Dosage unit containing a substance showing a topical effect on the eye, and a method of preparing same

Claim 1

THE METHOD OF MEDICATING THE EYE WITH OPHTHALMIC MEDICATION THE IMPROVEMENT WHICH INCLUDES THE STEP OF PLACING BENEATH ONE EYELID A SOLID SHAPED BODY HAVING A LARGEST DIMENSION BETWEEN THE LIMITS OF 2 - 20 MM AND REMAINING DIMENSIONS WITHIN THE RANGE OF 0.5 - 10 MM, WITH SOFTLY ROUNDED CORNERS SO AS NOT TO CAUSE EYE IRRITATION, THE BODY BEING EITHER PLANAR OR SUITABLY MOLDED TO OBTAIN THE SHAPE OF A LENS CAPABLE OF FITTING INTO THE SPACE BETWEEN THE EYE AND THE SURROUNDING TISSUE WITH A SURFACE FACING TOWARD THE EYE, SAID SOLID SHAPED BODY AS A RESULT OF ITS PLASTICITY FORMING ITSELF TO THE SHAPE OT THE EYE CAVITY WHEN INSERTED INTO THE EYE, SAID BODY COMPRISING A MIXTURE OF: A. 5 - 90% OF AT LEAST ONE LIPOPHILIC SUBSTANCE HAVING A MELTING POINT OF 37*-75*C AND BEING SELECTED FROM THE GROUP CONSISTING OF PARPFFIN, BEES WAX AND GLYCEROL ESTERS OF 8 - 22 CARBON ATOM FATTY ACIDS HAVING MELTING POINTS WITHIN THE AFOREMENTIONED RANGE, B. 0 - 40% OF AT LEAST ONE WATER-SOLUBLE OR WATER-SWELLABLE POLYMER SELECTED FROM THE GROUP CONSISTING OF DEXTRAN, LOWER HYDROXY-ALKYL DEXTRAN, CARNOXY-METHYL OF DEXTRAN, LOWER HYDROXY-ALKYL CELLULOSE, LOWER ALKYL-CELLULOSE, CARBOXYMETHYL CELLULOSE, POLYVINYL ALCOHOL, DEXTRIN, STARCH, POLYVINYL PRYROLLIDONE AND POLYALKYLENE GLYCOLS, IN SOLID FINELY-DIVIDED FORM HAVING A PARTICLE SIZE LESS THAN OPPROXIMATELY 150 MICRONS. C. 0.05 - 20% OF AT LEAST ONE DRUG SHOWING A TOPICAL EFFECT ON THE EYE WITH A PARTICLE SIZE LESS THAN APPROXIMATELY 150 MICRONS, AND D. 0.2 - 20% OF AT LEAST ONE WATER-INSOLUBLE LIPOPHILIC POLYMER HAVING A SOFTENING TEMPERATURE EXCEEDING 70*C AND HAVING A MELTING POINT EXCEEDING 85*C AND WHICH IS SOLUBLE IN THE LIPOPHILIC SUBSTANCE OR SUBSTANCES IN MOLTEN FORM TO SERVE AS STABLIZER FOR THE MIXTURE, SAID POLYMER BEING SELECTED FROM THE GROUP CONSISTING OF POLYVINYL ACETATE, ETHYLENEVINYLACETATE-COPOLYMER, POLYBUTYL METHACRYLATE, POLYETHYLENE, POLYPROPYLENE, ETHYLENEPROPYLENE-COPOLYMER AND MIXTURES THEREOF, THE PERCENTAGES RELATING TO PERCENT BY WEIGHT CALCULATED ON THE TOTAL WEIGHT OF THE MIXTURE.

Claim 2

THE METHOD OF MEDICATING THE EYE WITH OPHTHALMIC MEDICATION THE IMPROVEMENT WHICH INCLUDES THE STEP OF PLACING BENEATH ONE EYELID A SOLID SHAPED BODY HAVING A LARGEST DIMENSION BETWEEN THE LIMITS OF 2 - 20 MM AND REMAINING DIMENSIONS WITHIN THE RANGE OF 0.5 - 10 MM, WITH SOFTLY ROUNDED CORNERS SO AS NOT TO CAUSE EYE IRRITATION, THE BODY BEING EITHER PLANAR OR SUITABLY MOLDED TO OBTAIN THE SHAPE OF A LENS CAPABLE OF FITTING INTO THE SPACE BETWEEN THE EYE AND THE SURROUNDING TISSUE WITH A SURFACE FACING TOWARD THE EYE, SAID SOLID SHAPED BODY AS A RESULT OF ITS PLASTICITY FORMING ITSELF TO THE SHAPE OT THE EYE CAVITY WHEN INSERTED INTO THE EYE, SAID BODY COMPRISING A MIXTURE OF: A. 5 - 90% OF AT LEAST ONE LIPOPHILIC SUBSTANCE HAVING A MELTING POINT OF 37*-75*C AND BEING SELECTED FROM THE GROUP CONSISTING OF PARPFFIN, BEES WAX AND GLYCEROL ESTERS OF 8 - 22 CARBON ATOM FATTY ACIDS HAVING MELTING POINTS WITHIN THE AFOREMENTIONED RANGE, B. 0 - 40% OF AT LEAST ONE WATER-SOLUBLE OR WATER-SWELLABLE POLYMER SELECTED FROM THE GROUP CONSISTING OF DEXTRAN, LOWER HYDROXY-ALKYL DEXTRAN, CARNOXY-METHYL OF DEXTRAN, LOWER HYDROXY-ALKYL CELLULOSE, LOWER ALKYL-CELLULOSE, CARBOXYMETHYL CELLULOSE, POLYVINYL ALCOHOL, DEXTRIN, STARCH, POLYVINYL PRYROLLIDONE AND POLYALKYLENE GLYCOLS, IN SOLID FINELY-DIVIDED FORM HAVING A PARTICLE SIZE LESS THAN OPPROXIMATELY 150 MICRONS. C. 0.05 - 20% OF AT LEAST ONE DRUG SHOWING A TOPICAL EFFECT ON THE EYE WITH A PARTICLE SIZE LESS THAN APPROXIMATELY 150 MICRONS, AND D. 0.2 - 20% OF AT LEAST ONE WATER-INSOLUBLE LIPOPHILIC POLYMER HAVING A SOFTENING TEMPERATURE EXCEEDING 70*C AND HAVING A MELTING POINT EXCEEDING 85*C AND WHICH IS SOLUBLE IN THE LIPOPHILIC SUBSTANCE OR SUBSTANCES IN MOLTEN FORM TO SERVE AS STABLIZER FOR THE MIXTURE, SAID POLYMER BEING SELECTED FROM THE GROUP CONSISTING OF POLYVINYL ACETATE, ETHYLENEVINYLACETATE-COPOLYMER, POLYBUTYL METHACRYLATE, POLYETHYLENE, POLYPROPYLENE, ETHYLENEPROPYLENE-COPOLYMER AND MIXTURES THEREOF, THE PERCENTAGES RELATING TO PERCENT BY WEIGHT CALCULATED ON THE TOTAL WEIGHT OF THE MIXTURE.