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Oral Insulin Delivery Challenges And Current Status

Oral Insulin Delivery: How Far Are We?

Oral Insulin Delivery: How Far Are We?

1. J Diabetes Sci Technol. 2013 Mar 1;7(2):520-31. Fonte P(1), Arajo F, Reis S, Sarmento B. (1)Centro de Investigao em Cincias da Sade (CICS), Instituto Superior de Cincias da Sade-Norte, CESPU, Gandra, Portugal. Oral delivery of insulin may significantly improve the quality of life ofdiabetes patients who routinely receive insulin by the subcutaneous route. Infact, compared with this administration route, oral delivery of insulin indiabetes treatment offers many advantages: higher patient compliance, rapidhepatic insulinization, and avoidance of peripheral hyperinsulinemia and otheradverse effects such as possible hypoglycemia and weight gain. However, the oral delivery of insulin remains a challenge because its oral absorption is limited.The mainbarriers faced by insulin in the gastrointestinal tract are degradationby proteolytic enzymes and lack of transport across the intestinal epithelium.Several strategies to deliver insulin orally have been proposed, but without muchclinical or commercial success. Protein encapsulation into nanoparticles isregarded as a promising alternative to administer insulin orally because theyhave the ability to promote insulin paracellular or transcellular transportacross the intestinal mucosa. In this review, different delivery systems intendedto increase the oral bioavailability of insulin will be discussed, with a specialfocus on nanoparticulate carrier systems, as well as the efforts thatpharmaceutical companies are making to bring to the market the first oraldelivery system of insulin. The toxicological and safety data of deliverysystems, the clinical value and progress of oral insulin delivery, and the futureprospects in this research field will be also scrutinized. 2013 Diabetes Technology Society. Continue reading >>

Oral Insulin Delivery In A Physiologic Context: Review

Oral Insulin Delivery In A Physiologic Context: Review

Insulin remains indispensable to the treatment of diabetes, but its availability in injectable form only has hampered its timely and broader use. The development of an oral insulin remains an ultimate goal to both enhance ease of use, and to provide therapeutic advantages rooted in its direct delivery to the portal vein and liver. By mimicking the physiological path taken by pancreatic insulin, oral insulin is expected to have a distinct effect on the hepatic aspect of carbohydrate metabolism, hepatic insulin resistance, and, at the same time, avoid hyperinsulinemia and minimize the risk of hypoglycemia. With oral insulin approaching late stages of development, the goal of this review is to examine oral insulin in a physiological context and report on recent progress in its development. 1. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329(14):977-986. Google Scholar, Crossref, Medline 2. Nathan, DM. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group: intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353:2643-2653. Google Scholar, Crossref, Medline 3. Skyler, JS, Bergenstal, R, Bonow, RO. Intensive glycemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. J Am Coll Cardiol. 2009;53(3):298-304. Google Scholar, Medline 4. Turnbull, Continue reading >>

Oral Nano-insulin Therapy: Current Progress On Nanoparticle-based Devices For Intestinal Epithelium-targeted Insulin Delivery

Oral Nano-insulin Therapy: Current Progress On Nanoparticle-based Devices For Intestinal Epithelium-targeted Insulin Delivery

