title: Formulation and characterization of an oily-based system for oral delivery of insulin.
abstract: The present work explored the possibility of formulating an oral insulin delivery system by combining the advantages of nanoencapsulation and the use of oily vehicle. The parameters affecting formulation such as association efficiency were characterized. The preparation was evaluated for its chemical, physical and biological stability. The preparation has unimodal particle size distribution with a mean diameter of 108+/-9 nm. Insulin was protected from gastric enzymes by incorporation into lipid-based formulation. The results of RP HPLC and ELISA indicated that insulin was able to withstand the preparation procedure. Insulin in the preparations was stable for a period of one month at storage temperatures of 4 and 25 degrees C. It was also biologically active and stable as demonstrated by the remarkable reduction of blood glucose levels of the STZ-diabetic rats after oral administration of the preparation. Moreover, hypoglycemic effect of nanoparticles administered orally was sustained for a longer period of time compared to the subcutaneous injection. These results clearly evidenced the ability of the nanoparticles to enhance the pharmacological response of insulin when given orally and could be used to deliver other peptides.
authors.affiliation: Department of Pharmaceutics, Gezira University, Medani, Sudan.
authors.forename: Amani
authors.initials: A
authors.lastname: Elsayed
authors.forename: Mayyas Al
authors.initials: MA
authors.lastname: Remawi
authors.forename: Nidal
authors.initials: N
authors.lastname: Qinna
authors.forename: Asim
authors.initials: A
authors.lastname: Farouk
authors.forename: Adnan
authors.initials: A
authors.lastname: Badwan
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001786:Blood Glucose / Q000187:drug effects*; D002626:Chemistry, Pharmaceutical; D048271:Chitosan / Q000737:chemistry; D003921:Diabetes Mellitus, Experimental / Q000097:blood / Q000188:drug therapy*; D004337:Drug Carriers; D004339:Drug Compounding; D004355:Drug Stability; D004655:Emulsions; D005750:Gastric Juice / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000737:chemistry; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000737:chemistry; D008297:Male; D008970:Molecular Weight; D053758:Nanoparticles; D009821:Oils / Q000737:chemistry*; D055550:Protein Stability; D051381:Rats; D017208:Rats, Wistar; D011994:Recombinant Proteins / Q000008:administration & dosage; D013696:Temperature; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D004337:Drug Carriers; D004655:Emulsions; D007004:Hypoglycemic Agents; D007328:Insulin; D009821:Oils; D011994:Recombinant Proteins; D048271:Chitosan