Design and Development of Solid Self Emulsifying Osmotic Delivery System of Nifedipine

Objectives: In order to enhance solubility and to obtain controlled release characteristics, preparation of nifedipine has been made into a osmotic pump tablet which includes Gelucire 44/14, Lutrol F127, Transcutol P, silicon dioxide, lactose, mannitol, citric acid, and sodium bicarbonate. Material and methods: The developed dosage form was evaluated for particle size, solid state properties and release profile. Effect of orifice size and amount of plasticizers on drug release was also studied. Results: The results revealed that Self-emulsifying osmotic pump tablet (SEOPT) has not only provided improvement in solubility of nifedipine by self-emulsifying effect (SEDDS) but also controlled release due to elementary osmotic pump system. The particle size analysis revealed no difference in the droplet size of liquid SEDDS & reconstituted SEDDS. Conclusion: Release studies revealed that nifedipine followed zero order release profile for 12 h independent of agitational intensity with cumulative release of 83.85%. The in vitro release profiles of the optimized system & commercialized conventional tablet (Nicardia ® Retard 20) in different amount of sodium lauryl sulphate (SLS) were also compared.