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RECOMMENDATIONS

OF THE INTERNATIONAL COMMITTEE

FOR THE NOMENCLATURE OF ANTIBIOTICSВ

A. If the chemical structure of a new antibiotic is established

1. The name should be chosen taking into account the class of chemical compounds to which this substance belongs

2. The name should be harmonious.

3. The choice of the name of the antibiotic should be based on the chemical structure of the antibiotic.

B. If the chemical structure of the antibiotic compound is unknown or poorly understood

1. The name of the antibiotic should be formulated based on the name of the genus or order to which the producer belongs. At the same time, it is recommended to assign the suffix "mycin" only to antibiotics produced by microorganisms belonging to the order Actinomycetales.

2. If the name based on the genus, family or order has been used before, the species name is used.3. In the name of the antibiotic, you can use the spectrum of its antimicrobial action or the mode of action.

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NOMENCLATURE OF ANTIBIOTICS

By genus or species name of the producer

Penicillin – Penicillium Polymyxin – Bacillus polymyxa

Cephalosporin – Cephalosporium Viridin – Trichoderma viridi

Streptomycin – Streptomyces Griseofulvin – Penicillium griseofulvum

By the name of the area

Miamycin - Miami (Florida, USA)

Nikkomycin - Nikki (Japan).

By chemical structure

Tetracyclines - contain 4 six-membered rings

Bicyclomycin - 2 cyclic components

According to the compounds that make up the molecule

Valinomycin – valine

Ileomycin – isoleucine

By strain number of the producer

Etamycin from number 8 (eight)

Eifavin - from A5

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GROWTH RATE OF INDUSTRIAL PRODUCTION OF ANTIBIOTICS

Penicillin1943 - 13 kg/year

1979 - 14.8 tons/year

1957 – 400 tons of broad-spectrum antibiotics (mainly tetracyclines)

1974 - 4,000 tons

1977 – 5000 tons

90s 25,000 tons/year

Penicillins - 17,000 tons worth $350 million.

Tetracyclines – 5,000 tons worth $135 million.

Cephalosporins - 1.2 tons worth $ 100 million.

Erythromycin - 800 tons

Other antibiotics - 1000 tons

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USD million, aminoglycoside share, USA

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COST OF ANTIBIOTICS

Penicillin1943 - 18 dollars per 1 million units.

1960 - $0.02 per 1 million units.

Streptomycin

1944 - 15 dollars per gram

1959 - $0.03 per gram

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STAGES OF INDUSTRIAL PRODUCTION OF ��ANTIBIOTICS

Stage of biosynthesis is the creation of optimal conditions for the development of the producer
Stage of pre-treatment of culture liquid, cells (mycelium) of a microorganism and filtration (separation of culture liquid from producer biomass)
Stage of isolation and purification of the antibiotic
Stage of obtaining final products, manufacturing dosage forms, packaging

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DEEP CULTIVATION

Periodic cultivation
Take out method
Battery method
Continuous cultivation

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STRUCTURE OF THE FERMENTER

(5000) Infors-ht Minifors 2 - YouTube

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TYPES OF FERMENTERS

LABORATORY - material glass or stainless steel, capacity - up to 30 l.

SEMI-MANUFACTURING (SEMI-INDUSTRIAL) - stainless steel, up to 100 l.

INDUSTRIAL - stainless steel, 0.5-100 m3.

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PREPARATION OF SEED MATERIAL

Inoculation of conserved material on slanted agar
Transfer into flasks with liquid medium (2 generations on a shaker)
From the 2nd generation, transfer into a small inoculator (10 l)
Transfer to a large inoculator (100-500 l)
Inoculation of the main fermenter (5-10 vol.%)

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Primary treatment of culture medium

Aim – to separate cell biomass from liquid phase with metabolites

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FILTER PRESS

(5000) Filter Press Working | How Filter Press Work? | Filter Press Principle | Process of Filter Press - YouTube

(5000) How does filter press work? - YouTube

(5000) How a Filter Press Works - Animation - YouTube

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NUTSCHE FILTER

(5000) Filtration and Drying in Agitated Nutsche Filter Process 3d Animation - YouTube

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DRUCKFILTER

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ISOLATION AND PURIFICATION OF THE ANTIBIOTIC

Sorption methods
Extraction
Sedimentation

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LYOPHILIC DRYING

https://www.youtube.com/watch?v=HpRruVe5XWE

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SPRAY DRYER

(5000) Vacuum Tray Dryer Oven Operation (Animation) - YouTube

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VACUUM DRYING CABINET

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MEDICINAL FORMS OF ANTIBIOTICS

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Standardization of final product is carried out according to the following indicators:

biological activity,

sterility,

toxicity,

pyrogenicity,

therapeutic effect,

pharmacological parameters (pharmacodynamics, pharmacokinetics).

STANDARDIZATION OF FINAL PRODUCT

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GMP

Good Manufacturing Practice (GMP)

Good Manufacturing Practice is a part of quality assurance that guarantees that drugs are constantly manufactured and controlled in accordance with quality standards that meet their purpose, as well as in accordance with the requirements of the registration dossier, the dossier of the investigated drug for clinical trials or the specification for these products.

GMP regulations are primarily intended to reduce the risk inherent in any pharmaceutical product, which cannot be completely prevented by testing the finished product.

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GMP

Principles of GMP

1. Continuous improvement of the quality system.

2. Hygiene, staff engagement and understanding of key competencies.

3. Adequate premises, equipment and engineering systems.

4. Systematicity and simplicity of documentation.

5. Controlled production processes.

6. Reliability of quality control.

7. Interaction with partners (management of outsourcing works).

8. Reaction to complaints and effective withdraw of products.

9. Constant self-assessment of activity.

10. Process validation.

11. Role of the Authorized Person.

12. Decision-making based on facts, taking into account potential risks to quality.

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