Biowaiver monographs for immediate release solid oral dosage forms: Prednisone

Journal of Pharmaceutical Sciences

Volumn 96, Issue 6, 2007, Pages 1480-1489

  Vogt, M ^a   Derendorf, H ^b   Kramer J ^c   Junginger, H E ^d   Midha, K K ^e   Shah, V P ^f   Stavchansky, S ^g   Dressman, J B ^a   Barends, D M ^h  

^a GOETHE UNIVERSITY   (Germany)

^b UNIVERSITY OF FLORIDA HEALTH   (United States)

^c PHAST GmbH   (Germany)

^d NARESUAN UNIVERSITY   (Thailand)

^e UNIVERSITY OF SASKATCHEWAN   (Canada)

^f International Pharmaceutical Federation FIP   (Netherlands)

^g UNIVERSITY OF TEXAS AT AUSTIN   (United States)

^h NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

Absorption; Bioequivalence; Biopharmaceutics classification system (BCS); Permeability; Prednisone; Regulatory science; Solubility

Indexed keywords

CARBOXYMETHYLCELLULOSE; CELLULOSE; CROSCARMELLOSE SODIUM; GELATIN; HYDROXYPROPYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; MAGNESIUM STEARATE; POTATO STARCH; PREDNISOLONE; PREDNISONE; SILICON DIOXIDE; STARCH; STARCH GLYCOLATE SODIUM; TALC;

ALLERGIC DISEASE; ARTHRITIS; ASTHMA; BIOEQUIVALENCE; CONGENITAL ADRENAL HYPERPLASIA; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM; DRUG EXCRETION; DRUG FORMULATION; DRUG INDICATION; DRUG METABOLISM; DRUG PENETRATION; DRUG RELEASE; DRUG SOLUBILITY; GRAFT REJECTION; LOW DRUG DOSE; PARTITION COEFFICIENT; PKA; REVIEW; SYSTEMIC LUPUS ERYTHEMATOSUS;

EID: 34250790189     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20817     Document Type: Article

References (66)

