Formulation Development, Optimization, and Characterization of Cilnidipine-Loaded Self-microemulsifying Drug Delivery System

Authors

  • Kumar Anand Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India
  • Samit Karmakar Medical College, Kolkata, West Bengal, India
  • Pallab Mandal Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India
  • Md. Adil Shaharyar Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India
  • Rudranil Bhowmik Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India
  • Avishek Mondal Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India
  • Subhabrata Ray Dr. B. C. Roy College of Pharmacy and Allied Health Sciences, Dr. Meghnad Saha Sarani, Durgapur, West Bengal, India
  • Sanmoy Karmakar Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India

DOI:

https://doi.org/10.21276/apjhs.2022.9.1.05

Keywords:

Biopharmaceutical classification system Class II, Cilnidipine, Design expert, Goat intestinal membrane permeability, Pseudo-ternary phase diagram, Self-microemulsifying drug delivery system

Abstract

Cilnidipine, a 2, 4-dihydropyridine antihypertensive, is poorly bioavailable and belongs to Biopharmaceutical Classification System Class II. The present study was carried out to develop and evaluate a cilnidipine-loaded self-microemulsifying drug delivery system (SMEDDS) using food grade oil for enhanced pharmacokinetic parameters. The SMEDDS was prepared by low-energy method. A pseudo-ternary phase diagram was developed using triacetin, Tween 20, and Transcutol HP as oil, surfactants, and cosurfactants, respectively. The statistically optimized formulation was obtained and was evaluated for relevant in vitro characterizations. Globule size, zeta potential, and polydispersity index (PDI) of the optimized formulation were found to be 9.045 nm, −2.32 mv and 0.203, respectively, indicating stable and uniformly distributed microemulsion nature of the formulation. Developed SMEDDS of viscosity 31 cps was found to be clear in 500 times dilution in water and phosphate buffer pH 1.2. Selection of the optimized SMEDDS was followed by various formulation characteristics, including goat intestinal membrane permeability. The in vitro dissolution study of optimized SMEDDS exhibited much better result as compared to the marketed tablet of cilnidipine.

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Published

2022-01-15

How to Cite

Kumar Anand, Samit Karmakar, Pallab Mandal, Md. Adil Shaharyar, Rudranil Bhowmik, Avishek Mondal, Subhabrata Ray, & Sanmoy Karmakar. (2022). Formulation Development, Optimization, and Characterization of Cilnidipine-Loaded Self-microemulsifying Drug Delivery System. Asian Pacific Journal of Health Sciences, 9(1), 23–29. https://doi.org/10.21276/apjhs.2022.9.1.05