Excipient selection and criteria for injectable dosage forms

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

Volumn , Issue , 2006, Pages 271-290

  Chaubal, Mahesh V ^a   Kipp, James ^a   Rabinow, Barrett ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84928167302     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (71)

1. Duma RJ, Akers MJ, Turco SJ. Parenteral drug administration: routes, precautions, problems, complications, and drug delivery systems. Chapter 2. In: Avis KE, Lieberman HA, Lachman L, eds. Pharmaceutical Dosage Forms: Parenteral Medications. 1. New York: Marcel Dekker, Inc., 1992.
2. Prescott B, Kauffman G, James WG. Further studies on effect of glycerine on toxicity of isoniazid-streptomycin mixtures in mice. Antibiot Chemother 1958; 8: 225.
3. Cohen LS, Rosenthal JE, Horner DW, et al. Plasma levels of lidocaine after intramuscular administration. Am J Cardiol 1948; 29: 520.
4. Feldman S, Brazeau GA. Biopharmaceutic factors influencing drug availability. Chapter 7. In: S Turco, ed. Sterile Dosage Forms. 4th ed. Philadelphia: Lea & Febiger, 1994.
5. Steiner N, Bruera E. Methods of hydration in palliative care patients. J Palliat Care 1998; 14: 6-13.
6. Strickley RG. Solubilizing excipients in oral and injectable formulations. Pharm Res 2004; 21: 201-230.
7. Britton RC, Habif DV. Clinical uses of hyaluronidase. Surgery 1953; 33: 917-942.
8. Zuidema J, Pieters FA, Duchateau G. Release and absorption rate aspects of intramuscularly injected pharmaceuticals. Int J Pharm 1988; 47: 1-12.
9. Kostenbauder HB, Rapp RP, McGovern JP, et al. Bioavailability and single dose pharmacokinetics of intramuscular phenytoin. Clin Pharmacol Ther 1975; 18: 449.
10. Schlichtkrull J. Insulin Crystals. Copenhagen: Ejnar Munksgaard Publisher, 1958.
11. Buckwalter FJ, Dickison HL. The effect of vehicle and particle size on the absorption, by the intramuscular route, of procaine penicillin G suspension. J Am Pharm Assoc; Sci Ed 1958; 47: 661.
12. Malmsten M. Liposomes. Chapter 4. In: Malmsten M, ed. Surfactants and Polymers in Drug Delivery. New York: Marcel Dekker, Inc., 2002.
13. Jackson AJ. Intramuscular absorption and regional lymphatic uptake of liposomeentrapped insulin. Drug Met Disp 1981; 9: 535.
14. Tabata Y, Ikada Y. Phagocytosis of polymer microspheres by macrophages. Adv Polym Sci 1990; 94: 107-141.
15. Allen TM, Stuart DD. Liposome pharmacokinetics. Chapter 3. In: Janoff AS, ed. Liposomes. New York: Marcel Dekker, Inc., 1999.
16. Moghimi SM, Hunter AC, Murray JC. Long-circulating and target-specific nanoparticles: theory to practice. Pharmacol Rev 2001; 53: 283-318.
17. Reed KW, Yalkowsky SH. Lysis of human red blood cells in the presence of various cosolvents. J Parent Sci Tech 1985; 39: 64-68.
18. Reed KW, Yalkowsky SH. Lysis of human red blood cells in the presence of various cosolvents. II. The effect of differing NaCl concentrations. Bull Parent Drug Assoc 1986; 40: 88-94.
19. Al-Suwayeh SA, Tebbett IR, Wielbo D, Brazeau GA. In vitro-in vivo myotoxicity of intramuscular liposomal formulations. Pharm Res 1996; 13: 1384-1388.
20. Akers MJ. Excipient-drug interactions in parenteral formulations. J Pharm Sci 2002; 91: 2283-2300.
21. Weiner ML, Kotkoskie LA, eds. Excipient Toxicity and Safety. New York: Marcel Dekker, Inc., 2000.
22. Shackney S, Hasson J. Precipitious fall in serum calcium hypotension and acute renal failure after IV phosphate treatment of hypercalcemia. Arch Intern Med 1968; 122: 150.
23. Spencer H. Studies of the effect of chelating agents in man. Ann N Y Acad Sci 1960; 88: 435.
24. Thomas D, Hales P. Overhydration during transurethral resection of the prostate using glycine as an irrigating solution. Anesth Intensive Care 1984; 12: 366-369.