1. Vogelpoel H, Welink J, Amidon GL, Junginger HE, Midha KK, Möller H, Olling M, Shah VP, Barends DM. 2004. Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol. J Pharm Sci 93:1945-1956.
2. WHO. 2005. Model list of essential medicines, 14th edition. Available from URL http://whqlibdoc.-who.int/hq/2005/a87017_eng.pdf.
3. WHO. 2006. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Technical Report Series No. 937, 40th Report, Annex 8 of WHO Expert committee on specifications for pharmaceutical preparations. Available from URL http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf.
4. Kalantzi L, Reppas C, Dressman JB, Amidon G, Junginger HE, Midha KK, Shah VP, Stavchansky SA, Barends DM. 2006. Biowaiver monographs for immediate release solid oral dosage forms: Acetaminophen (paracetamol). J Pharm Sci 95:4-14.
5. Manzo HR, Olivera ME, Amidon GL, Dressman JB, Barends DM. 2006. Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline Hydrochloride. J Pharm Sci 95: 966-973.
6. Verbeeck RK, Junginger HE, Midha KK, Shah VP, Barends DM. 2005. Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Chloroquine phosphate, chloroquine sulfate and chloroquine hydrochloride. J Pharm Sci 94:1389-1395.
7. Jantratid E, Prakongpan S, Dressman JB, Amidon GL, Junginger HE, Midka KK, Barends DM. 2006. Biowaiver monographs for immediate release solid oral dosage forms: Cimetidine. J Pharm Sci 95: 974-984.
8. Potthast H, Dressman JB, Junginger HE, Midha KK, Oeser H, Shah VP, Vogelpoel H, Barends DM. 2005. Biowaiver monographs for immediate release solid oral dosage forms: Ibuprofen. J Pharm Sci 94:2121-2131.
9. Kortejärvi H, Yliperttula M, Dressman JB, Junginger HE, Midha KK, Shah VP, Barends DM. 2005. Biowaiver monographs for immediate release solid oral dosage forms: Ranitidine hydrochloride. J Pharm Sci 94:1617-1625.
10. Francisco GE, Honigberg IL, Stewart JT, Kotzan JA, Brown WJ, Schary WL, Pelsor FR, Shah VP. 1984. In vitro and in vivo bioequivalence of commercial prednisone tablets. Biopharm Drug Dispos 5:335-344.
11. Pickup ME. 1979. Clinical pharmacokinetics of prednisone and prednisolone. Clin Pharmacokinet 4:111-128
12. Rote Liste. 2004. Online. Häßner K, editor. Frankfurt, Germany: Rote Liste Service GmbH. Available from URL www.rote-liste.de
13. Fachinformation Decortin. 2002. Bundesverband der Pharmazeutischen Industrie Service GmbH, Aulendorf, Germany.
14. Kaiser H, Kley HK. 2002. Cortisontherapie. Corticoide in Klinik und Praxis. 11. Auflage. Stuttgart, Germany: Georg Thieme Verlag.
15. Salem M, Tainsh RE, Jr., Bromberg J, Loriaux DL, Chernow B. 1994. Perioperative glucocorticoid coverage. A reasessment 42 years after emergence of a problem. Ann Surg 219:416-425.
16. O'Driscoll BR, Kalra S, Wilson M, Pickering CA, Carroll KB, Woodcock AA. 1993. Double-blind trial of steroid tapering in acute asthma. Lancet 341: 324-327.
17. Hatton MQF, Vathenen AS, Allen MJ, Davies S, Cooke NJ. 1995. A comparison of 'abruptly stopping' with 'tailing off' oral corticosteroids in acute asthma. Respir Med 89:101-104.
18. Wenning GK, Wietholter H, Schnauder G, Muller PH, Kanduth S, Renn W. 1994. Recovery of the hypothalamic-pituitary-adrenal axis from suppression by short-term, high-dose intravenous prednisolone therapy in patients with MS. Acta Neurol Scand 89:270-273.
19. USP 29-NF 24. 2006. The United States Pharmacopeia - The National Formulary. Rockville, MD, 20852: The United States Pharmacopeial Convention, Inc.
20. European Directorate for the Quality of Medicines. European pharmacopoeia, 5th edition. Strasbourg, France: European Directorate for the Quality of medicines, Council of Europe, Strasbourg, France.
21. Mesley RJ, Johnson CA. 1965. Infrared identification of pharmaceutically important steroids with particular reference to the occurrence of polymorphism. J Pharm Pharmacol 17:329-340.
