G.Sailesh's blog

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Stability testing

First of all I would like to apologize for not being blogging since a long time. I am some what hectic with M.pharm project submission and job searching by moving to other areas. My mind is not stable and could not concentrate on blogging. I would like to share some of my knowledge on stability testing and its significance.

Technology transfer (Lab to commercial scale):

I would like to share some basic knowledge about Technology transfer or LTC (Lab to commercial scale) gained during seminar in Bapatla College of pharmacy by Adan Sabir sir (Ex-Vice president Dr.Reddy's Laboratories). It takes much time to transfer a product developed in the laboratory to large scale manufacturing. The example given by him was so simple and everyone can easily understand about the complexity involved in technology transfer. It is easy to cook rice or food for a group of 2 to 4 people.

Enhancement of dissolution using multiparticulates

About 40% of the drug compounds are poorly water soluble1. This poor water solubility results in decreased rate and extent of dissolution and hence bioavailability. The formulation of a dosage form for these compounds is a challenging aspect. A number of techniques like micronization, nanonization, salt formation, complexation, solid dispersions, and use of different polymorphic form of the drug are being tried to improve the water solubility of drug compound. Each technique has its own limitations.

Antibiotic resistance – super bug

Antibiotics are a particular class of anti-microbials. Anti-microbials is a general term used to cover all class of microbes like bacteria, protozoa, fungi and other such organisms. Antibiotic refers to a drug that is generally used against the infections caused due to bacteria. Starting from the pencilins, cephalosporins and other classes, a number of antibiotics that might be natural, semi-synthetic or synthetic ones are being discovered to fight against different type of infections.

Scale up and post approval changes(SUPAC)

This is a guidance document that comes under Chemistry manufacturing and controls section of USFDA. During formulation development, initially, development process is carried out in small batch sizes generally in the multiples of 10X i.e., small scale or lab scale. The batch size is then increased to multiples of 100X i.e., medium scale or pilot scale. In production scale or large scale, manufacturing is carried out in large numbers usually multiples of 1000X depending upon the requirement.


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