Generated Narrative: PublicationRecord 267500 version: 18; Last updated: 2026-06-26 21:17:44+0000 Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/PublicationRecord/267500 identifier: FEvIR Object Identifier/267500, https://pubmed.ncbi.nlm.nih.gov/26502880 title: 26502880 A novel nasal powder formulation of glucagon: toxicology studies in animal models. status: Active author: Computable Publishing®: MEDLINE-to-FEvIR Converter: publisher: Computable Publishing LLC contact: support@computablepublishing.com description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide. UseContexts - Code Value[x] * Citation Classification Type: fevir-platform-use (FEvIR Platform Use) Medline Base copyright: Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse). approvalDate: 2016-07-11 lastReviewDate: 2024-03-24 classification type: Citation Source classifier: MEDLINE classification type: MEDLINE Citation Owner classifier: National Library of Medicine, Index Section currentState: Medline Citation Status of Medline, PubMed PublicationStatus of epublish statusDate activity: PubMed Pubstatus of Received period: ?? --> 2015-05-09 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2015-09-21 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2015-10-28 06:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2015-10-28 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2016-07-12 06:00:00+0000 statusDate activity: PubMed Pubstatus of PMC release period: ?? --> 2015-10-26 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/26502880, https://www.ncbi.nlm.nih.gov/pmc//PMC4621930, https://doi.org/10.1186/s40360-015-0026-9, pii/10.1186/s40360-015-0026-9 Titles - Type Language Text * Primary title English A novel nasal powder formulation of glucagon: toxicology studies in animal models. Abstracts - Type Text * Primary human use BACKGROUND: Glucagon nasal powder (GNP), a novel intranasal formulation of glucagon being developed to treat insulin-induced severe hypoglycemia, contains synthetic glucagon (10% w/w), beta-cyclodextrin, and dodecylphosphocholine. The safety of this formulation was evaluated in four studies in animal models. METHODS: The first study evaluated 28-day sub-chronic toxicology in rats treated intranasally with 1 and 2 mg of GNP/day (0.1 and 0.2 mg glucagon/rat/day). The second study evaluated 28-day sub-chronic toxicology in dogs administered 20 and 40 mg of formulation/dog/day (2 and 4 mg glucagon/dog/day) intranasally. A pulmonary insufflation study assessed acute toxicology following intra-tracheal administration of 0.5 mg of GNP (0.05 mg glucagon) to rats. Local tolerance to 30 mg of GNP (equivalent to 3 mg glucagon, the final dose for humans) was tested through direct administration into the eyes of rabbits. RESULTS: There were no test article-related adverse effects on body weight and/or food consumption, ophthalmology, electrocardiography, hematology, coagulation parameters, clinical chemistry, urinalysis, or organ weights, and no macroscopic findings at necropsy in any study. In rats, direct intra-tracheal insufflation at a dose of 0.5 mg of GNP/rat (0.05 mg glucagon/rat) did not result in adverse clinical, macroscopic, or microscopic effects. In dogs, the only adverse findings following sub-chronic use were transient (<30 s) salivation and sneezing immediately post-treatment and mild to moderate reversible histological changes to the nasal mucosa. Daily dosing over 28 days in rats resulted in mild to moderate, unilateral or bilateral erosion/ulceration of the olfactory epithelium, frequently with minimal to mild, acute to sub-acute inflammation of the lamina propria at the dorsal turbinates of the nasal cavity in 2/10 males and 3/10 females in the high-dose group (0.2 mg glucagon/day). These lesions resolved completely over 14 days. Histological examination of tissues from both sub-chronic studies in dogs and rats revealed no microscopic findings. In rabbits, clinical observations noted in the GNP-treated eye and/or surrounding areas included ≥1 of the following: clear discharge, red conjunctiva, partial closure, and swelling of the peri-orbital area, which correlated with erythema and edema noted