22. Kuhnert-Brandstatter M. 1977. Polymorphe und pseudopolymorphe Kristallformen von Steroidhormonen. Pharm Ind 39:377-383.
23. Masse J, Terol A, Chauvet A. 1990. Contrôle de qualité et optimisation de l'activité thérapeutique à l'aide de methods thermoanalytiques. Ann Pharm Fr 48:57-69.
24. Ran Y, Yalkowsky SH. 2001. Prediction of drug solubility by the general solubility equation (gse). J Chem Inf Comput Sci 41:354-357.
25. Hayton WL, Guttman DE, Levy G. 1972. Effect of complex formation on drug absorption XI: Complexation of prednisone and prednisolone with dialkylpropionamides and its effect on prednisone transfer through an artificial lipoid barrier. J Pharm Sci 61:356-361.
26. Sjoblom L. 1967. Pharmaceutical applications and physiological aspects of solubilisation in solvent properties of surfactant solutions. In: Shinoda K, editor. Solvent Properties of Surfactant Solutions. New York: Dekker. pp 189-247.
27. Avdeef A, Ruell J, Du C. 2002. PAMPA structure-permeability relations of several steroids: Development of the high-throughput gastrointestinal and blood-brain barrier transport models. Available from URL: http://pion-inc.com/ images/Gastro-BBBPAMPA2002.pdf.
28. Petereit LB, Meikle AM. 1977. Effectiveness of prednisolone during phenytoin therapy. Clin Pharmacol Ther 22:912-916.
29. Tanner A, Bochner F, Caffin J, Halliday J, Powell L. 1979. Dose dependent prednisolone kinetics. Clin Pharmacol Ther 25:571-578.
30. Al-Habet S, Rogers HJ. 1980. Pharmacokinetics of intravenous and oral prednisolone. Br J Clin Pharmacol 10:503-508.
31. Jenkins JS, Sampson PA. 1967. Conversion of cortisone to cortisol and prednisone to prednisolone. Br Med J 1:205-207.
32. Powell LW, Axelson E. 1972. Corticosteroids in liver disease: Studies on the biological conversion of prednisone to prednisolone and plasma protein binding. Gut 13:690-696.
33. Frey BM, Frey FJ. 1990. Clinical pharmacokinetics of prednisone and prednisolone. Clin Pharmacokinet 19:126-146.
34. Täuber U, Haack D, Nieuweboer B, Kloos G, Vescei P, Wendt H. 1984. The pharmacokinetics of fluocortolone and prednisolone after intravenous and oral administration. Int J Clin Pharmacol Ther Toxicol 22:48-55.
35. Ferry JJ, Horvath AM, Bekersky I, Heath EC, Ryan CF, Colburn WA. 1988. Relative and absolute bioavailability of prednisone and prednisolone after separate oral and intravenous doses. J Clin Pharmacol 28:81-87.
36. Szefler SJ. 1989. General pharmacology of glucocorticoids. In: Schleimer RP, Claman HN, Oronsky AL, editors. Anti-inflammatory steroid action basic and clinical aspects. San Diego: Academic Press, Inc. pp 353-376.
37. Lulay GR. 1982. Einfluss der Zusammensetzung der Nahurng und des Füllungszustandes des Magens auf die enterale Resorption von Prednison. Inaugural-Dissertation.
38. Garg V, Jusko WJ. 1994. Bioavailability and reversible metabolism of prednisone and prednisolone in man. Biopharm Drug Dispos 15:163-172.
39. Frey FJ, Horber FF, Frey BM. 1988. Altered metabolism and decreased efficacy of prednisolone and prednisone in patients with hyperthyroidism. Clin Pharmacol Ther 44:510-521.
40. Zürcher RM, Frey BM, Frey FJ. 1989. Impact of ketoconazole on the metabolism of prednisolone. Clin Pharmacol Ther 45:366-372.
41. Stuck AE, Frey BM, Frey FJ. 1988. Kinetics of prednisolone and endogenous cortisol suppression in the elderly. Clin Pharmacol Ther 43:354-362.
42. Rose JQ, Yurchak AM, Jusko WJ. 1981. Dose dependent pharmacokinetics of prednisone and prednisolone in man. J Pharmacokinet Biopharm 9:389-417.
43. Sullivan TJ, Hallmark MR, Sakmar E, Weidler DJ, Earhart RH, Wagner JG. 1976. Comparative bioavailability: Eight commercial prednisone tablets. J Pharmacokinet Biopharm 4:157-172.
