Cyclosporin-containing soft capsule compositions

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules

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424452, 514975, 514970, A61K 948

Patent

active

056039514

ABSTRACT:
The present invention relates to a soft capsule composition containing a stable microemulsion concentrate which is more stable and suitable for the preparation of cyclosporin-containing soft capsules. More specifically, the present invention relates to a microemulsion concentrate containing cyclosporin as an active ingredient, dimethylisosorbide as a co-surfactant, one component or a mixture of two or more selected from the group consisting of an esterified compound of fatty acid and primary alcohol, medium chain fatty acid triglyceride and monoglyceride as an oil component, and a surfactant having HLB value of 10 to 17, such as Nikkol HCO-50 or Tween 20, which is suitable for formulation into soft capsules and to a soft capsule composition containing said microemulsion concentrate. In the microemulsion concentrate according to the present invention, cyclosporin, dimethylisosorbide, the oil component and the surfactant are present in the ratio of 1:11-5:1-5:3-6, preferably 1:3-4:1.5-3:4-6, and particularly 1:3.6:2.6:5.5, by weight.

REFERENCES:
patent: 4388307 (1983-06-01), Cavanak
patent: 4817367 (1989-04-01), Ishikawa et al.
patent: 4895725 (1990-01-01), Kantor et al.
patent: 4970076 (1990-11-01), Horrobin
patent: 5098606 (1992-03-01), Nakajima et al.
patent: 5338761 (1994-08-01), Nakajima et al.
Zia et al., Chemical Abstracts, vol. 114, #214309, Jan. 1991.

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