during ocular observations and grading. <AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">The studies reported here revealed no safety concerns associated with GNP in animal models. Studies published earlier have highlighted the local safety profile of intranasally administered cyclodextrins (a component of GNP). The choline group, the phosphate group, and the saturated 12-carbon aliphatic chain that are present in the dodecylphosphocholine excipient used in GNP are all present in the phospholipids and lecithins seen ubiquitously in mammalian cell membranes and are unlikely to pose safety concerns; this notion is supported by several studies conducted by the authors that revealed no safety concerns. Taken together, these results suggest that intranasal delivery of GNP holds promise as a future rescue medication for use by caregivers to treat insulin-induced hypoglycemic episodes in patients with type 1 or type 2 diabetes. CONCLUSION: This novel drug product is well tolerated in animal models. relatesTo type: Cites classifier: Journal Article citation: Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II Diabetes. Diabetologia. 2002;45:937–48. doi: 10.1007/s00125-002-0822-9. target: https://pubmed.ncbi.nlm.nih.gov/12136392/ relatesTo type: Cites citation: Deary IJ. Symptoms of hypoglycaemia and effects on mental performance and emotions. In: Frier BM, Fisher M, editors. Hypoglycaemia in clinical diabetes. 2. Chicester, West Sussex, England: John Wiley & Sons Limited; 2007. pp. 25–48. relatesTo type: Cites classifier: Journal Article citation: Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care. 2003;26:1902–12. doi: 10.2337/diacare.26.6.1902. target: https://pubmed.ncbi.nlm.nih.gov/12766131/ relatesTo type: Cites classifier: Journal Article citation: Leckie AM, Graham MK, Grant JB, Ritchie PJ, Frier BM. Frequency, severity, and morbidity of hypoglycemia occurring in the workplace in people with insulin-treated diabetes. Diabetes Care. 2005;28:1333–8. doi: 10.2337/diacare.28.6.1333. target: https://pubmed.ncbi.nlm.nih.gov/15920048/ relatesTo type: Cites classifier: Journal Article citation: Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005;28:2948–61. doi: 10.2337/diacare.28.12.2948. target: https://pubmed.ncbi.nlm.nih.gov/16306561/ relatesTo type: Cites classifier: Journal Article citation: UK Hypoglycemia Study Group Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia. 2007;50:1140–7. doi: 10.1007/s00125-007-0599-y. target: https://pubmed.ncbi.nlm.nih.gov/17415551/ relatesTo type: Cites citation: Cryer PE. Hypoglycemia in diabetes: pathophysiology, prevalence, and prevention. Alexandria, VA: American Diabetes Association; 2009. The clinical problem of hypoglycemia in diabetes; pp. 1–15. relatesTo type: Cites classifier: Journal Article citation: American Diabetes Association Standards of medical care in diabetes—2015. Diabetes Care. 2015;38(suppl 1):S1–94. target: https://pubmed.ncbi.nlm.nih.gov/15618112/ relatesTo type: Cites citation: Jain MK. Introduction to biological membranes. New York: John Wiley & Sons; 1988. Components of biological membranes; pp. 10–50. relatesTo type: Cites citation: GLUCACON (glucagon for injection, rDNA origin) Product Monograph. Toronto, Ontario: Eli Lilly Canada Inc.; 2012 http://www.lilly.ca/en/pdf/product-monograph/04_rglucagon-pm_9july2012.pdf. Accessed 26 September 2015. relatesTo type: Cites citation: GLUCAGEN® and GLUCAGEN® Hypokit 1 mg (glucagon) Product Monograph. Mississauga, Ontario: Novo Nordisk Canada Inc.; 2014. http://www.paladin-labs.com/our_products/PM_GlucaGen_EN.pdf. Accessed 26 September 2015. relatesTo type: Cites classifier: Journal Article citation: Root MA, Ellis J, Staub A. Effect of glucagon on insulin hypoglycemia. Proc Soc Exp Biol Med. 1954;85:507–11. doi: 10.3181/00379727-85-20934. target: https://pubmed.ncbi.nlm.nih.gov/13167121/ relatesTo type: Cites classifier: Journal Article citation: Eistrup C, Hjortkjaer RK, Pickersgill N, Virgo DM, Woolley AP. Glucagon produced by recombinant DNA technology: repeated dose toxicity studies, intravenous administration to CD rats and beagle dogs for four weeks. Pharmacol Toxicol. 