Validation of a method to study the dissolution behaviour of norfloxacin tablets

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Analytical Chemistry

Background:

• Standard dissolution testing methods for norfloxacin tablets use large volumes of dissolution medium (750-900 ml).
• These volumes do not accurately reflect the physiological conditions within the human gastric tract.
• There is a need for dissolution methods that can simulate in vivo conditions more closely.

Purpose of the Study:

• To develop and validate a novel dissolution testing method for norfloxacin tablets.
• To establish a method utilizing a reduced volume of dissolution medium (100 ml).
• To validate a device enabling in vitro interaction studies with therapeutic substances like antacids.

Main Methods:

• Experimental development and validation of a new dissolution apparatus.
• Utilizing a 100 ml dissolution medium volume for norfloxacin tablets.
• Incorporating the capability to add therapeutic amounts of antacids or other substances.

Main Results:

• The developed method successfully evaluates the dissolution rate of norfloxacin tablets using a significantly smaller volume of dissolution medium.
• The 100 ml volume more closely approximates the conditions in the human gastric tract.
• The validated device allows for in vitro interaction dissolution studies.

Conclusions:

• A novel, validated method for norfloxacin tablet dissolution testing has been established.
• The use of a smaller dissolution volume (100 ml) offers a more physiologically relevant in vitro assessment.
• The method facilitates the study of drug-antacid interactions under simulated gastric conditions.