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US 20030104052A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2003/0104052 A1 (43) Pub. Date: Berger et al. (54) GASTRIC RETENTIVE ORAL DOSAGE FORM WITH RESTRICTED DRUG
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What is gastric retentive oral dosage?
Gastric retentive oral dosage refers to a type of medication or drug formulation that is designed to remain in the stomach for an extended period of time, allowing for controlled release and absorption into the body.
Who is required to file gastric retentive oral dosage?
There is no specific requirement to file gastric retentive oral dosage. However, pharmaceutical companies or drug manufacturers may be responsible for developing and submitting regulatory filings for this type of medication.
How to fill out gastric retentive oral dosage?
The process of filling out gastric retentive oral dosage may vary depending on the regulatory requirements of the specific jurisdiction. Generally, it involves providing detailed information about the formulation, release mechanisms, and pharmacokinetics of the medication.
What is the purpose of gastric retentive oral dosage?
The purpose of gastric retentive oral dosage is to optimize drug delivery and improve therapeutic efficacy by controlling the release and absorption of medication in the stomach. This can be particularly useful for drugs with specific absorption requirements or those that exhibit poor bioavailability.
What information must be reported on gastric retentive oral dosage?
The information that must be reported on gastric retentive oral dosage typically includes details about the formulation, release mechanisms, pharmacokinetics, stability, manufacturing process, and any supporting data on safety and efficacy.
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