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Botulax vs Xeomin | Purity, and Use

The difference between Botulax (South Korea) and Xeomin (Germany) primarily lies in purity and use. Xeomin has a molecular weight of only 150 kDa and contains 0% complex protein. This high purity makes it less likely to cause antibody-induced failure after long-term injections, making it very suitable for fine facial wrinkle removal and populations prone to tolerance. Botulax has a molecular weight of approximately 900 kDa and contains complex proteins. However, due to its extremely high cost-effectiveness, it is more suitable for large-dose intramuscular injections such as for the masseter muscle and leg slimming.

Purity

At the purity level, the molecular weight of Xeomin is only 150 kDa. It utilizes XTRACT patented technology to remove all hemagglutinins and non-toxin proteins, making it currently the only “zero complex protein” Type A botulinum toxin approved by the. Botulax has a molecular weight of 900 kDa and retains the traditional complex protein coating structure. According to medical literature statistics, when a single injection of botulinum toxin containing complex proteins exceeds 300 units, the probability of patients producing neutralizing antibodies (NAbs) is around 1.2%; In contrast, in a large-sample clinical data set spanning 3 years, the number of cases of secondary failure caused by antibodies for Xeomin was 0.

Substance Composition

When Type A botulinum toxin is extracted from Clostridium botulinum culture media in nature, it by default appears in a 900 kDa complex protein form. Botulax retains the 750 kDa neurotoxin-associated proteins (NAPs), which include approximately 500 kDa of hemagglutinin (HA) and 130 kDa of non-toxin non-hemagglutinin (NTNH). Xeomin utilizes XTRACT purification technology to completely strip away the 750 kDa of inactive components. The 150 kDa active monomer inside a Xeomin consists of a 100 kDa heavy chain and a 50 kDa light chain, connected at both ends by a disulfide bond. When the Xeomin in 2011, its ingredient list clearly stated that a single (100 units) contains 1.0 mg of human serum albumin and 4.7 mg of sucrose. In addition to the 900 kDa botulinum toxin complex, the excipients in a single (100 units) of Botulax lyophilized powder include 0.5 mg of human serum albumin and 0.9 mg of sodium chloride. Sodium chloride acts as an isotonic regulator, while human serum albumin prevents trace amounts of toxin from adsorbing onto the inner glass walls of the. During production at the Hugel factory in South Korea, each batch of product must pass rigorous mouse median lethal dose (LD50) testing. The 900 kDa complex protein structure remains intact in an acidic environment with a pH value of 4.2 to 6.8. When Botulax is injected into human tissue fluid with a pH value of 7.3 to 7.4, the 750 kDa peripheral protective proteins will shed within 1 to 3 minutes. The dissociated 150 kDa neurotoxin monomer then begins to bind with the SNAP-25 receptor protein at the neuromuscular junction. Xeomin is already in a 150 kDa free state before entering the human body and does not need to undergo the dissociation step induced by the pH value of tissue fluid. After injection into the muscle layer, the C-terminal of the heavy chain recognizes and binds to the SV2 receptors of cholinergic nerve endings. The time for the free toxin monomer to enter the intracellular endocytic vesicle is typically between 10 to 20 minutes.

Substance Parameter Xeomin (100-Unit Specification) Botulax (100-Unit Specification)
Free Neurotoxin Molecular Weight 150 kDa 150 kDa (Encapsulated before dissociation)
Non-toxin Non-hemagglutinin (NTNH) 0 kDa Approx. 130 kDa
Hemagglutinin Complex (HA) 0 kDa Approx. 500 kDa
Human Serum Albumin Content 1.0 mg 0.5 mg
Excipient Ingredients 4.7 mg Sucrose 0.9 mg Sodium Chloride
pH Value Required for Dissociation No dissociation required 7.3 – 7.4
Storage Activity Temperature Limit Up to 36 months below 25°C Refrigerated storage at 2°C – 8°C for 36 months

