Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review
Article (Published version)
Metadata
Show full item recordAbstract
To satisfy the needs of pediatric and other patients with focal onset seizures who cannot swallow solid dosage forms of zonisamide, an oral liquid form of this drug is necessary in clinical practice. Although there are two oral suspensions of zonisamide with marketing authorization (MA), there are issues of availability and high cost which limit their use and inspire extemporaneous compounding. Extemporaneously compounded oral suspensions of zonisamide are prepared according to different formulas and vary in stability; therefore it is essential to test this characteristic. Bioequivalence of extemporaneously compounded oral suspensions has never been tested, and the efficacy and safety of zonisamide oral suspensions have generally not been demonstrated in clinical trials. As a narrow therapeutic window drug, zonisamide requires precision in dosing, which could be achieved only with dosage forms with established bioavailability, efficacy, and safety. In order to avoid underdosing and tox...icity with zonisamide oral suspensions and utilize their full therapeutic potential, it is necessary to perform bioequivalence studies with each variation of extemporaneously compounded oral suspension and also clinical trials with both commercial and extemporaneous oral suspensions of zonisamide.
Keywords:
bioequivalence / oral suspension / stability / zonisamideSource:
Patient Preference and Adherence, 2023, 17, 2841-2845Publisher:
- Dove Medical Press Ltd
Funding / projects:
- Ministry of Science, Technological Development and Innovation of the Republic of Serbia, institutional funding - 200111 (University of Kragujevac, Faculty of Medicine) (RS-MESTD-inst-2020-200111)
DOI: 10.2147/PPA.S383038
ISSN: 1177-889X
PubMed: 37953980
Scopus: 2-s2.0-85176398997
Collections
Institution/Community
PharmacyTY - JOUR AU - Stević, Ivana AU - Petrović, Nemanja AU - Janković, Slobodan PY - 2023 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5266 AB - To satisfy the needs of pediatric and other patients with focal onset seizures who cannot swallow solid dosage forms of zonisamide, an oral liquid form of this drug is necessary in clinical practice. Although there are two oral suspensions of zonisamide with marketing authorization (MA), there are issues of availability and high cost which limit their use and inspire extemporaneous compounding. Extemporaneously compounded oral suspensions of zonisamide are prepared according to different formulas and vary in stability; therefore it is essential to test this characteristic. Bioequivalence of extemporaneously compounded oral suspensions has never been tested, and the efficacy and safety of zonisamide oral suspensions have generally not been demonstrated in clinical trials. As a narrow therapeutic window drug, zonisamide requires precision in dosing, which could be achieved only with dosage forms with established bioavailability, efficacy, and safety. In order to avoid underdosing and toxicity with zonisamide oral suspensions and utilize their full therapeutic potential, it is necessary to perform bioequivalence studies with each variation of extemporaneously compounded oral suspension and also clinical trials with both commercial and extemporaneous oral suspensions of zonisamide. PB - Dove Medical Press Ltd T2 - Patient Preference and Adherence T1 - Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review VL - 17 SP - 2841 EP - 2845 DO - 10.2147/PPA.S383038 ER -
@article{ author = "Stević, Ivana and Petrović, Nemanja and Janković, Slobodan", year = "2023", abstract = "To satisfy the needs of pediatric and other patients with focal onset seizures who cannot swallow solid dosage forms of zonisamide, an oral liquid form of this drug is necessary in clinical practice. Although there are two oral suspensions of zonisamide with marketing authorization (MA), there are issues of availability and high cost which limit their use and inspire extemporaneous compounding. Extemporaneously compounded oral suspensions of zonisamide are prepared according to different formulas and vary in stability; therefore it is essential to test this characteristic. Bioequivalence of extemporaneously compounded oral suspensions has never been tested, and the efficacy and safety of zonisamide oral suspensions have generally not been demonstrated in clinical trials. As a narrow therapeutic window drug, zonisamide requires precision in dosing, which could be achieved only with dosage forms with established bioavailability, efficacy, and safety. In order to avoid underdosing and toxicity with zonisamide oral suspensions and utilize their full therapeutic potential, it is necessary to perform bioequivalence studies with each variation of extemporaneously compounded oral suspension and also clinical trials with both commercial and extemporaneous oral suspensions of zonisamide.", publisher = "Dove Medical Press Ltd", journal = "Patient Preference and Adherence", title = "Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review", volume = "17", pages = "2841-2845", doi = "10.2147/PPA.S383038" }
Stević, I., Petrović, N.,& Janković, S.. (2023). Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review. in Patient Preference and Adherence Dove Medical Press Ltd., 17, 2841-2845. https://doi.org/10.2147/PPA.S383038
Stević I, Petrović N, Janković S. Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review. in Patient Preference and Adherence. 2023;17:2841-2845. doi:10.2147/PPA.S383038 .
Stević, Ivana, Petrović, Nemanja, Janković, Slobodan, "Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review" in Patient Preference and Adherence, 17 (2023):2841-2845, https://doi.org/10.2147/PPA.S383038 . .