Pharmaceutical soft capsules containing lysine clonixinate and a process for their preparation
AssigneeRoemmers S.A.I.C.F.
InventorCarlos E. M. V asquez
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Abstract
A soft gelatin capsule with a filling including lysine clonixinate as an active ingredient and in a hydrophilic matrix and with a shell comprising gelatin, a plasticizer and sorbitol, wherein the plasticizer in many instances will be glycerol but may comprise the sorbitol alone. The presence of sorbitol in the gelatin capsule of a lysine clonixinate dosage form imparts unexpectedly good drug release and stability thereto.
Claims12
A pharmaceutical dosage unit form of the type soft gelatin capsule with a filling comprising lysine clonixinate as active ingredient, said filling being based on a hydrophilic matrix comprising polyethylene glycol having an average molecular weight of from about 200 to 1000, or a mixture of the polyethylene glycol with propylene glycol and/or propylen carbonate, glycerol in 3 to 10% by weight and water in 5 to 15% by weight, and with a shell comprising about 30 to 70% by weight gelatin and a plasticizer, wherein the improvements is that said shell includes 50 to 10% by weight sorbitol.
A process for the preparation of a soft gelatin capsule with a filling comprising lysine clonixinate, comprising the steps of (A) forming gelatin capsules consisting essentially of gelatin, a plasticizer and sorbitol, and (B) filling the capsules with lysine clonixinate as an active ingredient, a hydrophilic matrix comprising polyethylene glycol having an average molecular weight of from about 200 to 1000, or a mixture of said polyethylene glycol with propylene glycol and/or propylene carbonate, glycerol in 3 to 10% by weight, and water in 5 to 15% by weight.
Dependencies are inferred from the claim text.