Formulation of Different Dosage Forms of Insulin
Year: 2025
Type: article
Abstract: In order to improve the absorption of insulin through biological barriers, Labra sol ALF and Labra fil M 2125 CS were chosen as permeation-enhancing excipients. The development of oral insulin drug delivery systems remains a challenge for pharmaceutical technology researchers, as the formulation process must overcome a number of obstacles due to the adverse characteristics of peptides. The goal of this study was to formulate different sodium-alginate microparticles as a potential method for oral insulin administration. In our previous studies, the method has been successfully optimized using a small model peptide. To improve oral bioavailability, they were applied at a concentration of 0.10% (v/v %), along with different combinations of the two. Encapsulation efficiency demonstrated adequate drug incorporation, as it produced over 80% in each composition. The results of the enzymatic stability and in vitro dissolution tests demonstrated that, as a pH-responsive polymer, alginate bead swelling and drug release occur at higher pH, protecting insulin against the harsh environment of the gastrointestinal tract. After 120 minutes, SIF degradation caused 66% of the remaining insulin content. Permeability experiments demonstrated the effects of permeation enhancers and natural polymers on drug absorption, as they significantly improved drug transport through Caco-2 cells in the case of alginate microparticle formulations, compared to the placebo insulin solution. These results imply that these formulations are able to increase the oral bioavailability of insulin.Keywords: microbead; oral bioavailability; absorption enhancement; Labra sol ALF; Labra fil M 2125 CS; Caco-2 cells. An efficient oral insulin product is even more important for the management of patients with diabetes because of the increasing evidence that earlier initiation of intensive insulin therapy produces sustained tight glycaemic control, which results in a significant delay in complications. Oral insulin is one of the most exciting areas of development in the treatment of diabetes because of its potential benefits for patient convenience, rapid insulinization of the liver, and adequate insulin delivery avoiding peripheral hyper insulinaemia while potentially avoiding adverse effects of weight gain and hypoglycaemia. The development status of oral insulins that are publicly reported to be undergoing clinical studies is summarized in this review. Two oral insulin products are currently in an advanced stage of clinical development, and the first data from long-term therapy are anticipated to be available in the second half of 2010. Despite awareness of this unmet medical need, oral delivery of insulin has failed due to a number of obstacles. Researchers have attempted to develop oral insulin using various technologies for several decades with little clinical or commercial experience
Author: Shaikh Shirin Fatema Maulana*, Waghmare Vyanktesh, Wangawar Pallavi, Shinde Devanand, Suryawanshi Yogita, Swami Bhujayya
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W6949499996
FWCI:
Cites:
Cited by:
Related to: