pharma & healthcare news november 2010

1

Publisher: Alsiano A/SCirculation: 650 copies

Editor-in-chief: Anders Hager

Coordinator, text, lay-out: Dorthe Andersson

Contents

Maximising yeast’s potential .................................1

Update - EU approvalof stevia ..................................2

AEROSIL® and SIPERNAT®

for free-flowing and non-caking sugars and sugaralcohols ...................................3

KLEPTOSE®: multifunctionalexcipients for molecularencapsulation .........................6

Heavy metals: an overviewof European legislation .........8

SEPIFILMTM - the break-through in moistureprotection ...............................9

The Alsiano Healthcareteam ......................................10

Maximising yeast’s health potential

Pharma & Healthcare News is published twice a year and distributed to customers and other interested parties. Reproduction of articles appearing in Pharma & Healthcare News requires prior consent of the author. Alsiano is not responsible for the content of articles written by external authors.

Pharma & Healthcare News AlsianoNo. 13 • November 2010

Lesaffre Human Care is presenting a new probiotic yeast for people suffering from intestinal discom-fort and Irritable Bowel Syndrome (IBS)

By Robin Wyers

Lesaffre Human Care has broadened its range of probiotic yeasts with Lyn-side Pro GI+, a probiotic yeast intend-ed for people suffering from intesti-nal discomfort such as that caused by Irritable Bowel Syndrome (IBS).

Lynside Pro GI+ is a Saccharomyces cerevisiae yeast targeted at intestinal discomfort. It was selected by Lesaf-fre among 6,000 proprietary strains and has been registered with the French National Collection of Micro-organism Cultures (CNCM). A patent application covering many different areas has been filed. Furthermore, many preclinical trials and one large clinical trial have been conducted successfully with Lynside Pro GI+, and two other clinical trials will have been carried out by the end of 2011.

A European Article 13.5 functional health claim has been submitted to EFSA, regarding the new probiotic yeast, Lynside Pro GI+. The proposed health claim is: “Noticeably reduces digestive discomfort after 4 weeks of consumption”.

Scientific supportSince 2005, preclinical trials (in-vitro, ex-vivo, in-vivo) have been ongoing with Lynside Pro GI+. These trials have demonstrated that the strain

• survives transit through the gas-trointestinal tract

• has anti-inflammatory properties• reduces the perception of intes-

tinal pain

One of the preclinical trials on the anti-inflammatory potential of sev-eral non-pathogenic yeast strains was published in the World Journal of Gastroenterology (May 2010). Two oral presentations were given at the American Digestive Disease Week convention in May 2010. The first presented the results of Lynside Pro GI+ on the modulation of bowel pain in preclinical trials, while the second presented interesting effects of Lynside Pro GI+ on the adhesion of entero-invasive Escherichia. coli in patients with Crohn’s disease.

In 2008, a large placebo-controlled double-blind randomised clinical trial was conducted with an international specialist of ... (continues >>)

2

Pharma & Healthcare News No. 13 • November 2010 Alsiano

Update – EU approval of steviaSince the positive safety opinion on steviol glycosides from the European Food Safety Authority in April this year, the process seems to continue as planned with approval expected in July 2011

• The end-products containing these stevia extracts will probab-ly be labelled “contains stevia glycosides”.

• The E-number (E 960) will most probably never be used on pro-duct labels.

• The maximum authorised use levels will probably be lower than the ones currently applying in France (for beverages in particu-lar) - this in order to be consistent with the current ADI and experi-ence gathered from the market.

• There are no news regarding a possible approval of unpurified extracts (crushed leaves in par-ticular).

• Within the European food and beverage sector, the interest for stevia is increasing as the date of approval is now almost official.

inflammatory bowel diseases, Profes-sor Pierre Desreumaux of the Univer-sity of Lille (France). In the clinical tri-al, 200 volunteers with symptoms of IBS took 500 mg/day of Lynside Pro GI+ (8x109 cfu/g) for 8 weeks. The scientists showed that:

• Intestinal pain and discomfort are greatly relieved after 4 weeks of taking Lynside Pro GI+ (signifi-cant difference between placebo and active product).