25. Dowdy EG, HollandWC, Yamanaka I, Kaya K. Cardioactive properties of d-tubocurarine with and without preservatives. Anesthesiology 1971; 34: 256-260.
26. Benda GI, Hiller JL, Reynolds JW. Benzyl alcohol toxicity: impact on neurologic handicaps among surviving very low birth weight infants. Pediatrics 1986; 77(4): 507-512.
27. Moller H. Merthiolate allergy: a nationwide iatrogenic sensitization. Acta Derm Venereol (Stokh.) 1977; 57: 509-517.
28. Gunnison AF, Jaconsen DW. Sulfite sensitivity. A critical review. Crit Rev Toxicol 1987; 17: 185-214.
29. Ring J, Messmer K. Incidence and severity of anaphylactoid reactions to colloid volume substitutes. Lancet 1977; 1: 466-469.
30. Poothullil J, Shimizu A, Day RP, Dolovich J. Anaphylaxis from the product(s) of ethylene oxide gas. Ann Intern Med 1975; 82: 58-60.
31. Gupta PK, Patel JP, Hahn KR. Evaluation of pain and irritation following local administration of parenteral formulations using the rat paw lick model. J Pharm Sci Technol 1994(May-Jun); 48(3): 159-166.
32. Mottu F, Stelling MJ, Rufenacht DA, Doelker E. Comparative hemolytic activity of undiluted organic water-miscible solvents for intravenous and intra-arterial injection. PDA J Pharm Sci Technol 2001(Jan-Feb); 55(1): 16-23.
33. Mottu F, Laurent A, Rufenacht DA, Doelker E. Organic solvents for pharmaceutical parenterals and embolic liquids: a review of toxicity data. PDA J Pharm Sci Technol 2000(Nov); 54(6): 456-469.
34. Yalkowsky SH, Valvani SC, Johnson BW. In vitro method for detecting precipitation of parenteral formulations after injection. J Pharm Sci 1983(Sep); 72(9): 1014-1017.
35. Chaubal MV. Polyactides/glycolides-excipients for injectable drug delivery and beyond. Drug Delivery Tech 2002; 2(5).
36. Anderson JM. In vivo biocompatibility of implantable delivery systems and biomaterials. Eur J Pharm Biopharm 1994; 40: 1-8.
37. Anderson JM. Mechanisms of inflammation and infection with implanted devices. Cardiovasc Pathol 1993; 23(suppl): 33S-41S.
38. Anderson JM. Perspectives on the in vivo responses of biodegradable polymers. In: Hollinger JO, ed. Biomedical Applications of Synthetic Biodegradable Polymers. Boca Raton, FL: CRC Press, 1995: 223-233.
39. Anderson JM. Inflammation and the foreign body response. Prob Gen Surg 1994; 11: 147-160.
40. Chaubal MV. Role of excipients in parenteral sustained-release formulations. Drug Deliv Tech 2003; 3(7).
41. Sznitowska M, Janicki S, Dabrowska EA, Gajewska M. Physicochemical screening of antimicrobial agents as potential preservatives for submicron emulsions. Eur J Pharm Sci 2002(Jun); 15(5): 489-495.
42. El Jastimi R, Edwards K, Lafleur M. Characterization of permeability and morphological perturbations induced by nisin on phosphatidylcholine membranes. Biophys J 1999(Aug); 77(2): 842-852.
43. Zhang Y, Roy S, Jones LS, et al. Mechanism for benzyl alcohol-induced aggregation of recombinant human interleukin-1 receptor antagonist in aqueous solution. J Pharm Sci 2004(Dec); 93(12): 3076-3089.
44. Akers MJ, Boand AV, Binkley DA. Preformulation method for parenteral preservative efficacy evaluation. J Pharm Sci 1984(Jul); 73(7): 903-905.
45. Sutton SV, Porter D. Development of the antimicrobial effectiveness test as USP chapter 51. PDA J Pharm Sci Technol 2002(Nov-Dec); 56(6): 300-311.
46. Alvarez-Nunez FA, Yalkowsky SH. Buffer capacity and precipitation control of pH solubilized phenytoin formulations. Int J Pharm 1999(Aug 5); 185(1): 45-49.