1993;73:103–8. doi: 10.1111/j.1600-0773.1993.tb01544.x. target: https://pubmed.ncbi.nlm.nih.gov/8248004/ relatesTo type: Cites classifier: Journal Article citation: Merkus FW, Verhoef JC, Marttin E, Romeijn SG, van der Kuy PH, Hermens WA, et al. Cyclodextrins in nasal drug delivery. Adv Drug Deliv Rev. 1999;36:41–57. doi: 10.1016/S0169-409X(98)00054-4. target: https://pubmed.ncbi.nlm.nih.gov/10837708/ relatesTo type: Cites classifier: Journal Article citation: Asai K, Morishita M, Katsuta H, Hosoda S, Shinomiya K, Noro M, et al. The effects of water-soluble cyclodextrins on the histological integrity of the rat nasal mucosa. Int J Pharm. 2002;246:25–35. doi: 10.1016/S0378-5173(02)00345-9. target: https://pubmed.ncbi.nlm.nih.gov/12270606/ publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/2050-6511, ISOAbbreviation/BMC Pharmacol Toxicol, ISSN Linking/2050-6511, Medline Title Abbreviation/BMC Pharmacol Toxicol, NLM Unique ID/101590449 title: BMC pharmacology & toxicology publisherLocation: England citedMedium: Internet volume: 16 articleDate: 2015-10-26 publicationDateText: 2015-Oct-26 pageString: 29 publicationForm citedMedium: Internet without issue articleDate: 2015-10-26 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/26502880/ webLocation classifier: DOI Based url: https://doi.org/10.1186/s40360-015-0026-9 classification type: Publishing Model classifier: Electronic classification type: Chemical classifier: Powders, beta-Cyclodextrins, Phosphorylcholine, dodecylphosphocholine, Glucagon, betadex classification type: MeSH heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Publication type classifier: Journal Article, Research Support, Non-U.S. Gov't classification type: Knowledge Artifact Type classifier: Journal Article artifactAssessment: Classifier added by Computable Publishing LLC classification type: Citation subset classifier: IM contributorship complete: true entry contributor: Reno FE forenameInitials: FE affiliation: , 130 Macaw Lane, Merritt Island, FL, 32952, USA. freno1@cfl.rr.com. entry contributor: Normand P forenameInitials: P affiliation: ITR Laboratories Canada Inc. (ITR), 19601 Clark Graham Blvd, Baie d'Urfe, Quebec, Canada. pnormand@itrlab.com. entry contributor: McInally K forenameInitials: K affiliation: ITR Laboratories Canada Inc. (ITR), 19601 Clark Graham Blvd, Baie d'Urfe, Quebec, Canada. kmcinally@itrlab.com. entry contributor: Silo S forenameInitials: S affiliation: CiToxLAB North America, 445 Armand-Frappier Blvd, Laval, Québec, Canada. silos@ca.citoxlab.com. entry contributor: Stotland P forenameInitials: P affiliation: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. patricia.stotland@locemia.com. entry contributor: Triest M forenameInitials: M affiliation: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. myriam.triest@locemia.com. entry contributor: Carballo D forenameInitials: D affiliation: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. dolores.carballo@locemia.com. entry contributor: Piché C forenameInitials: C affiliation: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. claude.piche@locemia.com. Generated Narrative: Practitioner #contributor0 name: Frederick E Reno Generated Narrative: Practitioner #contributor1 name: Patrick Normand Generated Narrative: Practitioner #contributor2 name: Kevin McInally Generated Narrative: Practitioner #contributor3 name: Sherwin Silo Generated Narrative: Practitioner #contributor4 name: Patricia Stotland Generated Narrative: Practitioner #contributor5 name: Myriam Triest Generated Narrative: Practitioner #contributor6 name: Dolores Carballo Generated Narrative: Practitioner #contributor7 name: Claude Piché Generated Narrative: ArtifactAssessment #meshHeading0 artifact: PublicationRecord 26502880 A novel nasal powder formulation of glucagon: toxicology studies in animal models. content type: components (if present) include qualifier codings classifier: Administration, Intranasal freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Animals freeToShare: true Components - 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26502880 A novel nasal powder formulation of glucagon: toxicology studies in animal models.
