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The active pharmaceutical ingredient Choline fenofibate was subjected to preformulation study, which encompasses the “Accelerated, intermediate, long term Drug – excipient compatibility study” , and the result obtained with selected excipients showed good compatibility with Choline fenofibrate.Choline fenofibrate pellets were formulated by utilization of FBP, and Choline fenofibrate coated pellets were filled by capsule filling machine.
The stability study of the capsule and pellets were detected by conducting “accelerated 40°C±5%/75%RH” for 6 months. Finally, after the duration, the product was analyzed for content and dissolution study. By the stability studies, the formulated Fenofibric acid Delayed release capsules and pellets proved to be throughout the period of storage.TheFenofibric acid delayed release pellets were loaded in size ‘0’ capsules. It showed good results in formulation of stable dosage.
Kim NH, Kim SG. Fibrates Revisited: Potential Role in Cardiovascular Risk Reduction. Diabetes Metab J. 2020 Apr;44(2):213-221. doi: 10.4093/dmj.2020.0001. PMID: 32347023; PMCID: PMC7188966.
Rhee EJ, Kim HC, Kim JH, Lee EY, Kim BJ, Kim EM, Song Y, Lim JH, Kim HJ, Choi S, Moon MK, Na JO, Park KY, Oh MS, Han SY, Noh J, Yi KH, Lee SH, Hong SC, Jeong IK. 2018 Guidelines for the management of dyslipidemia. Korean J Intern Med. 2019;34:723–771.
Heinz Drexel and others, Fibrates: one more lost paradise in lipid treatment, European Heart Journal - Cardiovascular Pharmacotherapy, Volume 9, Issue 2, March 2023, Page 121, https://doi.org/10.1093/ehjcvp/pvac072.
Bile Acid Resins or Sequestrants. (2017). In LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. National Institute of Diabetes and Digestive and Kidney Diseases.
Feng, Y., Li, Q., Ou, G., Yang, M., & Du, L. (2021). Bile acid sequestrants: a review of mechanism and design. The Journal of pharmacy and pharmacology, 73(7), 855–861. https://doi.org/10.1093/jpp/rgab002.
Hansen, M., Sonne, D.P. & Knop, F.K. Bile Acid Sequestrants: Glucose-Lowering Mechanisms and Efficacy in Type 2 Diabetes. Curr Diab Rep 14, 482 (2014). https://doi.org/10.1007/s11892-014-0482-4.
Liu X, Yang R, Dai B, Zhang H, Wang J, Ma N. Nicotinic acid and related compounds: A meta-analysis of their use for hyperphosphatemia in dialysis patients. Medicine (Baltimore). 2018 Mar;97(12):e0117. doi: 10.1097/MD.0000000000010117. PMID: 29561409; PMCID: PMC5895315.
Francesco Piacente, Irene Caffa & Alessio Nencioni (2017) Nicotinic acid: A case for a vitamin that moonlights for cancer?, Cell Cycle, 16:18, 1635-1636, DOI: 10.1080/15384101.2017.1360633.
Ratul, Deb & Ahmed, Abdul. (2013). Pellets and pelletization techniques: A critical review. International Research Journal of Pharmacy. 4. 10.7897/2230-8407.04414.
Miranda, Teresa & Montero, Irene &Sepúlveda Justo, Francisco &Arranz, José Ignacio & Rojas, Carmen & Nogales, Sergio. (2015). A Review of Pellets from Different Sources. Materials. 8. 1413. 10.3390/ma8041413.
Das, Swagatika& Giri, Souvik& Mohapatra, Manmayee&Parida, Sidhartha& Karan, Debasish &Pattanaik, Archana. (2022). Update And Challenges Of Pellets.
Aher UD, Shelke TT, Patel EP; Recently used technologies in Pellet Formulation - A Review;PharmaTutor; 2017; 5(7); 22-30