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<p>In preformulation studies, the evaluation of solid-state interactions between the active pharmaceutical ingredient and different excipients is essential to guarantee the quality of the final dosage form. Studies of drug–excipient should be performed using sensitive instrumental techniques, under ambient conditions as well as under thermal stress. In this study, we aimed towards obtaining information regarding the compatibility of desogestrel, an active pharmaceutical ingredient used as an oral contraceptive, with eleven commonly used pharmaceutical excipients, namely sodium carboxymethyl cellulose, methyl 2-hydroxyethyl cellulose, methylcellulose, talc, trimagnesium dicitrate nonahydrate, D-mannitol, starch, calcium lactate pentahydrate, magnesium stearate, colloidal SiO<sub>2</sub> and polyvinylpyrrolidone K-30, after the preparation of the mixtures using Fourier-transform Infrared Spectroscopy (FTIR) and thermoanalytical tools, as well as after a storage period of 9&#xa0;months under ambient conditions using Ultraviolet spectroscopy (UV) alongside with X-ray powder diffraction (XRPD) as to assess the solid-state interactions that may occur during long-term storage. Both sets of techniques revealed that the development of new generic formulations or new pharmaceutical forms containing desogestrel can take into consideration the use of these excipients, since no interactions were observed between the components of the binary mixtures at temperatures below 112&#xa0;°C. The phase composition of each binary mixture revealed a good compatibility even after the 9&#xa0;month storage period.</p>

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Instrumental investigations and preformulation study of the progestin drug desogestrel

  • 期刊论文

  • 发表日期：

    2025年12月8日

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  • Ionuț Ledeți,
  • Cosmina Bengescu,
  • Adriana Ledeți,
  • Gabriela Vlase,
  • Titus Vlase,
  • Cezara Maria Mureșan,
  • Carmen Tomoroga,
  • Valentina Buda,
  • Anca Dragomirescu,
  • Felicia Andrei,
  • Lenuța-Maria Șuta,
  • Tudor Olariu,
  • Oana Suciu,
  • Laura Sbârcea,
  • Cornelia Muntean,
  • Denisa Ivan

摘要

In preformulation studies, the evaluation of solid-state interactions between the active pharmaceutical ingredient and different excipients is essential to guarantee the quality of the final dosage form. Studies of drug–excipient should be performed using sensitive instrumental techniques, under ambient conditions as well as under thermal stress. In this study, we aimed towards obtaining information regarding the compatibility of desogestrel, an active pharmaceutical ingredient used as an oral contraceptive, with eleven commonly used pharmaceutical excipients, namely sodium carboxymethyl cellulose, methyl 2-hydroxyethyl cellulose, methylcellulose, talc, trimagnesium dicitrate nonahydrate, D-mannitol, starch, calcium lactate pentahydrate, magnesium stearate, colloidal SiO2 and polyvinylpyrrolidone K-30, after the preparation of the mixtures using Fourier-transform Infrared Spectroscopy (FTIR) and thermoanalytical tools, as well as after a storage period of 9 months under ambient conditions using Ultraviolet spectroscopy (UV) alongside with X-ray powder diffraction (XRPD) as to assess the solid-state interactions that may occur during long-term storage. Both sets of techniques revealed that the development of new generic formulations or new pharmaceutical forms containing desogestrel can take into consideration the use of these excipients, since no interactions were observed between the components of the binary mixtures at temperatures below 112 °C. The phase composition of each binary mixture revealed a good compatibility even after the 9 month storage period.