• Lynside Pro GI+ has favour-able effects on bowel disorders caused by IBS (abdominal/intes-tinal pain and discomfort, bloat-ing, flatulence and constipation).

These clinical results have just been presented by Professor Desreumaux at the United European Gastroen-terology Week in Barcelona (Octo-ber 2010). Publication will follow in 2011.

By Thierry Liot, Stevia Development Manager, Seppic

The approval of stevia is long await-ed, and the potential of this natural high intense sweetener is expected to be significant, especially as consum-ers are veering away from artificial additives towards ingredients with more natural perceptions.

On 29 September, the conference, Preparing for Stevia Approval, was held in London. The main messages delivered at this conference were the following:

• European approval of stevia ex-tracts (all grades complying with JECFA standards) is expected in July 2011. Furthermore, there should be no delay between the approval by the European Com-mission and the authorisation to launch products on the market.

Article 358

Article 357

>>

3


AEROSIL® and SIPERNAT® for free-flowing and non-caking sugars and sugar alcohols Avoid lumps in sugars and sugar alcohols with AEROSIL® fumed silica and SIPER-NAT® precipitated silica productsBy Evonik Degussa

Nearly everyone has discovered the downsides of hygroscopic carbohy-drates. Due to the high number of polar hydroxyl groups in those mole-cules, they greedily attract moisture from the environment. The con-cerned agglomerates and hard lumps as a consequence are difficult to process further. To ensure a conve-nient as well as an efficient handling of sugars without time and resource consuming measures to break ag-glomerates again, it is important to reduce caking and avoid formation of lumps reliably.

Examples of carbohydrates that bene-fit from the treatment with SIPER-NAT® precipitated silica or AEROSIL® fumed silica

• Fructose • Glucose • Lactose • Sucrose • Sugar substitutes, e.g. xylitol,

sorbitol and other polyols • Polysaccharides, such as mal-

todextrin, polydextrose or even starches

Reasons for carbohydrate agglomeration and prevention

As soon as the humidity in the en-vironment reaches a concentration specific to each carbohydrate, they immediately start taking up moisture from the vapour phase. This rela-tive humidity is defined as the water activity of the substance. At which point the carbohydrate commences absorbing water depends, amongst other things, on the chemical nature of the substance, its purity and its particle size. Impurities and smaller particle sizes increase the hygro-scopicity, which means that moisture is absorbed already at lower ambient humidity [1]. Figure 1 compares the water content of various sugars and

polyols depending on the relative hu-midity of the atmosphere. In figure 1, it can be seen that fructose tends to take up moisture already at relatively low humidity. It is one of the most hygroscopic carbohydrates, followed by polyols such as sorbitol and xylitol.

The absorbed water builds liquid bridges between the individual par-ticles causing them to agglomerate. At continued exposure to moisture, some amount of the carbohydrate becomes dissolved in this water and,

when dry again at lower relative humidity, the carbohydrate will re-crystallise resulting in solid bridges between the particles which lead to the formation of very hard lumps. This principle is demonstrated in fig-ure 2. SIPERNAT® precipitated silica and AEROSIL® fumed silica can pre-vent the formation of these liquid or even solid bridges. The silica absorbs the water film on the surface thereby breaking liquid bridges and avoiding growth of solid bridges. (continues >>)

Figure 1: Water uptake of various sugars and polyols depending on relative humidity in the atmosphere. [Based on 1, 2, 3]

Figure 2: Model describing caking and caking-avoidance by silica of moist and hygroscopic powders.

4


Additionally, the silica acts as a spacer preventing direct contact between the individual carbohydrate crystals. Especially very fine powders tend to cake as the small particles come into close contact with each other. Increasing the distance between the individual particles is important to reduce the attraction forces be-tween those small particles and thus improving the flowability of the fine sugar grades.

Detailed information on the mode of action of silicon dioxide to improve and ensure powder flowability can be found in the Technical Information 1351 “SIPERNAT® and AEROSIL® as Flow Aid and Anticaking Agent” [4].

Example: caking because of moisture uptake

As described in figure 1, xylitol is very hygroscopic; it tends to absorb mois-ture from the environment very fast. Even when stored at room tempera-ture and humidity levels well below the water activity of this polyol, it absorbs water and forms large lumps decreasing the flowability.

Defined glass funnels can be used to determine flow properties of pow-ders. The powder that flows out without interruption through a small-er outlet diameter of the funnel has a better flowability. Figure 3 (left side) shows the result of keeping xylitol in a sealed glass bottle at ambient con-ditions. It is obvious that the mate-rial is nearly completely caked and therefore not able to flow through the largest funnel opening. This poor flowability is classified as flow grade 7.

In contrast to this, when the polyol is treated with AEROSIL® fumed silica or SIPERNAT® precipitated silica, this is reliably avoided. An example of xy-litol treated with 1 wt% SIPERNAT® 50 S is shown in figure 3 on the right side. Under the same storage condi-tion, the particles do not agglome-rate or form lumps. It is still an easy-to-handle, free-flowing powder. It reaches the flow grade 3.

Figure 3: Xylitol (particle size max. 10% >250 µm, initial water content max. 0.5 wt%). Left: untreated Xylitol with flow grade 7. Right: treated with 1 wt% SIPERNAT® 50 S, flow grade 3. Mixing in tumbling-mixer type Turbula 45 rpm for 5 min. After storage at uncontrolled ambient conditions in closed glass bottles for approximately one week

Example: poor flowability because of small particle size

Another reason for poor flowability and caking of sugars is the size of the particles. The finer the powder, the worse the flow. In figure 4, a dis-accharide with a particle size of ap-proximately 130 µm on average was tested for its caking behaviour during storage at elevated temperature and humidity. With a texture analyser, the

hardness of the caked disaccharide was measured and the ability of vari-ous anti-caking aids to reduce this hardness was evaluated. The test shows that a dosage of less than 1 wt% of AEROSIL® or SIPERNAT® products is very efficient in reducing the hardness of the caked material. Figure 4 summarises the results of the test.

(continues >>)

Figure 4: 1-α-glucopyranosyl-1-α-glucopyranosid (mean particle size ~ 130 µm) treated with 1 wt% silica. Mixing conditions: vertical lab mixer (Somakon) for 0.25 or 0.5 minutes at 400 rpm. Storage at 30°C, 40% RHumidity for 4 days. Hardness deter-mines the force necessary to scratch off a certain layer of the caked material

>>

5


>>

Article 359

Besides the obvious reduction in hard-ness, the importance of adapting the mixing procedure can be seen in figu-re 4. Depending on the material itself, the silica used and the dosage, it is necessary to adjust the mixing time in combination with shear-intensity. In this case, short mixing time at me-dium shear intensity resulted in the best anti-caking effect. Furthermore, other tests have shown that to reduce the caking of very fine powders, sili-ca with fine particles itself offers the best performance like e.g. AEROSIL® 200 F.

Dustiness - another aspect to be taken into consideration

By reducing the adhesion forces of fine powders, the individual particles become freely movable and separate from each other. Because of this, it might happen that the dustiness of this powder increases. As dust is incon-venient and a possible irritant during manufacturing and packaging pro-cesses it needs to be avoided reliably.

When it comes to very fine powders, especially SIPERNAT® 350 outper-forms other flow aids with regard to both reduced caking and no dust. Here a dosage of about 0.4 wt% is already sufficient to reduce the cak-ing significantly without increasing the dustiness. Higher dosages might bring only a limited additional ad-vantage with regard to hardness of lumps, but there is the risk to gen-erate some dust. Consequently, the type of flow aid used and its dosage need to be optimised carefully.

