Preparation of a fast dissolving oral thin film containing dexamethasone: A possible application to antiemesis during cancer chemotherapy

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 73, Issue 3, 2009, Pages 361-365

  Shimoda, Hiroyoshi ^a,b   Taniguchi, Kazumi ^c   Nishimura, Misao ^d   Matsuura, Katsuhiko ^a   Tsukioka, Tadao ^d   Yamashita, Hirotaka ^c   Inagaki, Naoki ^c   Hirano, Kazuyuki ^c   Yamamoto, Mayumi ^b,e   Kinosada, Yasutomi ^b,f   Itoh, Yoshinori ^a  

^a GIFU UNIVERSITY HOSPITAL   (Japan)

^b GIFU UNIVERSITY   (Japan)

^c GIFU PHARMACEUTICAL UNIVERSITY   (Japan)

^d Tsukioka Co Ltd   (Japan)

^e GIFU UNIVERSITY   (Japan)

^f GIFU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

Author keywords

Antiemesis; Dexamethasone; Dissolution test; Fast dissolving oral thin film; Pharmacokinetic parameters; Rat

Indexed keywords

DEXAMETHASONE; HYDROXYPROPYLMETHYLCELLULOSE; MACROGOL; MICROCRYSTALLINE CELLULOSE;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CHEMOTHERAPY INDUCED EMESIS; CONTROLLED STUDY; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG HALF LIFE; DRUG INDICATION; DRUG RESPONSE; DRUG SOLUBILITY; DRUG STABILITY; FILM COATING; HUMIDITY; MALE; NONHUMAN; RAT; STORAGE TEMPERATURE;

ADMINISTRATION, ORAL; ANIMALS; ANTIEMETICS; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; DEXAMETHASONE; DRUG CARRIERS; DRUG STABILITY; DRUG STORAGE; EXCIPIENTS; HALF-LIFE; MALE; NAUSEA; RATS; RATS, SPRAGUE-DAWLEY; SOLUBILITY; VOMITING;

EID: 70350427665     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2009.08.010     Document Type: Article

References (26)