After fermenting Clostridium botulinum, Hugel laboratories change the ionic strength of the solution by adding ammonium sulfate, causing the 900 kDa macromolecular complex to precipitate. After two rounds of crystal precipitation, the solution purity reaches over 98%, and finally, it is sterilized and packaged through a 0.2-micron filter membrane. The XTRACT process for Xeomin relies on continuous chromatographic analysis. The Merz factory first uses cation-exchange chromatography to separate the macromolecular complex, and subsequently adjusts the environmental pH to above 7.0 to promote the dissociation of the complex. The dissociated solution enters an anion-exchange chromatography column, where the 150 kDa neurotoxin with a purity as high as 99.4% is accurately adsorbed and extracted based on charge differences. The 750 kDa complex retained by Botulax is specifically assembled from the following types of proteins:

  • HA70 (Hemagglutinin 70): Contains approximately 3 molecules, occupying a total mass of 210 kDa.
  • HA33 (Hemagglutinin 33): Contains approximately 4 molecules, occupying a total mass of 132 kDa.
  • HA17 (Hemagglutinin 17): Contains approximately 4 molecules, occupying a total mass of 68 kDa.
  • NTNH (Non-toxin Non-hemagglutinin): Single molecule, occupying a mass of 130 kDa, connected to the 150 kDa toxin.

In every 100 units of botulinum toxin, the actual weight of the neurotoxin that takes effect is extremely minute. Inside a 100-unit of Xeomin, the physical weight of the 150 kDa active toxin is only 0.44 nanograms (ng). Inside a 100-unit of Botulax, the total weight of the 900 kDa complex, including the 150 kDa active toxin, is approximately 5.0 nanograms. After 5.0 nanograms of powder enter the deltoid or masseter muscle, the injection liquid volume (usually diluted with 1.0 ml to 2.5 ml of physiological saline) dominates the initial physical diffusion. The molecular concentration difference between 0.44 nanograms of monomer toxin and 5.0 nanograms of complex toxin in 2.5 ml of physiological saline reaches 11 times. In electromyography (EMG) tests at clinics in Europe and the US, the diffusion radius for both products at 48 hours post-injection remained stable between 1.5 to 2.0 cm. Sucrose acts as a cryoprotectant during the lyophilization process of Xeomin. When the temperature drops to -50°C for vacuum drying, 4.7 mg of sucrose molecules replace water molecules to form hydrogen bonds with the 150 kDa toxin. Botulax uses 0.9 mg of sodium chloride; when reconstituted with 2.5 ml of sterile physiological saline, the powder typically dissolves within 5 to 10 seconds. A very small amount of white powder is present at the bottom of an unopened Xeomin, which is sometimes extremely difficult to detect with the naked eye. When 2.5 ml of 0.9% sterile sodium chloride injection is injected into the ampoule, the pressure inside the is usually negative, and the liquid will be sucked in automatically. The bottom of a Botulax shows a visible white lyophilized mass. According to data from Hannover Medical School in Germany, the threshold for a single injection to trigger dendritic cell phagocytosis and antigen presentation is typically above 10 nanograms of foreign protein. Based on Xeomin’s content of 0.44 nanograms per 100 units, a single injection of 400 units to treat cervical dystonia results in a total protein load of only 1.76 nanograms. An injection of the same dose of Botulax results in a total protein load of 20.0 nanograms. 1 gram of purified 150 kDa neurotoxin can theoretically produce approximately 2.27 billion units of Xeomin. To prevent the extremely small amount of active ingredients from deactivating on the glass walls, 1.0 mg of human serum albumin acts as a sacrificial agent, preferentially occupying the adsorption sites on the glass surface. The 0.5 mg of human serum albumin in the Botulax formula performs the same physical isolation task. Inside the 150 kDa monomer, the 100 kDa heavy chain is responsible for penetrating the nerve cell membrane. The 50 kDa light chain is a zinc endopeptidase that, after entering the cytoplasm, specifically cleaves the SNAP-25 protein. A successful cleavage reaction takes less than 20 microseconds, physically blocking the fusion process of acetylcholine vesicles with the presynaptic membrane. Botulax vs Xeomin Purity, and Use