Summary and Recommendation

Depending on the causes of caking and poor flowability of powdered sugars, the type of flow aid used and the mode of addition should be cho sen accordingly. In figure 5, the dif-

Figure 5: Reasons for caking of carbohydrates and mode of action of silica.

ferent reasons for caking and the ef-fects of silica are summarised.

• In case of hygroscopicity, mois-ture absorption is the main chal-lenge. Silica with a high absorp-tion capacity, such as SIPERNAT® 50 S, will be beneficial.

• When the particle size or fine-ness of the carbohydrate is the limiting factor for the flowabil-ity, flow aids like AEROSIL® 200 F or AEROSIL® 380 F are good choices. Because of their particle structure, they improve flowabi-lity of small-sized powders very efficiently.

• For special applications where, besides flowability, dustiness is an important aspect SIPERNAT®

350 offers a very good perform-ance. Because of its fine particle size, it improves flowability effici-ently, but does not increase dust

• For all powders, the mode of mixing the flow aid into the ma-terial has a significant influence on the effectiveness of the silica

Adapting the flow aid used, its dos-age and the way of processing it de-pending on the individual condition and requirements, will finally lead to a product with optimal powder and handling characteristics.

References [1] “Zucker und Zuckerwaren”, H.Hoffmann, W. Mauch. W. Untze, Behr’s Verlag, p53ff

[2] “Polyols in Confectionery”, British Journal of Nutrition (2001), 85, Suppl. 1, p31ff

[3] „Handbuch Alkoholfreie Erfrischungs-getränke“, Südzucker AG (1998)

[4] TI 1351 „SIPERNAT® and AEROSIL® as Flow Aid and Anticaking Agent“, Technical Informa-tion, Evonik Degussa GmbH, September 2008

Humidity

without silica

with AEROSIL® or SIPERNAT®

without silica

Particle size

Receive Pharma & Healthcare News by emailPharma & Healthcare News is also available electronically. Click into www.alsiano.com to subscribe. At our website you can also find all previous issues of our newsletter.

with AEROSIL® or SIPERNAT®

6


KLEPTOSE®: multi-functional excipients for molecular encapsulationMolecular encapsulation with native and modified cyclodextrins offers attrac-tive and alternative tools in formulation development By Elham Blouet, Pharmaceutical Project & Development Manager, Roquette

To cover the specific needs of the pharmaceutical and cosmetic indus-try, Roquette offers a range of KLEP-TOSE® products: β-cyclodextrins, hydroxypropyl β-cyclodextrins and methylated β-cyclodextrins.

The versatile excipient

Cyclodextrins (CDs), native and modi-fied, have the ability to form inclu-sion compounds through molecular encapsulation with a wide range of organic molecules. This ability makes the CDs and their derivatives valuable as formulation aids. They are used to increase aqueous solubility of poorly soluble drugs and consequently to avoid the use of organic solvents. Their use is also of great interest for improving physical and chemical stability of drugs (protection against

light, oxidation, etc.), for enhancing local tolerance of drugs and for any other applications where inclusion compounds would enable innovative solutions. Medicinal products con-taining cyclodextrins and their deriva-tives are world-wide marketed includ-ing, among others, oral, parenteral, topical and eye preparations.

Native cyclodextrins

CDs are cyclic oligosaccharides ob-tained from starch by enzymatic cyclisation using cycloglycosyltrans-ferases. They are composed of α-(1,4) linked glucopyranose subu-nits. Several native cyclodextrins ex ist; the most referenced ones being α-cyclodextrin, β-cyclodextrin and γ-cyclodextrin constituted of 6, 7 or 8 α-(1,4) glucopyranose units re-spectively. β-cyclodextrin (βCD) is the most accessible and useful one with a significant industrial usage.

