Pharmaceutical drug products stability studies are important for establishing the shelf life of the products. Stability studies can be performed for finished drug substances and drug products with the real time, intermediate and accelerated storage conditions. All stability study guidelines are mentioned in ICH, FDA, EMEA and WHO guidelines.
HOLD TIME STUDY
Hold time stability is evaluating
for each stage in the product manufacturing. Hold stability study can
demonstrates how much time is suitable for hold the blend or bulk stage before
processing to the next stage. When appropriate, time limits for the completion
of each phase of production shall be established to assure the quality of the
drug product. Hold time stability results should meet the product
specifications. Hold time study shall be carried out with the storage container
packing’s only. If the dosage form is stored in bulk containers for over 30
days, real-time stability data under specified conditions should be generated
to demonstrate comparable stability to the dosage form in the marketed package.
As an example, for oral tablets that
are coated, the following stages may be considered:
– binder preparation to
granulation
– consider the granulate
– wet granulation to drying
– consider the dried granulate
– dried granules to
lubrication/blending
– consider the lubricated blend
– blend to compression
– compression to coating
– consider the tablet cores
– coating solution to
preparation
– consider the coating solution
– coating to packing
– consider the bulk coated tablets
– coating to packing in bulk
– packing of bulk to finished packed
dosage form
Hold time flow in pharmaceutical
industry
Hold time study stages in all type
of dosages form
Tests dependent on the requirement
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