Breakout session summary from AAPS/CRS joint workshop on critical variables in the in vitro and in vivo performance of parenteral sustained release products

Journal of Controlled Release

Volumn 142, Issue 1, 2010, Pages 2-7

  Martinez, Marilyn N ^a   Rathbone, Michael J ^b   Burgess, Diane ^c   Huynh, Mai ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b GRIFFITH UNIVERSITY   (Australia)

^c UNIVERSITY OF CONNECTICUT   (United States)

Author keywords

Implant; In situ forming implant; In vitro drug release testing; In vivo in vitro relationship; Lipophilic solution; Liposome; Long acting; Microsphere; Modified release; Parenteral; Quality by design; Sustained release

Indexed keywords

IN VITRO DRUG RELEASE TESTING; IN-SITU FORMING; IN-VITRO; IN-VIVO; LIPOPHILIC SOLUTION; QUALITY BY DESIGNS; SUSTAINED RELEASE;

CYTOTOXICITY; DRUG DELIVERY; MICROSPHERES;

DRUG PRODUCTS;

BIOMATERIAL; DRUG; GENERIC DRUG;

BIOCOMPATIBILITY; BIOEQUIVALENCE; CHEMICAL MODIFICATION; COLUMN CHROMATOGRAPHY; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SAFETY; IMMUNE RESPONSE; IN VITRO STUDY; IN VIVO STUDY; LABORATORY TEST; LIPOPHILICITY; PARTICLE SIZE; PATIENT COMPLIANCE; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SPECTROSCOPY; SURFACE PROPERTY; SUSTAINED DRUG RELEASE; WORKSHOP;

ANIMALS; DRUG DELIVERY SYSTEMS; DRUG DESIGN; EDUCATION; HUMANS; INFUSIONS, PARENTERAL; QUALITY CONTROL;

EID: 76749157815     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jconrel.2009.09.028     Document Type: Review

References (25)

1. Martinez M., Rathbone M., Burgess D., Huynh M. In vitro and in vivo considerations associated with parenteral sustained release products: a review based upon information presented and points expressed at the 2007 Controlled Release Society Annual Meeting. J. Control. Release 2008, 129(2):79-87.
2. G. Pifferi G, P. Restani, The safety of pharmaceutical excipients, Il Farmaco. 58 (8) (2003) 541-550.
3. FDA Guidance for Industry Guidance for IndustryNonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients May 2005, http://www.fda.gov/cder/guidance/5544fnl.pdf.
4. Sinkovics J.G. Adult human sarcomas. II. Medical oncology. Expert Rev. Anticancer Ther. 2007, 7(2):183-210.
5. Schepelmann S., Ogilvie L.M., Hedley D., Friedlos F., Martin J., Scanlon I., Chen P., Marais R., Springer C.J. Suicide gene therapy of human colon carcinoma xenografts using an armed oncolytic adenovirus expressing carboxypeptidase G2. Cancer Res. 2007, 67(10):4949-4955.
6. Hirano K., Ichihashi T., Yamada H. Studies on the absorption of practically water-insoluble drugs following injection: I. Intramuscular absorption from water-immiscible oil solutions in rats. Chem. Pharm. Bull. (Tokyo) 1981, 29(2):519-531.
7. Larsen D.B., Joergensen S., Olsen N.V., Hansen S.H., Larsen C. In vivo release of bupivacaine from subcutaneously administered oily solution. Comparison with in vitro release. J. Control. Release 2002, 81(1-2):145-154.
8. Murdan S. Organogels in drug delivery. Expert Opin. Drug Deliv. 2005, 2(3):489-505.
9. Nanjawade B.K., Manvi F.V., Manjappa A.S. In situ-forming hydrogels for sustained ophthalmic drug delivery. J. Control. Release 2007, 122(2):119-134.
10. Ruel-Gariépy E., Leroux J.C. In situ-forming hydrogels-review of temperature-sensitive systems. Eur. J. Pharm. Biopharm. 2004, 58(2):409-426.
11. Larsen S., Larsen C. Critical factors influencing the in vivo performance of long-acting lipophilic solutions-impact on in vitro release method design. AAPS J. 2009, 11(4):762-770.
12. USP Dissolution and Drug Release monographs. USP <711> - Dissolution. USP <724> Drug Release.
13. Voisine J.M., Zolnik B.S., Burgess D.J. In situ fiber optic method for long-term in vitro release testing of microspheres. Int. J. Pharm. 2008, 356(1-2):206-211.
14. Kamberi M., Nayak S., Myo-Min K., Carter T.P., Hancock L., Feder D. A novel accelerated in vitro release method for biodegradable coating of drug eluting stents: insight to the drug release mechanisms. Eur. J. Pharm. Sci. 2009, 37(3-4):217-222.
15. Burgess D.J., Crommelin D.J., Hussain A.S., Chen M.L. Assuring quality and performance of sustained and controlled release parenterals: EUFEPS workshop report. AAPS J. 2004, 6(1):100-111.
16. M.N. Martinez, Interspecies Differences That Influence Parenteral Product Performance. Manuscript in preparation for AAPS Journal Theme Issue on Parenteral Dosgae Forms.
17. Martinez M.N., Papich M.G. Factors influencing the gastric residence of dosage forms in dogs. J. Pharm. Sci. 2009, 98(3):844-860.
18. Zolnik B.S., Burgess D.J. Effects of acidic pH on PLGA microspheres and release. J. Control. Release 2007, 122(3):338-344.
19. Zolnik B.S., Leary P.E., Burgess D.J. Elevated temperature accelerated release testing of PLGA microspheres. J. Control. Release 2006, 112(3):293-300.
20. Viswanathan N.B., Patil S.S., Pandit J.K., Lele A.K., Kulkarmi M.G., Mashelkar R.A. Morphological changes in degrading PLGA and P(DL)LA microspheres: implications for the design of controlled release systems. J. Microencapsul 2001, 18(6):783-800.
21. Mellstedt H., Niederwiese D., Ludwig H. The challenge of biosimilars. Ann. Oncol. 2008, 19(3):411-419.
22. Schellekens H. Assessing the bioequivalence of biosimilars: the Retacrit® case. Drug Discov. Today 2009, 14(9/10):495-499.
23. Frequently Asked Questions for New Drug Exclusivity. http://www.fda.gov/cder/about/smallbiz/exclusivity.htm.
24. United States Pharmacopeial Convention Inc. Critical quality and performance parameters for modified-release parenteral dosage forms. Pharmacopeial Forum Stimuli Article 2007, vol. 31 (6).
25. Lionberger R.A., Lee S.L., Lee L., Raw A., Yu L.X. Quality by design: concepts for ANDAs. Quality by design: concepts for ANDAs 2008, 10(2):268-276.