Comparison of a novel fast-dissolving acetaminophen tablet formulation (FD-APAP) and standard acetaminophen tablets using gamma scintigraphy and pharmacokinetic studies

Drug Development and Industrial Pharmacy

Volumn 37, Issue 7, 2011, Pages 747-753

  Wilson, C G ^a   Clarke, Cyril P ^b   Starkey, Yan Yan L ^c   Clarke, Geoffrey D ^c  

^a UNIVERSITY OF STRATHCLYDE   (United Kingdom)

^b ICON Development Solutions   (United States)

^c GLAXOSMITHKLINE   (United States)

Author keywords

analgesia; disintegration; dissolution; onset; Optizorb

Indexed keywords

PANADOL ADVANCE; PARACETAMOL; PENTETATE INDIUM IN 111; UNCLASSIFIED DRUG;

ADULT; ANALGESIA; AREA UNDER THE CURVE; ARTICLE; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG SOLUBILITY; DRUG TOLERABILITY; FEMALE; FEVER; GAMMA SCINTIGRAPHY; HUMAN; HUMAN EXPERIMENT; ISOTOPE LABELING; MALE; NORMAL HUMAN; OPEN STUDY; PAIN; PHARMACODYNAMICS; PHARMACOKINETICS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TABLET DISINTEGRATION; TABLET FORMULATION; UNSPECIFIED SIDE EFFECT;

ACETAMINOPHEN; ADULT; ANALGESICS, NON-NARCOTIC; CROSS-OVER STUDIES; FEMALE; HUMANS; INTESTINAL ABSORPTION; MALE; MIDDLE AGED; TABLETS; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 79958739212     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2010.538058     Document Type: Article

References (24)

