Gentamicin Sulfate Uses, Price and API manufacturers in China

Definition

Gentamicin sulfate is used to treat minor skin infections such as impetigo or folliculitis. It also helps in treating other skin conditions such as eczema, psoriasis, minor cuts/burns/wounds. Gentamicin is a broad-spectrum aminoglycoside antibiotic, which works only on bacterial infections. It stops the growth of certain bacteria when treated with. Any overdose of the compound can, however, cause adverse effects. Gentamicin works against many bacterial infections of gram-negative bacteria (like pseudomonas, Proteus, Escherichia coli, Klebsiella pneumonia, Enterobacter aerogenes, Serratia) and the gram-positive (like Staphylococcus aureus and streptococci). (1)(2)(3)

Chemical and Physical Features

• CAS number: 1405-41-0. (4)

• Molecular Structure: (5)

• Molecular Formula: C60H125N15O25S. (6)

• Weight: 1488.8 g/mol. (6)

• Appearance:  

• As injection/vial/eye drops- It is a clear, colorless solution, free from visible particulate matter

• As a cream- It comes in a tube and has a creamy texture.

• As an ointment- It comes in a tube with a greasy texture

Gentamicin sulfate comes in white amorphous powder form also.

• Other Physical Features: 

• Gentamicin sulfate injection is stable at room temperature and does not need cold chain storage. Its shelf life is 2-4 years, depending on the manufacturer. It should not be stored above 25-degree centigrade, should not be refrigerated or frozen, and should be protected from light.

• Gentamicin sulfate is soluble in water (50gm/ml), giving a very clear to slightly hazy, colorless to faint yellow solution. It is insoluble in alcoholic and organic solvents. 4% of the solution has a ph of 3.5- 5.5.6 in water. (7)

• Gentamicin sulfate has to be stored in airtight containers. It loses its potency in plastic disposable syringes and forms a brown precipitate. It should not be stored in glass disposable syringes for more than 30 days. (8)

• Brand Names

• Gentamicin systemic- 

• Injection- Garamycin, Cidomycin, Septopal, Genoptic, Cidomycin. (8)

• Gentamicin ophthalmic- Gentak, Genoptic, Gentacidin, Garamycin Ophthalmic

• Gentamicin topical- 

• Creams- Garamycin Topical, G-Myticin Gental cream, Lyramycin cream, Merigenta 0.1% cream, Gentapar cream, Supragent cream. (9)(10)

Vitamin B6 forms and specifications

• Gentamicin Sulfate API Powder

It is a white amorphous powder, freely soluble in water, pyridine, dimethylformamide, and in acidic media with salt formation. It is moderately soluble in methanol, ethanol, and acetone. The powder is practically insoluble in benzene and halogenated hydrocarbons. (11)

• Gentamicin injections:

Gentamicin injection comes in the form of liquid to be injected intravenously or intramuscularly. It is usually infused over 30 minutes to 2 hours, once every 6 to 8 hrs. Gentamicin is used to treat infections that are serious and caused by bacteria such as meningitis and infections of the skin, blood, lungs, joints, abdomen, bones, and urinary tract. (2) 

• Gentamicin eye drops (ophthalmic solution):

Genoptic is used as the ophthalmic solution to treat bacterial infections such as bleparitis and conjunctivitis. One or two drops may be administered into the infected eye every 4 hours. The drops are to be avoided during pregnancy and breastfeeding. One should be careful to use the dosage precisely as per the prescription, else there could be side effects such as burning or irritation. Bacterial or fungal corneal ulcers have developed due to the usage of these ophthalmic solutions, in very rare instances. (12)

• Gentamicin Sulfate cream:

Each gram of Gentamicin sulfate cream contains Gentamicin sulfate USP equivalent to 1mg of gentamicin base in a cream base of propylene glycol, isopropyl myristate, purified water, propylene glycol monostearate, polysorbate, stearic acid, and sorbitol solution, with methylparaben, and butylparaben as preservatives. In primary skin infections, the cream usually clears lesions promptly. It has been recommended for oozing primary infections and seborrheic dermatitis. It has also been successfully used in infants over one year of age, children, and adults. (13)

• Gentamicin ointment:

Similar to creams, gentamicin ointment (1%) is used for treating skin infections such as impetigo, folliculitis, eczema, psoriasis, and minor burns, cuts, and wounds. Generally, topical gentamicin is stored at a temperature between 15C to 30C (59F to 86F). (14)