Xeomin

Through XTRACT chromatographic purification technology, the 750 kDa complex proteins attached to the periphery of the neurotoxin are physically stripped away. Inside the 100-unit specification, only the 150 kDa bare neurotoxin is retained, and the generic drug name is IncobotulinumtoxinA. Stripping away accessory proteins reduces the physical mass of exogenous proteins in a single of medicine. Registration data from the shows that each 100 units of lyophilized powder actually contains 0.44 nanograms of active neurotoxin molecules. Compared to formulas with hemagglutinin complexes, the extremely low protein load of 0.44 nanograms significantly reduces the probability of being recognized by the human immune system. The total amount of exogenous protein ingested in a single dose is positively correlated with the production rate of neutralizing antibodies (NAbs). In a 3-year follow-up test conducted by the University of Miami Miller School of Medicine, data from 476 patients receiving continuous injections of IncobotulinumtoxinA was recorded. Among cervical dystonia patients receiving an average of one injection every 12 weeks with a single dose reaching 400 units, the secondary non-response rate due to antibody production was 0%. Clinical data shows extremely low immunogenicity, based on the following formula parameters:

  • Hemagglutinin (HA) mass: 0 nanograms
  • Non-toxin Non-hemagglutinin (NTNH) mass: 0 nanograms
  • Physical weight of 100 units of active toxin: 0.44 nanograms
  • Vacuum drying residual moisture: Below 3%

To maintain the spatial conformation of the 150 kDa monomer inside the glass after removing the complex proteins, 4.7 mg of sucrose was added to the formula. Sucrose molecules replace water molecules during the freeze-drying stage at minus 50 degrees Celsius, forming a hydrogen bond network with the amino acid residues on the toxin’s surface. 1.0 mg of human serum albumin is added to the ampoule, preferentially attaching to the inner walls of the borosilicate glass. The coating effect of human serum albumin prevents 0.44 nanograms of active toxin from being irreversibly adsorbed by the glass surface. After removing the temperature-sensitive 750 kDa macromolecular protein complex, the drug gains extremely high thermal stability in its solid state before reconstitution. When the EU EMA approved the drug in 2005, it confirmed that it can be stored in a room temperature environment below 25 degrees Celsius for up to 36 months without deteriorating. Lyophilized powder stored at room temperature needs to be reconstituted with 0.9% sterile sodium chloride injection before clinical use. Plastic surgeons in Beverly Hills, Los Angeles, typically use 2.5 ml of physiological saline injected into the 100-unit ampoule. Every 0.1 ml of liquid contains 4 units of active neurotoxin, suitable for precise point-by-point injection into facial muscle groups. The dosage and point data distribution for conventional medical aesthetic injections are as follows:

  • Glabellar frown line complex: 20 units total, distributed across 5 injection points
  • Lateral canthal lines (crow’s feet): 24 units total for both sides, 3 points per side
  • Frontalis transverse wrinkles: 10 to 20 units total, distributed across 4 to 8 points
  • Masseter hypertrophy: 50 to 60 units total for both sides, 3 to 4 points per side

After the prepared sterile solution is injected into subcutaneous or muscle tissue, the 2.5 ml liquid volume drives the initial physical diffusion. The 150 kDa free toxin monomer does not need to wait for tissue fluid pH neutralization and starts contacting the presynaptic membrane instantly. The C-terminal of the toxin heavy chain recognizes and binds to SV2 receptor proteins on the surface of cholinergic nerve endings within 5 minutes. Binding to receptors triggers endocytosis, and the 150 kDa monomer is encapsulated in an endocytic vesicle to enter the interior of the nerve ending. The acidic environment inside the vesicle triggers a change in the heavy chain’s conformation, causing it to form an ion channel on the vesicle membrane. The 50 kDa light chain enters the neuron’s cytoplasm through the channel, acting chemically as a highly specific zinc endopeptidase. The light chain finds and cleaves the SNAP-25 protein in the cytoplasm, a reaction that takes about 20 microseconds. After the 25 kDa SNAP-25 protein has 9 amino acids removed from its C-terminal, it can no longer assist vesicles encapsulated with acetylcholine in fusing with the presynaptic membrane. The release of chemical transmitters is physically blocked, and muscle fibers begin to show a relaxed state within 48 to 72 hours after injection. The degree of muscle paralysis at the injection site reaches its peak on the 14th day, and unbound free toxins have long since been completely degraded by tissue proteases in the body. The duration of the paralyzed state is limited by the re-sprouting of nerve terminal axons and the resynthesis of SNAP-25 protein at the original synaptic site. Clinical observation reports from Mount Sinai Hospital in New York show that the average maintenance time for the smoothing effect on facial expression lines is around 120 days. Physicians in Europe and the US, when dealing with patients who have developed resistance to the 900 kDa complex, will test the response to switching to a non-complex protein formula. Antibodies are usually produced against the peripheral 750 kDa hemagglutinin complex rather than the 150 kDa core active monomer. Clinical logs from the University of Munich recorded 12 patients who were non-responsive to traditional macromolecular botulinum toxins; after switching to IncobotulinumtoxinA, 8 of them recovered a normal muscle relaxation response after 14 days. Onset performance after switching formulas involves the following time stages:

  • Time for free toxin to bind to receptors: 5 to 10 minutes
  • Time for light chain to enter the cytoplasm: 15 to 30 minutes
  • Initial observation of decreased muscle tension: Days 2 to 3
  • Receptor protein metabolic renewal cycle: Approx. 90 to 120 days

A single dose of pure protein load of less than 2 nanograms reduces long-term immune risk to the base level of the data model. The physical substances inside a 100-unit are greatly streamlined, retaining only the single effective ingredient that blocks nerve conduction and two basic excipients. Under US Pharmacopeia (USP) testing standards, the potency variation rate between production batches is strictly controlled within a minimal error range of 3%.

Botulax

Hugel Bioscience Lab in Chuncheon, South Korea, uses the CBFC26 Clostridium botulinum strain for deep fermentation culture. Engineers add a specific concentration of ammonium sulfate solution to the fermentation broth to induce physical precipitation of protein molecules at a specific ionic strength. Two rounds of crystal elution processes remove more than 98% of culture medium impurities. The isolated substance retains its complete 900 kDa macromolecular protein conformation as found in its natural state. This includes the 150 kDa pure toxin monomer with neuro-blocking activity, and the peripheral complex proteins weighing as much as 750 kDa. The 750 kDa adjuncts are collectively referred to in the medical field as neurotoxin-associated proteins (NAPs). NAPs physically form a protective shell, encapsulating the 150 kDa monomer inside. Pharmacological physical models from Yonsei University in Seoul show that this protective shell is assembled from several subunits with different molecular weights:

  • HA70 (Hemagglutinin 70): Contains approximately 3 molecules, occupying a total mass of 210 kDa
  • HA33 (Hemagglutinin 33): Contains approximately 4 molecules, occupying a total mass of 132 kDa
  • HA17 (Hemagglutinin 17): Contains approximately 4 molecules, occupying a total mass of 68 kDa
  • NTNH (Non-toxin Non-hemagglutinin): Composed of a single molecule, occupying a mass of 130 kDa

The complex protein shell maintains the stability of the 150 kDa monomer’s three-dimensional spatial conformation in an acidic medicinal solution environment with a pH of 4.2 to 6.8, preventing it from degrading before contacting the presynaptic membrane.

When the South Korean Botulax (generic name: LetibotulinumtoxinA), it recorded the precise excipient ratio inside the 100-unit specification. Each has 0.5 mg of human serum albumin and 0.9 mg of sodium chloride added. The 0.9 mg of sodium chloride acts as an isotonic regulator when the powder is reconstituted, making the osmotic pressure of the medicinal solution close to that of human extracellular fluid. The 0.5 mg of human serum albumin physically covers the inner walls of the borosilicate glass. The total physical weight of the 100-unit 900 kDa macromolecular complex is approximately 5.0 nanograms, and the human serum albumin occupies the electrostatic adsorption sites on the glass surface. After freeze-drying the 5.0 nanograms of effective ingredients at minus 40 degrees Celsius, a visible white lyophilized mass is formed at the bottom of the. For clinical use, plastic surgeons use 2.5 ml of sterile physiological saline to puncture the rubber stopper and inject it into the ampoule. The lyophilized powder containing sodium chloride dissolves completely within 5 to 10 seconds, forming a clear solution. Upon drawing 0.1 ml of the solution, the will contain 4 units of the 900 kDa botulinum toxin complex. After the macromolecular complex is pushed into the muscle fiber gaps, it comes into physical contact with human tissue fluid.

