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.

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.

Pharmaceutical development of a dosage form will be easier if a system is developed that exactly mimics the conditions of human body. Unfortunately, till date, such a system does not exist. Dissolution serves the

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A Polymer consists of repeated subunits of monomers which may or may not be similar in structure¹

They may be attached linearly or branched
High molecular weight compounds¹

Hello friends, Due to inevitable circumstances, I was unable to post my second blog on invitro- invivo correlation in the previous month which I will present it this month.

Hello friends,

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.