Processes for preparing compositions for inhalation

Details Processes for preparing compositions for inhalation Processes for preparing compositions for inhalation

1997-05-19

1999-09-14

Harrison, Robert H.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

424 46, 424489, 424502, 424 852, 424434, 514 2, 514 3, 514951, 530399, A61K 914, A61K 972, A61K 3816, A61K 4712

Patent

active

059520086

ABSTRACT:
A pharmaceutical composition including a mixture of active compounds (A) a pharmaceutically active polypeptide, and (B) an enhancer compound which enhances the systemic absorption of the polypeptide in the lower respiratory tract of a patient, the mixture being in the form of a dry powder for inhalation in which at least 50% of the total mass of the active compounds consists of primary particles having a diameter less than or equal to about 10 microns, the primary particles optionally being formed into agglomerates.

REFERENCES:
patent: 3014844 (1961-12-01), Thiel
patent: 4524769 (1985-06-01), Wetterlin
patent: 4534345 (1985-08-01), Wetterlin
patent: 4548922 (1985-10-01), Carey et al.
patent: 4613500 (1986-09-01), Suzuki et al.
patent: 4668218 (1987-05-01), Virtanen
patent: 4690952 (1987-09-01), Kagatani et al.
patent: 4746508 (1988-05-01), Carey et al.
patent: 4788221 (1988-11-01), Kagatani et al.
patent: 4847298 (1989-04-01), Alexander
patent: 4895719 (1990-01-01), Radhakrishnan
patent: 4900730 (1990-02-01), Miyauchi
patent: 4907583 (1990-03-01), Wetterlin et al.
patent: 4959358 (1988-09-01), Carey et al.
patent: 4963367 (1990-10-01), Ecanow
patent: 4994439 (1991-02-01), Longenecker
patent: 5006343 (1991-04-01), Benson
patent: 5011678 (1991-04-01), Wang
patent: 5118494 (1992-06-01), Schultz
patent: 5122127 (1992-06-01), Stanley
patent: 5122376 (1992-06-01), Aliverti
patent: 5179079 (1993-01-01), Hansen et al.
patent: 5192548 (1993-03-01), Velasquez et al.
patent: 5200393 (1993-04-01), Weiner
patent: 5202129 (1993-04-01), Samejima et al.
patent: 5254330 (1993-10-01), Ganderton et al.
patent: 5260306 (1993-11-01), Boardman et al.
patent: 5284656 (1994-02-01), Platz et al.
patent: 5288498 (1994-02-01), Stanley et al.
patent: 5341800 (1994-08-01), Clark et al.
patent: 5348730 (1994-09-01), Greenleaf
patent: 5354562 (1994-10-01), Platz et al.
patent: 5364838 (1994-11-01), Rubsamen
patent: 5376386 (1994-12-01), Ganderton et al.
patent: 5384133 (1995-01-01), Boyes et al.
patent: 5419315 (1995-05-01), Rubsamen
patent: 5437271 (1995-08-01), Hodson et al.
patent: 5482032 (1996-01-01), Smith et al.
patent: 5482706 (1996-01-01), Igari et al.
patent: 5506203 (1996-04-01), Baeckstroem et al.
patent: 5514670 (1996-06-01), Friedman
patent: 5518998 (1996-05-01), Baeckstroem et al.
patent: 5658878 (1997-08-01), Backstrom et al.
patent: 5707644 (1998-01-01), Illum
patent: 5747445 (1998-05-01), Backstrom et al.
patent: 5830853 (1998-11-01), Backstrom et al.
patent: 5858968 (1999-01-01), Weiner et al.
Olanoff et al., "Method to Enhance Intranasal Peptide Delivery", in "Controlled-Release Technology Pharmaceutical Applications", Lee et al., Ed., Published 1987 by The American Chemical Society, pp. 301-309.
Mishima et al., "Studies on the Promoting Effects of Medium Chain Fatty Acid Salts on the Nasal Absorption of Insulin in Rats", J. Pharm. Sci., vol. 10, issued 1987, pp. 624-631.
Lee et al., "Intranasal Bioavailability of Insulin Powder Formulations: Effect of Permeation Enhancer-to-Protein Ratio", Journal of Pharmaceutical Sciences, vol. 80, No. 8, issued Aug. 1991, pp. 725-729.
Schipper et al., "Nasal Insulin Delivery with Dimethyl-beta-Cyclodextrin as an Absorption Enhancer in Rabbits: Powder More Effective than Liquid Formulations", Pharmaceutical Research, vol. 10, No. 5, issued 1993, pp. 682-686.
Chien et al., "Intranasal Drug Delivery For Systemic Medications", CRC Critical Reviews in Therapeutic Drug Carrier Systems 4:67-194, 1987.
Eppstein et al., "Alternative Delivery Systems for Peptides and Proteins As Drugs", CRC Critical Reviews in Therapeutic Drug Carrier Systems 5:99-139, 1988.
O'Hagan et al., "Absorption of Peptides and Proteins from the Respiratory Tract and the Potential for Development of Locally Administered Vaccine", Critical Reviews in Therapeutic Drug Carrier Sys 7:35-97, 1990.