Received Date: February 25, 2012; Accepted Date: March 17, 2012; Published Date: March 31, 2012 Citation: Ahmad A, Othman I, Md Zain DAZ, Chowdhury EH (2012) Oral Nano-Insulin Therapy: Current Progress on Nanoparticle-Based Devices for Intestinal Epithelium-Targeted Insulin Delivery. J Nanomedic Nanotechnol S4:007. doi:10.4172/2157-7439.S4-007 Copyright: 2012 Ahmad A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Insulin; Nanoparticles; Oral delivery; Diabetes; Chitosan; Poly(-Glutamic Acid); Poly(Lactide-Co-Glycolide); Poly(Acrylic Acid); Poly(Isobutylcyanoacrylate); Poly(Alkylcyanoacrylate); Poly(Ethylene Glycol); Vitamin B12; Wheat germ agglutinin; Lectin; Solid lipid nanoparticles; Tight junction NP: Nanoparticle; CS: Chitosan; pga: Poly(- Glutamic acid); DTPA: Diethylene triamine pentaacetic acid; TMC: N-Trimethyl chitosan; CSK: CSKSSDYQC targeting ligand; Cys: Cysteine; HTCC: N-(2-hydroxyl) Propyl-3-trimethyl ammonium chitosan; PLGA: Poly(lactide-co-glycolide); PL: Phospholipid; HP55: Hydroxypropyl methylcellulose phthalate; RS: Eudragit RS; PAA: Poly(acrylic acid); PIBCA: Poly(isobutylcyanoacrylate); PACA: Poly(alkylcyanoacrylate); MAA: Methacrylic acid; PEG: Poly(ethylene glycol); AA: Acrylic acid; P(MAA-g-PEG): Copolymer of poly(ethylene glycol)-grafted methacrylic acid; P(AA-g-PEG): Copolymer of poly(ethylene glycol)-grafted acrylic acid; PEGDMA: Poly(ethylene glycol) dimethacrylates; PLA-F127-PLA: PLA-b-Pluronic-b-PLA; PCL: Poly(-caprolactone); VB12: Vitamin B12; DPPC: Dipalmitoylphosphatidylcholine; WGA: Wheat germ agglutinin; TL: Tomato lectin; UEA1: Ulex Europae Continue reading >>

Oral Insulin Phase 1 Trials Begin

Oral Insulin Phase 1 Trials Begin

Novo Nordisk has initiated its first Phase 1 clinical trial with an oral insulin analog, NN1952, which was created using Merrion Pharmaceuticals GIPET technology. There are many challenges with the development and production of a reliable insulin formulation for oral use. These include avoiding enzymatic degradation in the gastrointestinal tract, overcoming poor spontaneous insulin permeability over the intestinal wall, limiting variability of absorption (caused, for example, by interaction with food), and producing insulin at a sufficient scale cost-effectively. NN1952 has been designed to address some of the key challenges relating to oral insulin delivery. The GIPET formulation technology from Merrion Pharmaceuticals helps facilitate insulin absorption from the gut. NN1952 is not the only oral insulin formulation being tested. The Chinese State Food and Drug Administration (SFDA) has recently approved the investigational new drug application (IND) for Shanghai Biolaxys (Shanghai, China) oral insulin project (Nodlin). This IND approval allows Biolaxy to initiate its first Phase 1 clinical study. Nodlin is developed with a patented bio-adhesive nanoparticle oral delivery (NOD) technology to overcome the barriers of oral insulin. Nodlin is the first candidate developed with NOD technology and is positioned as basal insulin formulation based on the preclinical data. Continue reading >>

Emerging Trends In Noninvasive Insulin Delivery

Emerging Trends In Noninvasive Insulin Delivery

Emerging Trends in Noninvasive Insulin Delivery Department of Pharmacy, School of Medical & Allied Sciences, Galgotias University, Yamuna Expressway, Greater Noida, Uttar Pradesh, India Received 2 January 2014; Revised 26 March 2014; Accepted 16 April 2014; Published 14 May 2014 Copyright 2014 Arun Verma et al. This is an open access article distributed under the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. J. R. Kurien, Oral insulin Delivery-challenges and current status: a pharmaceutical review, 2008, . H. Richard and F. Denise, Biochemistry-Lippincotts Illustrated Reviews, Lippincott Williams and Wilkins, 5th edition, 2012. M. D. Donovan, G. L. Flynn, and G. L. Amidon, Absorption of polyethylene glycols 600 through 2000: the molecular weight dependence of gastrointestinal and nasal absorption, Pharmaceutical Research, vol. 7, no. 8, pp. 863868, 1990. View at Google Scholar View at Scopus R. Hejazi and M. Amiji, Chitosan-based gastrointestinal delivery systems, Journal of Controlled Release, vol. 89, no. 2, pp. 151165, 2003. View at Publisher View at Google Scholar View at Scopus M. Rinaudo, Chitin and chitosan: properties and applications, Progress in Polymer Science, vol. 31, no. 7, pp. 603632, 2006. View at Publisher View at Google Scholar View at Scopus O. Felt, P. Buri, and R. Gurny, Chitosan: a unique polysaccharide for drug delivery, Drug Development and Industrial Pharmacy, vol. 24, no. 11, pp. 979993, 1998. View at Google Scholar View at Scopus S. A. Agnihotri, N. N. Mallikarjuna, and T. M. Aminabhavi, Recent advances on chitosan-based micro- and nanoparticles in drug delivery, Journal of Controlled Release, vol. 100, no. 1, pp. 528, 2004. Vi Continue reading >>

