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Raw M II
Raw M II
Fillers fill out the size of a tablet or capsule, making it practical to produce and convenient for the
consumer to use. By increasing the bulk volume, the fillers make it possible for the final product to have
the proper volume for patient handling.
Glidants are used to promote powder flow by reducing interparticle friction and cohesion. These are used
in combination with lubricants as they have no ability to reduce die wall friction. Examples include
colloidal silicon dioxide, talc, and magnesium carbonate.
Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or capsule
filling machine. Lubricants also ensure that tablet formation and ejection can occur with
lowfriction between the solid and die wall.
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There are two different type of raw material one is active or it may be termed as active pharmaceutical
ingredient (API) and another one may be inert substances which aid in formulation development and
necessarily add some of its technical properties to the drug products. It may be either bulk increasing
agent, viscosity inducers, and formulation stabilizer against oxygen, atmospheric water, and
temperature or hydrolysis inhibitors.
There are various types of active ingredient, which are manufactured in specially, designed plants using
different machinery, following different reaction processes and stored in adequately protected
environment. Firstly their processing is so highly sophisticated that a standard of cleanliness and
environment control has to maintain. These should be protected from temperature, air, water and light
that may seriously harm on the physical and or the chemical stability of the drug product. These factors
may leads to harsh degradation reaction such as hydrolysis, oxidation, decarboxylation, addition, or
elimination. Other serious disadvantages likely to come in the drug product may be due to the physical
changes associated with the drug like sublimation, polymorphism, change in the particle size distribution
etc. It must therefore be stored where physical and chemical changes in the drug product are minimized
and stability of the drug and drug product maintained. The important guidelines related with the
stability and storage conditions are designed and framed by the different authorities such as World
Health Organization (WHO), International Conference on Harmonization (ICH), different national or
state Drug Regulatory Authorities. Initially, a caution must be exercised in testing raw material to assure
that it is not altered during the sampling procedure. For further stage of compounding, testing etc., the
samples should be taken in dry, controlled atmosphere condition, dust free, and microbiologically clean
environment. Active ingredients should be checked before the compounding using the method designed
to establish its identity, purity and potency. These records are to be maintained, protected and
preserved for comprehensive review of the production process. Again the specific purpose is to strictly
follow the good manufacturing practices