Biowaiver monographs for immediate release solid oral dosage forms: Acetazolamide

Journal of Pharmaceutical Sciences

Volumn 97, Issue 9, 2008, Pages 3691-3699

  Granero, G E ^a   Longhi, M R ^a   Becker, C ^b   Junginger, H E ^c   Kopp, S ^d   Midha, K K ^e   Shah, V P ^f   Stavchansky, S ^g   Dressman, J B ^b   Barends, D M ^h  

^a UNIVERSIDAD NACIONAL DE CÓRDOBA   (Argentina)

^b GOETHE UNIVERSITY   (Germany)

^c NARESUAN UNIVERSITY   (Thailand)

^d WORLD HEALTH ORGANIZATION   (Switzerland)

^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; Acetazolamide; Biopharmaceutics classification system (BCS); Dissolution; Permeability; Regulatory science; Solubility

Indexed keywords

ACETAZOLAMIDE;

APLASTIC ANEMIA; BIOEQUIVALENCE; BLOOD DYSCRASIA; DIARRHEA; DIURESIS; DRUG ABSORPTION; DRUG APPROVAL; DRUG DISTRIBUTION; DRUG DOSAGE FORM; DRUG ELIMINATION; DRUG FORMULATION; DRUG METABOLISM; DRUG PENETRATION; DRUG SOLUBILITY; EPIGASTRIC BURNING; GASTROINTESTINAL SYMPTOM; HUMAN; METABOLIC ACIDOSIS; NAUSEA; NONHUMAN; NOTE; PANCYTOPENIA; SIDE EFFECT; THROMBOCYTOPENIC PURPURA;

EID: 53549102209     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21282     Document Type: Article

References (62)

