Manufacture, characterization, and pharmacodynamic evaluation of engineered ipratropium bromide particles

Pharmaceutical Development and Technology

Volumn 11, Issue 3, 2006, Pages 321-336

  Taylor, Michael K ^a   Hickey, Anthony J ^b   VanOort, Michiel ^a  

^a GLAXOSMITHKLINE   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

Author keywords

Aerosols; Bronchodilation; Dissolution; Ipratropium bromide; Polymer coating

Indexed keywords

BRONCHODILATING AGENT; CHOLINERGIC RECEPTOR BLOCKING AGENT; CRYSTALLIN; DIPALMITOYLPHOSPHATIDYLCHOLINE; EXCIPIENT; IPRATROPIUM BROMIDE; LONG ACTING DRUG; POLYGLACTIN; POLYLACTIC ACID; SHORT ACTING DRUG; TIOTROPIUM BROMIDE;

AERATOR; ANALYTICAL PARAMETERS; ANIMAL EXPERIMENT; ARTICLE; CHEMICAL STRUCTURE; CHRONIC OBSTRUCTIVE LUNG DISEASE; DIFFERENTIAL SCANNING CALORIMETRY; DISSOLUTION; DRUG COATING; DRUG EFFECT; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SCREENING; DRUG SOLUBILITY; DYNAMIC VAPOR SORPTION; EXPERIMENTAL DESIGN; FEMALE; GUINEA PIG; INHALATION; LASER DIFFRACTION; MALE; NONHUMAN; PARTICLE SIZE; PARTICULATE MATTER; PHARMACEUTICAL ENGINEERING; PHARMACODYNAMICS; POWDER; PRIORITY JOURNAL; PROCESS OPTIMIZATION; PRODUCT DEVELOPMENT; SCANNING ELECTRON MICROSCOPY; SPRAY DRYING; SUSTAINED RELEASE FORMULATION; THERMOGRAVIMETRY; VAPOR;

1,2-DIPALMITOYLPHOSPHATIDYLCHOLINE; ADMINISTRATION, INHALATION; AEROSOLS; ANIMALS; BRONCHODILATOR AGENTS; CHOLINERGIC ANTAGONISTS; DRUG EVALUATION, PRECLINICAL; EXCIPIENTS; FEMALE; GUINEA PIGS; IPRATROPIUM; LACTIC ACID; MALE; MICROSCOPY, ELECTRON, SCANNING; MOLECULAR STRUCTURE; PARTICLE SIZE; POLYGLYCOLIC ACID; POLYMERS; POWDERS; SOLUBILITY; TECHNOLOGY, PHARMACEUTICAL; TIME FACTORS; WATER; X-RAY DIFFRACTION;

EID: 33747087794     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.1080/10837450600769637     Document Type: Article

References (33)

