spacer
home > pmps > spring 2007 > unmasking the blind of over-encapsulation
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Unmasking the Blind of Over-Encapsulation

Richard Shannon at Almac Clinical Services, assesses the impact of over-encapsulation in the clinical supplies industry

A study conducted by the Tufts Center for the Study of Drug Development estimated that the cost of bringing a novel compound to market is in excess of $800 million, so the need to prove superior efficacy and safety when compared to an already marketed product is of critical importance. When developing protocol designs, blinding or masking of clinical supplies is an integral part of many studies. This can help remove both investigator and patient bias due to the visibility of the marketed product, and can limit any potential placebo effect. One of the extensively used mechanisms available to sponsor companies to promote blinding is the over-encapsulation of tablets or capsules.

Over-encapsulation is now a widely accepted mechanism used throughout the clinical supplies industry, and while the process itself may appear relatively straightforward, packaging for clinical supplies is a complex process that is strictly controlled by good manufacturing practice (GMP). The principle of overencapsulation is simply the addition of a product or products to a hard gelatin capsule, which may or may not be backfilled with an inactive bulk agent or excipient. This process can be used for comparator products, investigational medicinal products (IMP) and/or placebos, providing an output of visually identical capsules for each product or strength, thus maintaining the blind and removing any potential bias.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Richard Shannon joined Almac Clinical Services (formerly Clinical Trial Services) in 1999 and has served in various business development functions during this time. He began his Almac career in Europe, before relocating to Almac, US, in 2001, where he gained valuable insight into the US clinical trial supply market and was integral in establishing a new business development team. Richard returned to Almac Europe in October 2005, and was appointed Head of Business Development (Europe). Prior to joining Almac, Richard was employed by MDS Harris (now MDS Pharmaservices) where he performed various clinical trial conduct roles. Richard holds a BSc (Hons) from Queen’s University, Belfast.
spacer
Richard Shannon
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Registration Opens for Inaugural HPAPI USA Conference in October

The HPAPI global market is growing at an ever-increasing rate of CAGR at 8.6% that is projected to reach USD $31.56 Billion by 2025, with a significant segment market of HPAPI being oncology ADC which is at a CARG of a staggering 20%. The continual elevation of HPAPI potencies along with toxicity will further drive the needs for more cutting-edge containment solutions and best practices guidelines to ensure workers safety.
More info >>

White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
More info >>

 
Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement