Formulations for spray-drying large porous particles

Details Formulations for spray-drying large porous particles Formulations for spray-drying large porous particles

2007-10-04

2010-10-05

Kishore, Gollamudi S (Department: 1612)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

C424S043000, C424S044000, C424S046000, C424S502000

Reexamination Certificate

active

07807200

ABSTRACT:
Particles having a tap density less than about 0.4 g/cm3 are formed by spray drying from a colloidal solution including a carboxylic acid or salt thereof, a phospholipid, a divalent salt and a solvent such as an aqueous-organic solvent. The colloidal solution can also include a therapeutic, prophylactic or diagnostic agent. Preferred carboxylic acids include at least two carboxyl groups. Preferred phospholipids include phosphatidylcholines, phosphatidylethanolamines, phosphatidylglycerols, phophstidylserines, phosphatidylinositols and combinations thereof. The particles are suitable for pulmonary delivery.

REFERENCES:
patent: 4069819 (1978-01-01), Valentini et al.
patent: 4857311 (1989-08-01), Domb et al.
patent: 4995385 (1991-02-01), Valentini et al.
patent: 5855913 (1999-01-01), Hanes et al.
patent: 5874064 (1999-02-01), Edwards et al.
patent: 5985309 (1999-11-01), Edwards et al.
patent: 5997848 (1999-12-01), Patton et al.
patent: 6136295 (2000-10-01), Edwards et al.
patent: 6315983 (2001-11-01), Eistetter
patent: 6503480 (2003-01-01), Edwards et al.
patent: 6586008 (2003-07-01), Batycky et al.
patent: 6749835 (2004-06-01), Lipp et al.
patent: 6858199 (2005-02-01), Edwards et al.
patent: 7279182 (2007-10-01), Lipp et al.
patent: WO 97/44013 (1997-11-01), None
Tabata, Y. and Y. Ikada, “Macrophage phagocytosis of biodegradable microspheres composed of L-lactic acid/glycolic acid homo- . . . ,”J. Biomed. Mater. Res., 22:837-858 (1988).
Ganderton, D., “The Generation of Respirable clouds from coarse powder aggregates,” J. Biopharmaceutical Sciences, 3: 101-105 (1992).
Gonda, I., in Topics in Pharmaceutical Sciences 1991, D. Crommelin and K. Midha, Editors, Stuttgart: Medpharm Scientific Publishers, 95-117 (1992).
Zeng, X., et al., “The controlled delivery of drugs to the lung,” Int. J. Pharm., 124:149-164 (1995).
French, D.L, et al., “The influence of formulation on emission, deaggregation and depositon of dry powders for inhalation,” J. Aerosol Sci., 27(5):769-783 (1996).
Pavia, D. “Lung Mucociliary Clearance,” in Aerosols and the Lung: Clinical and Experimental Aspects, Clarke, S.W. and Pavia, D., Eds., Butterworths, London, 1984. Anderson.
Warheit, M.B. and Hartsky, M.A., “Role of alveolar macrophage chemotaxis and phagocytosis in Pulmonary clearance responses to . . . ,” Microscopy Res. Tech., 26:412-422 (1993).
Edwards, D.A., “The Macrotransport of Aerosol Particles in the Lung: Aerosol Depositon Phenomena,” J. Aerosol Sci., 26(2):293-317 (1995).
Dorries, A.M. and Valberg, P.A., “Heterogeneity of Phagocytosis for Inhaled versus instilled material,” Am. Rev. Resp. Disease 146:831-837 (1991).
Gehr, P. et al., “Surfactant and Inhaled Particles in the conducting airways: strutural, stereological, and biophysical . . . ,” Microscopy Res. and Tech., 26:423-436 (1993).
Kawaguchi, H., et al., “Phagocytosis of latex particles by leucocytes I Dependence of phagocytosis on the size and surface potential,” Biomaterials 7:61-66 (1986).
Krenis, L.J. and Strauss, B., “Effect of size and concentration of latex particles of human blood leucocytes,” Proc. Soc. Exp. Med., 107:748-750 (1961).
Hrkach et al., Synthesis of Poly(L-lactic acid-co-l-lysine) graft copolymers,: Macromolecules, 28:4736-4739 (1995).
Heyder, J., t al., “Deposition of particles in the human respiratory tract in the size range 0.005-15um,” J. Aerosol Sci., 17(5):811-825 (1986).
Hrkach et al., “CH 8: Poly(L-Lactic acid-co-amino acid) Graft Copolymers: A Class of . . . ,” in Hydrogels and Bioderadable Polymers for Bioapplication, pp. 93-102 (1996).
Langer, R., “New Methods of Drug Delivery,” Science, 249:1527-1533 (1990).
K. Masters in “Spray Drying Handbook”, John Wiley & Sons, New York, 1984.
Gonda, I., “Preface. Major issues and future prospects in the delivery of therapeutic and diagnositc agents to the respiratory tract,” Adv. Drug Del. Rev., 5: 1-9 (1990).
Wall, “Pulmonary Absorpton of Peptides and Proteins,” Drug Delivery, 2:1-20 (1995).
USP Bulk Density and Tapped Density, United States Pharmacopia convention, Rockville, MD, 10th Supplement, 4950-4951, 1999.
Byron, P., “Determinants of drug and polypeptide bioavailability from aerosols delivered to the lung,” Adv. Drug. Del. Rev., 5:107-132 (1990).
Patton, J.S., et al., “Bioavailability of pulmonary delivered peptides and proteins: a-interferon, calcitonins and parathyroid hormones,” J. Contr Release, 28: 79-85 (1994).
Damms, B. and Bains, W., “The Cost of Deliverying Drugs Without Needles,” Nature Biotechnology , 13:1438-1440 (1995).
Niven, R.W., et al., “The Pulmonary Absorption of Aerosolized and Intrataacheally Instilled rhG-CSF and monoPEGylated rhG-CSF,” Pharm. Res., 12(9):1343-1349 (1995).
Kobayashi, S., et al., “Pulmonary Delivery of Salmon Calcitonin Dry Powders Containing Absorption Enhancers in Rats,” Pharm. Res., 13(1):80-83 (1996).
(Liu, R., et al., “Mositure-Induced Aggregation of Lyophilized Proteins in the Solid State,” Biotechnol. Bioeng., 37: 177-184 (1991).
Mumenthaler, M., et al., “Feasibility Study on Spray-Drying Protein Pharmaceuticals: Recombininant Human Growth Hormone and Tissue-type . . . ,” Pharm. Res., 11(1):12-20 (1994).
Moren, “Aerosol dosage forms and formulations,” in: Aerosols in Medicine. Principles, Diagnosis and Therapy, Moren, et al., Eds, Esevier, Amsterdm, 1985.
Adjei, A. and Garren, J., Pulmonary Delvery of Peptide Drugs: Effect of Particle Size on Bioavailability of Leuprolide Acetate in Healthly Male . . . Pharm. Res., 7:565-569 (1990).
Zanen, P. and Lamm, J.-W.J., “The optimal particle size for parasympathicolytic aerosols in mild asthmatics,” Int. J. Pharm., 114: 111-115 (1995).
Gonda, I. “Aerosols for delivery of therapeutic and diagnostic agents to the respiratory tract,” In Critical Reviews in Therapeutic Drug Carrier Systems, 6(4):273-313 (1990).
Anderson P, J et al., “Effect of Cystic Fibrosis on Inhaled Aerosol Boluses,” Am. Rev. Respir. Dis., 140: 1317-1324 (1989).
Patton and Platz, (D) Routes of Delivery: Case Studies (2) Pulmonary delvieyr of peptides and proteins for systemic . . . , Advanced Drug Delivery Reviews, 8:179-196 (1992).
Timsina et. al., “Drug delivery to the respiratory tract using dry powder inhalers,” Int. J. Pharm., 101:1-13 (1994).
Tansey, I.P., “The Challenges in teh development of metered dose inhalation aerosols using ozone-friendly propellants,” Spray Technol. Market, 4: 26-29 (1994).
French, D.L., et al., “The Infuluence of Formulation on Emission Deaggreaton and Deposition of Dry Powders for Inhalation,” J. Aerosol Sci., 27:769-783 (1996).
(Visser, J., “An Invited Review Van der Waals and Other Cohesive Forces Affecting Powder Fluidization,” Powder Technology, 58:1-10 (1989).
Rudt, S. and R.H. Muller, “In vitro phagocytosis assay of nano-and microparticles by chemiluminescence. I. Effect of analytical . . . ”, J. Controlled Release, 22:263-272 (1992).
U.S. Appl. No. 09/337,245, filed Jun. 22, 1999, Edwards, et al.

Affiliated with

Also associated with

Rating

Formulations for spray-drying large porous particles does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Formulations for spray-drying large porous particles, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Formulations for spray-drying large porous particles will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-4184277