Evaluation Of An Oral Insulin Formulation In Normal And Diabetic Rats Najafzadeh H, Kooshapur H, Kianidehkordi F - Indian J Pharmacol

Evaluation Of An Oral Insulin Formulation In Normal And Diabetic Rats Najafzadeh H, Kooshapur H, Kianidehkordi F - Indian J Pharmacol

Aim: As injection is not an ideal means for insulin delivery, various attempts have been made to administer insulin orally until now. The development of an oral dosage form of insulin would help diabetic patients and make the treatment more convenient. The aim of the present study is to evaluate the effectiveness of an oral insulin formulation containing polar and non-polar ingredients. Materials and Methods: New excipient for oral insulin administration in normal and diabetic rats was evaluated by measuring blood glucose concentrations in two groups (10 rats each) of normal and streptozotocin-induced diabetic rats. Oral insulin was administrated and blood glucose was measured by glucometer at 0, 1, 2, 3 and 4 h post-feeding. The data was compared by Student's t test. Results: Oral insulin formulation significantly (P<0.05) reduced blood glucose from 100 mg/dl to 33.73 mg/dl and 451.66 mg/dl to 200.83 mg/dl at 4 h in normal and diabetic rats, respectively. Conclusion: The novel excipient used could protect insulin from gastric and pancreatic enzymes and reduce blood glucose concentration in both healthy and diabetic rats suggesting that oral delivery of insulin is feasible in a near future. Keywords:Blood glucose, normal and diabetic rats, oral insulin Najafzadeh H, Kooshapur H, Kianidehkordi F. Evaluation of an oral insulin formulation in normal and diabetic rats. Indian J Pharmacol 2012;44:103-5 Najafzadeh H, Kooshapur H, Kianidehkordi F. Evaluation of an oral insulin formulation in normal and diabetic rats. Indian J Pharmacol [serial online] 2012 [cited2018 Apr 12];44:103-5. Available from: Since the initial discovery of insulin by Banting and Best in 1922, an orally effective form of the drug has been an elusive goal for many investigators. Current dosage regimens Continue reading >>

Insulin Delivery Methods: Past, Present And Future

Insulin Delivery Methods: Past, Present And Future

1 Department of Pharmacology, GMERS Medial College, Gandhinagar, Gujarat, India 2 Brain Research and Intervention Center, University of Illinois, Chicago, USA 3 Barbara Davis Center for Diabetes, University of Colorado, Denver, USA Correspondence Address: Dr. Rima B Shah Department of Pharmacology, GMERS Medical College, Gnadhinagar - 382 012, Gujarat India Viral N Shah Barbara Davis Center for Diabetes, 1775 Aurora Ct, MS A140, Colorado USA Source of Support: None, Conflict of Interest: None DOI: 10.4103/2230-973X.176456 Many patients with advanced type 2 diabetes mellitus (T2DM) and all patients with T1DM require insulin to keep blood glucose levels in the target range. The most common route of insulin administration is subcutaneous insulin injections. There are many ways to deliver insulin subcutaneously such as vials and syringes, insulin pens, and insulin pumps. Though subcutaneous insulin delivery is the standard route of insulin administration, it is associated with injection pain, needle phobia, lipodystrophy, noncompliance and peripheral hyperinsulinemia. Therefore, the need exists for delivering insulin in a minimally invasive or noninvasive and in most physiological way. Inhaled insulin was the first approved noninvasive and alternative way to deliver insulin, but it has been withdrawn from the market. Technologies are being explored to make the noninvasive delivery of insulin possible. Some of the routes of insulin administration that are under investigation are oral, buccal, nasal, peritoneal and transdermal. This review article focuses on the past, present and future of various insulin delivery techniques. This article has focused on different possible routes of insulin administration with its advantages and limitation and possible scope for the new drug d Continue reading >>

Oral Insulin: Current Status, Challenges, And Future Perspectives.