47. Simamora P, Pinsuwan S, Alvarez JM, Myrdal PB, Yalkowsky SH. Effect of pH on injection phlebitis. J Pharm Sci 1995(Apr); 84(4): 520-522.
48. Strickley RG. Solubilizing excipients in oral and injectable formulations. Pharm Res 2004(Feb); 21(2): 201-230.
49. Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer 2001(Sep); 37(13): 1590-1598.
50. Price KS, Castells MC. Taxol reactions. Allergy Asthma Proc 2002(May-Jun); 23(3): 205-208.
51. Kwon GS. Polymeric micelles for delivery of poorly water-soluble compounds. Crit Rev Ther Drug Carrier Syst 2003; 20(5): 357-403.
52. Kim TY, Kim DW, Chung JY, et al. Phase I and pharmacokinetic study of Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies. Clin Cancer Res 2004(Jun 1); 10(11): 3708-3716.
53. Yalkowsky SH, He Y. Handbook of Aqueous Solubility Data. Boca Raton, FL: CRC Press, 2003: 764.
54. Thiopental package insert (Pentothal, Abbott-US), Rev 7/84, Rec 5/86.
55. Wood M, Wood AJ, eds. Drugs and Anesthesia: Pharmacology for Anesthesiologists. Baltimore, MD: Williams & Wilkins; 1983: 200 19.
56. Larsen JR, Larsen LS. Clinical features and management of poisoning due to phenytoin. Med Toxicol Adverse Drug Exp 1989; 4(4): 229-245.
57. Wheless JW. Pediatric use of intravenous and intramuscular phenytoin: lessons learned. J Child Neurol 1998; 13(Suppl 1): S11-S14; discussion S30-S32.
58. Yalkowsky SH. Solubility and Solubilization in Aqueous Media. Washington, D.C.: American Chemical Society, 1999: 184-226.
59. Derjaguin BV, Landau L. Theory of stability of highly charged lyophobic sols and adhesion of highly charged particles in solutions of electrolytes. Acta Physicochimica (USSR) 1941; 4: 633
60. Verwey EJ, Overbeek J, Th G. Theory of the stability of lyophobic colloids. Amsterdam: Elsevier, 1948
61. Crocker JC, Grier DG. When like charges attract: the effects of geometrical confinement on long-range colloidal interactions. Phys Rev Lett 1996; 77(9): 1897-1900.
62. Diprivan® (propofol for injection) package insert. AstraZeneca 2001, 2004.
63. Alexandridis P, Hatton TA. Poly(ethylene oxide)-poly(propylene oxide)- poly(ethylene oxide) block copolymer surfactants in aqueous solutions and at interfaces: thermodynamics, structure, dynamics, and modeling (review). Colloid Surf A: Physicochem Eng Aspects 1995; 96: 1-46.
64. Lee RW, Shaw JM, McShane J, Wood RW. Particle size reduction. In: Liu R, ed. Water-Insoluble Drug Formulation. Interpharm, 2000: 478.
65. Lee RW, Shaw JM, McShane J, Wood RW. Particle size reduction. In: Liu R, ed. Water-Insoluble Drug Formulation. Interpharm, 2000: 487-488.
66. Bahal SM, Romansky JM. Sorption of parabens by fluoropolymer or fluoropolymer laminated flexible tubing. PDA J Pharm Sci Technol 2001(Nov-Dec); 55(6): 417-421.
67. Jenke D, Poss M, Story J, Odufu A, Zietlow D, Tsilipetros T. Development and validation of chromatographic methods for the identification and quantitation of organic compounds leached from a laminated polyolefin material. J Chromatogr Sci 2004(Aug); 42(7): 388-395.
68. Hayes P, Martin T, Pybus J. Aluminum content of intravenous solutions, additives and equipment used to prepare parenteral nutrition mixtures. Aust J Hosp Pharm 1992; 22: 353.
69. Rabinow B et al. Aluminum in parenteral products: analysis, reduction, and implications for pediatric TPN. J Parent Sci Tech 1989; 43: 132.
70. Rabinow BE, Roseman TR. Plastic packaging materials. Chapter 54. In: Remington: The Science and Practice of Pharmacy. 21st ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2005.
71. Jenke DR, Chess EK, Zietlow D, Rabinow BE. Model for estimating the accumulation of solutes leaching from polymeric containers into parenteral solutions. Int J Pharm 1992; 78: 115.