Sulfoalkyl ether cyclodextrin based controlled release solid pharmaceutical formulations
Patent 6046177 Issued on April 4, 2000. Estimated Expiration Date: January 13, 2019. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
514/58, Dextrin or derivative514/778, Starch or derivative514/964, SUSTAINED OR DIFFERENTIAL RELEASE TYPE514/965, Discrete particles in supporting matrix536/103Dextrin or derivative
Sulfoalkyl ether cyclodextrin (SAE-CD) based controlled release pharmaceutical formulations are provided by the present invention. The present solid pharmaceutical formulations consist of a core comprising a physical mixture of one or more SAE-CD derivatives, an optional release rate modifier, a therapeutic agent, a major portion of which is not complexed to the SAE-CD, and an optional release rate modifying coating surrounding the core. The present formulations are advantageously easier to prepare than other SAE-CD based formulations in the art yet provide similar or improved effectiveness. The SAE-CD derivative is used to modify the bioavailability and/or rate of bioabsorption of therapeutic agents. Multi-layered, osmotic pump, coated, and uncoated tablet, minitablet, pellet, micropellet, particle, powder, and granule dosage forms are disclosed herein.
Other References
Kaneto Uekama, Kazutaka Matsubara, Kentaro Abe, Yasuhide Horiuchi, Fumitoshi Hirayama, and Nobuo Suzuki, "Design and In Vitro Evaluation of Slow-Release Dosage Form of Pirentanide: Utility of ଲ-Cyclodextrin: Cellulose Derivative Combination as a Modified-Release Drug Carrier," Journal of Pharmaceutical Sciences, vol. 79, No. 3, Mar. 1990, pp. 244-248
O.I. Corrigan and C.T. Stanley, "Dissolution Properties of Phenobarbitone-ଲ-Cyclodextrin Systems," Pharm. Acta. Hel., vol. 56, No. 7 (1981), pp. 204-208
A. Martini, C. Torricelli, L. Muggetti, R. DePonti, "Use of Dehydrated Beta-Cyclodextrin As Pharmaceutical Excipient," Proceed. Intern.-Symp. Control. Rel. Bioact. Mater., 20 (1993), Controlled Release Society, Inc., pp. 304-305
A. Gursoy, M. Turkoglu, B. Senyucel, F. Kalkan, and I. Okar, "Evaluation of Tableted Microspheres of Dipyridamole," Drug Development and Industrial Pharmacy, 21(4) (1995), pp. 503-507
H.O. Ammar, M. Ghorab, S. A. El-nahhas, S. M. Omar and M. M. Ghorab, "Improvement of some pharmaceutical properties of drugs by cyclodextrin complexation," Pharmazie, vol. 51 (1996), pp. 42-51
Kristiina Jarvinen, Tomi Jarvinen, Diane O. Thompson and Valentino J. Stella, "The effect of a modified ଲ-cyclodextrin, SBE4-ଲ-CD, on the aqueous stability and ocular absorption of pilocarpine," Current Eye Research (1994)
V. J. Stella, H. K. Lee, D. O. Thompson, "The effect of SBE4-ଲ-CD on i.m. prednisolone pharmacokinetics and tissue damage in rabbits: Comparison to a co-solvent solution and a water-soluble prodrug," International Journal of Pharmaceutics, vol. 120 (1995), pp. 197-204
V. J. Stella, H. K. Lee, D. O. Thompson, "The effect of SBE4-ଲ-CD on i.v. methylprednisolone pharmacokinetics in rats: Comparison to a co-solvent solution and two water-soluble prodrugs," International Journal of Pharmaceutics, vol. 120 (1995), pp. 189-195
C. X. Song, V. Labhasetwar, R. J. Levy, "Controlled release of U-97983 from double-layer biodegradable matrices: effect of additives on release mechanism and kinetics," Journal of Controlled Release, vol. 45 (1997), pp. 177-192
Valentino J. Stella and Roger A. Rajewski, "Cyclodextrins: Their Future in Drug Formulation and Delivery," Pharmaceutical Research, vol. 14, No. 5 (1997), pp. 556-567
