Food and Drug Administration
Sterility testing attempts to reveal the presence or absence of viable micro-organisms in a sample number of containers taken from batch of product. Based on results obtained from testing the sample a decision is made as to the sterility of the batch1.
There are two common types of sterility test methods:
There were many reasons for dose dumping of an extended release dosage form like improper design of dosage form, drug excipient interactions, crushing or chewing by patient1, intake of food or alcohol2 of which dose dumping due to alcohol is of more concern. Dose dumping due to alcohol was initially identified in palladone capsules that contain hydromorphone used to treat pain2. It is a potent narcotic with the dose of 12mg.
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.
Orally disintegrating tablets also called as fast dissolving or mouth dissolving tablets are such kind of dosage forms which when placed in mouth disintegrates rapidly in a matter of seconds(1). They are different from lozenges or buccal tablets which require more than a minute to get dissolved in mouth(1). Any dosage form or a novel drug delivery system which improves patient compliance is of great interest to scientists in which orally disintegrating tablets stands first among them.