Computable Publishing®: MEDLINE-to-FEvIR Converter
This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).
National Library of Medicine, Index Section
A novel nasal powder formulation of glucagon: toxicology studies in animal models.
**BACKGROUND:** Glucagon nasal powder (GNP), a novel intranasal formulation of glucagon being developed to treat insulin-induced severe hypoglycemia, contains synthetic glucagon (10% w/w), beta-cyclodextrin, and dodecylphosphocholine. The safety of this formulation was evaluated in four studies in animal models. **METHODS:** The first study evaluated 28-day sub-chronic toxicology in rats treated intranasally with 1 and 2 mg of GNP/day (0.1 and 0.2 mg glucagon/rat/day). The second study evaluated 28-day sub-chronic toxicology in dogs administered 20 and 40 mg of formulation/dog/day (2 and 4 mg glucagon/dog/day) intranasally. A pulmonary insufflation study assessed acute toxicology following intra-tracheal administration of 0.5 mg of GNP (0.05 mg glucagon) to rats. Local tolerance to 30 mg of GNP (equivalent to 3 mg glucagon, the final dose for humans) was tested through direct administration into the eyes of rabbits. **RESULTS:** There were no test article-related adverse effects on body weight and/or food consumption, ophthalmology, electrocardiography, hematology, coagulation parameters, clinical chemistry, urinalysis, or organ weights, and no macroscopic findings at necropsy in any study. In rats, direct intra-tracheal insufflation at a dose of 0.5 mg of GNP/rat (0.05 mg glucagon/rat) did not result in adverse clinical, macroscopic, or microscopic effects. In dogs, the only adverse findings following sub-chronic use were transient (<30 s) salivation and sneezing immediately post-treatment and mild to moderate reversible histological changes to the nasal mucosa. Daily dosing over 28 days in rats resulted in mild to moderate, unilateral or bilateral erosion/ulceration of the olfactory epithelium, frequently with minimal to mild, acute to sub-acute inflammation of the lamina propria at the dorsal turbinates of the nasal cavity in 2/10 males and 3/10 females in the high-dose group (0.2 mg glucagon/day). These lesions resolved completely over 14 days. Histological examination of tissues from both sub-chronic studies in dogs and rats revealed no microscopic findings. In rabbits, clinical observations noted in the GNP-treated eye and/or surrounding areas included ≥1 of the following: clear discharge, red conjunctiva, partial closure, and swelling of the peri-orbital area, which correlated with erythema and edema noted during ocular observations and grading. <AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">The studies reported here revealed no safety concerns associated with GNP in animal models. Studies published earlier have highlighted the local safety profile of intranasally administered cyclodextrins (a component of GNP). The choline group, the phosphate group, and the saturated 12-carbon aliphatic chain that are present in the dodecylphosphocholine excipient used in GNP are all present in the phospholipids and lecithins seen ubiquitously in mammalian cell membranes and are unlikely to pose safety concerns; this notion is supported by several studies conducted by the authors that revealed no safety concerns. Taken together, these results suggest that intranasal delivery of GNP holds promise as a future rescue medication for use by caregivers to treat insulin-induced hypoglycemic episodes in patients with type 1 or type 2 diabetes. **CONCLUSION:** This novel drug product is well tolerated in animal models.
Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II Diabetes. Diabetologia. 2002;45:937–48. doi: 10.1007/s00125-002-0822-9.
Deary IJ. Symptoms of hypoglycaemia and effects on mental performance and emotions. In: Frier BM, Fisher M, editors. Hypoglycaemia in clinical diabetes. 2. Chicester, West Sussex, England: John Wiley & Sons Limited; 2007. pp. 25–48.
Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care. 2003;26:1902–12. doi: 10.2337/diacare.26.6.1902.
Leckie AM, Graham MK, Grant JB, Ritchie PJ, Frier BM. Frequency, severity, and morbidity of hypoglycemia occurring in the workplace in people with insulin-treated diabetes. Diabetes Care. 2005;28:1333–8. doi: 10.2337/diacare.28.6.1333.
Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005;28:2948–61. doi: 10.2337/diacare.28.12.2948.
UK Hypoglycemia Study Group Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia. 2007;50:1140–7. doi: 10.1007/s00125-007-0599-y.
Cryer PE. Hypoglycemia in diabetes: pathophysiology, prevalence, and prevention. Alexandria, VA: American Diabetes Association; 2009. The clinical problem of hypoglycemia in diabetes; pp. 1–15.
American Diabetes Association Standards of medical care in diabetes—2015. Diabetes Care. 2015;38(suppl 1):S1–94.
Jain MK. Introduction to biological membranes. New York: John Wiley & Sons; 1988. Components of biological membranes; pp. 10–50.
GLUCACON (glucagon for injection, rDNA origin) Product Monograph. Toronto, Ontario: Eli Lilly Canada Inc.; 2012 http://www.lilly.ca/en/pdf/product-monograph/04_rglucagon-pm_9july2012.pdf. Accessed 26 September 2015.
GLUCAGEN® and GLUCAGEN® Hypokit 1 mg (glucagon) Product Monograph. Mississauga, Ontario: Novo Nordisk Canada Inc.; 2014. http://www.paladin-labs.com/our_products/PM_GlucaGen_EN.pdf. Accessed 26 September 2015.
Root MA, Ellis J, Staub A. Effect of glucagon on insulin hypoglycemia. Proc Soc Exp Biol Med. 1954;85:507–11. doi: 10.3181/00379727-85-20934.
Eistrup C, Hjortkjaer RK, Pickersgill N, Virgo DM, Woolley AP. Glucagon produced by recombinant DNA technology: repeated dose toxicity studies, intravenous administration to CD rats and beagle dogs for four weeks. Pharmacol Toxicol. 1993;73:103–8. doi: 10.1111/j.1600-0773.1993.tb01544.x.
Merkus FW, Verhoef JC, Marttin E, Romeijn SG, van der Kuy PH, Hermens WA, et al. Cyclodextrins in nasal drug delivery. Adv Drug Deliv Rev. 1999;36:41–57. doi: 10.1016/S0169-409X(98)00054-4.
Asai K, Morishita M, Katsuta H, Hosoda S, Shinomiya K, Noro M, et al. The effects of water-soluble cyclodextrins on the histological integrity of the rat nasal mucosa. Int J Pharm. 2002;246:25–35. doi: 10.1016/S0378-5173(02)00345-9.
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, 130 Macaw Lane, Merritt Island, FL, 32952, USA. freno1@cfl.rr.com.
ITR Laboratories Canada Inc. (ITR), 19601 Clark Graham Blvd, Baie d'Urfe, Quebec, Canada. pnormand@itrlab.com.
ITR Laboratories Canada Inc. (ITR), 19601 Clark Graham Blvd, Baie d'Urfe, Quebec, Canada. kmcinally@itrlab.com.
CiToxLAB North America, 445 Armand-Frappier Blvd, Laval, Québec, Canada. silos@ca.citoxlab.com.
Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. patricia.stotland@locemia.com.
Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. myriam.triest@locemia.com.
Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. dolores.carballo@locemia.com.
Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. claude.piche@locemia.com.