Oral Insulin: Current Status, Challenges, And Future Perspectives.

Oral Insulin: Current Status, Challenges, and Future Perspectives. School of Pharmacy, International Medical University, Kuala Lumpur, Malaysia 57000. School of Health Sciences, International Medical University, Kuala Lumpur, Malaysia 57000. Jaipur National University, School of Pharmaceutical Sciences, Jagatpura, 302017, Jaipur, India; University of Newcastle, School of Medicine and Public Health, Newcastle, NSW 2308, Australia. Oral delivery of insulin is one of the most promising and anticipated areas in the treatment of diabetes, primarily because it may significantly improve the quality of life of diabetics who receive insulin regularly. Several problems have been reported regarding the subcutaneous delivery of insulin, ranging from cardiovascular complications to weight gain. One of the approaches to overcoming these issues is to administer insulin through the oral route. However, there are several challenges in developing an oral route for insulin delivery; insulin has extremely poor bioavailability and a low diffusion rate through the mucus layer. A wide range of oral insulin delivery techniques have recently been researched, ranging from nanoparticles to liposomes, self-emulsifying systems, and hydrogels. These techniques have shown promising potential in the oral delivery of insulin. This review considers the current literature on the advances and challenges in the development of oral insulin. Continue reading >>

Potential Of Nanoparticle Formulations For Oral Insulin Delivery

Potential Of Nanoparticle Formulations For Oral Insulin Delivery

Potential of nanoparticle formulations for oral insulin delivery Nanoparticles have demonstrated significant advancements in potential oral delivery of insulin. In this publication, we review the current status of polymeric, inorganic and solid-lipid nanoparticles designed for oral administration of insulin. Firstly, the structure and physiological function of insulin are examined. Then, the efficiency and shortcomings of insulin nanoparticle are discussed. These include the susceptibility to digestive enzyme degradation, instability in the acidic pH environment, poor mucus diffusion and inadequate permeation through the gastrointestinal epithelium. In order to optimise the nanocarriers, the following considerations, including polymer nature, surface charge, size, polydispersity index and morphology of nanoparticles, have to be taken into account. Some novel designs such as chitosan-based glucose-responsive nanoparticles, layer by layer technique-based nanoparticles and zwitterion nanoparticles are being adopted to overcome the physiological challenges. The review ends with some future directions and challenges to be addressed for the success of oral delivery of insulin-loaded nanoparticle formulation. Continue reading >>

Design Of Oral Insulin Delivery Systems

Design Of Oral Insulin Delivery Systems

Get access/doi/full/10.3109/10611860903302815?needAccess=true The possibility of administering insulin orally in replacement of painful subcutaneous route has been investigated over years but with varying degree of success. Nanoparticles, microparticles, hydrogel, capsule, tablet, and film patch are designed to deliver insulin orally. They are largely formulated with polymeric adhesive, protease inhibitor, insulin aggregation inhibitor, and functional excipients to induce transcellular, paracellular, Peyers patches, or receptor-mediated transport of insulin in gastrointestinal tract. Superporous matrix, intestinal patches, and charged-coupled micromagnet microparticles are recent formulation strategies to promote oral insulin absorption. The formulation emphasizes on assembly of insulin and excipients into a physical structure which provides an element of drug targeting to maintain stability and increase bioavailability of insulin. The overview of various strategies applied in oral insulin delivery system design denotes the significance of mucoadhesiveness whereby a prolonged retention of dosage form in intestinal tract translates to cumulative insulin release and absorption, overcoming the intestinal transport capacity limit. Synthesis and use of mucoadhesive excipients, chemical modification of insulin to promote its physicochemical and biological stability for encapsulation in dosage form with prolonged retention characteristics and identification of potential insulin adjuncts are efforts needed to accelerate the speed of obtaining a functional oral insulin delivery system. Continue reading >>