1. Stuart, B.O. Deposition and clearance of inhaled particles. Environmental Health Perspectives, 1984, 55, 380-384
2. Schlesinger, R.B. Deposition and clearance of inhaled particles In: Concepts in Inhalation Toxicology; McClellan, R.O.; Henderson, R.F., Eds. Taylor and Francis: Washington DC, 1995.
3. Marlas, C.; Nadel, J.A.; Roberts, J.M. The muscarinic receptors of airway smooth muscle: their characterization in vitro. J. Appl. Physiol. 1982, 52, 1084-1091.
4. Cheng, J.B.; Townley, R.G. Comparison of muscarinic and beta-adrenergic receptors between bovine peripheral lung and tracheal smooth muscles. A striking difference. Life Sci. 1982, 30, 2079-2086.
5. Barnes, P.J.; Nadel J.A.; Roberts, J.M.; Basbaum, C.B. Muscarinic receptors in lung and trachea: autoradiographic localization using 3quinuclidinyl benzilate. Eur. J. Pharmacol. 1983, 86, 103-106.
6. Gupta, P.K.; Hickey A.J. Contemporary approaches in aerosolized drug delivery to the lung. J. Control. Rel. 1991, 17, 129-148.
7. Govender, T.; Dangor, C.M.; Chetty, D.J. Microencapsulated Eudragit RS30D-coated controlled-release pellets: the influence of dissolution variables and topographical evaluation. J. Microencapsul. 1997, 14 (1), 1-13.
8. Jist, H.; Langer, R. Responsive polymeric delivery systems. Adv. Drug Dev. 2001, 46, 125-148.
9. Hinds WC. Respiratory deposition. In Aerosol Technology; John Wiley & Sons: New York, 1999, pp. 211-212.
10. Kanapilly, G.M.; Raabe, O.G.; Goh, C.H.T.; Chimenti, R.A. Measurement of in vitro dissolution of aerosol particles for comparison to in vivo dissolution in the lower respiratory tract after inhalation. Health Phys. 1972, 24, 459-507.
11. Sood, A.; Panchagnula, R. Role of dissolution studies in controlled release drug delivery systems. S.T.P. Pharma Sci. 1999, 9 (2), 157-168.
12. Physician's Desk Reference; Fifty-eighth Ed. Medical Economics Co.: Montvale, NJ, 2004.
13. Ratner, B.; Jackson, H.C.; Gruehl, H.L. Respiratory anaphylaxis. Sensitization, shock, bronchial asthma and death induced in the guinea-pig by the nasal inhalation of dry horse dander. Am. J. Dis. Child. 1927, 34, 23-47.
14. Daly, I.B.; Hebb, C. Pulmonary and Bronchial Vascular Systems; Williams and Wilkins: Baltimore, MD, 1966.
15. Nials, A.T. The inhibitory potency and duration of action of anti-muscarinic compounds (GR55998Am GR65283A, GR70344A and GR79867A) in the guinea pig superfused, electrically-stimulated trachea. GlaxoWellcome Internal Report, 1990.
16. Wieslander, E.; Andersson, P.; Linden, M.; Axelsson, B.; Kallstrom, L.; Brattsand, R.; Paulsson, I. Importance of particulate antigen for the induction of dual bronchial reaction in guinea-pigs. Agents Actions 1985, 16 (1-2), 37-38.
17. Morley, J.; Chapman, I.D.; Hoshiko, K.; Mazzoni, L. Acute airway hyperreactivity in the guinea pig. Eur. Resp. Rev. 1995, 5 (29), 202-210.
18. Chong, B.T.Y.; Agrawal, D.K.; Romero, F.A.; Townley, R.G. Measurement of bronchoconstriction using whole-body plethysmograph: Comparison of freely moving versus restrained guinea pigs. J. Pharmacol. Toxicol. Methods 1998, 39, 163-168.
19. Karol, M.H. Animal models of occupational asthma. Eur. Resp. J. 1994, 7, 555-568.
20. Allott, C.P.; Evans, D.P.; Marshall, P.W. A model of irritant-induced bronchoconstriction in the spontaneously breathing guinea-pig. Br. J. Pharmacol. 1980, 71, 165-180.
21. Schwarze, J.; Hamelmann, E.; Bradley, K.L.; Takeda, K.; Gelfand, E.W. Respiratory syncytial virus infection results in airway hyperresponsiveness and enhanced airway sensitization to allergen. J. Clin. Invest. 1997, 100 (1), 226-233.
22. Coyle, A.J.; Lloyd, C.; Tian, J.; Nguyen, T.; Erikkson, C.; Wang, L.; Ottoson, P.; Persson P.; Delaney, T.; Lehar, S.; Lin, S.; Poisson, L.; Meisel, C.; Kamradt, T.; Bjerke, T.; Levinson, D.; Gutierrez-Ramos, J.C. Crucial role of the interleukin 1 receptor family member T1/ST2 in T Helper cell Type 2-mediated lung mucosal immune responses. J. Exp. Med. 1999, 190 (7), 895-902.
23. Schwarze J.; Cieslewicz, G.; Joetham, A.; Sun, L.K.; Sun, W.N.; Chang, T.W.; Hamelmann, E.; Gelfand, E.W. Antigen-specific immunoglobulin-A prevents increased airway responsiveness and lung eosinophilia after airway challenge in sensitized mice. Am. J. Resp. Crit. Care Med. 1998, 158, 519-525.
24. Myers, R.H.; Montgomery, D.C. Response Surface Methodology; John Wiley & Sons, Inc.: New York, 1995, pp. 55-61.
25. Edwards, D.A.; Hanes, J.; Caponetti, G.; Hrkach, J.; Ben-Jebria, A.; Eskew, M.L.; Mintzes, J.; Deaver, D.; Lotan, N.; Langer, R. Large porous particles for pulmonary drug delivery. Science 1997, 276, 1868-1871.
26. Higuchi, T. Rate of release of medicaments from ointment bases containing drugs in suspensions. J. Pharm. Sci. 1961, 50, 874.
27. Zanen, P. Aerosol Formulation and Clinical Efficacy of Bronchodilators. Ph.D. Thesis, University of Utrecht, Netherlands, 1998.
28. Jalil, R.; Nixon, J.R. Biodegradable poly(lactic acid) and poly (lactide-co-glycolide) microcapsules: problems associated with preparative techniques and release properties. J. Microencapsul. 1990, 7 (3), 297-325.
29. DeLuca, P.P.; Hickey, A.J.; Hazrati; Wedlund, P.; Rypacek, F.; Kanke, M. Porous biodegradable microspheres for parenteral administration. Topics Phar. Sci. 1987, 429-442
30. Krowczynski, L. Theoretical principles applied in various extended-release dosage formulations; In Extended-Release Dosage Forms; CRC Press: Boca Raton, FL. 1987, pp.31-49.
31. Bodmeier, R.; Chen, H. Evaluation of biodegradable poly(lactide) pellets prepared by direct compression. J. Pharm. Sci. 1989, 78 (10), 819-822.
32. Huang, X.; Brazel, C.S. On the importance and mechanisms of burst release in matrix-controlled drug delivery systems. J. Control. Release 2001, 73, 121-136.
33. Sacchetti, M.; Van Oort, M. Spray-drying and supercritical fluid particle generation techniques. In Inhalation Aerosols; Hickey, A.J.; ed.; Marcel Dekker, Inc.: New York, 1996.