The pH value of human physiological tissue fluid is constant between 7.3 and 7.4. The weak alkaline environment breaks the charge balance of the 750 kDa complex protein shell, leading to the rapid dissociation of accessory proteins.

Within 1 to 3 minutes after injection, the HA and NTNH proteins shed from the internal toxin. The dissociated 150 kDa active monomer diffuses along the direction of the muscle fibers. At a 2.5 ml physiological saline dilution ratio, the diffusion radius of the dissociated monomer within 48 hours post-injection is controlled within a physical range of 1.5 to 2.0 cm. The blocking dose for facial branching nerve endings usually follows the following point data distribution:

  • Glabellar complex muscle group: 5 injection points distributed, total 20 units injected
  • Lateral orbicularis oculi (crow’s feet): 3 points distributed per side, 12 to 24 units injected
  • Masseter mandibular angle margin: 3 to 4 points evenly distributed per side, 25 to 30 units injected

The shed 750 kDa complex proteins, as exogenous macromolecules, float in the extracellular matrix and are ultimately phagocytosed and metabolized by macrophages. The C-terminal of the 100 kDa heavy chain of the isolated 150 kDa monomer rapidly locks onto cholinergic nerve endings. The heavy chain binds with SV2 receptor proteins on the presynaptic membrane, completing the physical anchoring which takes about 10 minutes. Endocytic vesicles ingest the 150 kDa monomer into the nerve ending. The 50 kDa light chain enters the cytoplasm by perforating the vesicle membrane, acting as a specific zinc endopeptidase to cleave the 25 kDa SNAP-25 receptor protein. The SNAP-25, which has lost 9 amino acid residues, can no longer carry out the task of pulling acetylcholine vesicles. Literature from the American Society of Plastic Surgeons (ASPS) records that when 5.0 nanograms of 900 kDa protein complex is injected, the chance of antigen presentation by dendritic cells increases in large-dose application scenarios exceeding 300 units. Within the conventional range of less than 50 units for facial wrinkle removal with extremely low protein load, the detection rate of neutralizing antibodies is less than 0.5%. Unopened of lyophilized powder must be placed in a specialized medical refrigerator at 2°C to 8°C and stored away from light. The low-temperature environment inhibits hydrolysis reactions caused by residual moisture, ensuring that the 5.0 nanogram complex toxin does not lose biological activity during its 36-month shelf life. The potency variation rate of each batch of finished products from the Hugel production line is strictly controlled within the 5% error threshold stipulated by the Korean Pharmacopoeia.

Use

Xeomin’s 150 kDa purified molecules, with inactive proteins removed, are suitable for long-term users who receive injections more than twice a year, as well as for fine periocular wrinkle removal requiring a smaller diffusion radius of 2-3 mm. Botulax uses a 900 kDa macromolecular structure, with a diffusion range of approximately 5 mm after injection, making it suitable for large-area atrophy targeting the mandibular masseter (averaging 50-100 U for both sides) or calf muscles (100-200 U per side). For large-dose muscle reduction, Botulax is typically chosen; for high-frequency maintenance of facial fine lines, Xeomin is preferred.

Different Areas

In clinical practice, the injection sites for botulinum toxin approved by the and EMA cover superficial facial expression muscles and deep large muscles of the body. Anatomical thickness differences require physicians to allocate different doses between 150 kDa Xeomin and 900 kDa Botulax. The medicinal solution input for a single treatment spans from 10U in facial areas to over 200U in body areas. The frontalis and corrugator muscles are relatively thin facial sheet-like muscles with a thin subcutaneous fat layer; injection depth is usually between 2 to 4 mm. The global standard operating procedure for treating glabellar lines is to divide 5 injection points, each accurately pushing in 4U of medicinal solution, for a total of 20U. The bottom of the frontalis muscle is only 1.5 to 2 cm away from the levator palpebrae superioris muscle, and the physical diffusion radius of the medicinal solution between tissues is strictly monitored.

