carpenter J. F.

    Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution. J. Pharm. Sci. 2009, 98 (9), 3167–3181.

    OpenUrlCrossRefPubMedWeb of Science
14. 14.↵
    1. Förch R.,
    2. Schönherr H.,
    3. Jenkins A. T.

    A. Surface Design: Applications in Bioscience and Nanotechnology, Wiley-VCH: Weinheim, Germany, 2009, p 471.
15. 15.↵
    1. Pant R.,
    2. Roy P. K.,
    3. Nagarajan A. K.,
    4. Khare K.

    Investigation of Slippery Behaviour of Lubricating Fluid Coated Smooth Hydrophilic Surfaces. arXiv preprint arXiv:1508.00675.
16. 16.↵
    1. Wiley C.

    Polysorbate-80 Adsorption to Silicone Oil During Long-Term Storage of Monoclonal Antibody Formulations in Prefilled Syringes. AAPS Conference Poster, 2016.