Variables Affecting Reconstitution Time of Dry Powder for Injection - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Variables Affecting Reconstitution Time of Dry Powder for Injection
The authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.


Pharmaceutical Technology


47. D.Q. Ma et al., "New Injectable Melphalan Formulations Utilizing (SBE)7m-[beta]-CD or HP-[beta]-CD," Int. J. Pharm. 189 (2), 227–234 (1999).

48. D.L. Teagarden and D. S. Baker, "Practical Aspects of Lyophilization Using Nonaqueous Cosolvent Systems," Eur. J. Pharm. Sci. 15 (2), 115–133 (2002).

49. M.E. Brewster et al., "Effect of Various Cyclodextrins on Solution Stability and Dissolution Rate of Doxorubicin Hydrochloride," Int. J. Pharm. 79 (1–3), 289–299 (1992).

50. P.P. Deluca and J.C. Boylan, Formulation of Small-Volume Parenterals, K.E. Avis et al. Eds. (Marcel Dekker Inc.,New York, NY 1992), pp.180–182.

51. H.R. Costantino et al., "Deterioration of Lyophilized Pharmaceutical Proteins," Biochemistry 63 (3), 357–422 (1998).

52. A.D. Kanavage et al., "Resistance of Antivenom Proteins to Foaming-Induced Denaturation," Toxicon 47 (4), 445–452 (2006).

53. "Guidelines for the Reconstitution of Synagis® (palivizumab)," http://www.synagis.com/hcp/pdf/SSP04%20072.pdf, accessed July 13, 2006.

54. T.P. Kravtchenko et al., "A Novel Method for Determining the Dissolution Kinetics of Hydrocolloid Powders," Food Hydrocolloids 13 (3), 219–225 (1999).

55. C. Confalonieri et al., "The Use of a New Laser Particle Size and Shape Analyser to Detect and Evaluate Gelatinous Microparticles Suspended in Reconstituted Anthracycline Infusion Solutions," J. Pharm. Biomed. Anal. 9 (1), 1–8 (1991).

56. J.D. Ewing et al., "Evaluating the Reconstitution of Intramuscular Ziprasidone (Geodon) into Solution," Ann. Emergency Med. 43 (3), 427–428 (2004).

57. H. Thiermann et al., "Dissolution Kinetics of Unstable Drugs in Two-Compartment Autoinjectors: Analysis of the Individual Shaking Behavior and Influence of Various Shaking Parameters on the Dissolution Rate of HI 6 in an Automated System," Int. J. Pharm. 170 (1), 23–32 (1998).

58. S.V. Balasubramanian, "Reconstituion Medium for Protein and Peptide Formulations," US Patent 2005/0069578 (2005).

59. J.T. Carstensen, Physical Testing, J. Swarbrick et al., Eds. (Marcel Dekker Inc., New York 2000), pp. 261–328.

60. K.E. Avis, Sterile Products, L. Lachman, et al., Eds. (Varghese Publishing House, Bombay 1986), p.639–677.

61. F.L. Grab, "Reconstitution of Dry Fill Cyclophosphamide,"US Patent 4775533 (1988).

62. S.A. Quraishi et al., "Dantrolene Reconstitution: Can Warmed Diluent Make a Difference?," J. Clin. Anaesth. 18, 339–342 (2006).

63. C. Allan and R.V. Boccia, "Temperature- and Volume-Dependent Dissolution of Amifostine 500 mg Reconstituted for Subcutaneous Injection in Normal Saline or Sterile Water for Injection," J. Clin. Oncol. (Meeting Abstracts) 23 (16), 3207 (2005).

64. L.W. Mitchell and B.L. Leighton, "Warmed Diluent Speeds Dantrolene Reconstitution," Can. J. Anaesth. 50 (2), 127–130 (2003).

65. K. Sieunarine and G. H. White, "Full-Thickness Burn and Venous Thrombosis following Intravenous Infusion of Microwave-Heated Crystalloid Fluids," Burns 22 (7), 568–569 (1996).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
8%
Protecting the supply chain
40%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here