  • Because the binding proteins have been stripped away, the diffusion radius of Xeomin after a single-point injection is fixed in the 1 to 1.5 cm range.
  • In the lateral 3-point injection for orbicularis oculi (crow’s feet), 150 kDa molecules can remain in place.
  • When treating forehead lines with Botulax, 100U of dry powder is usually reconstituted with 2.5 ml of sterile physiological saline.
  • The 900 kDa Botulax has a diffusion radius of 1.5 to 2.0 cm, suitable for patients with a wider coverage of muscle fibers.

Moving focus down to the lower third of the face, the masseter muscle thickness is typically measured at 10 to 15 mm and is a dense group of masticatory muscles. The clinical demand for this area shifts from preventing epidermal folding to inducing disuse volume reduction of muscle fibers. In clinics in Seoul or Los Angeles, physicians perform deep injections at the thickest protrusion of the muscle, 1.5 cm above the mandibular angle.

Masseter Injection Parameters Xeomin 150 kDa Botulax 900 kDa
Standard dose per side 20U – 30U 30U – 50U
Vertical injection depth 6 – 8 mm 6 – 8 mm
Injection points per side 3 – 4 points 3 – 5 points
Drug solution concentration ratio 4U / 0.1ml 4U / 0.1ml
Muscle atrophy observation period 4 – 6 weeks 3 – 4 weeks

For the trapezius muscle of the neck and shoulders and the gastrocnemius muscle of the calves, the cross-sectional area of the muscle groups increases geometrically. A single injection requires a large amount of botulinum toxin dry powder, and usually, a single 100U specification product cannot meet the dosage requirements for both sides. Physicians switch to longer 13 mm or 25 mm to ensure the medicinal solution breaks through the subcutaneous fascia layer and reaches the muscle belly directly.

  • When treating trapezius hypertrophy, the minimum standard dose for both sides is 100U, and the maximum can reach 200U.
  • Because its unit price is lower, Botulax accounts for over 60% of shoulder projects with consumption exceeding 150U.
  • Gastrocnemius (medial head) injection requires a matrix injection method, with 10 to 15 points per side.
  • Each point pushes in 5U to 8U, and Botulax’s large diffusion characteristics can accelerate absorption by adjacent muscle bundles here.

In addition to smoothing muscle tissue, the exocrine sweat glands in the dermis are also targets for Type A botulinum toxin. When treating primary axillary hyperhidrosis, the injection depth must be strictly controlled within the dermis (approx. 1.5 to 2 mm) rather than the muscle layer. Intradermal injection is more painful, so physicians usually apply a 5% lidocaine compound cream 30 minutes in advance.

  • Usually, 15 to 20 injection points are planned per side of the armpit, with point spacing maintained at 1.5 cm.
  • Each point is injected with 50 U, and the total consumption for both sides is fixed at 100 U.
  • Xeomin’s onset period for this area is 3 to 4 days, and sweat secretion typically decreases by over 80% by the 2nd week.
  • Because hyperhidrosis patients need repeated injections of 100U every 6 months, the probability of Xeomin without complex proteins triggering neutralizing antibodies is lower than 1%.

Botulax vs Xeomin Purity, and Use

Xeomin Application Directions

Only the 150 kDa purified neurotoxin molecules that produce muscle relaxation are retained in the lyophilized powder filtrate. Unlike preparations containing 900 kDa complex protein combinations, it can be safely stored in an unopened state at a room temperature of 25°C for up to 36 months. When performing routine preparation, the physical characteristics of being without accessory proteins require a more rigorous dilution process. The 100U contains only 1 mg of human serum albumin and 4.7 mg of sucrose in addition to the neurotoxin.

