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Development of Midazolam Orodispersible Films for Palliative Care

  • At: PPR SIG 2021 (2021)
  • Type: Digital
  • By: TAN, Poh Leng (National University of Singapore, Singapore)
  • Co-author(s): Poh Leng TAN, Zhi Zhen LIM, Kai Zhen YAP, Sui Yung CHAN
  • Abstract:

    Introduction

    Midazolam is prescribed in palliative care for a myriad of indications, including anxiety, insomnia, restlessness and delirium. The midazolam solution for injection is used to alleviate these symptoms through oral or subcutaneous administration as there is no suitable oral dosage form in Singapore. However, midazolam solution has a bitter taste with oral administration and increases the risk of asphyxiation. Subcutaneous administration is not ideal as it causes discomfort. Orodispersible film (ODF) is an alternative oral dosage formulation with low aspiration and choking risks. It rapidly dissolves in the oral cavity and serves as a less bulky substitute to liquid preparations. It may be prepared extemporaneously in a pharmacy setting to provide on-demand, personalised doses of medications.

    Objectives

    This study presents the extemporaneous compounding of midazolam into ODFs using the unit-dose solvent-casting method.

    Methods

    Midazolam 10 mg/ml solution was first prepared by solubilizing pure midazolam powder in water with citric acid, hydroxypropyl beta-cyclodextrin and sucralose. The casting solution was prepared to yield 10% w/w hydroxypropyl methylcellulose as the polymer and 9.6% w/w glycerol as the plasticizer. Equal parts of the midazolam solution and the casting solution were combined, dispensed into unit-dose wells and oven-dried to give ODFs containing 2.5 mg of midazolam.

    Results

    The resultant midazolam ODFs were transparent and round with diameter of 2 cm. They were flexible (folding endurance of 8.33 ± 2.1), thin (0.13 mm ± 0.018mm in central thickness), and had low moisture content (12.4 ± 0.3%) and short disintegration time (mean 57 seconds). Content uniformity was also demonstrated using UV-Visible spectroscopy. Nonetheless, stability and patient acceptance studies are warranted.

    Conclusion

    In conclusion, midazolam ODFs were successfully formulated and compounded. Future work includes modifying the composition of the casting solution to prepare midazolam buccal films for modified release to address other indications.

Last update 4 October 2019

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