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Compatibility of medroxyprogesterone acetate and pharmaceutical excipients through thermal and spectroscopy techniques

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Abstract

Studies of active drug-excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. For the development of conjugation estrogens and medroxyprogesterone acetate (MPA) double-layer tablets, techniques of thermal, isothermal stress testing (IST), and molecular vibrational spectroscopy analysis were performed to access the compatibility. Differential scanning calorimetry (DSC) studies were used as an important and complementary tool during preformulation to determine drug-excipient compatibility. On the basis of DSC results, MPA was found to be compatible with polyethylene glycol 6000. However, the results of Raman and IST studies showed that all the excipients defined in the prototype formula were found to be compatible with MPA. Overall, the compatibility of selected excipients with MPA was successfully evaluated using a combination of thermal and IST methods, and the formulations developed using the compatible excipients were found to be stable.

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Acknowledgements

This work has been supported by the National High Technology Research and Development Program of China (201291162) and the Fundamental Research Funds for the Central Universities (CXZZ12_0119).

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Authors and Affiliations

  1. College of Chemistry and Chemical Engineering, Southeast University, Nanjing, 211189, People’s Republic of China

    Rui Gao & Bai-Wang Sun

  2. School of Chemistry Science and Technology, Yunnan University, Kunming, 650031, People’s Republic of China

    Jun Lin

  3. Xinjiang Xinziyuan Biological Pharmaceutical Co. Ltd., Ürümqi, 830000, People’s Republic of China

    Bai-Wang Sun & Xiao-Li Gao

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  1. Rui Gao
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Correspondence to Bai-Wang Sun.

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Gao, R., Sun, BW., Lin, J. et al. Compatibility of medroxyprogesterone acetate and pharmaceutical excipients through thermal and spectroscopy techniques. J Therm Anal Calorim 117, 731–739 (2014). https://doi.org/10.1007/s10973-014-3773-8

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  • DOI: https://doi.org/10.1007/s10973-014-3773-8

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