Formulation and in vitro evaluation of pramipexole orally disintegrating tablets for pediatric restless leg syndrome

Ömer Türkmen; Leyla Beba Pojarani; Moein Amel

Formulation and in vitro evaluation of pramipexole orally disintegrating tablets for pediatric restless leg syndrome

Abstract

In this study, orally disintegrating tablets (ODT) of pramipexole dihydrochloride monohydrate (PPX) was developed with direct compression method by using ready-to-use excipients Parteck® ODT, Pharmaburst® 500, Ludiflash®, F-Melt®, and Prosolv® Easytab SP for pediatric restless leg syndrome (RLS). The formulated ODTs were circular in shape with a total weight of around 100 mg, which was appropriate for pediatric use. In spite of very low content of the drug, content uniformity could be obtained successfully in accordance to the pharmacopoeial specification with a satisfactory mechanical strength in terms of hardness and friability. However, formulations based on Parteck® ODT and Ludiflash® could not achieve a disintegration time <30 s according to in vitro disintegration test, which was also supported by the simulated wetting test. The optimal ODTs based on Pharmaburst® 500, F-Melt® and Prosolv® Easytab SP were further evaluated for in vitro dissolution study. A very fast release of the drug was observed with these formulations that reached a peak value in 10 min., which was superior than that of the reference conventional tablet formulation of PPX. As a result, pediatric orally disintegrating tablets of PPX were successfully formulated with Pharmaburst® 500, F-Melt® and Prosolv® Easytab SP by using direct compression method with suitable characteristics, which can be further studied to use in pediatric RLS.

Keywords

References

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Details

Primary Language

English

Subjects

Pharmacology and Pharmaceutical Sciences (Other)

Journal Section

Research Article

Authors

Ömer Türkmen ^*
0000-0002-2134-6196
Türkiye

Leyla Beba Pojarani
0000-0001-5051-4489
Cyprus

Moein Amel This is me
Cyprus

Publication Date

June 28, 2025

Submission Date

March 6, 2023

Acceptance Date

March 20, 2023

Published in Issue

Year 2023 Volume: 27 Number: 5

IZ

https://izlik.org/JA94CY54ZX

Cite

RIS / Bibtex

APA

Türkmen, Ö., Beba Pojarani, L., & Amel, M. (2025). Formulation and in vitro evaluation of pramipexole orally disintegrating tablets for pediatric restless leg syndrome. Journal of Research in Pharmacy, 27(5), 1808-1820. https://izlik.org/JA94CY54ZX

AMA

1.Türkmen Ö, Beba Pojarani L, Amel M. Formulation and in vitro evaluation of pramipexole orally disintegrating tablets for pediatric restless leg syndrome. J. Res. Pharm. 2025;27(5):1808-1820. https://izlik.org/JA94CY54ZX

Chicago

Türkmen, Ömer, Leyla Beba Pojarani, and Moein Amel. 2025. “Formulation and in Vitro Evaluation of Pramipexole Orally Disintegrating Tablets for Pediatric Restless Leg Syndrome”. Journal of Research in Pharmacy 27 (5): 1808-20. https://izlik.org/JA94CY54ZX.

EndNote

Türkmen Ö, Beba Pojarani L, Amel M (July 1, 2025) Formulation and in vitro evaluation of pramipexole orally disintegrating tablets for pediatric restless leg syndrome. Journal of Research in Pharmacy 27 5 1808–1820.

IEEE

[1]Ö. Türkmen, L. Beba Pojarani, and M. Amel, “Formulation and in vitro evaluation of pramipexole orally disintegrating tablets for pediatric restless leg syndrome”, J. Res. Pharm., vol. 27, no. 5, pp. 1808–1820, July 2025, [Online]. Available: https://izlik.org/JA94CY54ZX

ISNAD

Türkmen, Ömer - Beba Pojarani, Leyla - Amel, Moein. “Formulation and in Vitro Evaluation of Pramipexole Orally Disintegrating Tablets for Pediatric Restless Leg Syndrome”. Journal of Research in Pharmacy 27/5 (July 1, 2025): 1808-1820. https://izlik.org/JA94CY54ZX.

JAMA

1.Türkmen Ö, Beba Pojarani L, Amel M. Formulation and in vitro evaluation of pramipexole orally disintegrating tablets for pediatric restless leg syndrome. J. Res. Pharm. 2025;27:1808–1820.

MLA

Türkmen, Ömer, et al. “Formulation and in Vitro Evaluation of Pramipexole Orally Disintegrating Tablets for Pediatric Restless Leg Syndrome”. Journal of Research in Pharmacy, vol. 27, no. 5, July 2025, pp. 1808-20, https://izlik.org/JA94CY54ZX.

Vancouver

1.Ömer Türkmen, Leyla Beba Pojarani, Moein Amel. Formulation and in vitro evaluation of pramipexole orally disintegrating tablets for pediatric restless leg syndrome. J. Res. Pharm. [Internet]. 2025 Jul. 1;27(5):1808-20. Available from: https://izlik.org/JA94CY54ZX