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Wednesday, March 27, 2013

Formulating and Producing Tablets Containing Large, Coated Multiparticulates
By lya.machado@patheon.com @ 3:16 PM :: 141 Views :: 0 Comments ::

:: Process Development and QbD

Compared to bead-filled capsules, tablets are associated with better patient compliance, less risk of tampering, and lower production costs. However, the challenges of tabletting coated multiparticulates limit their production. This article summarizes how to formulate and establish process parameters for producing tablets that contain large, coated multiparticulates that perform as designed. Published in Tablets and Capsules, March 2013.

Monday, September 17, 2012

The Effect of Overencapsulation on Disintegration and Dissolution
By ann.roberson@patheon.com @ 2:47 PM :: 30727 Views

This article examines the disintegration and dissolution profiles of propranolol and rofecoxib tablets overencapsulated with standard hard-gelatin capsules and with capsules specifically designed for double-blind clinical trials.

Monday, September 17, 2012

Quality by Design: A Contract Organization’s Perspective
By ann.roberson@patheon.com @ 2:36 PM :: 2173 Views :: 6 Comments ::

:: Process Development, Quality by Design (QbD)

This article discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes. This article is part of a special issue on outsourcing.

Monday, September 17, 2012

Optimizing Pharmaceutical Products Using Formulation Science
By ann.roberson@patheon.com @ 2:32 PM :: 1348 Views

Approval of new drug products that treat unmet medical needs held steady or declined over the last decade. This article summarizes techniques for formulating poorly water-soluble APIs and how selecting the right outsourcing partner can accelerate development.

Monday, September 17, 2012

Parallel Screening
By ann.roberson@patheon.com @ 2:28 PM :: 1173 Views

Improving the bioavailability of poorly soluble new chemical entities is a leading challenge in drug development. Parallel screening is a cost-effective concept for selecting a suitable drug delivery system to enhance the chance of achieving the bioavailability target in the clinic.

Monday, September 17, 2012

Managing CMOs with Complementary Capabilities
By ann.roberson@patheon.com @ 2:22 PM :: 1631 Views

This article examines how the requirements for progressing a drug through to clinical trials include analytical characterization of the molecule, production of drug substance, manufacture of drug product, analytical method development and validation, and formulation development.

Monday, September 17, 2012

Bridging the Gap Between Early Phase Development and Commercialisation
By ann.roberson@patheon.com @ 12:19 PM :: 33089 Views

The challenge of taking a drug candidate from discovery through to market should not be underestimated, as there can be many hurdles to face along the path. This article discusses how the careful use of external contractors during development can alleviate some of these challenges.

Monday, September 17, 2012

Formulation Strategies for Poorly Soluble Drugs
By ann.roberson@patheon.com @ 11:42 AM :: 1394 Views

With the advent of combinatorial chemistry and high throughput screening, the number of poorly soluble drug candidates has dramatically increased. The "drugability" of new chemical entities (NCEs) and life-cycle management of marketing pharmaceutical products are becoming more challenging.

Monday, September 17, 2012

CDMO Industry Update: the Worst of Times... or the Best?
By ann.roberson@patheon.com @ 11:36 AM :: 1102 Views

This article discusses how the current economic condition could provide an opportunity for the CDMO industry to grow the scope and importance of its contribution to the overall pharmaceutical industry.

Monday, September 17, 2012

Disposable Technologies for Fill-Finish of Clinical Trial Materials
By ann.roberson@patheon.com @ 11:05 AM :: 1034 Views

This article examines the use and advantages of disposable technologies in the fill-finish of sterile pharmaceutical products and how these technologies can reduce costs and time in producing clinical trial materials.

Tuesday, September 04, 2012

The Changing Environment for Pharmaceutical Development Scientists
By host @ 11:02 AM :: 3192 Views :: 34 Comments ::

:: Biologics

AAPS has created a task force to review the changing nature of the pharmaceutical industry, especially with respect to the shift from big pharma to small and emerging companies and any potential impact on AAPS going forward. In this article,

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