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AAPS PharmSciTech. 2005 June; 6(2): E184–E189.
Published online 2005 September 30. doi:  10.1208/pt060227
PMCID: PMC2750530

Nasal insulin gel as an alternate to parenteral insulin: Formulation, preclinical, and clinical studies


The objective of the present study was to formulate insulin gel for intranasal administration and to evaluate with respect to in vitro release studies and hypoglycemic activity in animal model and healthy human volunteers. The insulin gel was formulated using the combination of carbopol and hydroxypropyl methylcellulose as gelling agent. The in vivo efficacy of insulin gel administered intranasally was assessed by measuring the blood glucose levels and serum insulin levels at specified time intervals in rats and humans. The use of bioadhesive nasal gel containing insulin not only promoted the prolonged contact between the drug and the absorptive sites in the nasal cavity but also facilitated direct absorption of medicament through the nasal mucosa. Absorption of the drug through the nasal mucosa was high in the first 0.5 to 1.5 hours of the study with a sharp decline in blood sugar and rise in insulin values corresponding to that decline in blood sugar. This study further demonstrates that administration of insulin intranasally in gel form is a pleasant and painless alternative to injectable insulin.

KeyWords: nasal, diabetes mellitus, insulin, gel, carbopol, preclinical, clinical

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
1. Pillai O, Panchagnula R. Insulin therapies—past, present and future. Drug Discov Today. 2001;6:1056–1061. doi: 10.1016/S1359-6446(01)01962-6. [PubMed] [Cross Ref]
2. Davis SN, Granner DK. Insulin, oral hypoglycemic agents, and the pharmacotherapy of the endocrine pancreas. In: Hardman JG, Limbird LE, editors. The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill; 1996. pp. 1487–1517.
3. Arunachalam S, Gunasekaran S. Diabetic research in India, and China today: from literature-based mapping to health-care policy. Curr Sci. 2002;9–10:1086–1097.
4. Ugwoke MI, Verbeke N, Kinget R. The biopharmaceutical aspects of nasal mucoadhesive drug delivery. J Pharm Pharmacol. 2001;53:3–22. doi: 10.1211/0022357011775145. [PubMed] [Cross Ref]
5. Jiang G, Qiu W, DeLuca PP. Preparation and in vitro/in vivo evaluation of insulin-loaded poly(acryloyl-hydroxyethyl starch)-PLGA composite microspheres. Pharm Res. 2003;20:452–459. doi: 10.1023/A:1022668507748. [PubMed] [Cross Ref]
6. Khan Ghilzai NM. New developments in insulin delivery. Drug Dev Ind Pharm. 2003;29:253–265. doi: 10.1081/DDC-120018199. [PubMed] [Cross Ref]
7. Shahiwala A, Misra A. Pulmonary absorption of liposomal levonorgestrel. AAPS PharmSciTech. 2004;5:E13–E13. doi: 10.1208/pt050113. [PMC free article] [PubMed] [Cross Ref]
8. Sanna V, Kirschvink N, Gustin P, et al. Preparation and in vivo toxicity study of solid lipid microparticles as carrier for pulmonary administration. AAPS PharmSciTech. 2004;5:E27–E27. doi: 10.1208/pt050227. [PMC free article] [PubMed] [Cross Ref]
9. Grover JK, Rathi SS, Vats V. Amelioration of experimental diabetic neuropathy and gastropathy in rats following oral administration of plant (Eugenia jambolana, Mucurna pruriens andTinospora cordifolia) extracts. Indian J Exp Biol. 2002;40:273–276. [PubMed]
10. Illum L, Davis SS. Microspheres for nasal administration. In: Duchene D, editor. Buccal and Nasal Administration as an Alternative for Parenteral Administration. Paris, France: Edition de Sante; 1992. pp. 125–137.
11. Moses AC, Gordon GS, Carey MC, Flier JS. Insulin administered as an insulin-bile salt aerosol: effectiveness and reproductibility in normal and diabetic subjects. Diabetes. 1983;32:1040–1047. doi: 10.2337/diabetes.32.11.1040. [PubMed] [Cross Ref]
12. Gizurarson S. The relevance of nasal physiology to the design of drug absorption studies. Adv Drug Deliv Res. 1993;11:329–347. doi: 10.1016/0169-409X(93)90015-V. [Cross Ref]
13. Singh S. Drug stability testing and shelf life determination according to international guidelines. Pharm Tech. 1999;7:69–79.

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