  • Reconstitution for a 100U specification usually involves injecting 2.5 ml of 0.9% sterile sodium chloride solution.
  • The should enter the rubber stopper at a 45-degree angle to allow the saline to flow slowly down the wall.
  • Violent shaking of the is strictly prohibited; gentle rotation for 3 to 5 seconds is required until the lyophilized powder is completely dissolved.
  • The reconstituted medicinal solution must be used within 24 hours under 2°C to 8°C refrigeration.

The clinical direction for purified molecules first focuses on anatomical areas requiring extremely precise muscle activity ranges. The subcutaneous tissue thickness lateral to the orbicularis oculi muscle is usually less than 1 mm, and slight deviations in injection depth or excessive medicinal solution diffusion will affect the levator palpebrae superioris muscle. The diffusion radius of 150 kDa molecules is physically locked within a 1 to 1.5 cm range. When treating dynamic wrinkles in this area, physicians use 30G to 32G ultra-fine to pierce the skin dermis. Three injection points on each side of the corner of the eye each push in 4U of medicinal solution, with the injection points strictly maintaining a safe margin of 1.5 cm from the orbital rim. The drug effect usually starts on the 3rd to 4th day after injection and reaches peak muscle inhibition on the 30th day. Anatomically precise control extends to the lower third of the face and the neck area. When treating the depressor anguli oris (DAO) or platysmal bands, muscle bundles are extremely thin and interwoven. Each injection point receives only 2U to 3U of Xeomin, with the total dose controlled within 10U to prevent medicinal solution from penetrating the zygomaticus major muscle, which could lead to an asymmetric loss of smile. For patient populations receiving BoNT-A treatment with high frequency or high doses, the immune system’s rejection reaction is the primary consideration for clinical intervention. The human immune system will recognize non-toxin proteins in the 900 kDa complex as foreign antigens. After continuous injections for 3 to 5 years, some patients will produce neutralizing antibodies (NABs), causing the maintenance time for a standard dose to plummet from 16 weeks to within 6 weeks.

  • Clinical data shows that the antibody production rate in patients using Xeomin for 5 consecutive years is less than 1%.
  • Mouse LD50 potency tests show that its unit toxicity is equivalent to Botox at a 1:1 ratio.
  • Patients with positive neutralizing antibodies on blood ELISA testing can recover a muscle relaxation response after switching to Xeomin.
  • The interval between each injection is strictly maintained at a minimum of 12 weeks to further lower the probability of immune response.

Large-dose therapeutic neurology projects account for a very large portion of Xeomin’s clinical consumption. The has approved it for the treatment of adult cervical dystonia and blepharospasm. These pathological, involuntary muscle contractions require a single input of an extremely high dose of toxin to cut off the acetylcholine release pathway. When treating cervical dystonia, the total dose for a single treatment of bilateral neck muscles is usually as high as 120U to 300U. Since such patients need large-dose injections every 12 weeks for life, the risk of immune rejection increases exponentially. Purified toxins with all complex proteins removed become the necessary medical foundation for long-term treatment at this point.

  • The single-point injection dose for the sternocleidomastoid muscle is 15U to 25U.
  • The total amount of drug injected into the splenius capitis can reach 50U to 75U.
  • After onset, the frequency of involuntary head rotation in patients decreases by over 60% by the 4th week.

In addition to deep interventions in the muscle layer, intradermal application of ultra-micro doses (Micro-Tox) has also been a derivative direction in recent years. Physicians highly dilute 20U of Xeomin with 2 to 3 ml of physiological saline and use a 34G for grid-like shallow injections within the whole face dermis. Each tiny wheal receives an extremely minute amount of medicinal solution, acting on the sebaceous glands and capillary smooth muscles, shrinking dermal pores and reducing sebum secretion by over 30% without affecting deep expression muscles.

