Parenteral Delivery of Peptides and Proteins - Challenges in Delivery of Therapeutic Genomics and Proteomics - page 526

11

Parenteral Delivery of Peptides
and Proteins

Himansh﻽ ���a�a﻽﻽ �i�a �ha����﻽ ���a�a﻽﻽ �i�a �ha����﻽ ﻽ �i�a �ha����﻽ �ha����﻽

�mbi�anandan Mis�a
Pharmacy Department, TIFAC - Centre of Relevance and Excellence
in New Drug Delivery Systems, The Maharaja Sayajirao University of
Baroda, PO Box 51, Kalabhavan, Vadodara 390 001, Gujarat, India

11.1 Introduction

Peptides and proteins (P/P) constitute a vital part of the human body as they are
involved in all-important physiological and biological processes like functioning as
enzymes for biochemical reactions, as hormones and growth factors, as ligands for
cell signalling, as receptors for pharmacological response elucidation, as antibodies in
immune system interactions, and as mediators in transcription and translation [1] . In
addition to their biochemical role, they have been recognized for their medicinal value
as biodrugs in low therapeutic doses for the treatment and prevention of diseases, and
for modulating the immune system to achieve the desired therapeutic response [1,2] .
With such upcoming biotechnology and bioengineering processes as recombinant
DNA technology, human genome sequencing, functional studies, solid phase synthesis,
and certainly various sophisticated instrumentations and analytical processes, it is now
possible to develop various P/P drugs in bulk quantities to fulfill the therapeutic needs
of the community [1-4] . As per The Pharmaceutical Research and Manufacturers of
America report 2006, “Biotechnology Medicines in Development,” 418 new biotech-
nology medicines have been recognized for more than 100 diseases, including severe
conditions like cancer, infectious diseases, autoimmune diseases, and AIDS/HIV and
related conditions, which are either in human clinical trials or under review by the
US Food and Drug Administration (US FDA) [5,6] .
Protein and peptide drugs can be categorized with respect to their therapeutic appli-
cations like hormones, growth factors, clotting factors, anticoagulants, toxins, enzymes,
and antibody-based drugs [1] . Among them, the most frequently marketed biopharma-
ceuticals include monoclonal antibody-based products for various types of cancer and
autoimmune diseases, therapeutic vaccines for immunization against hepatitis A and/or
B, insulin for diabetes, human growth hormone (hGH) for supplementation in hormone
deficiency, and interferon  for treatment of hepatitis B and/or C [7-9] .
The design of delivery systems for these biologicals still remains challenging,
especially to achieve site-specific pharmacological actions as this class of therapeutic