Formulation and evaluation of nifedipine injection

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems

Background:

• Nifedipine is a calcium channel blocker used to treat hypertension and angina.
• Developing stable aqueous formulations of poorly soluble drugs like nifedipine presents a significant challenge.
• Hydrotropic solubilization offers a potential method for enhancing the solubility and stability of such drugs.

Purpose of the Study:

• To formulate a stable aqueous injection of nifedipine using hydrotropic solubilization.
• To evaluate the stability of the nifedipine injection under various storage conditions.
• To assess the preliminary in vivo efficacy of the developed formulation.

Main Methods:

• Nifedipine injection was formulated using sodium benzoate and sodium salicylate as hydrotropic agents.
• Stability studies included accelerated conditions (4 weeks at 8°C, room temperature, 40°C, 50°C) and light exposure.
• Autoclaving stability and preliminary in vivo efficacy in rats were also evaluated.

Main Results:

• The nifedipine injection exhibited maximum stability at 8°C, indicating a need for refrigerated storage.
• Protection from light by covering ampoules with black chart paper ensured adequate stability.
• The formulation demonstrated stability upon autoclaving and showed preliminary effectiveness in rat models.

Conclusions:

• A stable aqueous nifedipine injection can be formulated using hydrotropic solubilization with sodium benzoate and sodium salicylate.
• Refrigeration and protection from light are crucial for maintaining the stability of this nifedipine formulation.
• The developed hydrotropic injection of nifedipine is stable, effective, and suitable for further investigation.