{
  "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.",
  "abstract_shown": true,
  "affiliations": [
    "Biological Systems Department, Metropolitan Autonomous University-Xochimilco, Calzada del Hueso 1100, Colonia Villa Quietud, Alcaldía Coyoacán, CP 04960, Mexico City, Mexico."
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 3,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Reyna L. Rayón-Luna",
      "orcid": "0009-0001-2187-1222"
    },
    {
      "affs": [
        0
      ],
      "name": "Alysa J. Pineda-Donlucas",
      "orcid": "0009-0005-2607-5339"
    },
    {
      "affs": [
        0
      ],
      "name": "Raúl Medina-López",
      "orcid": "0000-0002-4159-8403"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/75pgtyj3h7c2k.bib",
  "cited_by": 0,
  "doi": "10.26452/ijrps.v17i3.4420",
  "fulltext_url": "https://ijrps.com/v17i3/4420",
  "id": "75pgtyj3h7c2k",
  "issns": [
    "0975-7538"
  ],
  "landing_url": "https://doi.org/10.26452/ijrps.v17i3.4420",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "lcc",
      "HD9665-9675"
    ],
    [
      "lcc",
      "RS1-441"
    ],
    [
      "openalex",
      "1602|Analytical Methods in Pharmaceuticals"
    ]
  ],
  "openalex": "W7204198212",
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-07-01",
  "publisher": "JK Welfare & Pharmascope Foundation",
  "ris": "https://research.draconitic.com/paper/75pgtyj3h7c2k.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T13:43:07Z",
      "native_id": "f87e45ee69ca4a26848a67907afdb96d",
      "source": "doaj",
      "url": "https://doi.org/10.26452/ijrps.v17i3.4420"
    }
  ],
  "subjects": [
    {
      "field": "chemistry",
      "origin": "openalex:1602|Analytical Methods in Pharmaceuticals",
      "subfield": "analytical"
    }
  ],
  "title": "In Vitro Release Performance of Naproxen Sodium/Acetaminophen Pediatric Suspensions Using a Mini-Paddle Apparatus and USP Paddle Apparatus",
  "title_text": "In Vitro Release Performance of Naproxen Sodium/Acetaminophen Pediatric Suspensions Using a Mini-Paddle Apparatus and USP Paddle Apparatus",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T13:43:07Z",
  "url": "https://research.draconitic.com/paper/75pgtyj3h7c2k",
  "venue": "International Journal of Research in Pharmaceutical Sciences",
  "versions": []
}