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Specifications of Commercially Available Botulinum Toxin Products*

(chart still to be completed)

Product Name β0TOXINA® Neoβ0TOXINA BOTOX presently Vistabex in Europe in the 50UI version DYSPORT
Active Constituent Sterile form of purified Clostridium botulinum toxin type A Sterile form of purified Clostridium botulinum toxin type A Clostridium Botulinum Purified Neurotoxin Type A Clostridium botulinum type A toxin
Excipients Sucrose, Dextran, Gelatine Sodium chloride, human serum albumin Sodium chloride, human serum albumin Albumin solution 20%, 125 mcg Lactose, 2.5 mg
Serotype A A A A
Appearance White lyophilized powder White lyophilized powder White lyophilized powder White lyophilized powder
Target SNAP-25 SNAP-25 SNAP-25 SNAP-25
Specific biological activity 70 MU-EV/ng neurotoxin 60 MU-EV/ng neurotoxin 60 MU-EV/ng neurotoxin 100 MU-EV/ng neurotoxin
Molecular weight of macromolecular complex (kD) 900 kilodalton 900 kilodalton 900 kilodalton 900 kilodalton
Package contents expressed in biological units 35U 50U 55U 100U 100U 110 U 150 U 200U 250U 500U 100U 500U
Protein content per 100 biological units 4.8 ng 4.8 ng 5 ng 2.5 ng
Albumin content per 100 biological units 4.8 ng 4.8 ng 5 ng 2.5 ng
Package contents expressed in g of total protein 5 5 5 12.5
pH 7 7 7 7
Formulation Lyophilized Lyophilized Vacuum dried (without freezing) Lyophilized
Procedures β0ToxinA® Injectable is produced from the crude toxin of the culture of the Hall strain of Clostridium botulinum grown in a medium containing trypticase and yeast extract.

A series of purifying procedures are taken to form a crystalline complex consisting of the active high molecular weight toxin protein and an associated hemagglutinin. After being re-dissolved and dialyzed the crystalline toxin, an accurate amount of the sterile filtered toxin are added to a solution containing gelatine-dextran-sucrose, then lyophilized.

β0ToxinA® Injectable is produced from the crude toxin of the culture of the Hall strain of Clostridium botulinum grown in a medium containing trypticase and yeast extract.

A series of purifying procedures are taken to form a crystalline complex consisting of the active high molecular weight toxin protein and an associated hemagglutinin. After being re-dissolved and dialyzed the crystalline toxin, an accurate amount of the sterile filtered toxin are added to a solution containingsodium chloride and human serum albumin.

