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Tablets & Capsules SDD
imageIn this issue of T&C Solid Dose Digest:
 
 
 
 
 
 
 
 
 
coperion

nilfisk
 
Ask An Expert
 
To outsource or not? That is the question.
 
Q: Can you provide some insights into choosing a contract manufacturing organization? How do I ensure that the partnership will meet my goals?
 
 
The continuing debate for mature, emerging, and virtual biopharmaceutical companies remains whether to outsource production to a contract manufacturing organization (CMO) or not. At its core, the issue is brand protection. While outsourcing can minimize your capital and labor costs, your challenge lies in the process of evaluating CMOs to identify the right one to serve as your manufacturing partner.
 
How can you minimize the potential for negative consequences, including damage to your brand and loss of market share and revenue?
 
 
Do you have a question for our experts? Send your questions to pwright@cscpub.com and we'll have an expert answer it.
 
vacumax

gamlen
 
More Questions and Answers
 
Isolation and containment equipment for highly potent active pharmaceutical ingredients (HPAPIs)
 
Q: HPAPIs are becoming more common in solid dose manufacturing. How can isolation and containment equipment help manufacturers ensure safe and pure environments for working with these toxic compounds?
 
imageA: Gerard Geiger, Nilfisk, says:
 
In the last 5 to 7 years, pharmaceutical manufacturers have focused on developing highly targeted drugs that can treat patients faster using lower doses. This shift has brought with it a rapid increase in the use of HPAPIs, which are extremely toxic and can cause irreversible health problems. By one estimate, more than 25 percent of drug products worldwide are highly potent [1].
 
Traditionally, many pharmaceutical companies have used a five-band system to categorize API toxicity and determine safe protocols for handling compounds. Under this system, toxic APIs, meaning those in the occupational exposure band (OEB) of 3 or higher, typically require engineered controls for dust containment, such as an isolator or a dust containment unit [2]. Recently, with the increase in HPAPIs, some companies have added a new category—OEB 6—to their categorization system to account for increased toxicity, heightening the challenge for solid dose manufacturers because even nano-sized particles of these chemicals are extremely toxic.
 
 
 
kikusui

jost
 
In Tablets & Capsules magazine
 
Tabletability, compactibility, and compressibility: What's the difference?
 
Robert Sedlock, Natoli Engineering
 
To patients and consumers, tablets are a simple and convenient dosage form. But the science behind compressing a block of particles or granules into a single tablet can be complicated. That's where common compression studies can help. This article explains how to develop tabletability, compactibility, and compressibility profiles.
 
Advances in compaction science have been instrumental in improving tablet product development, scale-up, and manufacturing. Today, a variety of tools can help formulators, product developers, and other industry professionals to better understand the manufacturing science and engineering behind this ubiquitous solid dosage form. These tools enable us to study tablet performance at the development stage using small quantities of material.
 
This article describes how to conduct common compression studies, including how to develop profiles of tabletability, compactibility, and compressibility. Those terms—which are commonly misused—have specific meanings and offer different ways to characterize the material under compression.
 
To learn more about this topic, you can read the article "Tabletability, compactibility, and compressibility: What's the difference?." You can also find articles under "Analytical techniques" and "Tablets and tabletting" in Tablets & Capsules' Article Archive.
 
 
natoli

cmc
 
Feature
 
On-dose authentication: Walking softly, prepared to stick
 
Peter M.O. Wong, TruTag Technologies
 
While the exact size of the problem is unknown, counterfeit drug products harm patients and pharmaceutical manufacturers. This article discusses why on-dose authentication (ODA) is a superior anti-counterfeiting and diversion-detection approach and how it can defray costs in other business areas.
 
Adulterated and unsafe drugs have threatened public safety since before President Theodore Roosevelt signed the Pure Food and Drug Act into law in 1906. Today, the distribution of counterfeit and/or uncontrolled medicines is an enormous problem, measured in the tens of billions of dollars [1]. The exact size of the problem is not known because of the illicit nature of the activity, but counterfeiting continues to attract sophisticated criminal organizations. Making fakes, after all, is a lucrative business for criminals. For drug manufacturers, however, counterfeiting—including adulteration and illegal diversion—reduces revenue, increases costs, exposes them to liability, and damages brand reputations. But most important, fake drug products put patients' lives at risk.
 
 
 
jrs

tc
March 13, 2017
 
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Supplier Resources
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Supplier Directory
 
Bottle Packaging
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Coating(s) & Equipment
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Services
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T&C Solid Dosage Sourcebook
 
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Events & continuing education
 
 
 
 
 
 
 
 
Find more events and continuing education opportunities at the Tablets & Capsules website, click here.
 
Send your feedback or questions to Peggy Wright at pwright@cscpub.com.
Peggy Wright
T&C Solid Dose Digest
Editor
pwright@cscpub.com
 
Kurt Beckman
T&C Solid Dose Digest
Designer
kbeckman@cscpub.com
 
Alison Hartman
T&C Solid Dose Digest
Circulation
ahartman@cscpub.com
 
 
 
 
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