Peer-reviewedCC BYInternational Journal of Research in Pharmaceutical Sciences1 Jul 2026

In Vitro Release Performance of Naproxen Sodium/Acetaminophen Pediatric Suspensions Using a Mini-Paddle Apparatus and USP Paddle Apparatus

Reyna L. Rayón-Luna¹
Alysa J. Pineda-Donlucas¹
Raúl Medina-López¹

¹Biological Systems Department, Metropolitan Autonomous University-Xochimilco, Calzada del Hueso 1100, Colonia Villa Quietud, Alcaldía Coyoacán, CP 04960, Mexico City, Mexico.

Abstract

Background: Fixed-dose pediatric suspensions of naproxen sodium (NAP, 25 mg/mL) and acetaminophen (ACE, 20 mg/mL) are widely prescribed for childhood pain and fever, but lack official compendial dissolution monographs. Objective: To evaluate in vitro dissolution of three generic pediatric suspensions (G1–G3) against the reference product (Febrax®, R), comparing the discriminatory sensitivity of a mini-paddle apparatus versus the standard USP paddle apparatus. Methods: Dissolution was conducted in pH 6.8 phosphate buffer (37.0 ± 0.5 °C, 75 rpm) using a mini-paddle apparatus (200 mL, 2 mL dose) and USP Apparatus 2 (500 mL, 5 mL dose), maintaining identical 0.25 mg/mL NAP and 0.20 mg/mL ACE concentrations (n = 12). First-derivative spectrophotometry quantified NAP (243 nm) and ACE (253 nm). Model-independent metrics (Q60, MDT, DE) were analyzed by ANOVA with Dunnett's test. Results: Over 85% of both drugs dissolved within 15 min across all formulations, omitting f2 similarity calculations. Model-independent metrics revealed that the standard USP paddle apparatus detected statistically significant differences (p < 0.05) in 88.89% of comparisons against reference R, whereas the mini-paddle apparatus detected differences in only 38.89%. Conclusions: The standard USP paddle apparatus provides superior discriminatory sensitivity over the mini-paddle system for quality control and post-marketing surveillance of pediatric suspensions.

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BibTeX RIS

BibTeX

@article{rayonluna2026vitro,
  title = {{In Vitro Release Performance of Naproxen Sodium/Acetaminophen Pediatric Suspensions Using a Mini-Paddle Apparatus and USP Paddle Apparatus}},
  author = {Reyna L. Rayón-Luna and Alysa J. Pineda-Donlucas and Raúl Medina-López},
  journal = {International Journal of Research in Pharmaceutical Sciences},
  year = {2026},
  month = jul,
  doi = {10.26452/ijrps.v17i3.4420},
  url = {https://doi.org/10.26452/ijrps.v17i3.4420},
  note = {CC BY},
}

RIS

TY  - JOUR
TI  - In Vitro Release Performance of Naproxen Sodium/Acetaminophen Pediatric Suspensions Using a Mini-Paddle Apparatus and USP Paddle Apparatus
AU  - Reyna L. Rayón-Luna
AU  - Alysa J. Pineda-Donlucas
AU  - Raúl Medina-López
PY  - 2026
DA  - 2026/07/01
JO  - International Journal of Research in Pharmaceutical Sciences
DO  - 10.26452/ijrps.v17i3.4420
UR  - https://doi.org/10.26452/ijrps.v17i3.4420
AB  - Background: Fixed-dose pediatric suspensions of naproxen sodium (NAP, 25 mg/mL) and acetaminophen (ACE, 20 mg/mL) are widely prescribed for childhood pain and fever, but lack official compendial dissolution monographs. Objective: To evaluate in vitro dissolution of three generic pediatric suspensions (G1–G3) against the reference product (Febrax®, R), comparing the discriminatory sensitivity of a mini-paddle apparatus versus the standard USP paddle apparatus. Methods: Dissolution was conducted in pH 6.8 phosphate buffer (37.0 ± 0.5 °C, 75 rpm) using a mini-paddle apparatus (200 mL, 2 mL dose) and USP Apparatus 2 (500 mL, 5 mL dose), maintaining identical 0.25 mg/mL NAP and 0.20 mg/mL ACE concentrations (n = 12). First-derivative spectrophotometry quantified NAP (243 nm) and ACE (253 nm). Model-independent metrics (Q60, MDT, DE) were analyzed by ANOVA with Dunnett's test. Results: Over 85% of both drugs dissolved within 15 min across all formulations, omitting f2 similarity calculations. Model-independent metrics revealed that the standard USP paddle apparatus detected statistically significant differences (p < 0.05) in 88.89% of comparisons against reference R, whereas the mini-paddle apparatus detected differences in only 38.89%. Conclusions: The standard USP paddle apparatus provides superior discriminatory sensitivity over the mini-paddle system for quality control and post-marketing surveillance of pediatric suspensions.
SN  - 0975-7538
ER  -

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