KLEPTOSE® - main applications and benefits

Pharmaceutical field:

• Increase poor aqueous solubility of drugs with subsequently increased dissolution rate and hence improved bioavailability

• Increase physical and chemical stability of drugs (increase shelf-life and reduce time to market)

• Enhance local tolerance after topical or oral administration• Improve organoleptic properties of drugs (taste and/or odour masking)• Enhance drug delivery to and through biological membranes• Prevent drug-drug, drug-excipient interactions and drug-container inter-

action• Convert oily/liquid or volatile material into stable/microcrystalline powder• …

Cosmetics field:

• Fragrance masking or release• Delivery of specific substances• Enhancement of UV filter activity

• Reduction of local irritation

• …

KLEPTOSE®

Kleptose is Roquette’s brand name for β-cyclodextrin (βCD). The βCD molecule is a torus shaped ring. Due to the spatial distribution of its hy-droxyl groups, the βCD molecule has a polar hydrophilic outside and an apolar hydrophobic cavity. As a con-sequence of this particular structure, βCD is, when in presence of water, able to encapsulate or entrap guest molecules to form the so-called inclu-sion compounds.

βCD is a crystalline, homogeneous, non-hygroscopic substance with a low aqueous solubility (approx.1.85% at room temperature). It is currently considered to be an essentially non-toxic and non-irritant ingredient, au-thorized for food applications and used in oral and topical pharma-ceutical applications. Due to its ne-phrotoxicity, βCD is not suitable for parenteral applications. (continues >>)

Advantages for HPβCD for the pharmaceutical industry and patients

7


Modified cyclodextrins

The native CDs can be chemical-ly modified by hydroxyalkylation, alkylation or sulfoalkylation. The prin-cipal aim of such modification is to increase the solubility of the parent native cyclodextrins.

The hydroxypropyl betacyclodextrin (HPβCD) has the highest aqueous solubility (65% at 25°C) and com-bined with its safety profile it repre-sents an ideal profile for pharmaceu-tical applications. The high aqueous solubility of modified cyclodextrins HPβCD allows extension of the appli-cations as the method of preparation of the inclusion compounds is easier compared to native βCD (in aqueous solution versus in semi-solid state, “kneading method”). Thanks to its safety profile, the HPβCD is a suitable excipient for parenteral applications as well as for oral, topical and oph-thalmic applications.

KLEPTOSE® HPB / KLEPTOSE® HP

Roquette has developed a range of substituted HPβCD with different de-grees of substitution (DS = number of hydroxypropyl groups per mol-ecule of βCD) as described by the Molar Substitution value (MS = aver-age number of hydroxypropyl groups per anhydroglucose unit). KLEPTOSE® HPβCD derivatives, KLEPTOSE® HPB and KLEPTOSE® HP - are suitable for the cosmetic and pharmaceutical industries, including a pyrogen free grade produced under cGMP condi-tions for parenteral applications.

KLEPTOSE® CRYSMEB EXP

The pioneering product, ROQUETTE’s KLEPTOSE® HPB derivative, has now been successfully marketed and used for several years. KLEPTOSE® CRYS-MEB EXP is a second-generation product which has several advantages including the possibility of increased solubilization power while maintain-ing a high biological tolerance.

KLEPTOSE® CRYSMEB EXP is a mix-ture of methyl βCD containing on average 4 methyl groups per native βCD molecule (i.e. a typical MS of 0.57). Due to its high aqueous solu-bility (20% at 20°C), it dissolves easily in water (unlike βCD), and solubility increases with temperature.

As with the KLEPTOSE® HPB, the KLEPTOSE® CRYSMEB EXP can be used in pharmaceutical applications with different aims:

• to increase water solubility and rate of dissolution of poorly solu-ble drugs

• to increase the rate of transfer of a drug from solution into tissue without damaging the tissue

• to reduce side effects of active ingredients

• to reduce bitterness or unpleas-ant odour of some drugs.

KLEPTOSE® CRYSMEB EXP can also be used in cosmetics for different aims, in particular for solubilization or stabilization of ingredients.

Early preliminary toxicological infor-mation indicates that this methyl βCD shows potential for the development of injectable products and should be further investigated by formal toxicity studies.

