Optimization of intranasal corticosteroid formulations for the treatment of allergic rhinitis

Allergy and Asthma Proceedings

Volumn 28, Issue 3 SUPPL. 1, 2007, Pages

  Wingertzahn, Mark A ^a   Derebery, M Jennifer ^b   Nelson, Harold S ^c  

^a ALTANA Pharma US   (United States)

^b HOUSE EAR INSTITUTE   (United States)

^c NATIONAL JEWISH MEDICAL AND RESEARCH CENTER   (United States)

Author keywords

Allergic rhinitis; Benzalkonium chloride; Ciclesonide; Efficacy; Intranasal corticosteroids; Patient preference; Preservatives; Rhinitis; Tolerability; Tonicity

Indexed keywords

ANTIALLERGIC AGENT; HYDROXYCORTICOSTEROID;

DRUG DOSAGE FORM; HAY FEVER; HUMAN; INTRANASAL DRUG ADMINISTRATION; PATIENT SATISFACTION; PERENNIAL RHINITIS; REVIEW; TREATMENT OUTCOME;

ADMINISTRATION, INTRANASAL; ANTI-ALLERGIC AGENTS; DOSAGE FORMS; HUMANS; HYDROXYCORTICOSTEROIDS; PATIENT SATISFACTION; RHINITIS, ALLERGIC, PERENNIAL; RHINITIS, ALLERGIC, SEASONAL; TREATMENT OUTCOME;

EID: 34447248558     PISSN: 10885412     EISSN: None     Source Type: Journal    
DOI: 10.2500/aap.2007.28.2993     Document Type: Review

References (58)

1. Skoner DP. Allergic rhinitis: Definition, epidemiology, pathophysiology, detection, and diagnosis. J Allergy Clin Immunol 108:S2-S8, 2001.
2. Goetzel RZ, Long SR, Ozminkowski RJ, et al. Health, absence, disability, and presenteeism cost estimates of certain physical and mental health conditions affecting U.S. employers. J Occup Environ Med 46:398-412, 2004.
3. Meltzer EO. Quality of life in adults and children with allergic rhinitis. J Allergy Clin Immunol 108:S45-S53, 2001.
4. Lamb CE, Ratner PH, Johnson CE, et al. Economic impact of workplace productivity losses due to allergic rhinitis compared with select medical conditions in the United States from an employer perspective. Curr Med Res Opin 22:1203-1210, 2006.
5. Kay GG. The effects of antihistamines on cognition and performance. J Allergy Clin Immunol 105:S622-S627, 2000.
6. Bousquet J, Van Cauwenberge P, and Khaltaev N. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 108:S147-S334, 2001.
7. Meltzer EO. Intranasal steroids: Managing allergic rhinitis and tailoring treatment to patient preference. Allergy Asthma Proc 26:445-451, 2005.
8. Trangsrud AJ, Whitaker AL, and Small RE. Intranasal corticosteroids for allergic rhinitis. Pharmacotherapy 22:1458-1467, 2002.
9. Khanna P, and Shah A. Assessment of sensory perceptions and patient preference for intranasal corticosteroid sprays in allergic rhinitis. Am J Rhinol 19:316-321, 2005.
10. Mahadevia PJ, Shah S, Leibman C, et al. Patient preferences for sensory attributes of intranasal corticosteroids and willingness to adhere to prescribed therapy for allergic rhinitis: A conjoint analysis. Ann Allergy Asthma Immunol 93:345-350, 2004.
11. Katano K, Tsujitani S, Saito H, et al. Hypotonic intrapleural cisplatin chemotherapy as treatment for pleural carcinomatosis in an experimental model. Anticancer Res 17:4547-4552, 1997.
12. Stephen RL, Novak JM, Jensen EM, et al. Effect of osmotic pressure on uptake of chemotherapeutic agents by carcinoma cells. Cancer Res 50:4704-4708, 1990.
13. Lee YH, and Lee VH. Formulation influence on ocular and systemic absorption of topically applied atenolol in the pigmented rabbit. J Ocul Pharmacol 9:47-58, 1993.
14. Chan HK, Phipps PR, Gonda I, et al. Regional deposition of nebulized hypodense nonisotonic solutions in the human respiratory tract. Eur Respir J 7:1483-1489, 1994.
15. Min YG, Lee KS, Yun JB, et al. Hypertonic saline decreases ciliary movement in human nasal epithelium in vitro. Otolaryngol Head Neck Surg 124:313-316, 2001.
16. Wingertzahn MA, Sato H, Nave R, et al. Comparison of nasal tissue concentrations in rabbits following administration of hypotonic and isotonic ciclesonide suspensions. J Allergy Clin Immunol 115(suppl):S126, 2005 (Abs 503).
17. Wingertzahn MA, Takanashi K, Nagano A, et al. Persistence and effusion clearance to esophagus of ciclesonide in hypotonic and isotonic suspensions. J Allergy Clin Immunol 117(suppl): S260, 2006 (Abs 1008).
18. Bennett ML, Fountain JM, McCarty MA, et al. Contact allergy to corticosteroids in patients using inhaled or intranasal corticosteroids for allergic rhinitis or asthma. Am J Contact Dermat 12:193-196, 2001.
19. Basketter DA, Marriott M, Gilmour NJ, et al. Strong irritants masquerading as skin allergens: The case of benzalkonium chloride. Contact Dermatitis 50:213-217, 2004.
20. Berg OH, Lie K, and Steinsvag SK. The effects of topical nasal steroids on rat respiratory mucosa in vivo, with special reference to benzalkonium chloride. Allergy 52:627-632, 1997.
21. Cureoglu S, Akkus M, Osma U, et al. The effect of benzalkonium chloride on rabbit nasal mucosa in vivo: An electron microscopy study. Eur Arch Otorhinolaryngol 259:362-364, 2002.
22. Hofmann T, Gugatschga M, Koidl B, et al. Influence of preservatives and topical steroids on ciliary beat frequency in vitro. Arch Otolaryngol Head Neck Surg 130:440-445, 2004.
23. Riechelmann H, Deutschte T, Stuhlmiller A, et al. Nasal toxicity of benzalkonium chloride. Am J Rhinol 18:291-299, 2004.
24. Braat JP, Ainge G, Bowles JA, et al. The lack of effect of benzalkonium chloride on the cilia of the nasal mucosa in patients with perennial allergic rhinitis: A combined functional, light, scanning and transmission electron microscopy study. Clin Exp Allergy 25:957-965, 1995.
25. McMahon C, Darby Y, Ryan R, et al. Immediate and short-term effects of benzalkonium chloride on the human nasal mucosa in vivo. Clin Otolaryngol Allied Sci 22:318-322, 1997.
26. Stanley PJ, Griffin WM, Wilson R, et al. Effect of betamethasone and betamethasone with neomycin nasal drops on human nasal mucociliary clearance and ciliary beat frequency. Thorax 40: 607-612, 1985.
27. Naclerio RM, Baroody FM, Bidani N, et al. A comparison of nasal clearance after treatment of perennial allergic rhinitis with budesonide and mometasone. Otolaryngol Head Neck Surg 128:220-227, 2003.
