Tablets & Capsules magazine with technical articles and North American manufacturer links

Monday, September 06, 2010

Industry Update

Current Issue

Tablets & Capsules is the only technical publication devoted exclusively to readers in the tablet and capsule processing industries.

Cover photo courtesy of Asahi Kasei America

Complete table of contents

				This Month's Focus: Capsules and Capsule Filling & Excipients
		Special: Desktop Reference article: Micro-dosing equipment fills niche in R&D, clinical trial materials (Free) Lab work often involves repetitive, tedious tasks that are better handled by automation. Learn how micro-dosing equipment from three manufacturers speeds dosing, reduces errors, and frees personnel to pursue other activities. This updates a March 2009 article. Desktop Reference article: The fundamentals of optimizing machine and product yields in capsule filling operations (Free) This article identifies the core areas that, if well practiced, lead to successful capsule filling operations. Desktop Reference article: Breaking-force tests for empty and filled hard capsules and softgels This article discusses the benefits of conducting breaking-force tests on hard capsules and softgels. It also describes how to perform breaking-force tests and briefly assesses test results. Desktop Reference article: Asymmetric membrane capsules: A means for controlling drug release, even with a membrane defect This brief article describes how a non-disintegrating capsule system—previously optimized with and without an intentional defect—was used to deliver a poorly water soluble API and a readily water soluble API in a controlled manner. API release was not influenced by the defect. Rethinking neat-API capsule filling for Phase I clinical trials (Free) This article discusses the advantages and the disadvantages of filling capsules with API only (no excipients) for use in Phase I clinical trials. A case study illustrates how filling neat API into capsules can be problematic. Selection of non-synthetic disintegrants for pharmaceutical and nutraceutical orally disintegrating tablets The purpose of this study was to broaden the applications of mannitol-based orally disintegrating tablets (ODTs) by screening disintegrants suitable for pharmaceutical and nutraceutical applications. Formulations developed in this study meet nutraceutical market claims such as "no animal source," "natural source," "reduced calories," and "non-synthetic." Orally disintegrating tablets: Gaining momentum This article discusses why ODTs are destined for more widespread use and provides an overview of formulation, manufacturing, and business issues. General Features Spotlight on Nutraceuticals: Clearing the regulatory hurdles to bring a supplement product to market This article addresses the regulatory hurdles facing the dietary supplement industry--including product claims and labeling--and discusses laws and regulations to follow in order to successfully launch, market, and sell a dietary supplement. Accounting for differences in TSM and EU tooling Learn about the differences between US and European standard tablet press tooling and how those differences may complicate shifting production from one tablet press to another. Back Page: Eliminating magnesium stearate from tablets (Free) Tablets must deliver accurate doses of active pharmaceutical ingredients (APIs)—typically verified by dissolution testing—and that requires scrutinizing the function and effectiveness of every tablet excipient, including magnesium stearate. Magnesium stearate acts as a lubricant, helping powder formulations flow and preventing tablets from binding in the die and sticking to the upper punch. Its effectiveness as a lubricant has made magnesium stearate the most common excipient in tablets, but it has drawbacks. Perhaps the most serious of these is its slowing of dissolution, which may compromise delivery of the API. This, among other reasons, has led the pharmaceutical industry to seek alternatives.