Pharmacokinetics of Atropine Oral Gel

Summary

To evaluate the single-dose pharmacokinetics of atropine gel formulation after topical administration in the oral cavity of healthy adults.

Timeline

Start

2022-10-01

Primary completion

2023-06-30

Completion

2024-12-10

Publications

• Background Reid SM, Westbury C, Chong D, Johnstone BR, Guzys A, Reddihough DS. Long-term impact of saliva control surgery in children with disability. J Plast Reconstr Aesthet Surg. 2019 Jul;72(7):1193-1197. doi: 10.1016/j.bjps.2019.02.020. Epub 2019 Mar 2.
• Background Speyer R, Cordier R, Kim JH, Cocks N, Michou E, Wilkes-Gillan S. Prevalence of drooling, swallowing, and feeding problems in cerebral palsy across the lifespan: a systematic review and meta-analyses. Dev Med Child Neurol. 2019 Nov;61(11):1249-1258. doi: 10.1111/dmcn.14316. Epub 2019 Jul 22.
• Background Parkes J, Hill N, Platt MJ, Donnelly C. Oromotor dysfunction and communication impairments in children with cerebral palsy: a register study. Dev Med Child Neurol. 2010 Dec;52(12):1113-9. doi: 10.1111/j.1469-8749.2010.03765.x. Epub 2010 Aug 31.
• Background Reid SM, McCutcheon J, Reddihough DS, Johnson H. Prevalence and predictors of drooling in 7- to 14-year-old children with cerebral palsy: a population study. Dev Med Child Neurol. 2012 Nov;54(11):1032-6. doi: 10.1111/j.1469-8749.2012.04382.x. Epub 2012 Aug 9.
• Background Reid SM, Westbury C, Guzys AT, Reddihough DS. Anticholinergic medications for reducing drooling in children with developmental disability. Dev Med Child Neurol. 2020 Mar;62(3):346-353. doi: 10.1111/dmcn.14350. Epub 2019 Sep 8.
• Background Norderyd J, Graf J, Marcusson A, Nilsson K, Sjostrand E, Steinwall G, Arleskog E, Bagesund M. Sublingual administration of atropine eyedrops in children with excessive drooling - a pilot study. Int J Paediatr Dent. 2017 Jan;27(1):22-29. doi: 10.1111/ipd.12219. Epub 2015 Dec 27.
• Background Protus BM, Grauer PA, Kimbrel JM. Evaluation of atropine 1% ophthalmic solution administered sublingually for the management of terminal respiratory secretions. Am J Hosp Palliat Care. 2013 Jun;30(4):388-92. doi: 10.1177/1049909112453641. Epub 2012 Jul 24.
• Background De Simone GG, Eisenchlas JH, Junin M, Pereyra F, Brizuela R. Atropine drops for drooling: a randomized controlled trial. Palliat Med. 2006 Oct;20(7):665-71. doi: 10.1177/0269216306071702.
• Background Lawrence R, Bateman N. Surgical Management of the Drooling Child. Curr Otorhinolaryngol Rep. 2018;6(1):99-106. doi: 10.1007/s40136-018-0188-2. Epub 2018 Mar 20.
• Background Leung JG, Schak KM. Potential problems surrounding the use of sublingually administered ophthalmic atropine for sialorrhea. Schizophr Res. 2017 Jul;185:202-203. doi: 10.1016/j.schres.2016.12.028. Epub 2016 Dec 30. No abstract available.
• Background Singla AK, Chawla M, Singh A. Potential applications of carbomer in oral mucoadhesive controlled drug delivery system: a review. Drug Dev Ind Pharm. 2000 Sep;26(9):913-24. doi: 10.1081/ddc-100101318.
• Background Keegan G, Smart J, Ingram M, Barnes L, Rees G, Burnett G. An in vitro assessment of bioadhesive zinc/carbomer complexes for antimicrobial therapy within the oral cavity. Int J Pharm. 2007 Aug 1;340(1-2):92-6. doi: 10.1016/j.ijpharm.2007.03.023. Epub 2007 Mar 24.
• Background Kelly HM, Deasy PB, Busquet M, Torrance AA. Bioadhesive, rheological, lubricant and other aspects of an oral gel formulation intended for the treatment of xerostomia. Int J Pharm. 2004 Jul 8;278(2):391-406. doi: 10.1016/j.ijpharm.2004.03.022.
• Background Allison RR, Ambrad AA, Arshoun Y, Carmel RJ, Ciuba DF, Feldman E, Finkelstein SE, Gandhavadi R, Heron DE, Lane SC, Longo JM, Meakin C, Papadopoulos D, Pruitt DE, Steinbrenner LM, Taylor MA, Wisbeck WM, Yuh GE, Nowotnik DP, Sonis ST. Multi-institutional, randomized, double-blind, placebo-controlled trial to assess the efficacy of a mucoadhesive hydrogel (MuGard) in mitigating oral mucositis symptoms in patients being treated with chemoradiation therapy for cancers of the head and neck. Cancer. 2014 May 1;120(9):1433-40. doi: 10.1002/cncr.28553.
• Background Alcon (2018). Viscotears® Liquid Gel [carbomer (polyacrylic acid)] - Patient Information Leaflet
• Background Regulatory Information for Carbopol®* 971P NF Polymer & Carbopol® 71G NF Polymer. file:///C:/Users/u0840209/Downloads/TDS-328_Carbopol_971P_71G_Regulatory_PH_Version%20(1).pdf
• Background Zeller RS, Lee HM, Cavanaugh PF, Davidson J. Randomized Phase III evaluation of the efficacy and safety of a novel glycopyrrolate oral solution for the management of chronic severe drooling in children with cerebral palsy or other neurologic conditions. Ther Clin Risk Manag. 2012;8:15-23. doi: 10.2147/TCRM.S26893. Epub 2012 Jan 25.
• Background Reid SM, Johnson HM, Reddihough DS. The Drooling Impact Scale: a measure of the impact of drooling in children with developmental disabilities. Dev Med Child Neurol. 2010 Feb;52(2):e23-8. doi: 10.1111/j.1469-8749.2009.03519.x. Epub 2009 Oct 15.
• Background Jones JM, Watkins CA, Hand JS, Warren JJ, Cowen HJ. Comparison of three salivary flow rate assessment methods in an elderly population. Community Dent Oral Epidemiol. 2000 Jun;28(3):177-84. doi: 10.1034/j.1600-0528.2000.280303.x.
• Background Navazesh M, Christensen CM. A comparison of whole mouth resting and stimulated salivary measurement procedures. J Dent Res. 1982 Oct;61(10):1158-62. doi: 10.1177/00220345820610100901. No abstract available.
• Background Dias BLS, Fernandes AR, Maia HS Filho. Treatment of drooling with sublingual atropine sulfate in children and adolescents with cerebral palsy. Arq Neuropsiquiatr. 2017 May;75(5):282-287. doi: 10.1590/0004-282X20170033.
• Background Azapagasi E, Kendirli T, Perk O, Kutluk G, Oz Tuncer G, Teber S, Cobanoglu N. Sublingual Atropine Sulfate Use for Sialorrhea in Pediatric Patients. J Pediatr Intensive Care. 2020 Sep;9(3):196-200. doi: 10.1055/s-0040-1708552. Epub 2020 Apr 7.
• Background Rapoport A. Sublingual atropine drops for the treatment of pediatric sialorrhea. J Pain Symptom Manage. 2010 Nov;40(5):783-8. doi: 10.1016/j.jpainsymman.2010.02.007. Epub 2010 Jun 11.

Drugs

Indications