4. INTRODUCTION
•Modified release drug products are those
that alter the timing and the rate of release
of drug substance.
•Types of modified release drug products are –
1. Delayed release
2. Extended release
3. Orally disintegrating tablet
5. DISCRIBTION OF TYPE’S
DELAYED RELEASE-
Releases a discrete portion of drug at a time other
than promptly after administration. E.g. – enteric
coated dosage form’s like enteric coated aspirin,
other NSAIDS, etc
This products usually are enteric-coated tablets or
capsules designed to pass through the stomach
unaltered , later to release their medication within
the intestinal tract.
6. CONTINUED…
EXTENDED RELEASE-
Two fold release in dosage frequency. E.g.- include
controlled release, sustained release and long acting
drug products.
This products are designed to release their
medication in a controlled manner, at a
predetermined rate, duration and location to
achieve and maintain optimum therapeutic blood
levels of drug.
7. CONTINUED…
ORALLY DISINTEGRATING TABLETS-
1. Disintegrate rapidly in saliva after oral
administration.
2. Can be used without addition of water.
3. Drug dispersed in saliva and swallowed.
8. THE MECHANISM OF ACTION
IN THE INTESTINE:
1. Drug resinate + NaCl = Sodium resinate +
Drug hydrochloride
2. Resin salt + NaCl = Resin chloride + Sodium
salt of drug
9. CONTINUED…
IN THE STOMACH:
1. Drug resinate + HCl = Acidic resinate + Drug
hydrochloride
2. Resinate salt + HCl = Resinate chloride +
Sodium salt of drug
11. THE DRUG RELEASE RATE
Changing the surface area,
The thickness or composition of the membrane,
Changing the diameter of the drug release
orifice.
The drug-release rate is not affected by
gastrointestinal acidity, alkalinity, fed conditions,
or GI motility.
12.
13. THE ENTERIC COAT
pH dependent - Breaking don in the less
acidic environment of the intestine.
Time dependent- Eroding by moisture over
time during gastrointestinal transit.
Enzyme dependent- Deteriorating as a result
of the hydrolysis-catalyzing action of intestinal
enzymes.
14. ADVANTAGES
Reduction in drug blood level fluctuation
Frequency reduction in dosing
Patient compliance
Reduced adverse side effect
Reduction in health care cost
15. DRUG RELEASE
The USP test for drug release for extended-
release and delayed-release articles is based on
drug dissolution from the dosage unit against
elapsed test time.
Time(hr) Amount dissolved
1.0 between 15% and 40%
2.0 between 25% and 60%
4.0 between 35% and 75%
8.0 not less than 70%