Novel injectable formulations of insoluble drugs

Pharmaceutical Technology

Volumn 23, Issue 3, 1999, Pages 116-134

  Pace, Sarah N ^a   Pace, Gary W ^a   Parikh, Indu ^a   Mishra, Awadhesh K ^a  

^a RTP Pharma Inc   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

AMPHOTERICIN B; AMPHOTERICIN B LIPID COMPLEX; BUSULFAN; ITRACONAZOLE; LIPOSOME; NANOPARTICLE; PARENTERAL SOLUTION; PHOSPHOLIPID; SOLUBILIZER; SOLVENT; STABILIZING AGENT; SURFACTANT; WATER;

ARTICLE; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG LEGISLATION; DRUG SAFETY; DRUG SOLUBILITY; DRUG STABILITY; FREEZE DRYING; PARTICLE SIZE; PH; SUSPENSION;

EID: 0033015283     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (54)

1. S. Sweetana and M.J. Akers, "Solubility Principles and Practices for Parenteral Drug Dosage Form Development," PDA J. Pharm. Sci. Technol. 50, 330-342 (1996).
2. S. Nema, R.J. Washkuhn, and R.J. Brendel, "Excipients and Their Use in Injectable Products," PDA J. Pharm. Sci. Technol. 51, 166-171 (1997).
3. G.K. McEvoy, Ed., AHFS Drug Information (American Hospital Formulary Service, Bethesda, MD, 1997), pp. 1374-1378.
4. R.J. Duma, M.J. Akers, and S.J. Turco, "Parenteral Drug Administration: Routes, Precautions, Problems, Complications, and Drug Delivery Systems," in Pharmaceutical Dosage Forms: Parenteral Medications Vol. 1, K.E. Avis, H.A. Lieberman, and L. Lachman, Eds. (Marcel Dekker, New York, 2nd ed., 1992), pp. 17-58.
5. G. H. Ward and S. H. Yalkowsky, "Studies in Phlebitis. VI: Dilution-Induced Precipitation of Amiodarone HCl," J. Parenter. Sci. Technol. 47, 161-165 (1993).
6. B.A. Bivins et al., "Final Inline Filtration: A Means of Decreasing the Incidence of Infusion Phlebitis," Surgery 85, 388-394 (1979).
7. P. Mounier et al., "Anaphylactoid Reactions to an Injectable Solution of a Cremochor-Containing Solution of Multivitamins," Therapie 50, 571-573 (1995).
8. J.G. Theis et al., "Anaphylactoid Reactions in Children Receiving High-Dose Intravenous Cyclosporine for Reversal of Tumor Resistance: the Causative Role of Improper Dissolution of Cremophor EL," J. Clin. Oncol. 13, 2508-2516 (1995).
9. D.A. Moneret-Vautrin, M.C. Laxenaire, and F. Viry-Babel, "Anaphylaxis Caused by Anti-Cremophor ELIgG STS Antibodies in a Case of Reaction to Althesin," Br. J. Anaesth. 55, 469-471 (1983).
10. A. Eschalier et al., "Study of Histamine Release Induced by Acute Administration of Antitumor Agents in Dogs," Cancer Chemother. Pharmacol. 21, 246-250 (1988).
11. A. Muñoz et al., "A Randomized Hemodynamic Comparison of Intravenous Amiodarone with and without Tween-80," Eur. Heart J. 9, 142-148 (1988).
12. J.F. Mueller and J.E. Canham, "Symposium on Intravenous Fat Emulsions," Am. J. Clin. Nutr. 16, 1-223 (1965).
13. International Union of Pure and Applied Chemistry, Manual on Colloid and Surface Chemistry (Butterworth, New York, 1972).
14. L.C. Collins-Gold, R.T. Lyons, and L.C. Bartholow, "Parenteral Emulsions for Drug Delivery," Adv. Drug Deliv. Rev. 5, 189-208 (1990).
15. Y.A. Carpentier et al., "Recent Developments in Lipid Emulsions: Relevance to Intensive Care," Nutrition 13, 73S-78S (1997).
