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Wednesday, May 1, 2019

Why Betalactam Antibiotics require a separate manufacturing area in pharmaceutical manufacturing company

Why Betalactam Antibiotics require a separate manufacturing aria in a pharmaceutical manufacturing company?
Chemistry behind the allergic reactions and mode of action of betalactum antibiotics:

Answer:
To avoid cross contamination of other products with betalactam antibiotics because

A.The betalactum antibiotics may cause anaphylactic shock and anaphylaxis or may cause life threatening allergic reactions.

B.The betalactum antibiotics molecules mode of action is more or less cytotoxic as discussed below.

C.Untoward consumption of betalactam antibiotics as contaminant in other product in smaller amount may result in development untoward Drug Resistance or antibiotic Resistance for betalactam antibiotics, and when ever desired, betalactam drugs may not prove effective in individuals who got betalactam antibiotic in contamination.

The question is very simple and the answer too is very simple but we will like to provide you a answer to your question which is based up on chemistry of the betalactum antibiotic molecule.

Hence first one should know how a betalactam antibiotics act against microorganisms

What is the mode of action of betalactum antibiotics?

1. Acylation of proteins

2. Generation Free radical Iminium ions which are cytotoxic to bacterial enzymes and proteins

1. Betalactum antibiotics contain a betalactum ring; this ring is a chemically active portion of the betalactam antibiotics as it takes part in reaction in vitro to bring about acylation of amino acids in proteins and enzymes, a acylation at a terminal end in protein amino acid result in termination of polymerization process in protein synthesis specially the cell wall proteins.

2. Betalactam ring in presence of certain PH range get converted in to a very unstable free radical which is very cytotoxic to microorganisms cellular proteins and enzymes, Iminium ion is very active and cytotoxic moiety which takes part in numerous reactions which are responsible for cytotoxic effects.

Why an allergic reaction occurs in penicillin drugs
As discussed above penicillin’s are betalactam antibiotics and about 7% to 8 % of individuals in world are allergic to penicillin’s and the allergy may be a life threatening for an individual

Because in vitro penicillin get reacted with human proteins to form a penicilloilproteins these proteins are synthesized as a result of acylation reaction over the human proteins and they are now new proteins after acylation and recognized as antigens in human immune system, they triggers a sequence of immunological responses by developing antibodies against these penicilloilproteins which further reacts to form antibody and antigen complexes , these reactions are sever and may be harmful to an individual.

Authored By : B V Waghmare

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Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice and latest news and new drugs developments.
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http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an interesting article on world wide pharmaceutical industry
Article on Pharmaceutical Industry pharmaceutical industry

Here are some interesting articles on Quality assurance systems for pharmaceutical company

1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industryan explanation

Friday, November 9, 2018

New drug for treatment of flu with novel mode of action can also be used in treatment of Swine Flu

US FDA approves New drug for treatment of Flue baloxavir marboxil with novel mode of action. 

Drug baloxavir marboxil has potential to be useful in treatment of swine flu as well in combination therapy.

For treatment of flu there were two types or there are two classes of drugs.
Flu is caused by influenza virus, after infection person feels very tired and get fever if it is not treated within 24 hours of observation of symptoms, patients condition may worsen, and develop pneumonia.
Until now there were only two types of drugs available to treat flu, including swine flu the most life-threatening form of flu.
Virus infect the human cell by 1) Attaching it self to human cell,
                              2) Enter in to cell release its RNA to form new viral RNA.
                              3) Replicate inside the human cell.
Following drug categories based on the mode of action is formed.

1ST Category of drug is 
Neuraminidase inhibitors:  oseltamivir (Tamiflu) , zanamivir, laninamivir and peramivir.
2nd  Category of drug is 
1.)   M2 protein Inhibitor : (adamantane derivatives).

Neuraminidase inhibitor drugs prevent release of newly formed viral particles of influenza virus in the lifecycle of the virus and disrupts further infection of new cells, these class of drugs do not inhibit the formation new virus inside human cells.
M2 protein Inhibitor drugs work at second level of process of reproduction by inhibiting virus to release its RNA to form new viral RNA. Due to higher degree of resistance development these class of drugs are avoided.
Now after approval of baloxavir marboxil by USFDA a new class of drug is now available which is
Endonuclease inhibitor drugs to treat influenza, including Swine flu and other sever form of flu in combination therapy by combining drug from neuroamidase inhibitors and Endonuclease inhibitors together it will prove lifesaving drug combination. Patients stage of infection and age and overall level of infection should be considered before combination therapy it will work best in case the patient is treated in early stage of infection, treatment with drugs should be done under hospitalised condition.
First two class of drug has its drawbacks Neuraminidase inhibitors has limited benefit over its side effects and adamantane derivatives has greater risk of developing resistance, hence Endonuclease inhibitor drugs third class of drugs are of great importance.
Baloxavir marboxil
This drug inhibits enzyme endonuclease which is required for formation of new virus (New virus RNA) prevent reproduction or formation of new virus particle and if combined with any of one class of drug will be very effective in providing lifesaving treatment for against influenza viral infections like H1N1 H5N1.
What is influenza or flu.
Flu is caused by infection of influenza virus, Influenza virus spread through air, through sneezing, and by touching a contaminated surface and then touching mouth or nose or eyes, one get infected from influenza virus.
After infection person get fever, headache, and running nose, person feel tired and feel weakness.
Mode of infection : Influenza virus get attached epithelial cells with consist of sialic acids rich oligosaccharides in lungs and respiratory track, and damage these cells which trigger release of tumor necrosis factors cytokinin, which further damage cells through the process of inflammation, damaged cells has increase risk of pneumococcal infection.
Why person infected with influenza feel tired and get body pain and headache ?
Level of Adencorticosteroid hormone, cortisol which are responsible for lowering of inflammatory conditions are is reduced in patients infected with influenza virus drastically, Processes of inflammatory responses are at higher level which decreases level of threshold of pain, inflammatory process are also responsible for aggravating conditions of pneumonia.
Blockage of nostrils with mucus develops secondary bacterial infections of upper respiratory tract causing pneumonia.
There are four types of influenza Viruses.
influenza Virus A, influenza Virus B, influenza Viruse C, influenza Virus D

Following types of drugs currently available to treat flu, Swine flu
1)      Neuraminidase inhibitors:
        (oseltamivir (Tamiflu), zanamivir, laninamivir and peramivir)
       Prevent virus attachment to cell.
2) ion channel (M2 protein ) Inhibitor.: (adamantane derivatives)
   
New class of drugs approved by US FDA is
    3) Baloxavir marboxil : Which is an CAP defendant endonuclease inhibitor drugs.
Influenza virus is a RNA virus it makes use of host cell for its replication, through mRNA   Transcription. Baloxavir marboxil blocks mRNA Transcription and protein synthesis of viral particles.

Authored By : B V Waghmare

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