Formulation by design approach for effervescent granules of vitamin C using statistical optimization methodologies

Authors

  • Abdu Alemad Sana'a university
  • Maher Al-Absi Faculty of Pharmacy, Sana’a University
  • Safwan Alagbarri Faculty of Pharmacy, Sana’a University, Yemen
  • Mofeed Al- Nowihi Biology Department, Faculty of Science, Sana’a University, Yemen.

DOI:

https://doi.org/10.18231/j.joapr.2020.v.8.i.4.62.69

Keywords:

Formulation, Effervescent granules, FbD, Factorial design, Vitamin C

Abstract

Introduction: Ascorbic acid (vitamin C), is a potent antioxidant, and the human body cannot synthesis it, so ascorbic acid can be obtained from external sources as food and pharmaceutical products. Objective: This study was using formulation by design (FbD) concept to prepare effervescent granules of vitamin C with high quality and more patient compliance in less effort and cost. Methods: A 23 factorial design was used to study the physical and chemical characteristics of the granules (disintegration time (DT), taste of product (TP), carbon dioxide amount (CO2), and pH of the solution). Also the effects of and interaction between selected independent variables (citric acid, tartaric acid, and sodium bicarbonate) evaluated, while, their concentrations were optimized by application of optimization model methodology for factorial design. Formulations were prepared by non-aqueous wet granulation method. Results: From the results of designed batches, the disintegration time ranged from 33±2.7 to 153±3.3sec while the amount of carbon dioxide ranged from 0.360±0.004gm to 1,512±0.002gm also the pH range was from 2.9±0.09 to 6.42±0.07 but the taste of product was coded numerically in proportional with acceptability from 1 to 5.   According to the experimental design, both of studied independent variables have significant effect in determining the physicochemical characteristics of effervescent granules. Conclusion: FbD concept effectively was utilized for the development of vitamin C effervescent granules as per modern quality practices used in pharmaceutical industries.

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References

Pathy K. Process for Preparation of Vitamin C and Method for Determination of Vitamin C in Tablets. Surg. Case Stud. Open Access J., 1, (2018).

Schlueter AK, Johnston CS. Vitamin C: Overview and update. Complement. Health Pract. Rev., 16, 49–57 (2011).

G PS, Siddaiah M. Formulation and evaluation of effervescent tablets : a review. Journal of Drug Delivery and Therapeutics 8, 296–303 (2018).

Al-Mousawy J, Al-Hussainy Z, Alaayedi M. Formulation and evaluation of effervescent granules of ibuprofen. Int. J. Appl. Pharm., 11, 66–9 (2019).

Politis SN, Colombo P, Colombo G, Rekkas DM. Design of experiments (DoE) in pharmaceutical development. Drug Dev. Ind. Pharm., 43, 889–901 (2017).

Singh B, Kapil R, Nandi M, Ahuja N. Developing oral drug delivery systems using formulation by design: Vital precepts, retrospect and prospects. Expert Opin. Drug Deliv., 8, 1341–60 (2011).

Srinivasarao K, Adithya BS, Amar I, Sankeerth PT, Teja D, Manikiran SS, Ramarao N. An Overview on Preformulation for Pharmaceutical Product Development and Drug Excipient Incompatibility Studies. Int. J. Pharma Chem. Res. I, 3, 354–68 (2017).

British Pharmacopoeia commission. British Pharmacopoeia 2016. Append. XIII Part. Contam. Sub-visible Part., I, 1069 (2016).

Amol S. R, Basavaraj K. N. Development, Characterisation and Preclinical Evaluation of Some Novel Enzymes with Vitamin. World J. Pharm. Res., 3, 2096–123 (2015).

Patel AA, Parikh RH, Mehta TA. Mehta. Development optimization and evaluation of effervescent tablets of chlorpheniramine maleate using box behnken design. International Journal of Pharmacy and Pharmaceutical Sciences, 8(8), 317-323 (2015)

Tadros MI. Controlled-release effervescent floating matrix tablets of ciprofloxacin hydrochloride: Development, optimization and in vitro-in vivo evaluation in healthy human volunteers. Eur. J. Pharm. Biopharm., 74, 332–9 (2010).

Kumar S, Ashish B. Formulation by design approach for fizzy granules using statistical optimization methodologies. Asian J. Pharm., 9, S59–67 (2015).

Da Cunha-Filho MSS, Gustmann PC, Garcia FS, Lima EM, de Sá-Barreto LCL. Development and physical evaluation of Maytenus ilicifolia effervescent granules using factorial design. Brazilian J. Pharm. Sci., 50, 243–50 (2014).

Bahadur S, Roy A, Baghel P, Chanda R. Formulation of Glipizide Tablets using Fenugreek Seed Mucilage: Optimization by Factorial Design. Asian J. Pharm., 10, S662–8 (2016).

Published

2020-11-11

How to Cite

Alemad, A., Maher Al-Absi, Safwan Alagbarri, & Mofeed Al- Nowihi. (2020). Formulation by design approach for effervescent granules of vitamin C using statistical optimization methodologies. Journal of Applied Pharmaceutical Research, 8(4), 62-69. https://doi.org/10.18231/j.joapr.2020.v.8.i.4.62.69

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Articles