Development and characterization of controlled release bilayered tablets of Citicoline sodium

  • Neetesh Rayakwar Sagar Institute of Pharmaceutical Sciences (SIPS), Sagar, Madhya Pradesh
  • Yuvraj Singh Dangi Sagar Institute of Pharmaceutical Sciences (SIPS), Sagar, Madhya Pradesh


Objectives: The aim of present investigation was formulation development and evaluation of bi-layer tablets of citicoline sodium. Materials and Methods: An aqueous granulation process was adopted to formulate citicoline sodium (CTS) bilayer tablets. Wet granulation method has been utilized for the formulation of bilayer CTS tablet. Citicoline sodium, microcrystalline cellulose (pH 101 & 102), HPMC K4, K15, K-100, PVP K-30, Magnesium stearate, cross-carmellose sodium, sodium starch glycolate and red oxide were used for preparation. Pre-formulation studies of citicoline sodium and drug excipient compatibility study was carried to optimize the formulation variables. Two layers, immediate release (IR layer) and sustained release (SR) has been developed and evaluated for the various parameters e.g. micromeritic properties, percentage yield, particle size, hardness, thickness, weight variation, percent friability and percent assay,  In-vitro dissolution and In-vitro release studies. Result and Discussion: Pre-formulation study of citicoline sodium denotes that evaluated parameters confirm the suitability and compliance of drug with polymers.  Drug excipient compatibility study through the DSC confirmed that polymer, excipient and drug were compatible with each other and no incompatibility issue found during the preparation of formulation. FT-IR study is also executed to confirm the drug-excipient incompatibility. In all physical mixtures of drug and polymer, there was neither masking of single characteristic peak nor existence of additional peak in drug spectra; this has proven that drug and polymers are compatible with each other. Hardness 10-11 kg/cm2, thickness 7.3-7.4 mm, percent weight variation 1.2%, friability 0.1-0.3%, assay was 99-101% denotes the successful development of CTS tablets. Conclusion: These all parameters denote that the formulation has optimized, evaluated and were in the standard range. Hence, this optimized bilayer tablet formulation could be a potential formulation to promote sustained release, promote delivery of drugs from a single dosage form to improve patient compliance and give better disease management.

Keywords: Citicoline sodium, bi-layer tablet, DSC, immediate release, sustain release.


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Author Biographies

Neetesh Rayakwar, Sagar Institute of Pharmaceutical Sciences (SIPS), Sagar, Madhya Pradesh

Sagar Institute of Pharmaceutical Sciences (SIPS), Sagar, Madhya Pradesh

Yuvraj Singh Dangi, Sagar Institute of Pharmaceutical Sciences (SIPS), Sagar, Madhya Pradesh

Sagar Institute of Pharmaceutical Sciences (SIPS), Sagar, Madhya Pradesh


1. Bhosale MD, Kulkarni KS. Bi-layer tablet- A comprehensive review. European Journal of Pharmaceutical and Medical Research. 2017; 4(9):241-251.
2. Kumar KK, Mahesh M, Sasikanth K. Design, development and characterization of sustained release Metformin hydrochloride and Gliclazide bilayered tablets by wet granulation method. International Journal of Biopharmceutics. 2010; 1(2):67-71.
3. Shende P, Shrawne C, Gaud RS. Multi-Layer Tablet-Current Scenario and Recent Advances. International Journal of Drug Delivery. 2012; 4(4):418–426.
4. Vishwakarma AG, Mogal RT, Pawar AY. Bi-layer Tablet- A new ways in oral drug delivery system. International Journal of PharmTech Research. 2014; 6(5):1416–28.
5. Shiyani B, Gattani S, Surana S. Formulation and evaluation of bilayer tablet of Metoclopramide hydrochloride and Ibuprofen. AAPS Pharmaceutical Science and Technology. 2008; 9(3):818-27.
6. Ryakala H, Dineshmohan S, Ramesh A, Gupta VRM. Formulation and in-vitro evaluation of Bi-layer tablets of Nebivolol Hydrochloride and Nateglinide for the treatment of diabetes and hypertension. Journal of Drug Delivery. 2015; 2015:827-859.
7. Kale SS, Saste VS, Ughade PL, Baviskar DT. Bi-layer Tablet. International Journal of Pharmaceutics and Science Review and Research. 2011; 9(1):25–30.
8. Agut J, Font E, Sacrista NA, Ortiz JA. Radioactivity Incorporation into Different Cerebral Phospholipids After Oral Administration of 14C Methyl CDP-Cholin; Ar zneimittel Forschung; 1983; 33(7A):1048-1050.
9. Maryadel, Neil JO. The Merck Index, An Encyclopedia of chemicals, Drugs and Biologicals, Eds, 14th Ed, Published by Merck research lab, Division of Merck & co, White house station; NJ, USA, 2006,388.
10. Gauniya A, Bhadana V. A review on latest advancement in patented controlled/sustained release drug delivery system. Pharmaceutics Review. 2007; 5(6).
11. Patel JA, Panigrahi B, Patel CN. Development and validation of a UV spectrophotometric method for estimation of Citicoline sodium in Bulk and Dosage Form. Journal of Pharmacy Research; 2010; 3 (12):2876-2878.
12. Amol J, Chandrakant G. Bonde, RT. Jadhav IG. Formulation and Evaluation of Citicoline Sustained Release tablet; International Journal of Pharmacy & Technology; 2011; 3(1):1480-1493.
13. Sinica DP, Solanki ND, Shah S, Patel J, Upadhyay P. Formulation and Evaluation of once a day bilayer floating tablet of antihypertensive drug involving dissolution enhancement approach. Pelagia Research Library, 2013; 4(5):54–66.
14. The Indian Pharmacopoeia, Vol. 2, 9th Ed. The Controller of Publication, Govt. of India, Delhi, 2010, p. A82-A85.
15. Singh BN, Kim KH. Floating drug delivery systems- an approach to oral control drug delivery via gastric retention. Journal of Control Release. 2000; 63: 235-59
16. The Indian Pharmacopoeia, Vol. 2, 4th Ed. The Controller of Publication, Govt. of India, Delhi, 1996, p. A82-A85.
17. Kumar KK, Reddy NM, Kishore NR. Formulation and Evaluation of Bilayer matrix tablet of Pioglitazone HCl and Metformin HCl USP 15MG & 500MG. Asian J Pharm Clinical Research. 2013; 6(3):155–161.
18. Atram SC, Udavant YK, Salunke RJ, Neb GB, Shahi SR, Gulecha BS, Padalkar AN. Formulation and evaluation of bilayer tablet containing Metoprolol succinate and Amlodipine besylate as a model drug for anti hypertensive therapy. Journal of Pharmaceutical Research. 2009; 2(8):1335-47.
19. The United States Pharmacopoeia 29, National Formulary 24, Asian Edition. Rockville, MD:United States Pharmacopoeia Convention, Inc; 2006:1890.
20. Jacob S, Shirwaikar A, Joseph A, Srinivasan KK. Novel co-processed excipient of mannitol and microcrystalline callous for preparing fast dissolving tablet of Glipizide. Indian Journal of Pharmaceutical Science. 2007; 69(5):633-39.
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How to Cite
Rayakwar N, Dangi YS. Development and characterization of controlled release bilayered tablets of Citicoline sodium. JDDT [Internet]. 15Apr.2019 [cited 26May2020];9(2-s):125-31. Available from: