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Excipients & Actives for Pharma
No. 26, 2011
BREAKING NEWS
Andreas Gryczke, BASF’s expert for hot-melt extrusion, will appear
at this year's AAPS with posters covering various aspects of this
innovative production technology.
The use of melt extrusion processes in the
pharmaceutical industry is a highly promising
approach to the various challenges presented
by current and future formulations.
Melt extrusion is still a recent development in
the pharmaceutical industry. So far, academia
and industry focused on getting to grips with
the basics of hot-melt extrusion. However, it
has been established that this new technology
has great potential for the formulation of drugs
containing poorly soluble or poorly permeable
active ingredients. The first commercial formulations
confirm this.
Since there is an increasing desire on the part
of the industry to make better use of this technology
in development and manufacturing, the
proposed sessions aim to provide ideas and
Posters at AAPS 2011 presented by
Andreas Gryczke, featuring the hot-melt
extrusion technique
• Small-scale miscibility screening for
solid dispersions in tablets prepared by
injection molding: a study on itraconazole
in combination with Soluplus ® .
• In-line monitoring of a hot-melt extrusion
process using near-infrared spectros
copy.
• Investigation of tablets made by injection
molding: R&D-stage manufacturing and
characterization of theophylline-PEO
tablets.
guidance on the various aspects of implementation.
These lectures are different from other
HME sessions, which have focused on educating
scientists on the basics. Instead, the proposed
sessions will deal with the process itself,
its implementation and its characterization. The
goal is to provide the industry and researchers
with insights into the process, its advantages
and disadvantages and to offer guidance on
how to mitigate problems using a risk assessment
approach when implementing this exciting,
pioneering technology.
Kollicoat ® IR and Kollicoat ®
SR 30 D to be published in the
Handbook of Pharmaceutical
Excipients
Kollicoat IR approved by Australian Department
of Health and Ageing
It has been announced that the two coating polymers
Kollicoat IR (ethylene glycol and vinyl alcohol
grafted copolymer) and Kollicoat SR 30 D
(polyvinyl acetate dispersion) are to be included
in the Handbook of Pharmaceutical Excipients.
Both polymers will appear in the online version
of the handbook as of August 2011, and in the
upcoming 7th edition of the print version. Together
with the monographs in the US and the
EU pharmacopoeias, the inclusion of Kollicoat IR
and Kollicoat SR 30 D underlines BASF’s continuous
efforts to bring safe and innovative coating
excipients to its customers – helping them them
tackle today’s and future formulation challenges
successfully.
Kollicoat IR, BASF’s 3rd generation instant release
coating, has already been approved by the
health authorities in Europe, Canada and Japan.
We are pleased to inform you that Kollicoat IR
is now also approved by the Therapeutic Goods
Administration (TGA) of the Australian Department
of Health and Ageing.
According to the TGA, Kollicoat IR (Polyethylene
glycol-polyvinyl alcohol graft copolymer) is considered
to be safe for use as an excipient in oral
medicines at concentrations of less than 5% in
the finished product.
Kollicoat IR is currently monographed in the following
pharmacopoeias:
• Ph.Eur monograph – Macrogol poly(vinyl alcohol)
grafted copolymer
• USP-NF monograph – Ethylene Glycol and
Vinyl Alcohol Graft Copolymer
Self-affirmed GRAS status is expected end of
2011; listing in the FDA’s Inactive Ingredients
database (IIG) in early 2012.
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