What Is Polymyxin B Sulfate?
Introductions
Polymyxin B Sulfate is a white to off-white antibiotic derived from Bacillus polymyxa.
It is one of the key ingredients for dermal ointments along with Bacitracin, Bacitracin Zinc, Hydrocortisone, Neomycin sulfate, and Triamcinolone acetonide.
Polymyxin B sulfate API is easily soluble in water (50mg/mL) and stable in acidic solutions. It is almost insoluble in organic solvents such as ethers, ketones, esters, hydrocarbons, etc. For example, its solubility in ethanol is 0.115 mg/mL.
Polymyxin B sulfate is hygroscopic, so you may want to handle it quickly to prevent moisture in the air from being absorbed into the repacked product.
When polymyxin B sulfate dissolves in solvents, its neutral solution remains stable at room temperature for a week without affecting potency. In contrast, its alkaline solution is unstable and will disintegrate very quickly. Polymyxin has two types: Polymyxin B and Polymyxin E (colistin).
Polymyxin B is composed of polymyxins B1, B1-I, B2, B3, and B6, and polymyxins B1 and B2 are considered the primary active components within the compound.
These related components are structurally identical except for the different fatty acid groups in each fraction.
In vitro testing results have shown marginal differences in MIC values when comparing the fractions.
What Is Polymyxin B Sulfate Used For?
Polymyxin B sulfate is a cationic basic peptide antibiotic used in detergents.
People use it for urinary tract infections and meningitis because it exerts bactericidal activity against almost all Gram-negative bacilli, except those in the genera Proteus and Neisseria.
Polymyxin B’s primary mechanism of Bactericidal Action is binding to the bacterial cell membrane and altering its structure, making the cell more permeable.
As a result, the following water uptake leads to bacterial cell death.
#1. Usages
Polymyxin B sulfate is an antibiotic against gram-negative bacilli with bactericidal functions.
It has a strong antibacterial effect on most gram-negative bacilli.
It is also very effective on Pseudomonas aeruginosa, E. coli, Salmonella, dysentery bacillus, influenza bacillus, pertussis bacillus, gas-producing bacillus, and pneumonia bacillus.
However, proteus amoebae are not sensitive to polymyxin b sulfate. Polymyxin B is effective against bacteria in both growth and stationary phases.
In the past, people used polymyxin B sulfate to treat gram-negative bacterial infections, especially those caused by Pseudomonas aeruginosa and Escherichia coli, such as respiratory infections, peritonitis, bile duct infections, urinary tract infections, burn infections, ocular and corneal infections, and sepsis.
Gradually, polymyxin B sulfate has been replaced by other antibiotics with better efficacy and lower toxicity.
However, we can still use it topically for eye, ear, skin, and mucous membrane infections and Pseudomonas aeruginosa burns caused by sensitive bacteria.
#2. Mechanism of action
Its bactericidal working mechanism is to change the permeability of bacterial cells.
As a polypeptide antibiotic, Polymyxin B sulfate exhibits vigorous surface activity against bacterial cells.
Polymyxin b sulfate contains lipophilic functional groups (positively charged free amino groups), which can introduce lipoproteins, combine with phosphate in the cell membrane phospholipids, and change the composition of the cytoplasmic membrane synthesized by bacteria to increase its surface area.
Then it will disrupt the cytoplasmic membrane’s original protective function, making it much more permeable, leading to the leakage of many intracellular components and, ultimately, the death of the bacteria.
What is even better is that bacteria are less likely to develop resistance to polymyxin B sulfate.
What Are Polymyxin B Dosage Forms?
Polymyxin B sulfate dosages are as follows:
Polymyxin B sulfate powder for injection
Polymyxin B sulfate ear drops
Polymyxin B sulfate creams
Polymyxin B sulfate eye drops over the counter
Polymyxin B sulfate injection
Polymyxin B sulfate lyophilized powder for solution
It is also formulated into first-aid kits and topical ointments (Neosporin, Triple Antibiotics), combined with other ingredients such as bacitracin API, bacitracin zinc API, neomycin sulfate, lidocaine hydrochloride, hydrocortisone, trimethoprim API, etc.
What Is The HS Code Of Polymyxin B Sulfate API?
Its chemical structure shows that Polymyxin B sulfate belongs to the class of organic compounds known as polypeptides.
These are peptides containing ten or more amino acid residues.
But it is also an antibiotic. In China, it is classified under HS Code 2941909099 as Other Antibiotics and as a subclass under Antibiotics.
How Much Does Polymyxin B Sulfate API Cost?
The price of pharma-grade topical type by commercial order quantities is about 3500~4500 USD/kg as FOB Shanghai/Beijing.
The price above is for the micronized powder suitable for manufacturing powder spray and ointment.
The price for plain powder should be lower, and the EXW price is around 3600 USD per kg.
There is also injection-grade powder available on the market, with higher purity and stricter sterilization requirements.
The cost of injection-grade powder exceeds 6000 USD per kg.
For more accurate prices, please get in touch with us directly.
You can also check its export and import prices from PharmaCompass below:
As you can see, its import and export prices are around 5300 USD per kg for 100 kg.
So far as we know, 5300 USD per kg is a high price compared to 2021.
Due to rising capacity at Chinese factories, the unit price per kilo fell to 3,200 USD in mid-2021.
However, the price of injection-grade polymyxin B is much higher; it may cost twice as much as the topical grade.
This 3500 USD-per-kilo price is also the mainstream market price in Asia, and you should not pay 6000 USD per kilo before you order.
How To Store and Ship Polymyxin B Sulfate API?
#1. Storage
For long-term storage, polymyxin B sulfate API powder should be stored in the dark at 2-8°C.
During our stability tests at room temperature, after three years of storage, we did not observe any change in the appearance/potency of the samples. (Well sealed and protected from moisture and light)
If it dissolves into solutions, it should be filtered for sterilization and stored at 2-8°C. The solution is stable at 37°C for 5 days.
#2. Shipping
Polymyxin B proved to be a safe and common chemical for air shipping.
It is not poisonous. Check the acute toxicity data below:
Mice oral LD50: 790 mg/kg
mice abdominal LD50: 20500 ug/kg;
mice subcutaneous LD50: 59500 ug/kg;
mice venous LD50: 5400 ug/kg;
puppy intracerebral LDLo: 320 μg/kg;
Guinea pig subcutaneous LD50: 58 mg/kg.
If handled properly, it is not flammable, explosive, or oxidative so that it won’t cause fires or explosions. Therefore, unique packing materials are not needed.
Standard plastic bags and cartons are acceptable for packing.
Depending on the quantity of our order, you can ship it by air, courier, or sea.
If you are worried about potential potency loss, you can add ice packs during transport.
But our stability tests show it is okay to ship it without ice.
Many customers have proven this point through repeated orders over the years.
Disclaimer:
This content is for informational purposes only and is intended for business-to-business communication within the pharmaceutical industry. It is not intended as medical advice. The manufacture, import, and use of API must comply with all applicable laws and regulations in the relevant country or region.
This blog post is informational only and does not constitute medical advice.
Always consult a healthcare professional before starting any new medication or treatment.
