Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride

Journal of Pharmaceutical Sciences

Volumn 95, Issue 5, 2006, Pages 966-973

  Manzo, R H ^a   Olivera, M E ^a   Amidon, G L ^b   Shah, V P ^c   Dressman, J B ^d   Barends, D M ^e  

^a UNIVERSIDAD NACIONAL DE CÓRDOBA   (Argentina)

^b UNIVERSITY OF MICHIGAN   (United States)

^c International Pharmaceutical Federation FIP   (Netherlands)

^d GOETHE UNIVERSITY   (Germany)

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

Author keywords

Absorption; Amitriptyline hydrochloride; Biopharmaceutics Classification System (BCS); Biowaiver; Permeability; Solubility

Indexed keywords

AMINEURIN; AMITRIPTYLIN BETA; AMITRIPTYLIN-NEURAXPHARM; AMITRIPTYLINE; EXCIPIENT; NOVOPROTECT; SYNEUDON;

BIOEQUIVALENCE; DISSOLUTION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLASSIFICATION; DRUG DOSAGE FORM; DRUG PENETRATION; DRUG RELEASE; DRUG SOLUBILITY; DRUG STRUCTURE; MEDICAL LITERATURE; PARTITION COEFFICIENT; REVIEW; TABLET FORMULATION;

EID: 33646679648     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20615     Document Type: Note

References (43)

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. http://213.206.88.26/www2/sciences/index.php? page= pharmacy_sciences&pharmacy_sciences= sciences_bioavail_groupbcs.
3. 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.
4. 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.
5. 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.
6. 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.
7. Ph. Eur. 5th edn. 2005. Amitriptyline hydrochloride, monograph 0464. Strasbourg, France, Council of Europe.
8. The Merck Index. 1996. Version 12.1 on CD-ROM. Merck & Co., Whitehouse Station, NJ, USA.
9. Clinical Pharmacology © 2003, Gold Standard Multimedia Inc. http//www.cp.gsm.com.
10. Martindale: The complete drug reference. Electronic version. 2004. In: Sweetman S, editor, ed., London UK: Pharmaceutical Press, Thomson MICROMEDEX, Greenwood Village, Colorado.
11. The Pharmaceutical Codex. 1994. Principles and practice of pharmaceutics, 12th edn. Pharmaceutical Press.
12. USP 28-NF 23. 2005. The United States Pharmacopeia The National Formulary. Rockville MD. The United States Pharmacopeial Convention, Inc.
13. Green AL. 1967. Ionization constants and water solubilities of some aminoalkylphenothiazine trankillizers and related compounds. J Pharm Pharmac 19:10-16.
14. Avdeef A. Determination of drug solubility using a potentiometric acid-base titration method compared to the saturation shake-flask method: http://www.pion-inc.com/images/aaps00-solubility1.pdf. (after registration)
15. 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. US Food and Drug Administration, Center for Drug Evaluation and Research. USA. http://www.fda. gov/cder/guidance/ 3618fnl.pdf
16. CPMP. 2001. Note for guidance on the investigation of bioavailability and bioequivalence. http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf.
17. WHO. 2005. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Working document AS/04.093/Rev.4. World Health Organization. http://www.who.int/medicines/ services/expertcommittees/pharmprep/QAS04_093Rev4_final.pdf
18. Schreier S, Malheiros SVP, Paula E. 2000. Surface active drugs: Self-association and interaction with membranes and surfactants. Physicochemical and biological aspects. Biochim Biophys Acta 1508:210-234.
19. Nagappa AN, Kole PL, Pandi PV, Shanmukha I, Girish K, Mishra RPK. 2003. Role of surface activity in mechanism of actions of tricyclic anti-depressants. Colloids Surf B Biointerfaces 32:169-177.
20. Kim EJ, Shah DO. 2002. Cloud point phenomenon in amphiphilic drug solutions. Langmuir 18:10105-10108.
21. Hansch C, Leo A, Hoekman D. 1995. Exploring QSAR. Hydrophobic, electronic and steric constants. Washington, DC: American Chemical Society.
22. 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.
23. Faassen F, Vogel G, Spanings H, Vromansa H. 2003. Caco-2 permeability, P-glycoprotein transport ratios and brain penetration of heterocyclic drugs. Int J Pharm 263:113-122.
24. Blessel KW, Rudy BC, Senkowsky BZ. 1974. In: Florey-Analytical profiles of drug substances, Vol. 3. London, UK: Academic Press, pp 127-147.
25. WHO. 2005. Essential medicines model list, 14th edn.http://whqlibdoc.who. int/hq/2005/a87017_eng. pdf.
26. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina: http://www.anmat.gov.ar.
27. Rote Liste® Service GmbH FMG. 2005. Arzneimittelverzeichnis fur Deutschland. In Verlag EG, (after registration).
28. Elavil® Professional Information Brochure Elavil® (Amitriptyline HCl) Tablets and Injection: http://www.fda.gov/cder/foi/label/2001/12704s45lbl. pdf.
29. Varma MV, Sateesh K, Panchagnula R. 2005. Functional role of P-glycoprotein in limiting intestinal absorption of drugs: Contribution of passive permeability to P-glycoprotein mediated efflux transport. Mol Pharm 2:12-21.
30. Burch JE, Herries DG. 1983. The demethylation of amitriptyline administered by oral and intramuscular routes. Psychopharmacology (Berlin) 80:249-253.
31. Burch JE, Hullin RP. 1981. Amitriptyline Pharmacokinetics: A crossover study with single doses of amitriptyline and nortriptyline. Psychopharmacology (Berlin) 74:35-42.
32. Baldessarini RJ. 2001. Fármacos y Tratamientos de los trastornos psiquiátricos. Depresión y manía. In Hardman JG, Limbrid LE, Molinoff PB, Ruddon RW, Goodman Gilman A, editors. The Pharmacological Basis of Therapeutics, 9th edn, Mexico: McGraw-Hill Co., pp 459-489.
33. Saroten® Tabs 50 mg Fachinformation. 2004. Rote Liste® Service GmbH FMG. Arzneimittelverzeichnis fur Deutschland. In Verlag EG, editor. Aulendorf, Germany. www.rote-liste.de/online (after registration).
34. The Medical Letter® on Drugs and Therapeutics. 2002. 44(W 1141) October 14, pp. 89-90. The Medical Letter, Inc, NY. http//www.medletter.-com/ freedocs/gendrugs.pdf.
35. Yu LX, Amidon GL, Polli JE, Zhao H, Mehta MU, Conner DP, Shah VP, Lesko LJ, Chen ML, Lee VHL, Hussain AS. 2002. Biopharmaceutics Classification System: The scientific basis for biowaiver extensions. Pharm Res 19:921-925.
36. Bergström CA, Luthman K, Artursson P. 2004. Accuracy of calculated pH-dependent aqueous drug solubility. Eur J Pharm Sci 22:387-398.
37. Amidon GL, Lennernäs H, Shah VP, Crison JR. 1995. A theoretical basis for a Biopharmaceutics Drug Classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12:413-420.
38. Gleiter GH, 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.
39. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Office of Generic Drugs, Division of Labeling and Program Support. The Inactive Ingredients Database. http://www. fda.gov/cder/iig/iigfaqWEB.htm.
40. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina. 1999. Disp. 3185/99: Requerimientos de Estudios de Bioequivalencia. http://www.anmat. gov.ar/normativa/Normativa/Medicamentos/Disposición_ANMAT_3185-1999.pdf.
41. Lindenberg M, Kopp S, Dressman JB. 2004. Classification of orally administered drugs on the Word Health Organisation Model list of Essential Medicines according to the biopharmaceutics classification system. Eur J Pharm Biopharm 58:265-268.
42. Wu CY, Benet LZ. 2005. Predicting drug disposition via application of BCS: Transport/absorption/elimination interplay and development of a bio-pharmaceutics drug disposition classification system. Pharm Res 22:11-23.
43. Amidon GL. 1981. Drug derivatization as a means of solubilization: Physicochemical and biochemical strategies. In: Samuel H. Yalkowsky, editors. Techniques of solubilization of drugs. New York: Marcel Dekker, Inc.