| abstract |
IT REFERS TO A SOLID PHARMACEUTICAL FORMULATION THAT INCLUDES: a) 0.25 mg TO 100 mg PER UNIT DOSE OF A DIPHOSPHONIC ACID SUCH AS IBANDRONATE, ETHYDRONATE, CHLODRONATE, RISEDRONATE, PAMIDRONATE OR ALENDRONATE, IN THE FORM OF GRANULATE; b) PHARMACEUTICAL ADJUVANTS IN THE EXTERNAL PHASE LESS THAN 5% BY WEIGHT OF STEARIC ACID RELATIVE TO TOTAL WEIGHT AND A POLYVINYLPYRROLIDONE DESINTEGRANT AGENT; ii) IN THE INTERNAL PHASE LESS THAN 5% OF STEARIC ACID. IT ALSO REFERS TO A PROCEDURE TO PRODUCE A SOLID FORM IN WHICH THE ACTIVE SUBSTANCE TOGETHER WITH THE ADJUVANTS BECOMES GRANULATED, LESS THAN 5% OF STEARIC ACID IS ADDED AS A LUBRICANT AND OPTIONALLY OTHER ADJUVANTS AND INTERIOR RESULTS TO THE PHASE MIXTURE IS FILLED IN CAPSULES OR COMPRESSED. DIPHOSPHONE ACIDS ARE USED FOR THE TREATMENT OF DISEASES OF CALCIUM METABOLISM, HYPERCALCEMIA, TUMOR OSTEOLYSIS, OSTEOPOROSIS AND THE RESULTING PAIN |