1. Jordan, K.M., Arden, N.K., Doherty, M., Bannwarth, B., Bijlsma, J.W., Dieppe, P., Gunther, K., Hauselmann, H., Herrero-Beaumont, G., Kaklamanis, P., Lohmander, S., Leeb, B., Lequesne, M., Mazieres, B., Martin-Mola, E., Pavelka, K., Pendleton, A., Punzi, L., Serni, U., Swoboda, B., Verbruggen, G., Zimmerman-Gorska, I., Dougados, M.; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann. Rheum. Dis. 2003, 62, 1145-1155
2. Zhang, W., Doherty, M., Arden, N., Bannwarth, B., Bijlsma, J., Gunther, K.P., Hauselmann, H.J., Herrero-Beaumont, G., Jordan, K., Kaklamanis, P., Leeb, B., Lequesne, M., Lohmander, S., Mazieres, B., Martin-Mola, E., Pavelka, K., Pendleton, A., Punzi, L., Swoboda, B., Varatojo, R., Verbruggen, G., Zimmermann-Gorska, I., Dougados, M.; EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann. Rheum. Dis. 2005, 64, 669-681 (Pubitemid 40559291)
3. Schnitzer, T.J. Update on guidelines for the treatment of chronic musculoskeletal pain. Clin. Rheumatol. 2006, 25 (Suppl. 1), 22-29
4. van Tulder, M., Becker, A., Bekkering, T., Breen, A., del Real, M.T., Hutchinson, A., Koes, B., Laerum, E., Malmivaara, A.; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur. Spine J. 2006, 15 (Suppl. 2), S169-S191
5. Kehlet, H., Werner, M.U. [Role of paracetamol in the acute pain management]. Drugs 2003, 63 (Spec. No. 2), 15-22
6. Prescott, L.F. Therapeutic misadventure with paracetamol: factor fiction? Am. J. Ther. 2000, 7, 99-114
7. Dart, R.C., Bailey, E. Does therapeutic use of acetaminophen cause acute liver failure? Pharmacotherapy 2007, 27, 1219-1230 (Pubitemid 47339119)
8. Prescott, L. Mechanism and site of absorption. In Paracetamol (Acetaminophen): A Critical Bibliographic Review. Taylor & Francis, London, 2003, pp. 33-66
9. Kelly, K., OáMahony, B., Lindsay, B., Jones, T., Grattan, T.J., Rostami-Hodjegan, A., Stevens, H.N., Wilson, C.G. Comparison of the rates of disintegration, gastric emptying, and drug absorption following administration of a new and a conventional paracetamol formulation, using gamma scintigraphy. Pharm. Res. 2003, 20, 1668-1673 (Pubitemid 37268285)
10. Grattan, T., Hickman, R., Darby-Dowman, A., Hayward, M., Boyce, M., Warrington, S. A five way crossover human volunteer study to compare the pharmacokinetics of paracetamol following oral administration of two commercially available paracetamol tablets and three development tablets containing paracetamol in combination with sodium bicarbonate or calcium carbonate. Eur. J. Pharm. Biopharm. 2000, 49, 225-229 (Pubitemid 30229870)
11. Ibáez, Y., Rodrãguez, J.M., Luján, M., Grattan, T.J., Martin, A.J., Burnett, I. A pharmacokinetic study investigating the rate of absorption of a 500 mg dose of a rapidly absorbed paracetamol tablet and a standard paracetamol tablet. Curr. Med. Res. Opin. 2006, 22, 1893-1897 (Pubitemid 44663391)
12. Rostami-Hodjegan, A., Shiran, M.R., Tucker, G.T., Conway, B.R., Irwin, W.J., Shaw, L.R., Grattan, T.J. A new rapidly absorbed paracetamol tablet containing sodium bicarbonate. II. Dissolution studies and in vitro/in vivo correlation. Drug Dev. Ind. Pharm. 2002, 28, 533-543 (Pubitemid 34680553)
13. Rostami-Hodjegan, A., Shiran, M.R., Ayesh, R., Grattan, T.J., Burnett, I., Darby-Dowman, A., Tucker, G.T. A new rapidly absorbed paracetamol tablet containing sodium bicarbonate. I. A fourway crossover study to compare the concentration-time profile of paracetamol from the new paracetamol/sodium bicarbonate tablet and a conventional paracetamol tablet in fed and fasted volunteers. Drug Dev. Ind. Pharm. 2002, 28, 523-531 (Pubitemid 34680552)
14. Perkins, A.C., Wilson, C.G., Frier, M., Blackshaw, P.E., Juan, D., Dansereau, R.J., Hathaway, S., Li, Z., Long, P., Spiller, R.C. Oesophageal transit, disintegration and gastric emptying of a filmcoated risedronate placebo tablet in gastro-oesophageal reflux disease and normal control subjects. Aliment. Pharmacol. Ther. 2001, 15, 115-121 (Pubitemid 32055591)
15. Wilson, C.G., OáMahony, B., Connolly, S.M., Cantarini, M.V., Farmer, M.R., Dickinson, P.A., Smith, R.P., Swaisland, H.C. Do gastrointestinal transit parameters influence the pharmacokinetics of gefitinib? Int. J. Pharm. 2009, 376, 7-12
16. Dollery, C.T. Acetaminophen monograph. In Therapeutic Drugs. Churchill Livingstone, London, 1999, pp. A19-A21
17. Hills, M., Armitage, P. The two-period cross-over clinical trial. Br. J. Clin. Pharmacol. 1979, 8, 7-20 (Pubitemid 9234327)
18. Hollander, M., Wolfe, D.A. Nonparametirc Statistical Methods. Wiley, New York, 1973
19. Prescott, L.F., Yoovathaworn, K., Makarananda, K., Saivises, R., Sriwatanakul, K. Impaired absorption of paracetamol in vegetarians. Br. J. Clin. Pharmacol. 1993, 36, 237-240 (Pubitemid 23275341)
20. Wald, A., Van Thiel, D.H., Hoechstetter, L., Gavaler, J.S., Egler, K.M., Verm, R., Scott, L., Lester, R. Gastrointestinal transit: the effect of the menstrual cycle. Gastroenterology 1981, 80, 1497-1500 (Pubitemid 11113567)
21. Rygnestad, T., Zahlsen, K., Samdal, F.A. Absorption of effervescent paracetamol tablets relative to ordinary paracetamol tablets in healthy volunteers. Eur. J. Clin. Pharmacol. 2000, 56, 141-143 (Pubitemid 30341388)
22. Møller, P.L., Nørholt, S.E., Ganry, H.E., Insuasty, J.H., Vincent, F.G., Skoglund, L.A., Sindet-Pedersen, S. Time to onset of analgesia and analgesic efficacy of effervescent acetaminophen 1000 mg compared to tablet acetaminophen 1000 mg in postoperative dental pain: a single-dose, double-blind, randomized, placebocontrolled study. J. Clin. Pharmacol. 2000, 40, 370-378
23. Burnett, I., Schachtel, B., Sanner, K., Bey, M., Grattan, T., Littlejohn, S. Onset of analgesia of a paracetamol tablet containing sodium bicarbonate: a double-blind, placebo-controlled study in adult patients with acute sore throat. Clin. Ther. 2006, 28, 1273-1278 (Pubitemid 44596290)
24. Stillings, M., Havlik, I., Chetty, M., Clinton, C., Schall, R., Moodley, I., Muir, N., Little, S. Comparison of the pharmacokinetic profiles of soluble aspirin and solid paracetamol tablets in fed and fasted volunteers. Curr. Med. Res. Opin. 2000, 16, 115-124 (Pubitemid 30426774)