In vitro and in vivo evaluation of a new sublingual tablet system for rapid oromucosal absorption using fentanyl citrate as the active substance
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Alderborn, 1985, Studies on direct compression of tablets. X. Measurement of tablet surface area by permeametry, Powder Technol., 41, 49, 10.1016/0032-5910(85)85074-9
Ashburn, 1989, Oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: a case report, Anesthesiology, 71, 615, 10.1097/00000542-198910000-00026
Bisrat, 1992, Physicochemical aspects of drug release. XV. Investigation of diffusional transport in dissolution of suspended sparingly soluble drugs, Int. J. Pharm., 80, 191, 10.1016/0378-5173(92)90277-9
Bredenberg, 2003, In vitro evaluation of bioadhesion in particulate systems and possible improvement using interactive mixtures, J. Pharm. Pharmacol., 55, 169, 10.1211/002235702423
B.S. 2955, 1958. Glossary of Terms Relating to Powders, No. 505. British Standards Institute, Park Street, London.
Corveleyn, S., Remon, J.P., 1998. Bioavailability of hydrochlorothiazide: conventional versus freeze–dried tablets. Int. J. Pharm. 173, 149-155.
Dollery, C. (Ed.), Boobis, A.R., Margerison Davies, D., Davies, D., Davies, D.S., Harrison, P.I., Orme, M.L.E., Kevin Park, B., Goldberg, L.I. (Editorial Board), 1991. Therapeutic Drugs. Churchill Livingston, UK, pp. F26–F29.
Eriksson, 1990, Evaluation of a permeametry technique for surface area measurements of coarse particulate materials, Int. J. Pharm., 63, 189, 10.1016/0378-5173(90)90124-M
European Pharmacopoeia, 1997. Third ed. Council of Europe, Strasbourg Cedex, France, pp. 127–135.
Ferrari, 1995, Influence of porosity and formula solubility on disintegrant efficiency in tablets, S.T.P. Pharma Sci., 5, 116
Hanks, G.W.C., Portenoy, R.K., MacDonald, N., Forbes, K., 1998. Difficult pain problems. In: Doyle, D., Hanks, G.W.C., MacDonald, N. (Eds.), Oxford Textbook of Palliative Medicine, second ed. Oxford University Press, UK, pp. 463.
Jerwanska, 1995, The effect of water content on the porosity and liquid saturation of extruded cylinders, Int. J. Pharm., 121, 65, 10.1016/0378-5173(95)00007-6
Kaye, 1967, Permeability techniques for characterizing fine powders, Powder Technol., 1, 11, 10.1016/0032-5910(67)80003-2
Kornblum, 1973, A new tablet disintegrating agent: cross-linked polyvinylpyrrolidone, J. Pharm. Sci., 62, 43, 10.1002/jps.2600620107
Labroo, 1997, Fentanyl metabolism by human hepatic and intestinal cytochrome P450 3A4: implications for interindividual variability in disposition efficacy and drug interactions, Drug Metabol. Dispos., 25, 1072
Lennernäs, B., Hedner, T., Pettersson, A., Duberg, M., Lundqvist, T., Bredenberg, S., Nyström., C., Lennernäs, H. Clinical pharmacokinetics and safety of fentanyl following sublingual administration of a rapidly dissolving tablet in cancer patients: a new approach for treatment of incident pain, submitted for publication.
Mather, 1998, Pulmonary administration of aerosolised fentanyl: pharmacokinetic analysis of systemic delivery, Br. J. Clin. Pharmacol., 46, 37, 10.1046/j.1365-2125.1998.00035.x
Mattson, 2001, Evaluation of critical binder properties affecting the compactability of binary mixtures, Drug Dev. Ind. Pharm., 27, 181, 10.1081/DDC-100000236
Mattsson, 2001, Formulation of high tensile strength rapidly disintegrating tablets—evaluation of the effect of some binder properties, S.T.P. Pharma Sci., 11, 211
Mock, 1986, Transmucosal narcotic delivery: an evaluation of fentanyl (lollipop) premedication in man, Anesth. Analg., 65, S102
Moffat, 1971, Absorption of drugs through the oral mucosa, Top. Med. Chem., 4, 21
Noyes, 1897, The rate of solution of solid substances in their own solutions, J. Am. Chem. Soc., 19, 930, 10.1021/ja02086a003
Nyström, 1980, Studies on direct compression of tablets. I. The effect of particle size in mixing finely divided powders with granules, Acta Pharm. Suec., 17, 282
Nyström, 1986, The use of ordered mixtures for improving the dissolution rate of low solubility compounds, J. Pharm. Pharmacol., 38, 161, 10.1111/j.2042-7158.1986.tb04537.x
Nyström, 1982, Studies on direct compression of tablets. II. The influence of the particle size of a dry binder on the mechanical strength of tablets, Int. J. Pharm., 10, 209, 10.1016/0378-5173(82)90071-0
Nyström, 1985, Dissolution rate measurements of sparingly soluble compounds with the Coulter Counter model TAII, J. Pharm. Pharmacol., 37, 217, 10.1111/j.2042-7158.1985.tb05048.x
Portenoy, 1990, Breakthrough pain: definition, prevalence and characteristics, Pain, 41, 273, 10.1016/0304-3959(90)90004-W
Roy, 1989, Solubility behaviour of narcotic drugs analgesics in aqueous media: solubilities and dissociation constants of morphine fentanyl and sufentanil, Pharm. Res., 6, 147, 10.1023/A:1015932610010
Shangraw, 1980, A new era of tablet disintegrants, Pharm. Technol., 4, 49
Streisand, 1991, Absorption and bioavailability of oral transmucosal fentanyl citrate, Anesthesiology, 75, 223, 10.1097/00000542-199108000-00009
Streisand, 1998, Dose proportionality and pharmacokinetics of oral transmucosal fentanyl citrate, Anesthesiology, 88, 305, 10.1097/00000542-199802000-00006
Sundell-Bredenberg, 2001, The possibility of achieving an interactive mixture with high dose homogeneity containing an extremely low proportion of a micronised drug, Eur. J. Pharm. Sci., 12, 285, 10.1016/S0928-0987(00)00176-7
Wade, A., Weller, P.J., 1994. Handbook of Pharmaceutical Excipients. American Pharmaceutical Association and the Pharmaceutical Press, Washington, DC.
Weinberg, 1988, Sublingual absorption of selected opioid analgesics, Clin. Pharmacol. Ther., 44, 335, 10.1038/clpt.1988.159
Westerberg, M., 1992. Studies on Ordered Mixtures for Fast Release and Dissolution of Drugs with Low Aqueous Solubility. Ph.D. Thesis, Uppsala University, Reprocentralen, HSC, Uppsala, Sweden.
Westerberg, 1991, Physicochemical aspects of drug release. XII. The effect of some carrier particle properties and lubricant admixture on drug dissolution from tableted ordered mixtures, Int. J. Pharm., 69, 129, 10.1016/0378-5173(91)90218-D
Westerberg, 1993, Physicochemical aspects of drug release. XVII. The effect of drug surface area coverage to carrier materials on drug dissolution from ordered mixtures, Int. J. Pharm., 90, 1, 10.1016/0378-5173(93)90291-M
Westerberg, 1986, Physicochemical aspects of drug release. IV. The effect of carrier particle properties on the dissolution rate from ordered mixtures, Int. J. Pharm., 28, 23, 10.1016/0378-5173(86)90143-2
Zeppetella, 2001, Sublingual fentanyl citrate for cancer-related breakthrough pain: a pilot study, Palliat. Med., 15, 323, 10.1191/026921601678320304