Prefilled Syringes or Peptide Pills? - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Prefilled Syringes or Peptide Pills?
The impact of new delivery technologies in designing peptide therapies.


Pharmaceutical Technology
Volume 37, Issue 5, pp. 46-49


IMAGEMORE CO, LTD./GETTY IMAGES
The emerging field of peptide and protein therapeutics is responsible for a new therapeutic era. Peptides are attractive therapeutic molecules due to their high specificity and potency. Peptides biodegrade into nontoxic or low toxicity metabolites, with minimal potential for drug–drug interactions and low immunogenicity compared to larger proteins. These advantages are reflected in a regulatory approval rate of more than 20% probability, which is double that of small molecules (1). The average number of new candidates entering clinical evaluation every year has steadily increased from 1.2 per year in the 1970s to 4.6 per year in the 1980s, 9.7 per year in the 1990s, and 16.8 per year in the 2000s (2).

Peptides were not favored as drug candidates because of their physicochemical characteristics and the necessity for expensive and complicated manufacturing processes. Peptides often have short half-lives (of less than 20 minutes), thereby making chronic administration problematic and costly. Two major technological advances contributed to the industrial acceptability of peptide-drug candidates:

  • Advances in genetic engineering, recombinant technologies, and solid-phase peptide synthesis overcoming the problems of high cost of manufacture as well as stability issues of peptide molecules
  • Advancements of polymer technologies allowing controlled long-acting release formulations of peptides encapsulated in biodegradable polymers such as the gonadotrophin-releasing hormone (e.g., goserelin acetate [Zoladex, AstraZeneca]).


Aikaterini Lalatsa, PhD
Today, the most important drawback in translating peptides into clinically useful therapies is the lack of adequate oral bioavailability. As the preferred route of administration for medicines is the oral route, and given the lack of patient compliance with therapeutics that require chronic self-intravenous administration, the pharmaceutical industry originally opted to focus its efforts on the development of oral alternatives for peptide-based drugs.

Due to the increasing cost of R&D and the decreasing number of approved drugs, new alternative approaches are needed to boost the productivity of the pharmaceutical industry (3). Parenteral administration of peptides is usually painful, and requires sterile manufacturing or aseptic processing of thermally unstable biomacromolecules. Technologies that enable the delivery of biologicals across mucosal barriers such as the gastrointestinal tract (GIT), the nasal mucosa, and the blood-brain barrier (BBB), therefore, offer potential for the development of effective and safe noninvasive biologicals, and can enhance the commercial success of peptide therapeutics.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
43%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here