Development And Challenges Facing For Insulin Oral Delivery | International Journal Of Pharmaceutical Sciences And Research

Development And Challenges Facing For Insulin Oral Delivery | International Journal Of Pharmaceutical Sciences And Research

Home DEVELOPMENT AND CHALLENGES FACING FOR INSULIN ORAL DELIVERY DEVELOPMENT AND CHALLENGES FACING FOR INSULIN ORAL DELIVERY DEVELOPMENT AND CHALLENGES FACING FOR INSULIN ORAL DELIVERY Venkatachalam Senthil, Ilindra Saikishan, Natarajan Jawahar, Rizwan Basha Khatwal and Venkatesh Nagasamy Department of Pharmaceutics, J.S.S. College of Pharmacy, J.S.S University, Rocklands, Udhagamandalam- 643001, Tamil Nadu, India ABSTRACT: The Present study focuses on the challenges facing the development of oral insulin the fact we have no formulation in market, being an attractive and advantageous over the regular injections. Physiological and biological factors of the insulin has great influence for the development of an oral formulation with many difficulties regarding the stability over gastric pH and proteolytic enzymes, selection of the proper formulation and its components depends on these conditions. The development with insulin therapy are needed with better patience compliance, low toxicity, higher glycemic control, thereby Diabetes related complications occurrence can be prevented. Oral insulin, Hypoglycemia, Diabetes, Permeability, Enzymatic degradation, Encapsulation efficiency, Bioavailability, Stability, Emulsion, Liposomes INTRODUCTION: In terms of efficacy, insulin in form of parental route is satisfactory, however it is associated with some severe adverse conditions like, peripheral hyperinsulinemia, smooth muscle cell proliferation, diabetic macro and micro angiopathy, lipoatrophy or lipohyertophy have become very common. Insulin delivery by oral route is not effective due to its susceptibility to enzymatic degradation in GI & Permeability across intestinal epithelium is low 1, 2. The proper combination of Multifunctional polymers will result a better biocompatible Continue reading >>

Oral Delivery Of Insulin

Oral Delivery Of Insulin

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  • List of figures and tables
    • Figures
    • Tables
  • About the authors
  • 1: Diabetes mellitus – an overview
    • Abstract
    • 1.1 Diabetes mellitus – an introduction
    • 1.2 Glucose homeostasis
    • 1.3 Types of diabetes
    • 1.4 Symptoms of diabetes
    • 1.5 Complications of diabetes
    • 1.6 Diagnosis of diabetes mellitus
    • 1.7 Therapy for diabetes
    • 1.8 Non-insulin treatment options of type 1 diabetes
    • 1.9 Treatment options of type 2 diabetes
    • 1.10 Conclusion
  • 2: Routes of administration of insulin
    • Abstract
    • 2.1 Current approach for the delivery of insulin
    • 2.2 Routes of administration of insulin
    • 2.3 Conclusion
  • 3: Oral insulin delivery – challenges and strategies
    • Abstract
    • 3.1 Oral delivery of insulin
    • 3.2 Barriers to oral delivery of insulin
    • 3.3 Strategies and alternatives to improve oral insulin delivery
    • 3.4 Conclusion
  • 4: Experimental techni Continue reading >>

  • Application Of Polymeric Nanoparticles And Micelles In Insulin Oral Delivery - Sciencedirect

    Application Of Polymeric Nanoparticles And Micelles In Insulin Oral Delivery - Sciencedirect

    Volume 23, Issue 3 , September 2015, Pages 351-358 Open Access funded by Taiwan Food and Drug Administration Diabetes mellitus is an endocrine disease in which the pancreas does not produce sufficient insulin or the body cannot effectively use the insulin it produces. Insulin therapy has been the best choice for the clinical management of diabetes mellitus. The current insulin therapy is via subcutaneous injection, which often fails to mimic the glucose homeostasis that occurs in normal individuals. This provokes numerous attempts to develop a safe and effective noninvasive route for insulin delivery. Oral delivery is the most convenient administration route. However, insulin cannot be well absorbed orally because of its rapid enzymatic degradation in the gastrointestinal tract. Therefore, nanoparticulate carriers such as polymeric nanoparticles and micelles are employed for the oral delivery of insulin. These nanocarriers protect insulin from degradation and facilitate insulin uptake via a transcellular and/or paracellular pathway. This review article focuses on the application of nanoparticles and micelles in insulin oral delivery. The recent advances in this topic are also reviewed. Continue reading >>

