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Purpose <p>Solid dispersion formulation is a commonly used approach to enhance drug solubility and dissolution. Mouth-dissolving films can increase the disintegration rate and drug release, leading to a rapid onset of action while partially bypassing the first-pass effect. This study aimed to prepare and evaluate a Rosuvastatin calcium solid dispersion and incorporate it into a mouth-dissolving film to improve drug bioavailability.</p> Methods <p>Solid dispersions of Rosuvastatin calcium were prepared using the hot fusion method with various polymeric carriers at different drug-to-polymer ratios. The formulations were characterized in terms of solubility, yield percentage, FTIR, DSC, and PXRD. The best formulation was further used to prepare a Rosuvastatin calcium–loaded mouth-dissolving film employing carboxymethylcellulose as the film-forming agent. The film was characterized and subjected to an in vitro release study.</p> Results <p>Solid dispersion formulation 2 (SD-2), containing poloxamer 188 at a 1:3 w/w drug-to-polymer ratio, exhibited the highest increase in Rosuvastatin solubility compared with pure Rosuvastatin. The formation of the solid dispersion was confirmed by DSC and XRD analysis. SD-2 was successfully formulated as a mouth-dissolving film, with a drug content of 86.4 ± 1% and a disintegration time of 11.5 ± 0.7&#xa0;s. The in vitro release study showed approximately 80% drug release within 1&#xa0;min.</p> Conclusions <p>Combining solid dispersion and mouth-dissolving film formulations into a single dosage form can synergistically enhance drug solubility and release, and possibly improve oral bioavailability.</p>

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Formulation and Evaluation of Solid Dispersion Loaded-mouth Film of Rosuvastatin Calcium

  • 期刊论文

  • 发表日期：

    2026年3月18日

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  • Mais Salim Saadallah,
  • Amal F. Al-Dulaimi,
  • Omar Abdulhakeem Hamid,
  • Thamer A. Omar,
  • Amina Khalaf Rashid

摘要

Purpose

Solid dispersion formulation is a commonly used approach to enhance drug solubility and dissolution. Mouth-dissolving films can increase the disintegration rate and drug release, leading to a rapid onset of action while partially bypassing the first-pass effect. This study aimed to prepare and evaluate a Rosuvastatin calcium solid dispersion and incorporate it into a mouth-dissolving film to improve drug bioavailability.

Methods

Solid dispersions of Rosuvastatin calcium were prepared using the hot fusion method with various polymeric carriers at different drug-to-polymer ratios. The formulations were characterized in terms of solubility, yield percentage, FTIR, DSC, and PXRD. The best formulation was further used to prepare a Rosuvastatin calcium–loaded mouth-dissolving film employing carboxymethylcellulose as the film-forming agent. The film was characterized and subjected to an in vitro release study.

Results

Solid dispersion formulation 2 (SD-2), containing poloxamer 188 at a 1:3 w/w drug-to-polymer ratio, exhibited the highest increase in Rosuvastatin solubility compared with pure Rosuvastatin. The formation of the solid dispersion was confirmed by DSC and XRD analysis. SD-2 was successfully formulated as a mouth-dissolving film, with a drug content of 86.4 ± 1% and a disintegration time of 11.5 ± 0.7 s. The in vitro release study showed approximately 80% drug release within 1 min.

Conclusions

Combining solid dispersion and mouth-dissolving film formulations into a single dosage form can synergistically enhance drug solubility and release, and possibly improve oral bioavailability.