44. Tanner AR, Caffin JA, Halloday JW, Powell LW. 1979. Concurrent administration of antacids and prednisone: Effect on serum levels of prednisolone. Br J Clin Pharmacol 7:397-400.
45. Tembo AV, Sakmar E, Hallmark MR, Weidler DJ, Wagner JG. 1976. Effect of food on the bioavailability of prednisone. J Clin Pharmacol 16:620-624.
46. Uribe M, Schalm SW, Summerskill WHJ, Go VLW. 1976. Effect of liquid diet on serum protein binding and prednisolone concentrations after oral prednisone. Gastroenerology 71:362-364.
47. Bennett WM, Aronoff GR, Golper TA, Golper TA. 1994. Drug prescribing in renal failure. Philadelphia, PA: American Colleague of Physicians.
48. Pickup ME, Lose JR, Leatham PA, Rhind VM, Wright V, Downie WW. 1977. Dose dependent pharmacokinetics of prednisolone. Eur J Clin Pharmacol 12:213-219.
49. Loo JCK, McGilveray IJ, Jordan N, Moffat J, Brien R. 1978. Dose-dependent pharmacokinetics of prednisone and prednisolone in man. J Pharm Pharmacol 30:736.
50. HagerROM. 2001. Heidelberg: Springer Verlag.
51. Anderson PO. 1987. Corticosteroid use by breastfeeding mothers. Clin Pharm 6:445.
52. American Academy of Pediatrics. 2001. The transfer of drugs and other chemical into human milk. Pediatrics 108:776-789.
53. Hale V, Benet LZ. 1988. Prednisolone and prednisone exhibit linear extraction in the perfused rabbit liver. Drug Metab Dispos 19:87-93.
54. Gray CH, Green MAS, Holness NJ, Lunnon JB. 1956. Urinary metabolic products of prednisone and prednisolone. J Endocrinol 14:146-154.
55. Legler UF, Frey FJ, Benet LZ. 1982. Prednisolone clearance at steady state in humans. J Clin Endocrinol Metab 55:762-767.
56. Cheng H, Jusko WJ. 1993. Pharmacokinetics of reversible metabolic systems. Biopharm Drug Dispos 14:721-766.
57. Morris HG. 1978. Pharmacology and corticosteroids in asthma. In: Middleton E, Jr., Reed C, Ellis E, editors. Allergy principles and practice. St. Louis: C.V. Mosby. pp 464-480.
58. DiSanto AR, DeSante KA. 1975. Bioavailability and pharmacokinetics of prednisone in humans. J Pharm Sci 64:109-112.
59. Sullivan TJ, Sakmar E, Albert KS, Blair DC, Wagner JG. 1975. In vitro and in vivo availability of commercial prednisone tablets. J Pharm Sci 64:1723-1725.
60. Sullivan TJ, Sakmar E, Wagner JG. 1976. Comparative bioavailability: A new type of in vitro-in vivo correlation exemplified by prednisone. J Pharmacokinet Biopharm 4:173-181.
61. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). 2000. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System. Available from URL: http:// www.fda.gov/cder/guidance/ 3618fnl.pdf.
62. Committee for Proprietary Medicinal Products (CPMP). 2001. Note for guidance on the investigation of bioavailability and bioequivalence. Available from URL: http://www.emea.eu.int/pdfs/human/ ewp/140198en.pdf.
63. WHO. 2006. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Technical Report Series, No 937, 40th Report, Annex 7 of WHO Expert committee on specifications for pharmaceutical preparations. Available from URL: http://whqlibdoc.who.int/ trs/WHO_TRS_937_eng.pdf.
64. Kasim NA, Whitehouse M, Ramachandran C, Bermejo M, Lennernas H, Hussain AS, Junginger HE, Stavchansky SA, Midha KK, Shah VP, Amidon GL. 2004. Molecular properties of WHO essential drugs and provisional biopharmaceutical classification. Mol Pharm 1:85-96.
65. Polli JE, Yu LX, Cook JA, Amidon GL, Borchardt RT, Burnside BA, Burton PS, Chen M, Conner DP, Faustino PJ, Hawi AA, Hussain AS, Joshi HN, Kwei G, Lee VHL, Lesko LJ, Lipper RA, Loper AE, Nerurkar SG, Polli JW, Sanvordeker DR, Taneja R, Uppoor RS, Vattikonda CS, Wilding I, Zhang G. 2004. Summary Workshop Report: Biopharmaceutics classification system - Implementation challenges and extension opportunities. J Pharm Sci 93:1375-1381.
66. Amidon GL, Lennernas H, Shah VP, Crison JR. 1995. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12:413-420.