Grades

Article 360

>>

8

FoodNews No. 1 • February 2004 AlsianoPharma & Healthcare News No. 13 • November 2010 Alsiano

Heavy metals: an overview of European legislation

Article 361

Jost Chemical, who offers minerals that meet the most restrictive levels in the EU regulation, provides here a brief sum up of the new legislation on heavy metals in connection with minerals

By Jost Chemical

In order to improve the protection of human health, European regulations are getting more and more precise and restrictive regarding the levels of contaminants in food and nutritional products.

As far as heavy metals are concerned, there is a number of existing regula-tions that concern mineral salts.

Is my mineral salt a food additive?

Some mineral salts are considered food additives (e.g. Ca carbonate, Ca citrate, Ca gluconate, Ca hydroxide, Fe gluconate, Fe lactate, K gluconate, …)

These must be in compliance with the purity criteria defined for food additives described in the regulation 2009/10/EC of 13 February 2009 amending Directive 2008/84/EC.

What about the recent regula-tions 2006/1881/EC and 2008/629/EC which set limits on contami-nants in foodstuffs and food sup-plements?

As indicated, these regulations define the maximum levels of heavy metals in the final products (foodstuffs and food supplements) as Pb<3ppm, Cd<1ppm, Hg<0.1ppm).

Raw materials, including mineral salts, are not directly concerned. However, in food, and especially in food supplements, a high concen-tration of mineral salts can occur in some products (multi-mineral food supplements, for instance, or Zn-en-riched product).

What about the existing or future local regulations?

In addition, local regulations based on 2006/1881/EC and 2008/629/EC setting limits for heavy metals levels in raw material could appear in the short term.

In France, there is already a local regu-lation applicable to products that are not in the additives list and for which there is no existing monograph (USP, EP, FCC, …): these products (Zn lac-tate, Cu oxide, Cu citrate, Mn lactate, …) must comply with the following specifications: Pb<5ppm, As<2ppm, Cd<1ppm, Hg<1ppm.

Guaranteed high-purity mineralsJost Chemical has been pro-ducing guaranteed high-purity minerals for nearly 25 years and is now also well-known for the development of a new technology for manufacturing of ultra-pure calcium salts for infant for-mulations and drink applica-tions.

In order to offer our customers an added value to face these new regulatory challenges, Jost Chemi-cal has decided to offer dedicated products whose specifications include a compilation of the most restrictive levels in the EU regulations: Pb<1ppm, As<1ppm, Cd<1ppm and Hg<0.1ppm.

8

9


Reduced moisture permeability

Water vapour transmission rates have been measured on four film coatings. The results, which are shown in the graph below, demonstrate that SEPI-FILM™ LP shows significantly lower moisture permeability compared to

SEPIFILM™ LP - the breakthrough in moisture protectionSEPIFILM™ LP is a ready-to-use, gastro-soluble composition for film coating of moisture sensitive solid particles

By Seppic

SEPIFILM™ LP is a granular co-pro-cessed formulation which guarantees a homogenous formulation, an easy handling without dust, and a fast and easy dispersion without generation of lumps.

SEPIFILM™ LP is typically formulated from the following ingredients:

• Film forming agent: HPMC• Binder: cellulose• Hydrophobic plasticiser: stearic

acid • Colorants: pigments, lakes

SEPIFILM™ LP contains microcrystal-line cellulose which makes it possible to decrease coating time, to enhance the film adhesion, and to avoid logo bridging.

Tablets coated with SEPIFILM™ LP ex-hibit an improved resistance to mois-ture, allowing the use of higher per-meability packaging materials.

Unlike tacky PVA formulations or acrylic polymers, SEPIFILM™ LP is easy to handle, process, and clean as a classic coating based on HPMC.

