Porous paclitaxel matrices and methods of manufacture thereof

Details Porous paclitaxel matrices and methods of manufacture thereof Porous paclitaxel matrices and methods of manufacture thereof

2005-08-26

2008-09-09

Richter, Johann R. (Department: 1616)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

C424S484000, C424S422000, C424S428000, C514S951000, C514S449000, C549S512000

Reissue Patent

active

RE040493

ABSTRACT:
Paclitaxel is provided in a porous matrix form, which allows the drug to be formulated without Cremophor and administered as a bolus. The paclitaxel matrices preferably are made using a process that includes (i) dissolving paclitaxel in a volatile solvent to form a paclitaxel solution, (ii) combining at least one pore forming agent with the paclitaxel solution to form an emulsion, suspension, or second solution, and (iii) removing the volatile solvent and pore forming agent from the emulsion, suspension, or second solution to yield the porous matrix of paclitaxel. The pore forming agent can be either a volatile liquid that is immiscible with the paclitaxel solvent or a volatile solid compound, preferably a volatile salt. In a preferred embodiment, spray drying is used to remove the solvents and the pore forming agent. In a preferred embodiment, microparticles of the porous paclitaxel matrix are reconstituted with an aqueous medium and administered parenterally, or processed using standard techniques into tablets or capsules for oral administration.