K. Uekama, F. Hirayama, and T. Irie, "New Functions of Peracylated ଲ-Cyclodextrins as Sustained-Release Drug Carriers," Proceedings of the Eighth International Symposium on Cyclodextrins (1996), pp. 413-418
Tomi Jarvinen, Kristiina Jarvinen, Nancy Schwarting, and Valentino J. Stella, "ଲ-Cyclodextrin Derivatives, SBE4-ଲ-CD and HP-ଲ-CD, Increase the Oral Bioavailability of Cinnarizine in Beagle Dogs," Journal of Pharmaceutical Sciences, vol. 84, No. 3, Mar. 1995, pp. 295-299
Kazuto Okimoto, Masatoshi Miyake, Norlo Ohnishi, Roger A. Rajewski, Valentino J. Stella, Tetsumi Irie, and Kaneto Uekama, Design and Evaluation of an Osmotic Pump tablet (OPT) for Prednisolone, a Poorly Water Soluble Drug, Using (SBE)7m -ଲ-CD, Pharmaceutical Research, vol. 15, No. 1 (1998), pp. 1562-1568
P. Mura, G. P. Bettinetti, A. Liguori, G. Bramanti, "Improvement of Clonazepam Release from a Carbopol Hydrogel," Pharm. Acta Helv, vol. 67, No. 9-10 (1992), pp. 282-288
M. Chino, T. Kasama, Y. Noguchi, A. Ueda, and Y. Koyama, "Sustained-Release of Drugs from Cyclodextrin-Containing Hydrogels," Proceed. Intern. Symp. Control. Rel. Bioact. Mater., vol. 19 (1992), pp. 98-99
Paolo Gionchedi, Lauretta Maggi, Aldo La Manna and Ubaldo Conte, "Modification of the Dissolution Behaviour of a Water-insoluble Drug, Naftazone, for Zero-order Release Matrix Preparation," J. Pharm. Pharmacol. vol. 46 (1994), pp. 476-480
Kazuto Okimoto, Roger A. Rajewski, Kaneto Uekama, Janan A. Jona, and Valentino J. Stella, "The Interaction of Charged and Uncharged Drugs with Neutral (HP-ଲ-CD) and Anionically Charged (SBE7-ଲ-CD) ଲ-Cyclodextrins," Pharmaceutical Research, vol. 13, No. 2 (1996), pp. 256-264
Fumitoshi Hirayama, "Inclusion Ability of Hydrophobic Cyclodextrin Derivatives and Their Application as Controlled-Release Drug Carrier," Yakugaku Kenkyu No Shinpo (1990), (6), 90-98
J. J. Torres-Labanderia, J. Blanco-Mendez and J. L. Vila-Jato, "Biopharmaceutical stability of the glibornuride/ଲ-cyclodextrin inclusion complex after one year of storage," S.T.P. Pharma. Sciences 4(3), 1994, pp. 235-239
F.J. Otero-Espinar, S. Anguiano-Igea, N. Garcia-Gonzalez, J.L. Vila-Jato and J. Blanco-Mendez, "Oral bioavailability of naproxen-ଲ-cyclodextrin inclusion compound," International Journal of Pharmaceutics, 75 (1991), pp. 37-44
Hideaki Yajima, Jun Sumaoka, Sachiko Miyama, and Makoto Komiyama, "Lanthanide Ions for the First Non-Enzymatic Formation of Adenosine 3''5''Cyclic Monophosphate from Adenosine Triphosphate under Physiological Conditions,", Biochem, 115 (1994), pp. 1038-1039
M. T. Esclusa-Diaz, M. Gayo-Otero, M. B. Perez-Marcos, J. L. Vila-Jato, J. J. Torres-Labandeira, "Preparation and evaluation of ketoconazole-ଲ-cyclodextrin multicomponent complexes," International Journal of Pharmaceutics, 142 (1991), pp. 183-187
Noriyuki Muranushi, Mariko Yoshida, Haruki Kinoshita, Fumiaki Hirose, Takayo Fukuda, Masami Doteuchi and Hideo Yamada, "Studies on benexata-CD: Effect of inclusion compound formation on the antiulcer activity of benexate, the effective ingredient of benexate-CD," Folia pharmacol. Japon. 91 (1988), pp. 377-383
D. Peri, C. M. Wyandt, R. W. Cleary, A. H. Hikal and A. B. Jones, "Inclusion Complexes of Tolnaftate with -ଲ-Cyclodextrin and Hydroxypropyl-ଲ-Cyclodextrin," Drug Development and Industrial Pharmacy, 20(8) (1994), pp. 1401-141
January 13, 2019. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
