Major Advantages of Alpex`s “fast melt technology

Transcription

Major Advantages of Alpex`s “fast melt technology
ALPEX FP Profile
4/3/05
3:51 pm
Page 1
Fast Release Technology from Switzerland
Alpex Pharma is a drug delivery company focused on the
development and commercial manufacture of effervescent and
proprietary rapidly dissolving (fast melt) pharmaceutical and
nutraceutical products. The predominant focus for Alpex Pharma
is the development of solid dosage forms to deliver drugs
directly into the oral cavity in order to potentially improve the
bioavailability of drugs and at the same time, improve patient
compliance and convenience. Alpex Pharma has 20 years of
cGMP manufacturing experience and formulation development.
Alpex Pharma was established in 1985 and was managed from
1992 by Elan Corporation as Elan Pharma SA. The majority of its
share capital was acquired in 2004 by Private Equity Funds
managed by Sanders Morris Harris, USA. Alpex Pharma, which
currently employs about 70 people, is conveniently located in a
state of the art, cGMP 7’000 sq. meter facility, housing 2
independent dedicated plants for Pharmaceutical and
Nutraceutical Products in Mezzovico, Switzerland, approximately
15 kilometers north of Lugano and 75 kilometers north of
Milan,150 Km south of Zurich.
“fast melt technology” is being used for a Wide Range of
Pharmaceutical Products:
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Alpex Pharma employs a unique patent protected process
for the manufacturing of fast melt tablets.
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Alpex Pharma’s tablets have a significant advantage, as
they are robust enough to be filled into bottles and shipped
in bulk and do not have strict restrictions for drug loading
or use of taste masking technologies.
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Clinical studies – efficacy of fast melt approach has been
proved “in vivo” by many bioavailability/bioequivalence
studies conducted on Alpex Pharma products, where in all
cases the fast melt product is bioequivalent or
super-bioequivalent to the reference product.
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Alpex Pharma believes that the fast melt technology has
the potential to become the platform for a wide range of
drugs, as is evidenced by the significant number of fast
melt products on the market. Fast melt technology can be
applied across many therapeutic categories: Analgesics
/Inflammation, Parkinson’s Drugs, Migraine, Hypnotics /
Narcotics, Antacids / Ulcer, Erectile Dysfunction Drugs,
Anti-diarrhea’s, Cough/Cold/Flu remedies, Anti-emetics,
Cardiovascular, Antihistamines, Irritable Bowel.
Capabilities include:
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fast melt technology
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formulation development •
taste masking
effervescent technology
contract manufacturing
Major Advantages of Alpex’s
“fast melt technology” include:
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Convenient dosage form at any time and place, can be
taken without water
Easy to use for swallowing disorder
patients – a high proportion of
population have swallowing disorders,
dysphasia
Potential faster onset of action than
conventional oral dosage forms
Increased patient compliance
Broad applicability to many therapeutic categories
Proprietary Patented Technology
Life-cycle management, expanded patent protection
High drug concentration, up to 500 mg / tablet
Marketing advantage – offering greater choice to patients
and consumers
Major Advantages of Effervescent
Technology include:
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Better and faster absorption
Improved gastric tolerability because buffered solution
Optimal concentration distribution
Suitable for patients with swallowing
disorders
Simple handling and measuring into
exact doses
Increase in liquid intake
Patient compliance
For more information, please contact:
Alpex Pharma SA –Via Cantonale
CH-6805 Mezzovico – Switzerland
Tel: +41 (0) 91 935 51 10
Fax: +41 (0) 91 935 51 20
E-mail: [email protected]
www.alpex.com