Remington's Pharmaceutical Science, 18th edn., p. 1079 (1990).
Longenecker et al., Effects of Sodium Taurodihydrofusidate on Nasal Absorption of Insulin in Sheep, J. Pharm. Sci., 76(5):351-355 (1987).
Mizgala et al., Renal Handling of Phosphate, Physiological Reviews, 65(2):431-466 (1985).
Salzman et al., Intranasal Aerosolized Insulin Mixed-Meal Studies and Long-term Use in Type I Diabetes, The New England Journal of Medicine, 312:1078-1084, 1985.
Zingg et al., Transhepatic Absorption and Biliary Excretion of Insulin, Can. J. Physiol. Pharmacol., 65:1982-1987 (1987).
Ruin, Sydsvenska (Dagbladet), Monday, Jun. 12, 1989, Diabetics May Not Need Their Insulin Shots.
Almer et al., Diabetes Res. and Clin. Pract. 5:S163 (1988).
Bjork, Acta Univ. Uppsala, Comprehensive Summaries of Uppsala Dissertations from the Faculty of Pharmacy 103 (1993).
Timsina et al., Drug Delivery to the Respiratory Tract Using Dry Powder Inhalers, Int. J. Pharmaceutics 101:1-13 (1994).
Komada et al., Intratracheal Delivery of Peptide and Protein Agents: Absorption from Solution and Dry Powder by Rat Lung, J. Pharm. Sci. 83:863-867 (1994).
Lee et al., Intranasal Bioavailability of Insulin Powder Formulations: Effect of Permeation Enhancer-to-Protein Ratio, J. Pharm Sci. 80:725-729 (1991).
Schipper et al., Nasal Insulin Delivery with Dimethyl-.beta.-Cyclodextrin as an Absorption Enhancer in Rabbits: Powder More Effective than Liquid Formulations, Pharm. Res. 10:682-686 (1993).
Lee et al., Mucosal Penetration Enhancers for Facilitation of Peptide and Protein Drug Absorption, Critical Rev. Therapeut. Drug Carrier Systems 8:91-192 (1991).
Wearly, Recent Progress in Protein and Peptide Delivery by Noninvasive Routes, Critical Rev. Therapeut. Drug Carrier Systems 8:331-394 (1991).
Laube et al., Preliminary Study of the Efficacy of Insulin Aerosol Delivered by Oral Inhalation in Diabetic Patients, JAMA 269:2106-2109 (1993).
Dahlback et al., Regional Administration of Drugs to the Rabbit Respiratory Tract, Effects on Absorption, J. Aerosol Medicine 1:222-223 (1988).
Yoshida et al., Absorption of Insulin Delivered to Rabbit Trachea Using Aerosol Dosage Form, J. Pharma. Sci. 68:670-671 (1979).
Damasy et al., Diabetes Res. and Clin. Pract. 5:S163 (1988).
Chandler et al., Nasal Absorption in Rats. II. Effect of Enhancers on Insulin Absorption and Nasal Histology, Int. J. Pharmaceutics 76:61-70 (1991).
Hirai et al., Effect of Surfactants on the Nasal Absorption of Insulin in Rats, Int. J. Pharmaceutics 9:165-172 (1981).
Gordon et al., Nasal Absorption of Insulin: Enhancement by Hydrophobic Bile Salts, Proc. Natl. Acad. Sci. USA 82:7419-7423 (1985).
Moses et al., Insulin Administered Intranasally as an Insulin-Bile Salt Aerosol, Diabetes 32:1040-47 (1983).
Wigley et al., Insulin Across Respiratory Mucosae by Aerosol Delivery, Diabetes 20:552-556 (1971).
Cutie et al., The Role of Dispersing Agents in Inhalation and Intranasal Aerosol Suspensions, Aerosol. Age 30:52-54 (1985).
Allenby et al., The Absorption of Insulin Across the Respiratory Tract of the Guinea-Pig (U), The Aerosol Society, Fourth Annual Conference 1990, pp. 129-134.
Aungst and Rogers, Comparison of the Effects of Various Transmucosal Absorption Promoters on Buccal Insulin Delivery, Int. J. Pharm. (Netherlands), 1989, 53/3, 227-235.
Bjork, Starch Microspheres as a Nasal Delivery System for Drugs, Comprehensive Summaries of Uppsala Dissertations from the Faculty of Pharmacy 103, 1993.
Bjork and Edman, Degradable Starch Microspheres as a Nasal Delivery System for Insulin, Int. J. Pharm. 47:233-238, 1988.
Brange et al., Monomeric Insulins and Their Experimental and Clinical Implications, Diabetes Care 13:923-954, 1990.
Edman and Bjork, Routes of Delivery: Case Studies, Advanced Drug Delivery Reviews 8:165-177, 1992.
Igawa et al., Effect of Absorption Promoters in Intranasal Administration of Human Fibroblast Interferon as a Powder Dosage Form in Rabbits, Chem. Pharm. Bull. 37:418-421, 1989.
Komada et al., Intratracheal Delivery of Peptide and Protein Agents: Absorption from Solution and Dry Powder by Rat Lung, J. Pharm. Sci. 83:863-867, 1994.
Lasker, The Diabetes Control and Complications Trial, N. Engl. J. Med. 329:1035-1036, 1993.
Laube et al., Preliminary Study of the Efficacy o

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