30 Years of Pharmaceutical Technology and What Lies Ahead - Pharmaceutical Technology

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30 Years of Pharmaceutical Technology and What Lies Ahead
A review of advancements in areas such as active ingredients, formulation, technology, regulation, and analytical testing.

Pharmaceutical Technology



Table I: Progress in delivery systems*
Today's formulators have a better understanding of pharmaceutical ingredients, novel strategies for facing challenges old and new, computerized modeling methods, an increased interest in controlled and extended-release formulations, and more alternative routes of administration and delivery (see Table I). 30

Technology

One of the major stories to emerge during the past 30 years is globalization. In the pharmaceutical industry, this means that drugs are now manufactured, if not discovered, widely throughout the world, and sometimes in countries that are less vigilant than the United States in matters of safety and efficacy. Combine that with the other great phenomenon of the past 30 years—the globalization of information via the Internet—and you end up with a dilemma.

Consumers conducting simple Internet searches discovered that many prescription drugs could be bought more cheaply online from other countries. In addition, as drug products travel increasingly between various countries, it has become easier for counterfeit products to enter the supply chain.

The rise in counterfeiting has led to increased interest in anticounterfeiting technologies. Most attention has focused on radiofrequency identification (RFID). RFID tags are difficult for counterfeiters to copy and, unlike barcodes, do not require a line of sight. This technology also creates an electronic pedigree (epedigree) that records the chain of custody from the point of manufacture to the point of sale, making it easy to identify counterfeit products when they enter the supply chain.

Although RFID is encouraged by the US Food and Drug Administration, and several companies have participated in pilot studies of the technology, there are still some kinks to iron out before RFID can be widely adopted in the industry. One of the main problems is the lack of standardization of the chips so they can be read at every point in the supply chain. Currently, there are more than 100 types of chips with a wide band of frequencies.30

Regulation


Table II: Top 5* Regulatory Actions 1977-2007
No matter the technology, ingredients, or formulation a company has developed, in the end, it all boils down to regulation if the company wants its innovation on the market. Survey respondents felt that the "finalization of GMPs (21 CFR 210 and 211)" in 1978 and "21 CFR Part 11" in 1997 had an equally high impact (75%) on overall regulation in the past 30 years, with several respondents crediting GMPs as "landmark" policies that "changed the way we do business." Not only did the GMPs clarify standards for manufacturers—providing less room for error and safer drugs for users—but they also enabled FDA to enforce regulations.

Close seconds to the GMPs and CFR Part 11 were the 1987 "Guidelines on General Principles of Process Validation" (70%) and the more risk-based "GMPs for the 21st century" (67%) intiative.


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: Pharmaceutical Technology,
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