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

vacumax
 
Feature
 
FDA warning letters cite drug manufacturers for failing to test excipients or verify COAs
 
John Giannone, Michael Rashed, Peter Claise,
and Doug Podolsky, USP
 
This article discusses the recent increase in FDA warning letters citing cGMP violations related to excipients and describes USP's analysis of the excipient-related warning letters issued from 2013 through 2018. It also explains how USP's programs and resources can help drug companies comply with FDA regulations.
 
 
 
recro

kikusui
 
Ask an Expert
 
Multilayer and core tableting
 
Q: What are the benefits of multilayer and core tableting?
 
 
Currently about two-thirds of all prescription drug products are solid dosage forms. Many of these products provide a combination of immediate and extended or delayed release of one or more active pharmaceutical ingredients (APIs). With the increased production of high-potency formulations and specialized solid dose applications in recent years, pharmaceutical companies are increasingly turning to innovative oral drug delivery systems such as multilayer and core tableting technologies.
 
 
 
camfilapc

jrs pharma
 
More Questions and Answers
 
Formulating with complex APIs
 
Q: How can we reduce the challenges of formulating drug products with complex APIs?
 
 
imageAbout 90 percent of API molecules in the discovery pipeline are water insoluble, contributing to bioavailability challenges [1]. Pharmaceutical developers use special methodologies—such as spray drying and micronization—to improve the solubility and bioavailability of such poorly soluble APIs. However, successfully formulating a final dosage form and designing an appropriate manufacturing process with APIs prepared using such complex methods can be challenging.
 
 
 
gelita

mfgtray
 
In Tablets & Capsules magazine
 
Recent in vitro release testing activities, including FDA and USP
 
 
The FDA, USP, and the dissolution testing community have been very active in providing increased guidance for tablet and capsule dissolution. The areas specifically include immediate-release dosage forms, disintegration, capsules, split tablets, discriminatory methods, and alcohol dose dumping.
 
To learn more about this topic, you can read the article "Back page: Recent in vitro release testing activities, including FDA and USP.." You can also find articles under "dissolution testing" in Tablets & Capsules' Article Archive.
 
 
wilson

jost
 
Industry news
 
 
 
 
 
 
 
 
 
natoli

tc
 
Supplier news
 
 
 
 
To find more information about equipment suppliers at the Tablets & Capsules website, click here.
 
 
Events and continuing education
 
 
 
 
 
 
 
 
 
 
 
 
To find more events and continuing education opportunities at the Tablets & Capsules website, click here.
 
October 14, 2019
 
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Supplier Resources
click below for more info
 
natoli
 
jrs pharma
 
jost
 
wilson
 
gelita
 
camfil
 
mfgtray
 
kikusui
 
vacumax
 
recro
 
nilfisk
 
Supplier Directory
 
Capsule Filling Equipment
Vac-U-Max

Coating
(Equipment & Coatings)

JRS Pharma

Contract Formulation/
Manufacturing & Packaging

Recro Gainesville

Conveying/Mechanical
VAC-U-MAX

Dedusters
Natoli Engineering

Dust Collectors/Filters
Camfil APC
Nilfisk Industrial Vacuums
VAC-U-MAX

Excipients
Gelita
Jost Chemical
JRS Pharma

Feeders
VAC-U-MAX

Inspection Equipment
Natoli Engineering

Lifters
VAC-U-MAX

Metal Detectors/X-Ray Detectors
Natoli Engineering

Mixers & Blenders
VAC-U-MAX

Pneumatic Conveying
Nilfisk Industrial Vacuums
VAC-U-MAX

Services
Natoli Engineering
VAC-U-MAX
Wilson Tool

Softgels
MFG Tray Company

Storage/Bulk Handling
MFG Tray Company
VAC-U-MAX

Tablet Presses
Kikusui USA Inc.
Natoli Engineering

Testing Equipment
Natoli Engineering

Tooling
Natoli Engineering
Wilson Tool

Vacuum Cleaners
Nilfisk Industrial Vacuums
VAC-U-MAX

Weighing Equipment
VAC-U-MAX
 
T&C Solid Dosage Sourcebook
 
sourcebook

Send your feedback or questions to Peggy Wright at pwright@cscpub.com.
Peggy Wright
T&C Solid Dose Digest
Editor
pwright@cscpub.com
 
Kyle Myers
T&C Solid Dose Digest
Circulation
kmyers@cscpub.com
 
Kurt Beckman
T&C Solid Dose Digest
Designer
kbeckman@cscpub.com
 
Nate Todd
Tablets & Capsules
Editor
ntodd@cscpub.com
 
 
 
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