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MODIFIED RELEASE
DRUGS
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
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.
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.
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.
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
CONTINUED…
IN THE STOMACH:
1. Drug resinate + HCl = Acidic resinate + Drug
hydrochloride
2. Resinate salt + HCl = Resinate chloride +
Sodium salt of drug
CONTINUED…
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.
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.
ADVANTAGES
Reduction in drug blood level fluctuation
Frequency reduction in dosing
Patient compliance
Reduced adverse side effect
Reduction in health care cost
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%
DO YOU HAVE ANY
QUESTION?
THANK YOU

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Modified release drug made by Md.Shajaet

  • 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%
  • 16. DO YOU HAVE ANY QUESTION?