Vraag & antwoord
Chondroïtine sulfaat in Arthro-5
Arthro-5
Arthro-5
1
anoniem
Is dit gecontroleerd op BSE?
Powersupplements
Arthro-5 bevat chondroitine sulfaat van de #1 fabrikant in de wereld, het Spaanse BioIberica. Dit bedrijf staat bekend om de uitmuntende kwaliteit chondroïtine die het levert en die ook wordt gebruikt in wetenschappelijk onderzoek. Het product is gegarandeerd vrij van BSE (veroorzaker van de gekke koeienziekte). In onderstaande tekst, helaas alleen beschikbaar in het Engels, staat een uitleg van BioIberica over de garanties hiervoor.
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As Scientific Medical Director of BIOIBÉRICA S.A. (world leader in the manufacturing of chondroitin sulfate) we would like to make it clear that chondroitin sulfate is a safe and BSE-free product for the following reasons:
- First of all, chondroitin sulfate is NOT a processed protein. SODIUM CHONDROITIN SULFATE is a natural sulfated glycosaminoglycan formed by the polymerisation of a disaccharide unit composed of a N- acetylgalactosaminesulfate unit linked to glucuronic acid. It is obtained by enzymatic hydrolysis from cartilaginous tissue, undergoing a stepwise purification.
- Secondly, it is important to state that the animal tissue used in the manufacture of sodium chondroitin sulfate - cartilagenous tissue - belongs to category IV of “no detectable infectivity” in the same group as milk. (1).
- Regarding the source of animals, BIOIBERICA, S.A. selects the raw materials from countries which are not cited in 9CFR94.18., that is, official BSE-free countries (2) Moreover, the slaughterhouses from where the raw materials are collected are authorised and regulated by official veterinarians, who declare the animals fit for human consumption. The corresponding veterinary certificates are issued, accompanying the raw materials to identify their origin.
- The production process from BIOIBÉRICA comprises a strong alkaline treatment (1 N sodium hydroxide for 1 hour at 25ºC), which has been reported to be one of the few chemical compounds able to inactivate BSE agents in the European Union and validated by external audit by RBM (Italy).
- Inveresk Research (UK) also carried out in 1998, an assessment of the methods used in the control of prion contamination in BIOIBERICA, S.A. They concluded that chondroitin sulfate from BIOIBÉRICA is completely BSE- free.
- As a clinical point of view, there are several clinical trials conducted in Europe which evidence the efficacy and safety of this drug in osteoarthritis. (3, 4, 5, 6). It should be borne in mind that it is approved as a drug in several European Union countries such as: France, Austria, Italy, Portugal as well as Switzerland and Eastern Countries. Each of these countries have presented Drug Master Files (DMFs) of the product approved by their respective Drug Agencies. Also, it is noteworthy, that in some European Union countries, such as France, it has been administered for more than 10 years now without any serious adverse effects, according to the available pharmacosurveillance data in Europe.
- At the same time, we would also like to state that, at present, sodium chondroitin sulfate manufactured by BIOIBERICA, S.A. is being used by the National Institutes of Health in the U.S.A. as the active ingredient for the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT). The corresponding Investigational New Drug Application number (IND) is 59,181. Also, BIOIBÉRICA submitted its Drug Master File of chondroitin sulfate to the FDA (registration number: 13.107) in August 1998.
For these reasons, we can state that chondroitin sulfate is a sugar and thus it is a safe product without any possible risk of BSE-infection.
José Vergés MD, MSc, PhD
Clinical Pharmacologist
Member of the American Society of Clinical Pharmacology and Therapeutics
Scientific Medical Director, BIOIBÉRICA S.A.
References:
1. Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products. EMEA/410/01 FINAL.
2. http://www.access.gpo.gov/nara/cfr/index.html
3. Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol 1996; 23 (8): 1385-1391.
4. Uebelhart D, Thonar EJMA, Zhang J, Williams J.M. Protective effect of exogenous chondroitin 4,6 –sulfate in the acute degradation of articular cartilage in the rabbit. Osteoarthritis and Cartilage (1998) 6, (Supplement A): 6-13.