    Insulin Delivery: What Is New In The Queue? | Rahman | International Journal Of Basic & Clinical Pharmacology

    Insulin Delivery: What Is New In The Queue? | Rahman | International Journal Of Basic & Clinical Pharmacology

    Insulin delivery: what is new in the queue? Diabetes Mellitus (DM) is a cluster of metabolic disorders with the shared feature of hyperglycemia which may be due to discrete etiopathogenesis. India stands to be the diabetic capital of the world, second only to China. After its discovery by Banting and Best, it has been established that insulin plays a fundamental role in the management of DM. In spite of insulin being in the market for so long, what still remains a challenge is the invasive approach of its administration. Conventional pharmacotherapeutic approaches of insulin delivery that have been available over the years are insulin syringes, pumps and pens. Upcoming innovative modes of insulin delivery include oral insulin, inhaled insulin, colonic insulin delivery, transdermal insulin, intra-peritoneal insulin, intra-nasal insulin, nano-technology etc. Constant research has been going on since many years to discover a route of administration for insulin that is minimally or noninvasive, effective, safe, convenient and cost-effective for patients. If successful, alternative routes of administration could revolutionize the treatment of DM and help improve patients quality of life. Mukherjee B, Paul P, Choudhury A, Bhattacharya S, Maji R, Dutta L. Variation of pharmacokinetic profiles of some antidiabetic drugs from nanostructured formulations administered through pulmonary route. Curr Drug Metab. 2015. Global report on diabetes WHO Library Cataloguing-in-Publication Data. ISBN;978:92-4. Kaveeshwar SA, Cornwall J. The current state of diabetes mellitus in India. Australas Med J. Australasian Medical Journal. 2014;7(1):45-8. Rosenfeld L. Insulin: discovery and controversy. Clin Chem. 2002;48(12):2270-88. Al-Tabakha MM, Arida AI. Recent challenges in insulin delivery sy Continue reading >>

    Oral Delivery Of Insulin For Treatment Of Diabetes: Classical Challenges And Current Opportunities

    Oral Delivery Of Insulin For Treatment Of Diabetes: Classical Challenges And Current Opportunities

    Oral Delivery of Insulin for Treatment of Diabetes: Classical Challenges and Current Opportunities Oral dosage form is the most common form of delivery systems due to several benefits such as ease of manufacturing, ease of administration, better formulation stability and patient compliance. Recently many proteins and peptides have been investigated for their usefulness in therapy, but mainly as parenterals due to the associated inherent problems, for instance its rapid degradation, low permeability and absorption in gastrointestinal tract. These problems must be solved or minimized to an extent that would be clinically significant before the oral delivery of proteins and peptides becomes a reality. Among the proteins, oral delivery of insulin has been attempted extensively but without much success so far and yet no formulation with oral delivery of insulin could be marketed. Several approaches have been developed to enhance oral absorption of insulin, such as inhibition of acidic and enzymatic degradation, enhancement of membrane permeability or widening of tight junctions, enhancement of insulin uptake and development of novel insulin carriers. This review article mainly focuses on the classical challenge of oral delivery of insulin and different strategies to overcome the related issues. Moreover, the current drug delivery technologies adopted in an attempt to develop practicable oral insulin have been discussed. How to cite this article: M.J. Ansari , 2015. Oral Delivery of Insulin for Treatment of Diabetes: Classical Challenges and Current Opportunities. Journal of Medical Sciences, 15: 209-220. Received: September 15, 2015; Accepted: October 30, 2015; Published: November 25, 2015 Diabetes is a group of metabolic disorders of multiple etiologies characterized by ch Continue reading >>

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