Appeal No. 2001-1933
Application No. 08/940,058
Claim 1 is illustrative of the claims on appeal and reads as follows:
1. A solid, stabilized amorphous paroxetine composition which comprises
amorphous paroxetine hydrochloride and at least one hydroxyl-bearing compound.
The prior art references relied upon by the examiner are:
Tovey 4,493,822 Jan. 15,1985
Barnes et al. (Barnes) 4,721,723 Jan. 26,1988
Ares 5,399,584 Mar. 21, 1995
Leonard 5,811,436 Sep. 22, 1998
Francese et al. (Francese) WO 95/15155 Jun. 08, 1995
Pathak et al. (Pathak) WO 95/16448 Jun. 22, 1995
European Patent Application
Damani et al. (Damani) 0 212 641 Aug. 22, 1986
United Kingdom Patent Application
Jacewicz et al. (Jacewicz) 2 297 550 Aug. 07, 1996
Borodkin et al. (Borodkin), “Interaction of Amine Drugs with a Polycarboxylic acid Ion-
Exchange Resin,” Journal of Pharmaceutical Sciences, Vol. 59, No. 4, pp. 481-486
(1970)
Lieberman et al. (Lieberman), Pharmaceutical Dosage Forms – Tablets, In Three
Volumes, 2nd Ed., Revised and Expanded, Vol. 2, Marcel Dekkar, Inc., publisher. pp.
462-463 (1989)
Lin et al. (Lin), “Solid particulates of drug-$-cyclodextrin inclusion complexes directly
prepared by a spray-drying technique,” International Journal of Pharmaceutics, Vol. 56,
pp. 249-259 (1989)
Kai et al. (Kai), ?Oral Absorption Improvement of Poorly Soluble Drug Using Solid
Dispersion Technique,” Chem. Pharm. Bull., Vol. 44, No. 3, pp. 568-571 (1996)
Uekama et al. (Uekama), “Inhibitory Effect of 2-Hydroxypropyl-$-cyclodextrin on
Crystal-growth of Nifedipine During Storage: Superior Dissolution and Oral
Bioavailability Compared with Polyvinylpyrrolidone K-30,” J. Pharm. Pharmacol., Vol.
44, pp. 73-78 (1991)
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