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APIs / APIs and intermediates for human use / Framycetin Sulphate

FRAMYCETIN SULPHATE

structure

Molecular formula:

C23H46N6O13 . X H2SO4

Molecular weigh:

615 (base)

CAS registry No:

4146-30-9

Presentation:

Powder

Category:

Aminoglycoside antibiotic

Application:

For human and veterinary use.
For production of pharmaceutical products.

Quality:

Ph. Eur.

Contents:

Not less than 630 IU/mg

Most commonly used drug forms:

plaster, creams, ointments, eye drops, ear drops, eye ointments and tablets.

Packing:

5 kg in an aluminum can.

Re-test period:

2 years from manufacturing date.

Storage:

In a dry place, protected from light, at a temperature below 25°C.

Pharmacological action:

Framycetin Sulphate is an antibiotic, belonging to the Aminoglycoside group, with bactericidal effect with a wide antibacterial spectrum. The mechanism of action of framycetin appears to be related to inhibition of bacterial protein synthesis via binding to ribosomal subunits.

Framycetin is active against Staphylococcus spp., including coagulase-negative Staphylococci, Escherichia coli, Klebsiella spp., Salmonella, Shigella, Enterobacter spp., Proteus spp., Serratia marcescens, Pasteurella spp., Vibrio spp., Borellia and Leptospira spp. and Mycobacterium tuberculosis including also Streptomycin-resistant strains. Framycetin shows comparatively high activity against some strains of Pseudomonas aeruginosa, which is a main problematic pathogen.

The resistance to framycetin is hardly achieved after often and very prolonged use. For avoidance the occurrence of resistance or with reference to the extension of the therapeutic spectrum, usually in drug forms with framycetin are included other antibacterial agents, as well as steroid antiphlogistics. In dermatological practice framycetin is administered for treatment of wounds, ulcers, burns and other skin defects, infected with susceptible microorgan¬isms. The antibiotic is preferred agent for treatment of bacterial dermatoses and pyodermes as impetigo, furunculosis etc.

In ophthalmology the antibiotic is successfully applied for treatment of con¬junctivas, blepharitis and infections of the front ocular segments. The topical forms with framycetin manifest high effect at the treatment of corneal ulcers. In spite of the possible manifestation of ototoxicity Framycetin Sulphate alone or in combination with other antibacterial or anti-inflammatory agents is used also for preparation of ear drops. With reference to the wide usage of framycetin in otorhinolaryngology and the single incidents, it is accepted that the ototoxicity risks are insignificant after topical application. Topical forms containing framycetin are successfully used at the treatment of rhinitis caused by Staphylococci.