5. Bucsi L, Poór G. Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow-acting drug for osteoarthritis (SYSADOA) in the treatment of knee osteoarthritis. Osteoarthritis and Cartilage (1998) 6, (Supplement A): 31-36.
6. Leeb F, et al. A meta-analysis of chondroitin sulfate in the treatment of osteoarthritis. The Journal of Rheumatology 2000; 27: 1: 205-211.
---
As Scientific Medical Director of BIOIBÉRICA S.A. (world leader in the manufacturing of chondroitin sulfate) we would like to make it clear that chondroitin sulfate is a safe and BSE-free product for the following reasons:
- First of all, chondroitin sulfate is NOT a processed protein. SODIUM CHONDROITIN SULFATE is a natural sulfated glycosaminoglycan formed by the polymerisation of a disaccharide unit composed of a N- acetylgalactosaminesulfate unit linked to glucuronic acid. It is obtained by enzymatic hydrolysis from cartilaginous tissue, undergoing a stepwise purification.
- Secondly, it is important to state that the animal tissue used in the manufacture of sodium chondroitin sulfate - cartilagenous tissue - belongs to category IV of “no detectable infectivity” in the same group as milk. (1).
- Regarding the source of animals, BIOIBERICA, S.A. selects the raw materials from countries which are not cited in 9CFR94.18., that is, official BSE-free countries (2) Moreover, the slaughterhouses from where the raw materials are collected are authorised and regulated by official veterinarians, who declare the animals fit for human consumption. The corresponding veterinary certificates are issued, accompanying the raw materials to identify their origin.
- The production process from BIOIBÉRICA comprises a strong alkaline treatment (1 N sodium hydroxide for 1 hour at 25ºC), which has been reported to be one of the few chemical compounds able to inactivate BSE agents in the European Union and validated by external audit by RBM (Italy).
- Inveresk Research (UK) also carried out in 1998, an assessment of the methods used in the control of prion contamination in BIOIBERICA, S.A. They concluded that chondroitin sulfate from BIOIBÉRICA is completely BSE- free.
- As a clinical point of view, there are several clinical trials conducted in Europe which evidence the efficacy and safety of this drug in osteoarthritis. (3, 4, 5, 6). It should be borne in mind that it is approved as a drug in several European Union countries such as: France, Austria, Italy, Portugal as well as Switzerland and Eastern Countries. Each of these countries have presented Drug Master Files (DMFs) of the product approved by their respective Drug Agencies. Also, it is noteworthy, that in some European Union countries, such as France, it has been administered for more than 10 years now without any serious adverse effects, according to the available pharmacosurveillance data in Europe.
- At the same time, we would also like to state that, at present, sodium chondroitin sulfate manufactured by BIOIBERICA, S.A. is being used by the National Institutes of Health in the U.S.A. as the active ingredient for the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT). The corresponding Investigational New Drug Application number (IND) is 59,181. Also, BIOIBÉRICA submitted its Drug Master File of chondroitin sulfate to the FDA (registration number: 13.107) in August 1998.
For these reasons, we can state that chondroitin sulfate is a sugar and thus it is a safe product without any possible risk of BSE-infection.
José Vergés MD, MSc, PhD
Clinical Pharmacologist
Member of the American Society of Clinical Pharmacology and Therapeutics
Scientific Medical Director, BIOIBÉRICA S.A.
References:
1. Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products. EMEA/410/01 FINAL.
2. http://www.access.gpo.gov/nara/cfr/index.html
3. Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol 1996; 23 (8): 1385-1391.
4. Uebelhart D, Thonar EJMA, Zhang J, Williams J.M. Protective effect of exogenous chondroitin 4,6 –sulfate in the acute degradation of articular cartilage in the rabbit. Osteoarthritis and Cartilage (1998) 6, (Supplement A): 6-13.
5. Bucsi L, Poór G. Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow-acting drug for osteoarthritis (SYSADOA) in the treatment of knee osteoarthritis. Osteoarthritis and Cartilage (1998) 6, (Supplement A): 31-36.
6. Leeb F, et al. A meta-analysis of chondroitin sulfate in the treatment of osteoarthritis. The Journal of Rheumatology 2000; 27: 1: 205-211.
Natrium/sodium
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