Modified release drug made by Md.Shajaet
- 2. Group member •UG-08-28-16-030 •UG-08-28-16-032 •UG-08-28-16-034 •UG-08-28-16-040 •UG-08-28-16-044
- 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
- 10. CONTINUED…
- 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.
- 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%
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