8. MODIFIED-RELEASE DOSAGE FORMS AND DRUG DELEVERY SYSTEMS ●●●●● ●●●● ●●。●●
8. MODIFIED-RELEASE DOSAGE FORMS AND DRUG DELEVERY SYSTEMS
●●●●● CONTENTS ●●●● ●●0 ●●● ●●●● I. The rationale for extended-release pharmaceuticals ll. Terminology II. Extended-release oral dosage forms IV Delayed-release oral dosage forms V USP requirements and FDA Guidance for modified-release dosage forms VI Clinical considerations in the use of oral modified-release dosage form VI. Packaging and storing modified-release tablets and capsules
CONTENTS I. The rationale for extended-release pharmaceuticals II. Terminology III. Extended-release oral dosage forms IV. Delayed-release oral dosage forms V. USP requirements and FDA Guidance for modified-release dosage forms VI. Clinical considerations in the use of oral modified-release dosage form VII. Packaging and storing modified-release tablets and capsules
●●●●● ●●●● ●●0 ●●● ●●●● o In contrast to conventional forms, modified-release products provide either delayed-release or extended release of drug Delayed-release products usually are enteric-coated tablets or capsules designed to pass through the stomach unaltered. later to release their medication within the intestinal tract
⚫ In contrast to conventional forms, modified-release products provide either delayed-release or extendedrelease of drug. ⚫ Delayed-release products usually are enteric-coated tablets or capsules designed to pass through the stomach unaltered, later to release their medication within the intestinal tract
●●●●● ●●●● ●●0 ●●● ●●●● ● Extended- release products are designed to release their medication in controlled manner. at predetermined rate, duration and location to achieve and maintain optimum therapeutic blood levels of rug
⚫ Extended-release 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
I The rationale for extended- ●●●●● ●●●● ●●0 release pharmaceuticals ●●● ●●●● e Extended-release tablets and capsules are commonly taken only once or twice daily compared with counterpart conventional forms that may have to be taken three or four times daily to achieve the same therapeutic effect
I. The rationale for extendedrelease pharmaceuticals ⚫ Extended-release tablets and capsules are commonly taken only once or twice daily, compared with counterpart conventional forms that may have to be taken three or four times daily to achieve the same therapeutic effect