Botulax Application Directions

Developed by Hugel in South Korea, Botulax retains hemagglutinin (HA) and non-toxin non-hemagglutinin (NTNH) proteins in its biochemical structure, forming a large complex with a molecular weight of 900 kDa. These neurotoxin powders are vacuum-sealed in glass at the factory and must be transported throughout the cold chain environment at 2°C to 8°C and stored in dedicated refrigerators at medical aesthetic clinics. In the preparation phase, standard 100U lyophilized powder usually contains 0.5 mg of human serum albumin and 0.9 mg of sodium chloride as excipients. A nurse will use a sterile to draw 2.5 ml of 0.9% physiological saline and slowly push it into the at a 45-degree angle. Due to the presence of complex proteins, the 900 kDa macromolecular structure has high stability in liquid, and the reconstituted medicinal solution can be stored in a refrigerated state for 24 hours.

  • The reconstituted solution concentration is fixed at 4U of toxin per 0.1 ml.
  • A disposable 1 ml tuberculin is used for drawing the medicine.
  • Bubbles must be avoided during operation to prevent protein denaturation and deactivation.
  • For facial injections, the is usually changed to an ultra-fine 30G to 32G specification.

In facial contouring projects, the hypertrophy of the masseter is an anatomical area with very high consumption of Botulax. Since the muscle belly thickness of the masseter usually exceeds 12 mm, the 1.5 to 2.0 cm physical diffusion radius inherent in the 900 kDa molecule turns into a coverage advantage here. After the medicinal solution enters the deep muscle, it can penetrate more widely into adjacent masticatory muscle fibers.

Clinical injection records from Gangnam, Seoul, show that the starting dose for a single masseter using Botulax is usually set at 30U. For adult male patients with severe masseter hypertrophy or accompanied by nocturnal bruxism, the injection amount per side will be increased to 50U, and the vertical injection depth needs to reach the middle layer of the muscle at 8 mm.

Large-dose body sculpting is a major track where this toxin containing complex protein holds a high global market share. The trapezius muscle of the neck and shoulder is large, and a single 100U dose cannot meet the atrophy needs of bilateral muscles. In medical aesthetic institutions in Los Angeles or Sao Paulo, physicians will prescribe 200U of Botulax for a patient in a single treatment, replacing expensive Botox at a 1:1 equivalent dose.

  • Five to seven primary injection points are planned for each side of the trapezius.
  • Each injection point is maintained at a grid-like arrangement with 2 cm spacing.
  • Each point receives a deep muscle injection of 15U to 20U of medicinal solution.
  • The length of the injection used needs to be increased to 13 mm or more.

Moving focus down to the lower limbs, the medial head of the gastrocnemius muscle in the calf is particularly developed due to long-term weight-bearing walking. This requires the medicinal solution to be evenly distributed over a muscle cross-section as wide as 8 to 10 cm. Physicians will use a matrix-like multi-point array method, utilizing the medium-to-large diffusion range of macromolecular botulinum toxins to induce disuse volume reduction of the muscles.

For gastrocnemius hypertrophy, the total drug consumption for both calves is between 200U and 300U. Between 10 to 15 injection positions must be marked with a marker pen on the surface of each side of the muscle; calf circumference is measured in the 4th week after injection, and the circumference can typically be reduced by 1.5 to 2.5 cm.

In addition to large muscles, Botulax is also widely applied in the treatment of dynamic wrinkles in facial expression muscles. The subcutaneous tissue thickness in the frontalis and corrugator areas is only 2 to 4 mm. After the 900 kDa molecule medicinal solution is injected, its diffusion range in surrounding tissues is approximately 1.5 cm. This requires physicians to strictly control the distance during injection; the retention band from the supraorbital rim must be greater than 2 cm.

  • The treatment for glabellar lines is fixed with 5 injection points.
  • Two points are injected on each side of the corrugator, and one point is injected into the procerus.
  • Each point is accurately injected with 4U, and the total consumption is strictly controlled at 20U.
  • Forehead transverse wrinkles usually employ 10 to 20U of dispersed shallow injection.

In commercial environments in Southeast Asia and South America, the cost of a single treatment greatly influences the physician’s medication decisions. Since the purification process retains complex proteins, resulting in a higher production yield, the terminal supply price for a single 100U of Botulax is usually 30% to 40% lower than that of the 150 kDa purified toxin. In body projects requiring more than 200U in a single treatment, its economic advantage on the balance sheet has led to extremely high clinical popularity.