Hard gelatin capsules contg. nifedipine - as soln. in carrier not causing embrittlement

摘要

Hard gelatin capsules contain nifedipine (I) dissolved in a water-soluble carrier (II) which does not embrittle the capsule on storage at room temp. (II) is an ethoxylated fatty acid ester, esp. a reaction prod. of 1 mole hydrogenated castor oil with 40 moles ethylene oxide, e.g. 'Cremphor' RH40 (RTM). The (I):(II) ratio is 1:10-70. The capsule shell material contains dyes, pigments or opacifiers esp. Ti02, Fe oxide or CaCO3. The soln. of (I) in (II) is introduced into the capsules and the capsule halves are sealed together with a strip of gelatin film. ADVANTAGE - Embrittlement problems associated with hygroscopic carriers such as polyethylene glycol are avoided (cf. DE3438830 , US4450877 ) Bioavailability and absorption of (I) are as good as with conventional capsules.