Abstract A drug dosage form adaptable to further processing without secondary shaping and permitting controlled release of a therapeutically active ingredient therefrom, said dosage form comprises a capsule filled solely with beads of an average diameter from about 0.1 to about 2.5 millimeters, each bead being similar in composition and consisting essentially of A. FROM 48.4 UP TO 81.4 PERCENT OF A CASTABLE CARRIER, SPARINGLY SOLUBLE IN THE DIGESTIVE TRACT, WHICH IS A GLYCOL ESTER OF A WAX ACID CONTAINING 22 TO 39 CARBON ATOMS; B. FROM 13.6 UP TO 30 PERCENT, BY TOTAL WEIGHT OF THE BEADS, OF SAID ACTIVE INGREDIENT PRESENT IN SAID CARRIER IN DISSOLVED, DISPERSED OR EMULSIFIED FORM; AND C. FROM 5 PERCENT TO 21.5 PERCENT OF A PHYSIOLOGICALLY TOLERATED SURFACE-ACTIVE SUBSTANCE PRESENT AS AN OIL-IN-WATER EMULSIFIER AND HAVING A HLB value of 8 and higher; all said bead components of said capsule have a melting point of at least 45*C. and process for preparing it.
A DRUG DOSAGE FORM PERMITTING CONTROLLED RELEASE OF A THERAPEUTICALLY ACTIVE INGREDIENT THEREFROM, SAID DOSAGE FORM COMPRISES A CAPSULE FILLED SOLELY WITH BEADS OF AN AVERAGE DIAMETER FROM ABOUT 0.1 TO ABOUT 2.5 MILLIMETERS, EACH BEAD BEING SIMILAR IN COMPOSITION AND CONSISTING ESSENTIALLY OF A. FROM 48-4 PERCENT UP TO 81.4 PERCENT OF A CASTABLE CARRIER, SPARINGLY SOLUBLE IN THE DIGESTIVE TRACT, WHICH IS A GLYCOL ESTER OF A WAX ACID CONTAINING 22 TO 39 CARBON ATOMS; B. FROM 13.6 PERCENT UP TO 30 PERCENT, BY TOTAL WEIGHT OF THE BEADS, OF SAID ACTIVE INGREDIENT PRESENT IN SAID CARRIER IN DISSOLVED, DISPERSED OR EMULSIFIED FORM; AND C. FROM 5 PERCENT TO 21.5 PERCENT TO A PHYSIOLOGICALLY TOLERATED SURFACE-ACTIVE SUBSTANCE PRESENT AS AN OIL-IN-WATER EMULSIFIED AND HAVING A HLB VALUE OF 8 AND HIGHER; ALL SAID BEAD COMPONENTS OF SAID CAPSULE HAVING A MELTING POINT OF AT LEAST 45*C.
Claim 2
Dependent Claim
148 words
A DRUG DOSAGE FORM PERMITTING CONTROLLED RELEASE OF A THERAPEUTICALLY ACTIVE INGREDIENT THEREFROM, SAID DOSAGE FORM COMPRISES A CAPSULE FILLED SOLELY WITH BEADS OF AN AVERAGE DIAMETER FROM ABOUT 0.1 TO ABOUT 2.5 MILLIMETERS, EACH BEAD BEING SIMILAR IN COMPOSITION AND CONSISTING ESSENTIALLY OF A. FROM 48-4 PERCENT UP TO 81.4 PERCENT OF A CASTABLE CARRIER, SPARINGLY SOLUBLE IN THE DIGESTIVE TRACT, WHICH IS A GLYCOL ESTER OF A WAX ACID CONTAINING 22 TO 39 CARBON ATOMS; B. FROM 13.6 PERCENT UP TO 30 PERCENT, BY TOTAL WEIGHT OF THE BEADS, OF SAID ACTIVE INGREDIENT PRESENT IN SAID CARRIER IN DISSOLVED, DISPERSED OR EMULSIFIED FORM; AND C. FROM 5 PERCENT TO 21.5 PERCENT TO A PHYSIOLOGICALLY TOLERATED SURFACE-ACTIVE SUBSTANCE PRESENT AS AN OIL-IN-WATER EMULSIFIED AND HAVING A HLB VALUE OF 8 AND HIGHER; ALL SAID BEAD COMPONENTS OF SAID CAPSULE HAVING A MELTING POINT OF AT LEAST 45*C.
Claim 3
Dependent Claim
16 words
A drug dosage form as claimed in claim 1, wherein the surface-active substance is polyoxyethylene-(50)-stearate. polyoxyethylene-(50)-stearate.
Claim 4
Dependent Claim
15 words
A drug dosage form as claimed in claim 1, wherein the surface-active substance is polyoxyethylene-sorbitan-monooleate.
Claim 5
Dependent Claim
15 words
A drug dosage form as claimed in claim 1, wherein the surface-active substance is polyoxyethylene-sorbitan-monostearate.