Novel Delivery Technologies for Protein and Peptide Therapeutics

Abstract

The protein and peptide therapeutics have become an important class of drugs due to advancement in molecular biology and recombinant technology. There are more than 100 biopharmaceutical products approved and generating revenue of more than 56 billion US dollars. A safe, effective and patient friendly delivery of these agents is the key to commercial success. Currently, most of therapeutic proteins are administered by the parenteral route which has many drawbacks. Various delivery strategies and specialized companies have evolved over the past few years to improve delivery of proteins and peptides. Polymeric depot and PEGylation technologies have overcome some of the issues associated with parenteral delivery. A considerable research has been focused on non-invasive routes such as pulmonary, per oral and transdermal for delivery of proteins and peptides, in order to increase patient compliance yet their delivery via non-invasive routes remains challenge due to their poor absorption and enzymatic instability. Pulmonary route has shown some success evidenced by recent FDA approval of inhalable insulin. Development of an oral dosage form for protein therapeutics is still the most desirable one but with greater challenge. This review presents the issues of delivery of proteins and peptides, current and potential formulation technologies to improve delivery and current market trends.

Effect of Co-administration of Tacrolimus on the Pharmacokinetics of Multiple Subcutaneous Administered Interferon-Alpha in Rats

“…In addition, there is an increased understanding on the role of proteins belonging to advances in molecular biology. Consequently, recombinant therapeutic proteins, synthetic vaccines, and monoclonal antibodies have become an important class of therapeutic agent (1).…”

“…Immunosuppressants which suppress or prevent immune reactions, are clinically used to prevent allograft rejection 1 after transplantation (3,4) and to treat autoimmune diseases such as psoriasis, rheumatoid arthritis and Crohn's disease (5). The calcineurin inhibitors, tacrolimus and cyclosporine A, are widely used as immunosuppressants in the clinic and are known to inhibit T-cell function, although the activity of tacrolimus on immune suppression was 100 times higher than that of cyclosporine A (6).…”

Administration strategies for proteins and peptides

“…Until recently, therapeutic proteins and peptides were delivered by subcutaneous (SC), intramuscular (IM), and intravenous (IV) injections (Cleland et al, 2001;Almeida and Souto, 2007;Siddiqui and Chien, 1987;Shantha Kumar et al, 2006). However, using intravenous injection for protein administration raises many problems as it is painful and poorly tolerated by patients.…”

The Apical Junctional Complex in Respiratory Diseases

“…Tissue barriers associated with such non-invasive delivery pose a considerable challenge, particularly for macromolecules 35. This challenge can be met by employing permeation enhancers to facilitate paracellular transport 36. Permeation enhancers can be selected empirically from among currently acceptable excipients for pharmaceutical use, or novel TJM excipients can be developed rationally 36.…”