Low dose oral pharmaceutical composition of isotretinoin

Abstract

The present invention provides a low dose oral pharmaceutical composition of isotretinoin having reduced food effect, in particular no food effect. The present invention further relates to a process for preparing the oral pharmaceutical composition of the present invention.

1 - 13 . (canceled) 
     
     
         14 . An oral pharmaceutical composition comprising isotretinoin and a pharmaceutically acceptable excipient, wherein said composition is filled in a capsule having an amount (dose) of isotretinoin and a capsule size of: a 8 mg dose in a capsule with a capsule size 2 or smaller, a 16 mg dose in a capsule with a capsule size 1 or smaller, a 20 mg dose in a capsule with a capsule size 0 or smaller, a 24 mg dose in a capsule with a capsule size 0 or smaller, a 28 mg dose in a capsule with a capsule size 00 or smaller, a 32 mg dose in a capsule with a capsule size 00 or smaller, and wherein said isotretinoin to excipient ratio is 1:5 to 1:18. 
     
     
         15 . The oral pharmaceutical composition according to  claim 14  wherein the composition is in the form of a dispersion. 
     
     
         16 . The oral pharmaceutical composition according to  claim 14  wherein the isotretinoin is present in an amount of about 5.5% w/w to about 15% w/w based on the total weight of composition. 
     
     
         17 . The oral pharmaceutical composition according to  claim 14  wherein the composition has a viscosity of about 50 cps to about 450 cps at room temperature. 
     
     
         18 . The oral pharmaceutical composition according to  claim 14  wherein the composition has a density of about 0.8 to 1.1 g/ml. 
     
     
         19 . An oral pharmaceutical composition comprising isotretinoin and a pharmaceutically acceptable excipient wherein said composition is filled in a capsule having an amount (dose) of isotretinoin and a capsule size of: a 8 mg dose in a capsule with a capsule size 2 or smaller, a 16 mg dose in a capsule with a capsule size 1 or smaller, a 20 mg dose in a capsule with a capsule size 0 or smaller, a 24 mg dose in a capsule with a capsule size 0 or smaller, a 28 mg dose in a capsule with a capsule size 00 or smaller, a 32 mg dose in a capsule with a capsule size 00 or smaller, wherein said composition has a fill weight of less than 600 mg. 
     
     
         20 . The oral pharmaceutical composition according to  claim 19  wherein the isotretinoin is micronized and has D 90  less than 30 μm. 
     
     
         21 . The oral pharmaceutical composition according to  claim 19  wherein the composition further comprises a surfactant. 
     
     
         22 . The oral pharmaceutical composition according to  claim 21  wherein the surfactant is selected from the group consisting of anionic, cationic or non-ionic surfactants, sorbitan fatty acid esters; polysorbates prepared from lauric, palmitic, stearic and oleic acid; mononylphenyl ethers of polyethyleneglycols such as nanoxynols; polyoxyethylene monoesters such as polyoxyethylethylene monostearate, polyoxyethylene, monolaurate, polyoxyethylene monooleate; dioctyl sodium sulfosuccinate, sodium lauryl sulphate, lecithin, fatty acid esters of propylene glycol, fatty acid esters of glycerol, poloxamers, and mixtures thereof. 
     
     
         23 . An oral pharmaceutical composition comprising isotretinoin and a pharmaceutically acceptable excipient wherein said composition is filled in a capsule having an amount (dose) of isotretinoin and a capsule size of: a 8 mg dose in a capsule with a capsule size 3, a 16 mg dose in a capsule with a capsule size 2, a 20 mg dose in a capsule with a capsule size 1, a 24 mg dose in a capsule with a capsule size 1, a 28 mg dose in a capsule with a capsule size 0, a 32 mg dose in a capsule with a capsule size 0.