Abstract
DEVELOPMENT AND EVALUATION OF FILMS BASED ON MICROEMULSIFIED INSULIN FOR BUCCAL DELIVERY USING MAISINE® OIL, ACACIA AND POLYVINYL ALCOHOL
Dr. Chukwuma O. Agubata* and Augustus C. Eze
ABSTRACT
Insulin is a peptide hormone produced by beta cells in the pancreas which regulates the metabolism of carbohydrates, fats and, it is employed in the treatment of some forms of diabetes mellitus. It can be given as Intramuscular (I.M) injection due to its poor oral bioavailability. The aim of the present study was to develop a buccal film for the non-invasive delivery of insulin across the buccal cavity to the systemic circulation. The buccal films were formulated by dispersing microemulsions of insulin in bioadhesive, film-forming polymer dispersions and drying. The microemulsions contained varying concentrations of Maisine® oil and Phospholipon®90G, while the film-forming dispersions contained varying levels of polyvinyl alcohol and acacia. The prepared buccal films were evaluated for its thickness uniformity, folding endurance, % elongation, swelling index, thermal behaviour and in-vivo hypoglycaemic effects. The average thickness of the films was 0.4 mm, the folding endurance was found to be greater than 500 fold for each of the buccal films and the percentage elongation varied between 140 to 320%. The swelling index was found to be between 0.5 to 4.5%. The differential scanning calorimetry (DSC) results showed no drug-excipient interaction. In the in vivo studies, the optimized film showed a slow-acting profile in comparison to the glucose reduction capacity of I.M insulin administration.
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