1. Tortorice P.V., and O'Connell M.B. Management of chemotherapy-induced nausea and vomiting. Pharmacotherapy 10 (1990) 129-145
2. Jones A.L., Hill A.S., Soukop M., Hutcheon A.W., Cassidy J., Kaye S.B., Sikora K., Carney D.N., and Cunningham D. Comparison of dexamethasone and ondansetron in the prophylaxis of emesis induced by moderately emetogenic chemotherapy. Lancet 338 (1991) 483-487
3. The Italian Group for Antiemetic Research. Dexamethasone, granisetron, or both for the prevention of nausea and vomiting during chemotherapy for cancer. N. Engl. J. Med. 332 (1995) 1-5
4. Lofters W.S., Pater J.L., Zee B., Dempsey E., Walde D., Moquin J.P., Wilson K., Hoskins P., Guevin R.M., Verma S., Navari R., Krook J.E., Hainsworth J., Palmer M., and Chin C. Phase III double-blind comparison of dolasetron mesylate and ondansetron and an evaluation of the additive role of dexamethasone in the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapy. J. Clin. Oncol. 15 (1997) 2966-2973
5. Gralla R.J., Osoba D., Kris M.G., Kirkbride P., Hesketh P.J., Chinnery L.W., Clark-Snow R., Gill D.P., Groshen S., Grunberg S., Koeller J.M., Morrow G.R., Perez E.A., Silber J.H., and Pfister D.G. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. Am. Soc. Clin. Oncol. J. Clin. Oncol. 17 (1999) 2971-2994
6. Bloechl-Daum B., Deuson R.R., Mavros P., Hansen M., and Herrstedt J. Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J. Clin. Oncol. 24 (2006) 4472-4478
7. Navari R.M. Prevention of emesis from multiple-day and high-dose chemotherapy regimens. J. Natl. Compr. Canc. Netw. 5 (2007) 51-59
8. Naeim A., Dy S.M., Lorenz K.A., Sanati H., Walling A., and Asch S.M. Evidence-based recommendations for cancer nausea and vomiting. J. Clin. Oncol. 26 (2008) 3903-3910
9. Roila F., Hesketh P.J., and Herrstedt J. Antiemetic subcommittee of the multinational association of supportive care in cancer: prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia international antiemetic consensus conference. Ann. Oncol. 17 (2006) 20-28
10. M.G. Kris, P.J. Hesketh, M.R. Somerfield, P. Feyer, R. Clark-Snow, J.M. Koeller, G.R. Morrow, L.W. Chinnery, M.J. Chesney, R.J. Gralla, S.M. Grunberg, American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006, J. Clin. Oncol. 24 (2006) 2932-2947.
11. El-Sayed S., Nabid A., Shelley W., Hay J., Balogh J., Gelinas M., MacKenzie R., Read N., Berthelet E., Lau H., Epstein J., Delvecchio P., Ganguly P.K., Wong F., Burns P., Tu D., and Pater J. Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system. J. Clin. Oncol. 20 (2002) 3956-3963
12. Pauloski B.R., Rademaker A.W., Logemann J.A., Newman L., MacCracken E., Gaziano J., and Stachowiak L. Relationship between swallow motility disorders on videofluorography and oral intake in patients treated for head and neck cancer with radiotherapy with or without chemotherapy. Head Neck 28 (2006) 1069-1076
13. Dirix P., Nuyts S., Poorten V., Delaere P., and Van den Bogaert W. The influence of xerostomia after radiotherapy on quality of life: results of a questionnaire in head and neck cancer. Support. Care Cancer 16 (2008) 171-179
14. Starmer H.M., Tippett D.C., and Webster K.T. Effects of laryngeal cancer on voice and swallowing. Otolaryngol. Clin. North Am. 41 (2008) 793-818
15. Howden C.W. Management of acid-related disorders in patients with dysphagia. Am. J. Med. 117 Suppl. 5A (2004) 44S-48S
16. Carnaby-Mann G., and Crary M. Pill swallowing by adults with dysphagia. Arch. Otolaryngol. Head Neck Surg. 131 (2005) 970-975
17. Morita T. Development of deglutition aid jelly for oral administration. Yakugaku Zasshi 123 (2003) 665-671
18. Wu Y., Weller C.L., Hamouz F., Cuppett S.L., and Schnepf M. Development and application of multicomponent edible coatings and films: a review. Adv. Food Nutr. Res. 44 (2002) 347-394
19. Hambleton A., Debeaufort F., Beney L., Karbowiak T., and Voilley A. Protection of active aroma compound against moisture and oxygen by encapsulation in biopolymeric emulsion-based edible films. Biomacromolecules 9 (2008) 1058-1063
20. Chambin O., Champion D., Debray C., Rochat-Gonthier M.H., Le Meste M., and Pourcelot Y. Effects of different cellulose derivatives on drug release mechanism studied at a preformulation stage. J. Control. Release 95 (2004) 101-108
21. Cubeddu L.X. Mechanisms by which cancer chemotherapeutic drugs induce emesis. Semin. Oncol. 19 6 Suppl. 15 (1992) 2-13
22. Latreille J., Pater J., Johnston D., Laberge F., Stewart D., Rusthoven J., Hoskins P., Findlay B., McMurtrie E., Yelle L., Williams C., Walde D., Ernst S., Dhaliwal H., Warr D., Shepherd F., Mee D., Nishimura L., Osoba D., and Zee B. Use of dexamethasone and granisetron in the control of delayed emesis for patients who receive highly emetogenic chemotherapy. J. Clin. Oncol. 16 (1998) 1174-1178
23. Kris M.G., Gralla R.J., Tyson L.B., Clark R.A., Cirrincione C., and Groshen S. Controlling delayed vomiting: double-blind, randomized trial comparing placebo, dexamethasone alone, and metoclopramide plus dexamethasone in patients receiving cisplatin. J. Clin. Oncol. 7 (1989) 108-114
24. Ioannidis J.P., Hesketh P.J., and Lau J. Contribution of dexamethasone to control of chemotherapy-induced nausea and vomiting: a meta-analysis of randomized evidence. J. Clin. Oncol. 18 (2000) 3409-3422
25. Garcia-del-Muro X., Vadell C., Pérez Manga G., Bover I., Rifá J., Beltrán M., Barros M.M., Germá J.R., Fabregat X., Moreno V., Salvador A., and Viladiu P. Randomised double-blind study comparing tropisetron alone and in combination with dexamethasone in the prevention of acute and delayed cisplatin-induced emesis. Eur. J. Cancer 34 (1998) 193-195
26. Malik N.M., Moore G.B., Kaur R., Liu Y.L., Wood S.L., Morrow R.W., Sanger G.J., and Andrews P.L. Adaptive upregulation of gastric and hypothalamic ghrelin receptors and increased plasma ghrelin in a model of cancer chemotherapy-induced dyspepsia. Regul. Pept. 148 (2008) 33-38