Regulatory status

• Pharmaceutical applications: constituents of SEPIFILM™ LP

SEPIFILMTM LP

• Improves stability of moisture sensitive actives

• Improves stability of hygroscopic formulations

• Global acceptance: pharmaceu-tical and food/nutritional appli-cations

• Easy handling, fast and easy dis-persion

• Disintegration time not modified

comply with current editions of European, US and Japanese pharmacopoeias.

• Food applications: constituents of SEPIFILM™ LP are allowed for food applications in Europe and USA.

• For dyes: permission of use may differ from one country to anoth-er. Please consult us for specific requests. Our colour guide can help you in your choice.

classic HPMC or PVA based formula-tions.

Dissolution profileAs shown in the chart below, SEPI-FILM™ LP does not significantly change the dissolution profile of coated tablets. (continues >>)

Mg

/ h

m

Water vapour transmission rates Dissolution test of coated Theophyllin tablets

Dis

solv

ed T

heo

ph

yllin

(%

)

SEPIFILMTM LPclear

SEPIFILMTM LPwhite

HPMC + PEG400

PVA

120

100

80

60

40

20

0HPMC 15cps

SEPIFILMTM LP761

HPMC +TiO2 + PEG

Time(min)

10


The Alsiano Healthcare teamIt is always nice to be able to put a face on the person you talk to over the telephone or e-mail. So here we are ...

Lene Baldasano del Valle

Logistics manager

E-mail: [email protected]. dir.: +45 8230 0015

Logistics

Key accounts

Anders Hager

M.Sc. Chem.Sales manager

E-mail: [email protected]. dir.: +45 8230 0026Mobile: +45 2618 8545

Pharmaceuticals - cosmeticshealth & nutrition

Lene Aarøe Nissen

B. Chem. Eng.Area sales manager


Sales support

Birgitte Falkensteen

Sales assistant


Malene Rask Harder

Sales assistant


Sales support

Pharmaceuticals - cosmeticshealth & nutrition

Annette Strarup

B.Sc. (Hons.) Chem. Eng.Area sales manager


Pharmaceuticals - Fermentation

Annette Jarlskov

M.Sc. Food ScienceArea sales manager


Signe Mørck

Sales assistant


Sales support

Good Manufacturing Practices (GMPs)

In addition to its ISO 9001 and ISO 14000 certifications, SEPPIC follows the IPEC1 Good Manufacturing Prac-tices guidelines for its SEPIFILM™ and SEPISPERSE™ Dry product lines.

SEPPIC was also successfully audited by the French Drug Agency (AFS-SAPS2) according to the BPF part II (ICH-Q7A)3 guidelines. Injectable and oral route excipients, which in-clude SEPIFILM™ and SEPISPERSE™ Dry product range, were audited.

1IPEC : International Pharmaceutical Excipient Council2AFSSAPS : Agence Française de Sécurité Sani-taire des Produits de Santé (the "French FDA")3ICH-Q7A: International Conference of Har-monization. Q7A: Good Manufacturing Prac-tices for Active Pharmaceutical Ingredients

NotaThe analytical specifications warranted are only those mentioned on the certificate of analysis supplied with each delivery of the product. Except as set forth above, SEPPIC* makes no warranties, whether express, implied or statu-tory, as to the product which is the subject of this document. Without limiting the generality of the foregoing, SEPPIC* makes no warranty of merchantability of the product or of the

fitness of the product for any particular pur-pose.Buyer assumes all risk and liability result-ing from the use or sale of the product, wheth-er singly or in combination with other goods. The information set forth herein is furnished free of charge and is based on technical data that SEPPIC* believes to be reliable. It is intend-ed for use by persons having technical skill and at their own discretion and risk. Since condi-tions of use are outside SEPPIC*'s control, SEP-PIC* makes no warranties, express or implied, and assumes no liability in connection with any use of this information. Nothing herein is to be taken as a license to operate under or a recom-mendation to infringe any patents

Article 362

>>

We thank all our customers for a good cooperationduring 2010 and wish you a Merry Christmas and a Happy New Year

pharma & healthcare news november 2010

Documents