1. Vogelpoel H, Welink J, Amidon GL, Junginger HE, Midha KK, Möller H, Oiling 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, 2006. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Technical Report Series,No937,40thReport,Annex7http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf4.
3. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Technical Report Series, No937, 40th Report, Annex 8 http://whqlibdoc.who.int/ trsAVHO_TRS_937_eng.pdf.
4. FDA. 2000. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solidoral dosage forms based on a Biopharmaceutics Classification System. USA: US Food and Drug Administration, Center for Drug Evaluation and Research http://www.fda.gov/cder/guidance/ 3618fnl.pdf.
5. CPMP, 2001. Note for guidance on the investigation of bioavailability and bioequivalence. http://www.e-mea.eu.int/pdfs/human/ewp/140198en.pdf.
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. Kortejärvi H, Yliperttula M, Dressman JB, 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: Ranitidine hydrochloride. J Pharm Sci 94:1617-1625.
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. Kalanzti L, Reppas C, Dressman JB, Amidon GL, Junginger HE, Midha KK, Shah VP, Stavchansky SA, Barends DM. 2006. Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS): Acetaminophen (paracetamol). J Pharm Sci 95: 4-14.
10. Manzo HR, Olivera ME, Amidon GL, Dressman JB, Barends DM. 2006. Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS): Amitryptiline hydrochloride. J Pharm Sci 95:966-973.
11. Jantratid E, Prakongpan S, Dressman JB, Amidon GL, Junginger HE, Midha KK, Barends DM. 2006. Biowaiver monographs for immediate release solid oral dosage forms: Cimetidine. J Pharm Sci 95:974-984.
12. Becker C, Dressman JB, Amidon GL, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S, Barends DM. 2006. Biowaiver monographs for immediate release solid oral dosage forms: Isonia-zid. J Pharm Sci 96:522-531.
13. Vogt M, Derendorf H, Kramer J, Junginger HE, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM. 2007. Biowaiver monographs for immediate release solid oral dosage forms: Prednisolone. J Pharm Sci 96:27-37.
14. Vogt M, Derendorf H, Kramer J, Junginger HE, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM. 2007. Biowaiver monographs for immediate release solid oral dosage forms: Prednisone. J Pharm Sci 96:1480-1489.
15. Becker C, Dressman JB, Kopp S, Amidon GL, Junginger HE, Midha KK, Shah VP, Stavchansky S, Barends DM. 2007. Biowaiver monographs for immediate release solid oral dosage forms: Ethambutol dihydrochloride. J Pharm Sci (accepted for publication).
16. Sweetman S, editor. 2005. Martindale: The complete drug reference. Electronic version. London, UK; Greenwood Village, Colorado: Pharmaceutical Press, Thomson. MICROMEDEX.
17. Yano I, Takayama A, Takano M, Inatani M, Tanihara H, Ogura Y, Honda Y, Inui K. 1998. Pharmacokinetics and pharmacodynamics of acetazolamide in patients with transient intraocular pressure elevation. Eur J Clin Pharmacol 54:63-68.
18. Parasrampuria J. 1993. In: Brittain HG, editor. Analytical profiles of drug substances and excipients. Vol. 22 San Diego, London: Academic Press, pp 3-32.
19. Corbett JT. 1985. Acetazolamide and purpura. Br Med J 1:1122-1123.
20. Englund GW. 1969. Fatal pancytopenia and acetazolamide therapy. JAMA 210:2282.
21. Niven BI, Manoharan A. 1985. Acetazolamide-induced anaemia. Med J 1:1500-1505.
22. USP 28-NF 23. 2005. The United States Pharmacopeia - The National Formulary. Rockville MD2085: The United States Pharmacopeial Convention, Inc.
23. Griesser UJ, Burger A, Mereiter K. 1997. The polymorphic drug substances of the European Pharmacopoeia. Part 9. Physicochemical properties and crystal structure of acetazolamide crystal forms. J Pharm Sci 86:352-358.
24. Pudipeddi M, Serajuddin ATM. 2005. Trends in solubility of polymorphs. J Pharm Sci 94:929-939.
25. Duffel MW, Ing IS, Segarra TM, Dixson JA, Barf-knecht CF, Schoenwald RD. 1986. N-Substituted sulfonamide carbonic anhydrase inhibitors with topical effects on intraocular pressure. J Med Chem 29:1488-1494.
26. Haznedar S, Dortunç B. 2004. Preparation and in vitro evaluation of Eudragit microspheres containing acetazolamide. Int J Pharm 269:131-240.
27. Parasrampuria J, Das Gupta V. 1990. Development of oral liquid dosage forms of acetazolamide. J Pharm Sci 79:835-836.
28. BP. 1980. Pharm. Eur. 4.00 Kommentar (German).
29. Remko M, von der Lieth C-W. 2004. Theoretical study of gas-phase acidity, pKa, lipophilicity, and solubility of some biologically active sulfonamides. Bioorg Med Chem 12:5395-5403.
30. Machatha SG, Yalkowsky SH. 2005. Comparison of the octanol/water partition coefficients calculated by ClogP®, ACDlogP and Kow Win® to experimentally determined values. Int J Pharm 294:185-192.
31. Kasim NA, Whitehouse M, Ramachandran C, Bermejo M, Lennernäs 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.
32. WHO, Model List of Essential Medicines 13th edn. Available from URL www.who.int/medicines/orga-niz ation/par/edl/expcom 13/eml 13_en .doc
33. FDA/Center for Drug Evaluation and Research Office of Generic Drugs. Available from URL http://www.accessdata.fda.gov/scripts/cder/ob/docs/ tempai.cfm.
34. Administratión Nacional de Medicamentos, Alimentas y Tecnología Médica de la República Argentina. Available from URL http://www.anmat.gov.ar.
35. Ritschel WA, Paulos C, Arancibia A, Agrawal MA, Wetzelsberger KM, Lücker PW. 1998. Pharmacokinetics of acetazolamide in healthy volunteers after short- and long-term exposure to high altitude. J Clin Pharmacol 38:533-539.
36. Ellis PP, Price PK, Kelmenson R, Rendi MA. 1982. Effectiveness of generic acetazolamide. Arch Ophthalmol 100:1920-1922.
37. Schulz M, Schmoldt A. 2003. Therapeutic and toxic blood concentrations of more than 800 drugs and other xenobiotics. Pharmazie 58:447 - 473.
38. Kunka RL, Mattocks AM. 1979. Nonlinear model for acetazolamide. J Pharm Sci 68:342-346.
39. Alm A, Berggren L, Hartving P, Roosdorp M. 1982. Monitoring acetazolamide treatment. Acta Ophthalmol (Copenh) 60:24-34.
40. Crowe A, Teoh YK. 2006. Limited P-glycoprotein mediated efflux for anti-epileptic drugs. J Drug Target 14:291-300.
41. Yakatan GJ, Frome EL, Leonard RG, Shah AC, Doluisio JT. 1978. Bioavailability of acetazolamide tablets. J Pharm Sci 67:252-256.
42. Straughn AB, Gollamudi R, Meyer MC. 1982. Relative bioavailability of acetazolamide tablets. Biopharm Drug Dispos 3:75-82.
43. Gleiter CH, Gundert-Remy U. 1994. Bioin-equivaleance and drug toxicity. How great is the problem and what can be done? Drug Saf 11: 1-6.
44. RoteListe®. Arzneimittelsverzeichnis für Deutschland www.rote-liste.de (assessed 24-10-2006).
45. Laegemiddelstyrelsen www.dkma.dk (assessed 24-10-2006).
46. Lääkelaitos www.nam.fi (assessed 24-10-2006).
47. L'information de référence sur les produits de santé www.vidal.fr (assessed 24-10-2006).
48. Het College ter Beoordeling van Geneesmiddelen www.cbg-meb.nl (assessed 24-10-2006).
49. Statens lækjemiddelverk www.legemiddelverket.no (assessed 24-10-2006).
50. FDA, Inactive Ingredient Database http://www.fda.gov/cder/iig/iigfaqWEB. htm#purpose (version date 03-10-2006).
51. Läkemedelsverket www. lakemedelsverket.se (assessed 24-10-2006).
52. Gleiter CH, Klotz U, Kuhlmann J, Blume H, Stanislaus F, Harder S, Paulus H, Poethko-Muller C, Holz-Slomczyk M. 1998. When are bioavailability studies required? A German proposal. J Clin Pharmacol 38:904-911.
53. College ter Beoordeling van Geneesmiddelen. Lijst vrij Stelling bio-equivalentieonderzoek (positieve lijst) (List of APIs exempted from demonstration in vivo of bioequivalence when formulated in IR solid oral dosage forms) http://www.cbg-meb.nl/nl/reghoudr/vrij .htm.
54. Artursson P, Palm K, Luthman K. 2001. Caco-2 monolayers in experimental and theoretical predictions of drug transport. Adv Drug Del Rev 46:27-43.
55. Gres M-C, Julian B, Bourre M, Meunier V, Roques C, Berger M, Boulenc X, Berger Y, Fabre G. 1998. Correlation between oral drug absorption in humans and apparent drug permeability in TC-7 cells, a human epithelial intestinal cell line: Comparison with the parental Caco-2 cell line. Pharm Res 15:726-733.
56. Rinaki E, Valsami G, Macheras P. 2003. Quantitative biopharmaceutics classification system: The central role of dose/solubility ratio. Pharm Res 20:1917-1925.
57. Lindenberg M, Kopp S, Dressman JB. 2004. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. Eur J Pham Biopharm 58:265-278.
58. Wu C-Y, Benet LZ. 2005. Predicting drug disposition via application of BCS: Transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res 22:11-23.
59. FDA, Code of Federal Regulations. Title 21, Part 320: Bioavailability and Bioequivalence requirements. Section 320.33. 2003 www.accessdata.fda.-gov.
60. PAHO, Science based criteria for bioequivalence in vivo and in vitro, biowaivers, and strategic framework for implementation www.paho.org/english/ad/ ths/ev/be-doct-draft-eng.pdf.
61. FDA, 2005. Guidance for Industry. Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. (SUPAC-IR). www.fda.gov/cder/guidance/supac.htm.
62. European Commission, 2006. Guideline on Dossier requirements for Type LA and Type IB. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/ var_type_lalb_guideline_06-2006.pdf.