REFERENCES:
patent: 4818542 (1989-04-01), DeLuca et al.
patent: 4898734 (1990-02-01), Mathiowitz et al.
patent: 5382437 (1995-01-01), Ecanow
patent: 5468598 (1995-11-01), Miller et al.
patent: 5470583 (1995-11-01), Na et al.
patent: 5500331 (1996-03-01), Czekai et al.
patent: 5510118 (1996-04-01), Bosch et al.
patent: 5513803 (1996-05-01), Czekai et al.
patent: 5518187 (1996-05-01), Bruno et al.
patent: 5518738 (1996-05-01), Eickhoff et al.
patent: 5534270 (1996-07-01), De Castro
patent: 5552160 (1996-09-01), Liversidge et al.
patent: 5560932 (1996-10-01), Bagchi et al.
patent: 5565188 (1996-10-01), Wong et al.
patent: 5569448 (1996-10-01), Wong et al.
patent: 5571536 (1996-11-01), Eickhoff et al.
patent: 5580579 (1996-12-01), Ruddy et al.
patent: 5587143 (1996-12-01), Wong
patent: 5591456 (1997-01-01), Franson et al.
patent: 5609998 (1997-03-01), Texter et al.
patent: 5622279 (1997-04-01), Schutz
patent: 5622938 (1997-04-01), Wong
patent: 5657931 (1997-08-01), Nair et al.
patent: 5662279 (1997-09-01), Czekai et al.
patent: 5662883 (1997-09-01), Bagchi et al.
patent: 5665331 (1997-09-01), Bagchi et al.
patent: 5716642 (1998-02-01), Bagchi et al.
patent: 5718919 (1998-02-01), Ruddy et al.
patent: 5747001 (1998-05-01), Wiedmann et al.
patent: 5762961 (1998-06-01), Roser et al.
patent: 5853698 (1998-12-01), Straub et al.
patent: 5855913 (1999-01-01), Hanes et al.
patent: 5916596 (1999-06-01), Desai et al.
patent: 5919434 (1999-07-01), Dugstad et al.
patent: 5942253 (1999-08-01), Gombotz et al.
patent: 5976574 (1999-11-01), Gordon
patent: 5985285 (1999-11-01), Titball et al.
patent: 6001336 (1999-12-01), Gordon
patent: 6096331 (2000-08-01), Desai et al.
patent: 6395300 (2002-05-01), Straub et al.
patent: 6423345 (2002-07-01), Bernstein et al.
patent: 6565885 (2003-05-01), Tarara et al.
patent: 6645528 (2003-11-01), Straub et al.
patent: 6962696 (2005-11-01), Bermudes et al.
patent: 2001/0018072 (2001-08-01), Unger
patent: 2002/0009493 (2002-01-01), Schwendeman et al.
patent: 2002/0142050 (2002-10-01), Straub et al.
patent: 2003/0035845 (2003-02-01), Zale et al.
patent: 2005/0048116 (2005-03-01), Straub et al.
patent: 2 136 704 (1995-05-01), None
patent: 37 13 326 (1987-10-01), None
patent: 0 655 237 (1995-05-01), None
patent: 1 265 615 (1972-03-01), None
patent: WO 91/18590 (1991-12-01), None
patent: WO 98/31346 (1998-07-01), None
patent: WO 98/51282 (1998-11-01), None
patent: WO 99/56731 (1999-11-01), None
patent: WO 00/61147 (2000-10-01), None
Hastedt & Wright, “Diffusion in porous materials above the percolation threshold,” Pharm. Res. 7(9):893-901 (1990).
Hirschberg, et al., “Oral absorption of CGS-20625, an insoluble drug, in dogs and man,” J. Pharmacokinet. Biopharm. 23(1):11-23 (1995).
Hong, et al., “Accelerated oral absorption of glicazide in human subjects from a soft gelatin capsule containing a PEG 400 suspension of gliclazide,” J. Controlled Release 51(2-3):185-92 (1998).
Imai, et al., “Enhancement of the dissolution rates of poorly water-soluble drugs by water-soluble gelatin,” Chem. Pharm. Bull. (Tokyo). 37(8):2251-52 (1989).
Imai, et al., “Rapidly absorbed solid oral formulations of ibuprofen using water-soluble gelatin,” J. Pharm. Pharmacol. 42(9):615-19 (1990).
Ju, et al., “Drug release from hydropohilic matrices. 1. New scaling laws for predicting polymer and drug release based on the polymer disentanglement concentration and the diffusion layer,” J. Pharm. Sci. 84(12):1455-63 (1995).
Kagkadis, et al., “A freeze-dried injectable form of ibupropen: development and optimisation using response surface methodology,” PDA J. Pharm. Sci. Technol. 50(5):317-23 (1996).
Kai, et al., “Oral absorption improvement of poorly soluble drug using solid dispersion technique,” Chem. Pharm. Bull. 44(3):568-71 (1996).
Kaneniwa & Watari, “Dissolution of slightly soluble drugs. I. Influence of particle size on dissolution behavior,” Chem. Pharm. Bull. 22:1699-705 (1974).
Kaur, et al., “Comparison of polyethylene glycol and polyoxyethylene stearate as excipients for solid dispersion systems of griseofulvin and tolbutamide II: dissolution and solubility studies,” J. Pharm. Sci. 69(11):1312-26 (1980).
Kawashima, et al., “Improvement of solubility and dissolution rate of poorly water-soluble salicylic acid by a spray-drying technique,” J. Pharm. Pharmacol. 27(1):1-5 (1975).
Khan & Jiabi, “Preparation, characterization, and dissolution studies of ibuprofen solid dispersions using polyethylene glycol (PEG), talc, and PEG-talc as dispersion carriers,” Drug Dev. Ind. Pharm. 24(5):455-62 (1998).
Khan, et al., “Controlled release coprecipitates:formulation considerations,” J. Control. Rel. 37:131-41 (1995).
Kim & Yoon, “Development of digoxin dry elixir as a novel dosage form using a spray-drying technique,” J. Microencapsul. 12(5):547-56 (1995).
Kincl, et al., “Increasing oral bioavailability of progesterone by formulation,” J. Steroid Biochem. 9(1):83-84 (1978).
Kondo, et al., “Pharmacokinetics of micronized, poorly water-soluble drug, HO-221, in experimental animals,” Biol. Pharm. Bull. 16(8):796-800 (1993).
Kubo & Mizobe, “Improvement of dissolution rate and oral bioavailability of sparingly water-soluble drug (+/−)-5-[[2(-2-naphthalenylmethyl)-5-benzoxazolyl]-2, 4-thiazolidinedione, in co-ground mixture with D-mannitol,” Biol. Pharm. Bull. 20(4):460-63 (1997).
Kubo, et al., “Enhancement of oral bioavilability and pharmacological effect of 1-(3,4-dimethoxyphenl)-2,3-bis(methoxycarbonyl)-4hydroxy-6,7,8-trimethoxynaphthalene (TA-7552), a new hypocholesterolemic agent, by micronization in co-ground mixture with D-mannitol,” Biol. Pharm. Bull. 19(5):741-47 (1996).
Lee, et al., “Mathematical modelling of the release of drug from porous, nonswelling transdermal drug-delivery devices, ” IMA J. Math. Appl. Med. Biol. 15(2):135-63 (1998).
Lemos-Senna, et al., “Evaluation of the hydrophobic drug loading characteristics in nanoprecipitated amphiphillic cyclodextrin nanospheres,” Pharm. Dev. Tech. 3:85-94 (1998).
Leucuta, et al., “The kinetics of nifefipine release from porous hydrophillic matrices and the pharmacokinetics in man,” Pharmazie 43:845-48 (1988).
Lin et al., “Improved oral absorption of L-365260, a poorly soluble drug,” Biopharm. Drug Dispos.. 17(1):1-15 (1996).
Lin, et al., “Preparation of enteric-coated microspheres of Mycoplasma hyopneumoniae vaccine with cellulose acetate phthalate: (II). Effect of temperature and pH on the stability and release behaviour of microspheres,” J. Microencapsul. 8(4):537-45 (1991).
Martindale, The Extra Pharmacopoeia, 711 Dissolution, pp. 1791-1792, 30th Ed. (The Pharmaceutical Press, London 1993).
Mason & Winer, “Kinetics of aspirin salicylic acid, and

Affiliated with

Also associated with

Rating

Porous paclitaxel matrices and methods of manufacture thereof does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Porous paclitaxel matrices and methods of manufacture thereof, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Porous paclitaxel matrices and methods of manufacture thereof will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-3992798