Quality assessment of some commercial brands of Acyclovir tablet marketed in Abuja, FCT, Nigeria.
DOI:
https://doi.org/10.51412/psnnjp.2025.19Keywords:
Acyclovir, Herpes Simplex, Quality assessment, counterfeit and substandard medicineAbstract
Background: Acyclovir is a widely used medication for treating herpes simplex and varicella-zoster virus infections, including herpes encephalitis. This study aimed to evaluate the quality of different acyclovir tablet brands available in Abuja, Nigeria.
Methods: Four brands of acyclovir tablets were purchased from community pharmacies and assessed for quality control parameters, including weight variation, active ingredient content, hardness, thickness, diameter, friability, disintegration time, and dissolution.
Results: All samples met the USP specification limits for weight variation, active ingredient content, friability, thickness, and diameter. Except for brands A and D, which failed to meet hardness specifications, all samples passed the hardness test. All samples fulfilled disintegration time and dissolution tolerance limits, indicating that none of the samples were counterfeit or substandard.
Conclusion: This study demonstrated that all acyclovir brands evaluated met quality specifications for most parameters, ensuring their efficacy and safety for use in treating herpes infections.
References
Ahronowitz I and Fox LP (2018) Herpes zoster in hospitalized adults: Practice gaps, new evidence, and remaining questions. Journal of the American Academy of Dermatology, 78(1):223-230. https://www.10.1016/j.jaad.2017.07.054
Gori N, Caldarola G, De Simone C, Moretta G, Peris K (2019) Annular elastolytic giant cell granuloma following herpes zoster infection.
Journal of the European Academy of Dermatology and Venereology, 33 (9): 334 - 335. https://www.10.111/jdv.15627
Malvey S, Kshirasagar N, Vishnu VY, Srikanth J (2015) Formulation and evaluation of acyclovir orodispersible tablets using sublimation method. Journal of General Practice, 3: 208. https://www.10.4172/2329-9126.1000208
Stahl JP and Mailles A (2019) Herpes simplex virus encephalitis update. Current Opinion in Infectious Diseases, 32 (3): 239 - 243 https://10.1097/QCO.000000000554
Wang W and Ji M (2019) Efficacy of acyclovir for herpes simplex encephalitis: A protocol for a systematic review of randomized controlled trial. Medicine, 98 (15): 15254. https://www.10.1097/MD.00000000015254.PMID: 30985731
Bodack MI (2019) Case Series: Pediatric Herpes Simplex Keratitis. Optometry and Vision Science, 96 (3): 221 - 226.
https://www.10.1097/OPX.0000000001345
Pisitpayat P, Jongkhajornpong P, Lekhanont K, Nonpassopon M (2021) Role of intravenous acyclovir in treatment of herpes simplex virus
stromal keratitis with ulceration: A review of 2 cases. American Journal of Case Report, 16 (22): 930467 https://www.10.12659/AJCR.930467.PMID:34133412
Ozcan A, Kahale K and Nguyen D (2019) An 8-month-old girl with vesicular rash. Global Pediatric Health, 6: 2333794X19838526.
Ljubojević H, Kovačević M, Skerlev M, Zekan Š (2018) Genital herpes zoster as possible indicator of HIV infection. Acta Dermatovenerol Croat, 26(4):337-338.
Frimpong P, Amponsah E K, Abebrese J, Kim S M (2017) Oral manifestations and their correlation to baseline CD4 count of HIV/AIDS patients in Ghana. Journal of the Korean Association of Oral and Maxillofacial Surgeons, 43(1): 29-36.
Farhat N, Daoud S, Hdiji O, Sakka S, Damak M, Mhiri C (2021) Myelopathy after zoster virus infection in immunocompetent patients: A case series. Journal of Spinal Cord Medicine, 44(2): 334-338.
FDA Pharmaceutical Inspections and Compliance https://www.fda.gov/drugs/guidance-compliance-regulatory-information/pharmaceutical -inspections-and-compliance
FDA Pharmaceutical Inspections and Compliance https://www.fda.gov/drugs/guidance-compliance-regulatory-information/pharmaceutica-inspections-and-compliance
WHO Substandard and falsified medical products (2024) https://www.who.int/news-room/fact- sheets/detail/substandard-and-falsified-medical-products
United States Pharmacopeia and National Formulary (USP/NF) (2020) Acyclovir weight uniformity, hardness, thickness and diameter,
friability, disintegration and dissolution. In United States Pharmacopeia and National Formulary. Rockville, MD: United States Pharmacopeia and National Formulary.
British Pharmacopoeia Commission (2022) Acyclovir tablet assay. In British Pharmacopoeia.London, UK: Royal Pharmaceutical Society of Great Britain, pp. 1182-1183.
Karpe M, Mali N, Kadam V (2012) Formulation development and evaluation of acyclovir orally disintegrating tablets. Journal of Applied Pharmaceutical Science, 2(3):101-105.
Asish D, Jayesh D, Munira M (2019) Quality by design-based formulation and evaluation of acyclovir microsponges. Journal of Drug
Delivery and Therapeutics, 9 (1): 54-60 http://dx.doi.org/10.22270/jddt.v9i1.2159
Specialist Pharmacy Service (2023) Explaining the licensed status of medicine https://www.sps.nhs.uk/articles/explaining-the-licensed-status-of-medicine/
Adeniyi M (2024) Counterfeit medicines on the rise in Africa https://www.datelinehealthafrica.org/counterfeit-medicines-on-the-rise-in-africa
Wada HF, Abdulrahman A, Muhammad IM, Owanta VC, Chimelumeze PU, Khalid GM (2022) Falsified and substandard medicines
trafficking: a wakeup call for the African continent. Public Health in Practice, 3:100240. https://doi.org/10.1016/j.puhip.2022.100240
Adeleye P (2024) Nigeria's counterfeit drug epidemic https://www.thinkglobalhealth.org/article/nigerias-counterfeit-drug-epidemic
Sakore S, Chakraborthy B (2012) In vitro-in-vivo correlation of immediate release acyclovir tablet using Wagner Nelson method. International Journal of Pharmacy, 2(3):598-604.
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