16. R.J. Prankerd and V.J. Stella, "The Use of Oil-in-Water Emulsions as a Vehicle for Parenteral Drug," J. Parenter. Sci. Technol. 44, 139-149 (1990).
17. D. Papahadjopoulos, Ed., "Liposomes and Their Uses in Biology and Medicine," Ann. N.Y. Acad. Sci. 308 (1978).
18. D.J.A. Crommelin and H. Schreier, "Liposomes," in Colloidal Drug Delivery Systems, J. Kreuter, Ed. (Marcel Dekker, New York, 1994), pp. 73-190.
19. J.H. Senior, "Fate and Behavior of Liposomes in Vivo: A Review of Controlling Factors," Crit. Rev. Ther Drug. Carrier. Syst. 3, 123-193 (1987).
20. P. Palatini, "Disposition Kinetics of Phospholipid Liposomes," Adv. Exp. Med. Biol. 318, 375-391 (1992).
21. D. Papahadjopoulos and A. Gabizon, "Liposomes Designed to Avoid the Reticuloendothelial System," Prog. Clin. Biol. Res. 343, 85-93 (1990).
22. M.C. Woodle and D.D. Lasic, "Sterically Stabilized Liposomes," Biochim. Biophys. Acta 1113, 171-199 (1992).
23. P. P. Speiser, "Nanoparticles and Liposomes: A State of the Art," Methods. Find. Exp. Clin. Pharmacol. 13, 337-342 (1991).
24. J. Kreuter, "Nanoparticles," in Colloidal Drug Delivery Systems, J. Kreuter, Ed. (Marcel Dekker, New York, 1994), pp. 219-342.
25. D.M. Rust and G. Jameson, "The Novel Lipid Delivery System of Amphotericin B: Drug Profile and Relevance to Clinical Practice," Oncol. Nurs. Forum 25, 35-48 (1998).
26. D.H. Haynes, "Microdroplets of Water Insoluble Drugs," International Patent #WO 85/00011, issued 3 January 1985.
27. D.H. Haynes, "Method of Inducing Local Anesthesia Using Microdroplets of a General Anesthetic," US Patent #4,622,219, issued 11 November 1980.
28. D.H. Haynes, "Phospholipid-Coated Microcrystals: Injectable Formulations of Water-Insoluble Drugs," US Patents #5,091,187 and #5,091,188, issued 25 February 1992.
29. D.H. Haynes, "Microdroplets of Water-Insoluble Drugs and Injectable Formulations Containing Same," US Patent #4,725,442, issued 16 February 1988.
30. G.G. Liversidge et al., "Surface-Modified Drug Nanoparticles," US Patent #5,145,684, issued 8 September 1992.
31. K.J. Illig and P. Sarpotdar, "Formulations Comprising Olin 10-G to Prevent Particle Aggregation and Increase Stability," US Patent #5,340,564, issued 23 August 1994.
32. H. William Bosch et al., "Process for Preparing Therapeutic Compositions Containing Nanoparticles," US Patent #5,510,118, issued 23 April 1996.
33. 2+-triggered Membrane Aggregation Reaction of Phospholipid Membranes," Biochim. Biophys. Acta 394, 335-347 (1975).
34. D.H. Haynes and A. F. Kirkpatrick, "Ultra-Long Duration Local Anesthesia Produced by Injection of Lecithin-Coated Methoxyflurane Microdroplets," Anesthesiology 63, 490-499 (1985).
35. D.H. Haynes and A.F. Kirkpatrick "Ultra-Long Duration Local Anesthesia Produced by Intra-Dermal Injection of Lecithin-Coated Methoxyflurane Microdroplets," in Proceedings of the International Symposium on Controlled-Release Bioactive Material 14, 293-294 (1987).
36. I. Parikh and W. Stern, "MicroCrystal Drug Delivery System," in The Biotechnology Report 1993-94, H.S. Price, Ed. (Campden Publishing. Ltd., Hong Kong, 1993), pp. 219-220.
37. S.M. Karan et al., "Intravenous Lecithin-Coated Microcrystals of Dantrolene Are Effective in the Treatment of Malignant Hyperthermia. An Investigation in Rats, Dogs, and Swine," Anesth. Analg. 82, 796-802 (1996).
38. S.M. Karan et al., "Lecithin-Coated Dantrolene Sodium Microcrystals are Effective in the Treatment of Malignant Hyperthermia in Susceptible Swine," Anesthesiology 79, A437 (1993).
39. E.W. Lojeski et al., "Lecithin-Coated Dantrolene Sodium Microcrystals vs. Dantrolene Sodium: Dose Response to Muscular Twitch in Swine," Anesthesiology 79, A438 (1993).
40. P.F. Lackham, "The Physical Stability of Suspension Concentrates with Particular Reference to Pharmaceutical and Pesticide Formulations," Pestic. Sci. 25, 25-34 (1989).
41. D.J. Shaw, Introduction to Colloid and Surface Chemistry (Butterworth-Heinemann, Oxford, UK, 4th ed., 1992).
42. W. McCulloch et al., "Development of I.V. Busulfan," in Annual Meeting of the European Group for the Bone Marrow Transplantation (Harrogate, UK, 1994), p. 116.
43. D.H. Haynes and A.F. Kirkpatrick, "Long-Duration Local Anesthesia with Lecithin-Coated Microdroplets of Methoxyflurane: Studies with Human Skin," Regional Anesthesia 16, 173-180 (1991).
44. A.F. Kirkpatrick, M. Lavallee-Grey, and D.H. Haynes, "Long-Duration Local Anesthesia with Lecithin-Coated Microdroplets of Methoxyflurane: Studies with Rat Skin," Regional Anesthesia 16, 164-172 (1991).
45. J. Kreuter, "Evaluation of Nanoparticles as Drug-Delivery Systems II: Comparison of the Body Distribution of Nanoparticles with the Body Distribution of Microspheres (Diameter > 1 μm), Liposomes, and Emulsions," Pharm. Acta Helv. 58, 217-226 (1983).
46. R.H. Muller, "In-Vivo Distribution of Carriers" and "Relation of the In-Vivo Distribution to the Surface Characteristics of the Carriers," in Colloidal Carriers for Controlled Drug Delivery and Targeting (CRC Press, Boca Raton, FL, 1991).
47. M.A. Clement, W. Pugh, and I. Parikh, "Tissue Distribution and Plasma Clearance of a Novel Microcrystal-Encapsulated Flurbiprofen Formulation," The Pharmacologist 34, 204 (1992).
48. H.S. White et al., "Microparticle Felbamate Blocks Maximum Electroshock Following Intravenous Administration," Res. Comm. Biolog. Psychology and Psychiatry, in press.
49. I. Parikh, W. Watzek, and D. Haynes, "Microcrystal Technology-Based Sustained Delivery of Nifedipine in Rats," The Pharmacologist 33, 197 (1991).
50. B.H. Boedeker et al., "Ultra-Long Duration Local Anesthesia Produced by Injection of Lecithin-Coated Tetracaine Microcrystals," J. Clin. Pharmacol. 34, 699-702 (1994).
51. B.H. Boedeker et al., "Peripheral Neurotoxicity of Lecithin-Coated Tetracaine Microcrystals," Anesthesiology 79, A825 (1993).
52. M.D. Kline et al., "Intradermal Toxicity of Lecithin-Coated Microcrystalline Tetracaine," Anesthesiology 77, A800 (1992).
53. R.F. DeMeo, D.H. Haynes, and G.B. Bikhazi, "Comparing Efficacy and Intradermal Toxicity of Lecithin-Coated Microcrystal Dezocine," Anesthesiology 79, A865 (1993).
54. M.Y. Wu et al., "Pharmacokinetics of Methoxyflurane after Its Intradermal Injection as Lecithin-Coated Microdroplets," J. Controlled Release 9, 1-12 (1989).