Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal® Consta ®

International Journal of Pharmaceutics

Volumn 420, Issue 2, 2011, Pages 198-205

  Rawat, Archana ^a   Stippler, Erika ^b   Shah, Vinod P ^b   Burgess, Diane J ^a  

^a UNIVERSITY OF CONNECTICUT   (United States)

^b United States Pharmacopoeia   (United States)

Author keywords

In vitro release; PLGA microspheres; USP apparatus 4; Validation

Indexed keywords

MICROSPHERE; POLYGLACTIN; RISPERIDONE;

APPARATUS; ARTICLE; CONTROLLED RELEASE FORMULATION; IN VITRO STUDY; PRIORITY JOURNAL; REPRODUCIBILITY; TEMPERATURE; USP APPARATUS 4; VALIDATION STUDY;

ANTIPSYCHOTIC AGENTS; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DRUG CARRIERS; HYDROGEN-ION CONCENTRATION; LACTIC ACID; MICROSPHERES; MOLECULAR WEIGHT; POLYGLYCOLIC ACID; REPRODUCIBILITY OF RESULTS; RISPERIDONE; TEMPERATURE;

EID: 80054702104     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.08.035     Document Type: Article

References (26)

1. J.P. Adler-Moor, and R.T. Proffitt Case study: AmBiosome - a development case study of a liposomal formulation of the antifungal agent amphotericin B D.J. Burgess, Injectable Dispersed Systems 2005 Taylor and Francis Boca Raton 481 541
2. A. Albert, and E.P. Serjeant Determination of ionization constants by potentiometric titration using a glass electrode A. Albert, E.P. Serjeant, The Determination of Ionization Constants: A Laboratoty Manual third ed. 1984 Chapman and Hall New York 14 38
3. C.K. Brown Dissolution method development: an industry perspective J. Dressman, J. Kramer, Pharmaceutical Dissolution Testing 2005 Taylor and Francis 351 372
4. D.J. Burgess, D.J.A. Crommelin, A.S. Hussain, and M.-L. Chen Assuring quality and performance of sustained and controlled release parenterals: EUFEPS workshop report AAPS PharmSci. 6 2004 1 12
5. D.J. Burgess, A.S. Hussain, T.S. Ingallinera, and M.-L. Chen Assuring quality and performance of sustained and controlled release parenterals: workshop report AAPS PharmSci. 4 2002 1 11
6. Y. Cha, and C.G. Pitt A one week subdermal delivery system for l-methadone based on biodegradable microcapsules J. Control. Release 7 1988 69 78
7. P. Chue Risperidone long-acting injection Expert Rev. Neurother. 3 2003 435 446 (Pubitemid 36890049)
8. J.L. Cleland, E. Duenas, A. Daugherty, M. Marian, J. Yang, M. Wilson, A.C. Celniker, A. Shahzamani, V. Quarmby, H. Chu, V. Mukku, A. Mac, M. Roussakis, N. Gillette, B. Boyd, D. Yeung, D. Brooks, Y.-F. Maa, C. Hsu, and A.J.S. Jones Recombinant human growth hormone poly(lactic-co-glycolic acid) (PLGA) microspheres provide a long lasting effect J. Control. Release 49 1997 193 205 (Pubitemid 28020273)
9. S.S. D'Souza, and P.P. DeLuca Development of a dialysis in vitro release method for biodegradable microspheres AAPS PharmSci. Tech. 6 2006 E323 E328
10. V.A. Gray AAPS/FDA workshop on dissolution/in vitro release testing and specifications for special dosage forms. Diss. Technol. 9 2002 3 (article)
11. ICH-Q2A Guidelines for Industry Text on Validation of Analytical Procedures March, 1995
12. M.M. Jug, I. Kos, and M. Bećirević-Laćan The pH-dependent complexation between risperidone and hydroxypropyl-b-cyclodextrin J. Incl. Phenom. Macrocycl. Chem. 64 2009 163 171
13. K. Makino, M. Arakawa, and T. Kondo Preparation and in vitro degradation properties of polylactide microcapsules Chem. Pharm. Bull. 33 1985 1195 1201 (Pubitemid 15104072)
14. F.J. Martin Case study: DOXIL the development of pegylated liposomal doxurubicin D.J. Burgess, Injectable Dispersed Systems 2005 Taylor and Francis Boca Raton 427 480
15. M. Martinez, M. Rathbone, D. Burgess, and M. Huynh 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 129 2008 79 87
16. H.V. Maulding, T.R. Tice, D.R. Cowsar, J.W. Fong, J.E. Pearson, and J.P. Nazareno Biodegradable microcapsules: acceleration of polymeric excipient hydrolytic rate by incorporation of a basic medicament J. Control. Release 3 1986 103 117 (Pubitemid 16168144)
17. C.G. Oster, M. Wittmar, F. Unger, L. Barbu-Tudoran, A.K. Schaper, and T. Kissel Design of amine-modified graft polyesters for effective gene delivery using DNA-loaded nanoparticles Pharm. Res. 21 2004 927 931 (Pubitemid 38870140)
18. J.M. Ramstack, G.P. Grandolfi, E. Mannaert, P. D'Hoore, and R.A. Lasser Risperdal® CONSTA™: prolonged-release injectable delivery of risperidone using Medisorb® microsphere technology Abstr. Am. Assoc. Pharm. Sci. (AAPS) 2002
19. M. Siewert, J. Dressman, C. Brown, and V.P. Shah FIP/AAPS guidelines for dissolution/in vitro testing of novel/special dosage forms Diss. Technol. 2003 6 15
20. M.T. Tracy Case study: biodegradable microspheres for the sustained release of proteins D.J. Burgess, Injectable Dispersed Systems 2005 Taylor and Francis Boca Raton 571 581
21. J.M. Voisine, B.S. Zolnik, and D.J. Burgess In situ fiber optic method for long-term in vitro release testing of microspheres Int. J. Pharm. 356 2008 206 211
22. C. Wischke, and S.P. Schwendeman Principles of encapsulating hydrophobic drugs in PLA/PLGA microparticles Int. J. Pharm. 364 2008 298 327
23. X.S. Wu Synthesis and properties of biodegradable lactic/glycolic acid polymers D.L. Wise, D.J. Trantolo, D.E. Altobelli, Encyclopedic Handbook of Biomaterials and Bioengineering 1995 Marcel Dekker New York 1015
24. B.S. Zolnik, and D.J. Burgess Effect of acidic pH on PLGA microsphere degradation and release J. Control. Release 122 2007 338 344 (Pubitemid 47404676)
25. B.S. Zolnik, P.E. Leary, and D.J. Burgess Elevated temperature accelerated release testing of PLGA microspheres J. Control. Release 30 2006 293 300 (Pubitemid 43737147)
26. B.S. Zolnik, J.-L. Raton, and D.J. Burgess Application of USP apparatus 4 and in situ fiber optic analysis to microsphere release testing Diss. Technol. 2005 11 14