Risk-based approach for systematic development of gastroretentive drug delivery system

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems

Background:

• Diltiazem hydrochloride is a widely used cardiovascular drug.
• Optimizing oral drug delivery remains a key challenge in pharmaceutical development.

Purpose of the Study:

• To develop and optimize an effervescent floating matrix tablet for diltiazem hydrochloride.
• To utilize a risk-based approach and factorial design for formulation development.

Main Methods:

• Defined Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs).
• Conducted risk assessment of material attributes and process parameters.
• Employed a 3(2) full factorial design to study swelling polymer and gas-generating agent effects.
• Utilized desirability function for optimization and validation.

Main Results:

• Identified critical factors influencing floating lag time and drug release.
• Optimized formulation showed drug release and floating lag time close to predicted values.
• Validated model diagnostic plots indicated the absence of outliers.

Conclusions:

• Successfully developed a diltiazem hydrochloride effervescent floating matrix tablet.
• The optimized formulation is suitable for twice-daily oral administration.
• The risk-based approach and factorial design were effective in formulation development.