Mechanism of action of Gentamicin Sulfate

Gentamicin is an antibiotic that binds the 30S subunit of the bacterial ribosome, which impairs protein synthesis. First, it works through ablating the ability of the ribosome to discriminate on proper transfer RNA and messenger RNA interactions. If wrong tRNA pairs with mRNA codon at the aminoacyl site of the ribosome, adenosines 1492 and 1493 are excluded from the interaction and this signals the ribosome to reject the aminoacylated tRNA. The helix interactions cause the acceptance of the correct aa-tRNA and mRNA, causing the ribosomes to synthesize proteins with the wrong amino acids placed throughout. This further leads to the death of the bacterium. A secondary mechanism based on crystal structures of gentamicin in a secondary binding site of another helix interaction takes place. Here the two subunits of the ribosomes stay complexed even after translation completes. This creates a pool of inactive ribosomes that can no longer make new proteins. (3)

Gentamicin Sulfate manufacturing process

• Production of Gentamicin sulfate by fermentation 

Gentamicin is produced by fermentation of Micromonospora purpura ( a genus of  Gram-Positive bacteria widely present in water and soil). The source materials include samples of soil, which are well purified. (3)

• Production by Gentamicin Injection by sterilization process

The process is conducted under appropriate aseptic conditions. The first step involves adjusting the correct ph levels, prefiltration, and sterile filtration and sealing the ampoules. Once these parameters are fixed satisfactorily to extract the vials, the headspace of the vials is replaced with nitrogen, during the filling process, to prevent oxidation of the API. (15)

• Production of Gentamicin sulfate by fermentation in a yeast medium

Gentamicin antibiotic is produced by fermentation of Micromonospora purpura or M echinospora and allied variants. The fermentation broth is produced when two subspecies of Micromonospora purpura are grown in a yeast extract medium. (16)

• Production of Gentamicin sulfate by submerged fermentation using the fungal strain Aspergillus terreus  FZC3

A fungus strain, identified as Aspergillus terreus, derived by sequencing the PCR amplified ITS fragments of its r RNA-coding genes and also by its morphology, is used to isolate Gentamicin from solid waste and sewage water. The process involves both biosorption and biodegradation. (17)

Gentamicin Sulfate uses

• Gentamicin is used in the treatment of respiratory tract infections, urinary tract infections, blood, bone and soft tissue infections, Bacteremia, Endocarditis, Intraabdominal infection, Meningitis, Osteomyelitis, Pelvic inflammatory disease, Peritonitis, Plague, Pneumonia, Skin or soft tissue infection, surgical prophylaxis, tuberculosis-urinary tract, Sepsis, burns/cuts/wounds, Acute disseminated Encephalomyelitis, syphilitic Ruptured Cerebral Aneurysm, Syphilitic Parkinsonism, CNS disorder, CNS infection, CNS tuberculosis, Herpes Zoster Meningitis, Bartonellosis, and Herpes Zoster myelitis. (3)(18)

• Gentamicin is also useful against Yersinia pestis (responsible for plague), and Francisella tularensis (the organism responsible for tularemia). (3)

• Gentamicin is also useful in molecular biology research as an antibacterial agent in tissue and cell culture. (3)

Gentamicin Sulfate dosage

Gentamicin dosage can be understood better when analyzed separately for adults and children.

• For adults-

Conventional dosage: 3-5mg/kg/day split over every 8 hours.

Extended dosage: Initial 4-5 mg/kg/dose once/day, subsequent doses after consultation.

• For Paediatric-

Children who are 5 years and older: 2-2.5 mg/kg/dose every 8 hours.

Children who are under 5 years: 2.5 mg/kg/dose every 8 hours.

Infants who are under 30 weeks gestation: 0-28 days- 2.5 mg/kg/day

More than 28 days-3 mg/kg/day

Infants who are 30-36 weeks gestation: 0-14 days- 3 mg/kg/day

More than 14 days-5 mg/kg/day every 12 hours

Infants who are over 36 weeks gestation: 0-7 days- 5 mg/kg/day every 12 hours

More than 7 days-7.5 mg/kg/day every 8 hours.    (12)

Gentamicin Sulfate side effects

• Side effects caused by gentamicin applied topically, include skin redness, itching, warmth, swelling, or oozing. (2)

• Side effects caused due to gentamicin injections include nausea, vomiting, diarrhea, decreased appetite, pain at the injection site, headache, fever, joint pain, unusual tiredness. On the severe side it could lead to kidney or hearing issues, rashes, peeling or blistering of the skin, hives, itching, swelling of the eyes, throat, tongue, or lips, difficulty in breathing or swallowing, and hoarseness. (2)

• Side effects caused due to gentamicin ophthalmic solution include eye-stinging, redness, or temporary blurred vision. On the severe side, it could lead to new or worsening eye symptoms such as pain, swelling, thick discharge or pus, rash, itching, or swelling. There could also be bacterial or fungal corneal ulcers, non-specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia. Some rare adverse reactions can be thrombocytopenic purpura and hallucinations. (12)

• Side effects caused due to gentamicin ointments include allergic contact dermatitis, reddening of the skin, and itching. (14)

• Side effects caused due to gentamicin creams- Most of the side effects disappear as the body adjusts to the medicine. Some minor side effects can be related to site irritation. (9)

Gentamicin Sulfate API Price

The API price of Gentamicin sulfate is around $96 per Kg.26

Gentamicin Sulfate API manufacturers in China

Below are some API manufacturing companies in China.