During manufacturing, Botulinum NeuroToxin is produced from an anaerobic culture of a specific Clostridium botulinum strain. Adding sodium chloride protects the steric conformation of Botulinum NeuroToxin. Human serum albumin is added to prevent loss from surface adsorption. Finally, the toxin is dried without freezing. During manufacturing, Botulinum NeuroToxin is produced from an anaerobic culture of a specific Clostridium botulinum strain. Adding lactose (DYSPORT®, Ipsen, Inc.) protects the steric conformation of Botulinum NeuroToxin. Human serum albumin is added to prevent loss from surface adsorption. Finally, the toxin is dried with freezing.
Dosage One U of Botox® and β0ToxinA®/Neoβ0ToxinA® corresponds to 3-5 Units of Dysport®. One U of Botox® and β0ToxinA®/Neoβ0ToxinA® corresponds to 3-5 Units of Dysport®. One U of Botox® and β0ToxinA®/Neoβ0ToxinA® corresponds to 3-5 Units of Dysport®. One U of Botox® and β0ToxinA®/Neoβ0ToxinA® corresponds to 3-5 Units of Dysport®.
Suggested dilutant Nonpreserved 0.9% saline (which seems to offer no reduction in potency butreduces the pain of injection) but may be used with preserved saline. Or, for better results, β0ToxinA® Instant. Nonpreserved 0.9% saline (which seems to offer no reduction in potency butreduces the pain of injection) but may be used with preserved saline. Or, for better results, β0ToxinA® Instant. Nonpreserved 0.9% saline (which seems to offer no reduction in potency butreduces the pain of injection) but often used with preserved saline. Or, for better results, β0ToxinA® Instant. Nonpreserved 0.9% saline (which seems to offer no reduction in potency butreduces the pain of injection) but may be used with preserved saline. Or, for better results, β0ToxinA® Instant.
Dilution guidelines 100 U per vial diluted by 2.5 mL,4 U per 0.1 mL 100 U per vial diluted by 2.5 mL,4 U per 0.1 mL (BOTOX®,) 100 U per vial diluted by 2.5 mL,4 U per 0.1 mL 500 U per vial diluted with2.5 mL of saline20 U per 0.1 mL
Pain Sensation during Intradermal Injections Little (none with β0ToxinA® Instant) Little (none with β0ToxinA® Instant) Little (none with β0ToxinA® Instant) Little (some patients claim it is more painful than the other two formulations)(none with β0ToxinA® Instant)
Diffusion Some, almost none with β0ToxinA® Instant. Some, almost none with β0ToxinA® Instant. Some, almost none with β0ToxinA® Instant. Dysport may have a wider diffusion than the other three. Almost none with β0ToxinA® Instant.
Intolerance This product thanks to its modified glucose content, has a special place in the non-invasive category, as no cases of intolerance have ever been reported, not even when administered by inexperienced operators. No reports of anaphylaxis ever. There have been reports of anaphylaxis and other forms of reaction to the proteins in Botox. There have been reports of anaphylaxis and other forms of reaction to the proteins in Dysport.
Antibody formation The rate of antibody-induced therapy failure is reportedly less than 1%. The rate of antibody-induced therapy failure is reportedly less than 1%. For the current formulation of BOTOX®, the rate of antibody-induced therapy failure is reportedly less than 1%. It has been noted rarely in patients (approximately 1 in 10, 000 cases).
Effect Duration Varies depending on the cosmetic/therapeutical indication, site of injection, and subject's sensitivity. Average 3 months. Varies depending on the cosmetic/therapeutical indication, site of injection, and subject's sensitivity. Average 3 months. Varies depending on the cosmetic/therapeutical indication, site of injection, and subject's sensitivity. Average 3 months. The manufacturer claims the injections last longer, with patients returning twice a year for injections, instead of the four treatments with the other three products.
Shelf Life 48 months 48 months 24 months 24 months
Storage (packaged product) -5 to -20°C Thanks to its formulation, 0ToxinA is inimitable in not losing virtually any efficacy in case of temperature fluctuations.It will keep its efficacy at room temperature for one week, present a small drop in efficacy for 10 days, and a 15-20% drop in 3-12 months. -5 to -20°C -5°C -5 to -20°C
Storage (reconstituted product) 4 hoursat 2-8°C Maximum solution temperature 36°C 4 hours at 2-8°C.Maximum solution temperature 36°C 4 hours 8 hours at 2-8°C
Price Its price is the highest of the three, with the 500U version costing over twice as much as Dysport. Its price is the highest of the three, with the 500U version costing over twice as much as Dysport. U.S. doctors pay about $467 for a 100U vial of BOTOX Allergan raised the price of BOTOX,twice over the past year or so. Dysport is the cheapest of the four.
Counterfeit products It is the registered product for whichthereareatpresent most frequent counterfeit attempts. It is the registered product for whichthereareatpresent most frequent counterfeit attempts.    
History Since 1990, Botulinum Toxin Type A has been produced by a Military Pharmaceutical Institute, with use before 1993 being secret for military reasons.In 1993 the purified molecule was sold to a private firm, that started testing it for use on civilian patients. sealab LLC laboratory started the procedure for certification in 1994 and manufactured and distributed the product until 2005, when production shifted toMOBILAB's laboratory. Since 1990, Botulinum Toxin Type A has been produced by a Military Pharmaceutical Institute, with use before 1993 being secret for military reasons.In 1993 the purified molecule was sold to a private firm, that started testing it for use on civilian patients. Sealab LLC laboratory started the procedure for certification in 1994 and manufactured and distributed the product until 2005, when production shifted toMOBILAB's laboratory. In the late 1970s, Dr. Scott formed his company, Oculinum, Inc., where he studied botulinum toxin type A. Then, in 1978, Dr. Scott received permission from the Food and Drug Administration (FDA) to test botulinum toxin type A in human volunteers. In 1988, Allergan acquired the rights to distribute Dr. Scott's botulinum toxin type A product, Oculinum, and the responsibilities to conduct clinical trials In 1989 Allergan Inc., acquired Dr. Scott's company and changed the product's name to BOTOX It was developed in the United Kingdom in the early 1990s to successfully treat a number of neurological and ophthalmic conditions.
Production Since the manufacturing lab is still in the process of privatization, it has no expansion programs. Production is extremely limited and it is to remain within the military warehouse for use in case of national emergencies. Only a very small part, when approaching the expiry date, can be put on the market, to be used for trial purposes or in cases of real, medically-endorsed need. Since the manufacturing lab is still in the process of privatization, it has no expansion programs. Production is extremely limited and it is to remain within the military warehouse for use in case of national emergencies. Only a very small part, when approaching the expiry date, can be put on the market, to be used for trial purposes or in cases of real, medically-endorsed need. Data to be found in Allergan website. Data to be found in Ipsen website.
Indications Indicated for cosmetic therapy and the treatment of many heath conditions, including hyperidrosis, blepharospasm, hemifacial spasm, in adults and some types of strabismus and strabismus which cannot be corrected through operation in patients 12 years of age and above. Indicated for cosmetic therapy and the treatment of many heath conditions, including hyperidrosis, blepharospasm, hemifacial spasm, in adults and some types of strabismus and strabismus which cannot be corrected through operation in patients 12 years of age and above. Indicated for glabellar frown lines cervical dystonia, blepharospasm, spasmodic torticollis, strabismus, disorders of ocular motility, writer's cramp, hemifacial spasm and spasticity, achalasia, chronic anal fissure, and hyperhidrosis and over. 50 other different indications. Indicated for: focal spasticity, dynamic equinus foot deformity due to spasticity in ambulant paediatric, cerebral palsy patients, two years of age or older, only in hospital specialist centres with appropriately trained personnel.Spasmodic torticollis, Blepharospasm, and hemifacial spasm in adults.
Manufacturer/ Distribution MOBILAB European Agency Ltd., Southampton, UK - with agencies in Switzerland. MOBILAB European Agency Ltd., Southampton, UK - with agencies in Switzerland. Allergan Inc., Irvine, California, USA Ipsen Pharmaceuticals, Ltd., Maidenhead Berkshire, UK.It was originally produced by Porton Products in the UK and was licensed for distribution via the Department of Healthand Social Security by Speywood.

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