In Vitro Assessment of Some Brands of Fluconazole Capsules Marketed in Port Harcourt, Nigeria

Authors

  • Nwachukwu Nkemakolam Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Port Harcourt, Nigeria
  • Ugoeze Kenneth C Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Port Harcourt, Nigeria
  • Kennedy Emeka Oluigbo Department of Clinical Pharmacy and Biopharmaceutics, Faculty of Pharmaceutical Sciences, Enugu State University of Science and Technology, Agbani City, Enugu, Nigeria.

DOI:

https://doi.org/10.22270/ajprd.v8i3.722

Keywords:

Fluconazole capsule, in vitro, quality, fake, standard methods.

Abstract

Objectives: A routine in vitro pharmacopeial quality assessment of five brands of fluconazole capsules with label claims of 50.0 mg marketed in Port Harcourt, Nigeria was carried out to ascertain their consistencies.

Methods: The brands were procured from various pharmacies in Port Harcourt and coded Fluco-A, Fluco-B, Fluco-C, Fluco-D and Fluco-E. Visual assessments of the samples were carried out besides in vitro quality considerations such as identification of the active pharmaceutical ingredient (API), capsules uniformity of weight, disintegration, an assay of the total content of fluconazole and dissolution studies.

Results: Each brand contained fluconazole with relevant product packet information uncompromisingly conspicuous.The label claims for fluconazole contents were satisfactory. The weight variation of the capsulesacross the brands were between 170.25 mg ± 2.25% -333.14 mg ± 1.50 %. Each brand disintegrated within 10 min. Total drug content was within 88.43 ± 0.12% to 102.96 ± 0.53 %.Above 80.0% of fluconazole was released within 30.0 min in the release studies of the respective brands.

Conclusion: The results obtained for the capsules uniformity of weight, disintegration time, the total content of the API and the drug release profiles were within acceptable limits of the United States Pharmacopoeia (USP).

 

Downloads

Download data is not yet available.

Author Biographies

Nwachukwu Nkemakolam, Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Port Harcourt, Nigeria

Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Port Harcourt, Nigeria

Ugoeze Kenneth C, Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Port Harcourt, Nigeria

Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Port Harcourt, Nigeria

Kennedy Emeka Oluigbo, Department of Clinical Pharmacy and Biopharmaceutics, Faculty of Pharmaceutical Sciences, Enugu State University of Science and Technology, Agbani City, Enugu, Nigeria.

Department of Clinical Pharmacy and Biopharmaceutics, Faculty of Pharmaceutical Sciences, Enugu State University of Science and Technology, Agbani City, Enugu, Nigeria.

References

1. Rautamo M, Kvarnström K, Sivén M, Airaksinen M, Lahdenne P, Sandler N.A Focus Group Study about Oral Drug Administration Practices at Hospital Wards - Aspects to Consider in Drug Development of Age-Appropriate Formulations for Children. Pharmaceutics. 2020; 12(2):109.
2. Prasad VD. Formulation and modifying drug release from Hard and Soft Gelatin Capsules for Oral drug delivery, International Journal of Research and Development in Pharmacy & Life Science. 2017; 6(4):2663-2677.
3. Hoag S. Capsules Dosage Form: Formulation and Manufacturing Considerations. In Y. Qui, Y. Chen, G. Zhang, L. Yu, and R. Mantri (Eds.), Developing Solid Oral Dosage Forms – Pharmaceutical Theory and Practice, 2nd ed. UK: Elsevier Inc; 2017; 723-747.
4. Jones BE. (1985). Hard gelatin capsules and the pharmaceutical formulator. Pharm. Technol, 1985; 9:106–112.
5. Digenis A, Gold TB, Shah VP. Crosslinking of gelatin capsules and its relevance to their in vitro/in vivo performance. J. Pharm. Sci. 1994; 83(7):915-921.
6. Stanley JP. Soft gelatin capsules. In: Lachman L, Lieberman HA, Kanig JL Eds. The Theory and Practice of Industrial Pharmacy. 3rd ed. Philadelphia: Lea & Febiger; 1996; 398–429.
7. World Health Organization (WHO). Counterfeit and sub-standard drugs in Myanmar and Vietnam, WHO, Geneva; 1999. 1–55.
8. Ozawa S, Evans DR, Bessias S, Haynie DG, Yemeke TT, Laing SK, Herrington JE. Prevalence and estimated economic burden of substandard and falsified medicines in low-and middle-income countries: A systematic review and meta-analysis, JAMA Network Open 2018; 1(4):1-22.
9. Getu K, Asfaw D, Kaleab A. Comparative in vitro quality evaluation of ciprofloxacin tablets from drug retail outlets in Addis Ababa, Ethiopia. Ethiop PharmJ. 2007; 25: 1-8.
10. Cockburn R, Newton PN, Agyarko EK, Akunyili D, White NJ. The global threat of counterfeit drugs: why industry and governments must communicate the dangers.PLoS Med.2005; 2: 100–106.
11. Afu S. Incidence of substandard drugs in developing countries. Trop Med Int. Hlth. 1999;4(1): 73.
12. Verduin-Muttiganzi R, Verduin-Muttiganzi G. (1998). Assessment of the incidence of substandard drugs in developing countries. Trop. Med. Int. Hlth. 3: 602.
13. Shakoor O, Taylor RB, Behrens RH (1997). Assessment of the incidence of substandard drugs in developing countries, Trop. Med. Int. Hlth. 1997; 2:839–845.
14. World Health Organization (WHO). Combating counterfeit drugs: a concept paper for effective international collaboration. WHO, Geneva, 2014. Available at: http://www.who.int/medicines/services/counterfeit/CombatingCounterfeitDrugs_Conceptpaper.pdf. Retrieved on 16th April 2020.
15. Okuonghae HO, Ighogboja IS, Lawson JO, Nwana EJ. Diethylene glycol poisoning in Nigerian children. Ann Trop Paediatr. 1992; 12 (3):235-238.
16. Global Forum on Pharmaceutical Anti-Counterfeiting,(Online). Available: www.pharma-anticounterfeiting.info/PressMediaInfo.htm. Retrieved on 16th April 2020.
17. Menkes DB. Hazardous drugs in developing countries. BMJ. 1997; 315: 1557–1558.
18. Roy J (1994). The menace of substandard drugs. World Health Forum 15:406–407.
19. Addetla Sagarika, Boreda Sowmya, Aprajitha Bhatnagar and Dr.Kameswari. Fluconazole: Review. Indo American Journal of Pharmaceutical Sciences. 2016; 3 (9): 1004-1008.
20. British pharmacopeia. Her Majesty’s Stationery Office, 2012; London.
21. The United States Pharmacopeia, U.S.P, NF. The United States Pharmacopeial Convention, 2009; Rockville.

Published

2020-06-15

How to Cite

Nkemakolam, N., C, U. K., & Oluigbo, K. E. (2020). In Vitro Assessment of Some Brands of Fluconazole Capsules Marketed in Port Harcourt, Nigeria. Asian Journal of Pharmaceutical Research and Development, 8(3), 29–33. https://doi.org/10.22270/ajprd.v8i3.722

Issue

Vol. 8 No. 3 (2020): Vol 8 No 3 (2020): Vol 8 No 3 (2020): Volume 8 Issue 3 May - June. 2020

Section

Research Articles

AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:

Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.

Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.

Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).