Abstract
This chapter discusses dosage forms for rectal and vaginal use. The main focus is on suppositories and on small-scale preparation methods. The position of rectal and vaginal administration in therapy, for systemic or local action, and biopharmaceutical issues are discussed. This is followed by the design of the formulation and the preparation methods. For the most frequently used rectal dosage form, i.e. suspension suppositories, the quality of both active substance and excipients (including the base) largely influence the therapeutic outcome. Therefore, the chemical form of the active substance and its particle size as well as the suppository base receive ample attention. The preparation steps are discussed in detail, i.e. dispersing, mixing and pouring as well as in-process and final controls.
The onset of systemic action obtained with enemas (small volume) is often faster than with suppositories. To obtain a local effect, a greater part of the rectum and colon can be reached with larger volumes of enema containing an active substance that is not rectally absorbed. The chemical form of the active substance, the choice of the solvent or the vehicle and the pH are important parameters for the design of an enema.
Vaginal dosage forms are used for local treatment. They include pessaries, resembling rectal suppositories in many aspects, semi-solid preparations and vaginal solutions. Design, preparation and quality parameters are discussed.
Finally, new developments and perspectives using rectal and vaginal preparations are highlighted.
Based upon Chapter 11 Rectal and Vaginal, by Stineke Haas, Herman Woerdenbag and MaĆgorzata Sznitowska in the 2015 edition of Practical Pharmaceutics.
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Woerdenbag, H., Visser, J.C., Kauss, T., Sznitowska, M. (2023). Rectal and Vaginal. In: Le Brun, P., Crauste-Manciet, S., KrÀmer, I., Smith, J., Woerdenbag, H. (eds) Practical Pharmaceutics. Springer, Cham. https://doi.org/10.1007/978-3-031-20298-8_19
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