Formulation

Details Formulation Formulation

2004-06-22

2008-11-25

Hui, San-ming (Department: 1617)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Cyclopentanohydrophenanthrene ring system doai

C514S178000

Reexamination Certificate

active

07456160

ABSTRACT:
The invention relates to a novel sustained release pharmaceutical formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol, more particularly to a formulation adapted for administration by injection containing the compound 7α-[9-(4,4,5,5,5-pentafluoropentylsulphinyl)nonyl]oestra-1,3,5(10)-triene-3,17β-diol in solution in a ricinoleate vehicle which additionally comprises at least one alcohol and a non-aqueous ester solvent which is miscible in the ricinoleate vehicle.

REFERENCES:
patent: 2822316 (1958-02-01), Richter et al.
patent: 2983649 (1961-05-01), Ercoli et al.
patent: 3164520 (1965-01-01), Huber
patent: 3541209 (1970-11-01), Neumann et al.
patent: RE28690 (1976-01-01), Lehmann et al.
patent: 4048309 (1977-09-01), Chen et al.
patent: 4048310 (1977-09-01), Chen et al.
patent: 4212863 (1980-07-01), Cornelius
patent: 4388307 (1983-06-01), Cavanak
patent: 4659516 (1987-04-01), Bowler et al.
patent: 4888331 (1989-12-01), Elger et al.
patent: 5095129 (1992-03-01), Ottow et al.
patent: 5183814 (1993-02-01), Dukes
patent: 5484801 (1996-01-01), Al-Razzak et al.
patent: 5733902 (1998-03-01), Schneider
patent: 5929030 (1999-07-01), Hamied et al.
patent: 2001/0006963 (2001-07-01), Lachnit-Fixson et al.
patent: 0 138 504 (1985-04-01), None
patent: 0310542 (1989-04-01), None
patent: 0 346 014 (1989-12-01), None
patent: 0819431 (1999-03-01), None
patent: 0905143 (1999-03-01), None
patent: 6241 (1968-09-01), None
patent: 817241 (1959-07-01), None
patent: 1 126 892 (1968-09-01), None
patent: 1 207 571 (1970-10-01), None
patent: 1207571 (1970-10-01), None
patent: 1 569 286 (1980-06-01), None
patent: 43-27327 (1992-11-01), None
patent: 09-208496 (1997-12-01), None
patent: 10/203982 (1998-04-01), None
patent: 10-152438 (1998-06-01), None
patent: 11-501649 (1999-02-01), None
patent: 11-158200 (1999-06-01), None
patent: 549118 (1977-03-01), None
patent: 676284 (1979-07-01), None
patent: WO 95/12383 (1995-05-01), None
patent: WO 96/19997 (1996-07-01), None
patent: WO 97/21440 (1997-06-01), None
patent: WO 97/37653 (1997-10-01), None
patent: WO 97/40823 (1997-11-01), None
patent: WO 98/11902 (1998-03-01), None
patent: 681014 (1968-02-01), None
patent: 682530 (1968-04-01), None
Anschel, “Lösungsmittel und Lösungsvermittler in Injektionen”, Pharm, Ind., 1965, vol. 27 (11a), pp. 781-787.
Davis et al., “17-Alpha-Hydroxyprogesterone-Caproate: . . . with Chemically Pure Progesterone”, J. Clin. Endocrinol. And Metabolism, 1955, vol. 15, pp. 923-930.
Dukes et al., “Antiuterotrophic effects of the pure antioestrogen ICI 182, 780 . . . quantitative magnetic resonance imaging”; J. Endocrinology, 1992, vol. 138, pp. 203-209.
Dukes et al., “Antiuterotrophic effects of pure antioestrogen. ICI 182, 780, . . . the uterus in ovariectomized monkeys”, J. Endocrinology, 1992, vol. 135, pp. 239-247.
Howell et al., “Pharmacokinetics, pharmacological and anti-tumour effects of the specific anti-oestrogen ICI 182780 in women with advanced breast cancer”, British Journal of Cancer, 1996, vol. 74, pp. 300-308.
Martindale, 32nd Ed., “Alcohol”, Pharmaceutical Press, 1999, pp. 1099-1101.
Martindale, 32nd Ed., “Benzoates” and “Benzyl Alcohol”; Pharmaceutical Press, 1999, pp. 1102-1104.
Martindale, 32nd Ed., “Caster Oil”; 32nd Ed., Pharmaceutical Press, 1999, p. 1560.
Migally, “Effect of Caster Oil and Benzyl Benzoate Used as a Vehicle for Antiandrogens on the Adrenal Cortex”, Archives of Andrology 2, 1979, pp. 365-369.
Pellegrino, “Use of 17 α Hydroxyprogesterone Caproate in Threatened Abortion”, Current Therapeutic Research, vol. 4, No. 6, Jun. 1962, pp. 301-305.
Piver et al., “Medroxyprogesterone Acetate (Depo-Provera) vs . . . Women with Metastatic Endometrial Adenocarcinoma”, Cancer, vol. 45, American Cancer Society, 1980, pp. 268-272.
Riffkin et al., “Castor Oil as a Vehicle for Parenteral Administration of Steroid Hormones”, Journal of Pharmaceutical Sciences, vol. 53, No. 8, Aug. 1964, pp. 891-895.
Sawada et al., “Estrogen Receptor Antagonist ICII82,780 Exacerbates Ischemic Injury in Female Mouse”, Journal of Cerebral Blood Flow and Metabolism, vol. 20, No. 1, 2000, pp. 112-118.
Vidal, Le Dictionnaire, “Benzo-Gynoestryl Retard”, 1998 p. 201.
Vidal, Le Dictionnaire, “Gravibinan”, 1995, pp. 660-661.
Vidal, Le Dictionnaire, “Parabolan”, 1997, p. 1245.
Vidal, Le Dictionnaire, “Trophobolene”, 1997, pp. 1706-1707.
Wakeling et al., “A Potent Specific Pure Antiestrogen with Clinical Potential”, Cancer Research, 1991, vol. 51, pp. 3867-3873.
Waterton et al., “A Case of Adenomyosis in a Pigtailed Monkey . . . Treated with the Novel Pure Antiestrogen, ICI 182,780”; Laboratory Animal Science, 1993, vol. 43, No. 3, 1993, pp. 247-251.
Mackey et al, “Tolerability of intramuscular injections of testosterone ester in oil vehicle”, Human Reproduction, vol. 10, No. 4, pp. 869-865, 1995.
Howell et al., “Response to a specific antioestrogen (ICI 182780) in tamoxifen-resistant breast cancer”, The Lancet, Jan. 7, 1995, pp. 29-30.
Osborne et al., “Comparison of the Effects of a Pure Steroidal Antiestrogen With Those of Tamoxifen in a Model of Human Breast Cancer”, Journal of the National Cancer, May 1995, vol. 87, No. 10, pp. 746-750.
Robertson et al., “A Partially-Blind, Randomised, Multicentre Study Comparing the Anti-Tumor Effects of Single Doses (50, 125 and 250MG) of Long-Acting (LA) ‘Faslodex’ (ICI 182,780 with Tamoxifin in Postmenopausal Women with Primary Breast Cancer Prior to Surgery”; Abstract 28, 22nd Annual San Antonio Breast Cancer Symposium: Dec. 8-11, 1999, San Antonio, Breast Cancer Research and Treatment 1999; 57 (1; special issue); p. 31.
Remington's Pharmaceutical Sciences, 18th ed., 1990, p. 219.
P.K. Gupta and G.A. Brazeau (eds).Injectable Drug Development:Techniques to Reduce Pain and Irritation. Chapters 11 & 17 Interpharm Press, Denver, Colorado (1999).
P.V. Lopatin, V. P. Safonov, T. P. Litvinova and L. M. Yakimenko. Use of nonaqueous solvents to prepare injection solutions.Pharm. Chem. J. 6:724-733 (1972).
S. Nema, R.J. Washkuhn, and R.J. Brendel. Excipients and their use in injectable products.PDA J. Pharm. Sci. Technol. 51:166-71 (1997).
Physicians' Desk Reference(27th edition). 1277-1278, 1350-1354, 1391-1392 Medical Economics Company, Oradell, NJ (1973).
M. F. Powell, T. Nguyen, and L. Baloian. Compendium of excipients for parenteral formulations.PDA J. Pharm. Sci. Technol. 52:238-311 [pp. 238-255 provided] (1998).
R. G. Strickley. Parenteral formulations of small molecule therapeutics marketed in the United States (1999) -Part I.PDA J. Pharm. Sci. Technol. 53:324-349 (1999).
R. G. Strickley. Parenteral formulations of small molecule therapeutics marketed in the United States (1999)—Part IIPDA J. Pharm. Sci. Technol. 54:69-96 (2000).
R. G. Strickley. Parenteral formulations of small molecule therapeutics marketed in the United States (1999)—Part III.PDA J. Pharm. Sci. Technol. 54:152-169 (2000).
Y.C. J. Wang and R. R. Kowal. Review of excipients and pH's for parenteral products used in the United States.J. Parenteral Drug Assoc. 34:452-462 (1980).

Affiliated with

Also associated with

Rating

Formulation does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Formulation, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Formulation will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-4020673