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Patients with cancer often report a lower quality of life due to neuropathic pain, which is difficult to manage because resistance to opioids often develops. Pregabalin (PGB) is recommended as an adjuvant analgesic for neuropathic cancer­ related pain; however, PGB administration is currently limited to the oral route. We examined the pharmaceutical prop­ erties of a PGB hollow-type suppository for hospital use and assessed bioequivalence through examination of the phar­ macokinetic parameters in rabbits. The suppositories were prepared using melting (m-) and hollow (h-) methods with bases of polyethylene glycol (P), Witepsol H-15 (H), or Witepsol S-55 (S), yielding the following combinations: m-P, m-H, m-S, h-P, h-H, and h-S. Pharmaceutical properties, namely hardness, dispersibility, long-term stability, and drug release, were measured for each combination and were compared for orally administered (po) drugs and hollow-type suppositories. Sufficient hardness was demonstrated for all h-suppositories compared with m-suppositories. The release rate of PGB was higher from h-suppositories than from m-suppositories, particularly the h-S group, and bioavailability was similar in the h-S and po groups. The h-S group exhibited significant pathological changes compared with the h-H group. To reduce injury from the repeated administration of suppositories, an S:H blending ratio of 1:1 significantly reduced the pathological changes. Hollow-type suppositories may be useful as they are pharmaceutically stable and, when used with an S-base, able to deliver the same effects as orally administered drugs. The suppository was shown to be effective and is a promising clinical treatment owing to the enhanced convenience when used in hospitals.

iryō yakugaku/iryou yakugaku

Characterization of Pharmaceutical Properties of a Pregabalin Powder Containing Hollow-type Suppositories and Bioequivalence Study of the Pharmacokinetics in Rabbits