• Luohe Nanjiecun Pharmaceutical Group Pharmacy Co., Ltd: The factory covers a wide area of around 55000 sq meters and is one of the largest producers of Rifamycin API in the country. (19)

• Sichuan Long March Pharmaceutical Co., Ltd: Sichuan Long March Pharmaceutical Co., Ltd was established in 1968. It owns 3 subsidiary companies, one antibiotics institute and has over 150 main products including antibiotics manufacturing, bio-fermentation, chemical synthesis, bio-pesticides, animal health products, and pharmaceutical machinery. (20)

• North China Pharmaceutical Co., Ltd.: North China Pharmaceutical Group Aino Co., Ltd. was established in 1996. They have been the largest manufacturers and sellers of green APIs and preparations of bio-pesticides and veterinary products. (21)

• Fujian Fukang Pharmaceutical Co., Ltd.: Fujian Fukang Pharmaceutical Co., Ltd. was founded in 1958. They started with a single product and now cover a range of products including 7ACA intermediate, sterile cephalosporin API, antibiotic API, nutrition supplement,  vitamins, preparation, and animal feed.22

You can also find details around more suppliers for Gentamicin sulfate API in bulk at PharmaSources.com. PharmaSources.com is one of the leading and trustworthy vertical e-commerce online pharmaceutical marketplaces. It gives information on quality pharmaceutical products and suppliers for its esteemed customers and delivers services to 90,000+ active members. The services are provided to about 211 countries and regions. PharmaSources.com has been successfully selling over 1,600,000 products in 30 major pharmaceutical categories across the supply chain. (24)

FAQs:

What type of bacteria does gentamicin kill?

Gentamicin works against many bacterial infections of gram-negative bacteria (like pseudomonas, Proteus, Escherichia coli, Klebsiella pneumonia, Enterobacter aerogenes, Serratia) and the gram-positive (like Staphylococcus aureus and streptococci). (3)

Why is gentamicin not given orally?

Aminoglycosides like gentamicin cannot be given orally as they are not absorbed in the gastrointestinal tract. (23)

Sources:

1) https://www.webmd.com/drugs/drugreview-75145-gentamicin-topical

2) https://medlineplus.gov/druginfo/meds/a682275.html

3) https://en.wikipedia.org/wiki/Gentamicin

4) https://www.sigmaaldrich.com/catalog/search?term=1405-41-0&interface=CAS%20No.&N=0&mode=partialmax&lang=en&region=IN&focus=product#:~:text=Gentamycin%20Sulfate%20%2D%20CAS%201405%2D41%2D0%20%2D%20Calbiochem

5) https://www.ghsupplychain.org/sites/default/files/2019-02/MNCH%20Commodities-Gentamicin.pdf

6) https://pubchem.ncbi.nlm.nih.gov/compound/6419933

7) https://www.sigmaaldrich.com/content/dam/sigma-aldrich/docs/Sigma/Product_Information_Sheet/g1264pis.pdf

8) http://www.inchem.org/documents/pims/pharm/gentamic.htm#SubSectionTitle:1.4.1%20CAS%20number

9) https://www.1mg.com/drugs/gentamycin-cream-267546

10) https://www.drugs.com/ingredient/gentamicin.html

11) https://www.gembio.com/product/gentamicin-sulfate-powder

12) https://www.rxlist.com/genoptic-side-effects-drug-center.htm#overview

13) https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=4cfbe37e-11d6-46fc-b287-0561387b17b7&type=display

14) https://www.medicinenet.com/gentamicin-topical/article.htm#what_is_gentamicin_ointment_what_is_gentamicin_used_for

15) https://www.ghsupplychain.org/sites/default/files/2019-02/MNCH%20Commodities-Gentamicin.pdf

16) https://pubchem.ncbi.nlm.nih.gov/compound/Gentamicin#section=Safety-and-Hazards

17) https://www.nature.com/articles/srep35856

18) https://www.everydayhealth.com/drugs/gentamicin#:~:text=Gentamicin%20is%20usually%20given%20for,use%20an%20IV%20at%20home.

19) http://www.njcpharma.com/about-njc-en/overview/

20) https://www.pcfdata.com/com/longmarch/sell/

21) http://www.aino.com.cn/english/index.aspx

22) http://www.fz-antibiotic.com/en/page-11198.html

23) https://www.sciencedirect.com/topics/neuroscience/gentamicin

24) www.Pharmasources.com

25) https://www.pharmacompass.com/price/gentamicin-sulfate