28. Cho JH, Kwun YS, Jang HS, et al. Long-term use of preservatives on rat nasal respiratory mucosa: Effects of benzalkonium chloride and potassium sorbate. Laryngoscope 110:312-317, 2000.
29. Lebe E, Baka M, Yavasoglu A, et al. Effects of preservatives in nasal formulations on the mucosal integrity: An electron microscopic study. Pharmacology 72:113-120, 2004.
30. Limaye S, Steele RH, Quin J, et al. An allergic reaction to erythropoietin secondary to polysorbate hypersensitivity. J Allergy Clin Immunol 110:530, 2002.
31. ten Tije AJ, Verweij J, Loos WJ, et al. Pharmacological effects of formulation vehicles: Implications for cancer chemotherapy. Clin Pharmacokinet 42:665-685, 2003.
32. Dimova S, Mugabowindekwe R, Willems T, et al. Safety-assessment of 3-methoxyquercetin as an antirhinoviral compound for nasal application: Effect on ciliary beat frequency. Int J Pharm 263:95-103, 2003.
33. Isaksson M, and Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis 47:312-313, 2002.
34. Lucente P, Iorizzo M, and Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis 43:172, 2000.
35. Maibach H, and Conant M. Contact urticaria to a corticosteroid cream: Polysorbate 60. Contact Dermatitis 3:350-351, 1977.
36. Shelley WB, Talanin N, and Shelley ED. Polysorbate 80 hypersensitivity. Lancet 345:1312-1313, 1995.
37. Suber RL, Deskin R, Nikiforov I, et al. Subchronic nose-only inhalation study of propylene glycol in Sprague-Dawley rats. Food Chem Toxicol 27:573-583, 1989.
38. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: Update (subject review). Pediatrics 99:268-278, 1997.
39. Greenbaum J, Leznoff A, Schulz J, et al. Comparative tolerability of two formulations of Rhinalar (flunisolide) nasal spray in patients with seasonal allergic rhinitis. Ann Allergy 61:305-310, 1988.
40. Stafanger G. In vitro effect of beclomethasone dipropionate and flunisolide on the mobility of human nasal cilia. Allergy 42:507-511, 1987.
41. Waddell AN, Patel SK, Toma AG, et al. Intranasal steroid sprays in the treatment of rhinitis: Is one better than another? J Laryngol Otol 117:843-845, 2003.
42. Eccleston GM, Bakhshaee M, Hudson NE, et al. Rheological behavior of nasal sprays in shear and extension. Drug Dev Ind Pharm 26:975-983, 2000.
43. Oppliger R, and Hauser C. Anaphylaxis after injection of corticosteroid preparations - Carboxymethylcellulose as a hidden allergen. J Dtsch Dermatol Ges 2:928-930, 2004.
44. Patterson DL, Yunginger JW, Dunn WF, et al. Anaphylaxis induced by the carboxymethylcellulose component of injectable triamcinolone acetonide suspension (Kenalog). Ann Allergy Asthma Immunol 74:163-166, 1995.
45. HealthSTAR Communications, Inc., in partnership with Schulman, Ronca and Bucuvalas, Inc. Allergies in America: A Landmark Survey of Nasal Allergy Sufferers. Executive Summary. Florham Park, NJ: Altana Pharma US, Inc., 1-41. 2006.
46. Blaiss MS, Benninger MS, Fromer L, et al. Expanding choices in intranasal steroid therapy: Summary of a roundtable meeting. Allergy Asthma Proc 27:254-264, 2006.
47. Meltzer EO, Bardelas J, Goldsobel A, et al. A preference evaluation study comparing the sensory attributes of mometasone furoate and fluticasone propionate nasal sprays by patients with allergic rhinitis. Treat Respir Med 4:289-296, 2005.
48. Shah SR, Miller C, Pethick N, et al. Two multicenter, randomized, single-blind, single-dose, crossover studies of specific sensory attributes of budesonide aqueous nasal spray and fluticasone propionate nasal spray. Clin Ther 25:2198-2214, 2003.
49. Stokes M, Amorosi SL, Thompson D, et al. Evaluation of patients' preferences for triamcinolone acetonide aqueous, fluticasone propionate, and mometasone furoate nasal sprays in patients with allergic rhinitis. Otolaryngol Head Neck Surg 131: 225-231, 2004.
50. Bachert C, and El-Akkad T. Patient preferences and sensory comparisons of three intranasal corticosteroids for the treatment of allergic rhinitis. Ann Allergy Asthma Immunol 89:292-297, 2002.
51. Herman H. Once-daily administration of intranasal corticosteroids for allergic rhinitis: A comparative review of efficacy, safety, patient preference, and cost. Am J Rhinol 21:70-79, 2007.
52. Patient preference and sensory perception of three intranasal corticosteroids for allergic rhinitis. Clin Drug Investig 23:39-44, 2003
53. Schering Corp. Nasonex (mometasone furoate monohydrate) nasal spray, 50 mcg, package insert. Kenilworth, NJ; Sep. 2005.
54. GlaxoSmithKline. Flonase (fluticasone propionate) nasal spray, 50 mcg, package insert. Research Triangle Park, NC; Mar. 2004.
55. Aventis Pharmaceuticals, Inc. Nasacort HFA (triamcinolone acetonide) nasal aerosol, package insert. Bridgewater, NJ; Apr. 2004.
56. IVAX Laboratories, Inc. Nasarel (flunisolide) nasal spray, 25 mcg, package insert. Miami, FL; Jul. 2002.
57. AstraZeneca. Rhinocort Aqua (budesonide) nasal spray, 32 mcg, package insert. Wilmington, Del; Aug. 2004.
58. Altana Pharma US, Inc. Omnaris (ciclesonide) nasal spray, 50 mcg, labeling information. Florham Park, NJ; Oct. 2006.