An orally rapidly disintegrating tablet of propranolol and its process of preparation
AssigneeNovumgen Limited
InventorKamleshkumar Patel
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Abstract
The present invention relates to an Orally rapidly disintegrating tablet comprising Propranolol or pharmaceutically acceptable salts thereof, at least one disintegrant, at least one diluent, a lubricant, a sweetener, and a flavoring agent. The present invention is based on enhancing disintegration and dissolution, which is beneficial in the treatment of hypertension, angina, atrial fibrillation, myocardial infarction, migraine, essential tremor, hypertrophic subaortic stenosis, pheochromocytoma, proliferating infantile hemangioma and very convenient for administration for solid dosage form without swallowing difficulties, thereby increasing patient compliance.
Claims24
An Orally rapidly disintegrating tablet of propranolol for oral administration comprising:
- a) propranolol or pharmaceutically acceptable salts thereof, is present in an amount ranging from about 2% w/w to about 20% w/w, preferably in the range from about 5% w/w to about 15% w/w;
- b) at least one diluent;
- c) at least one disintegrant is present in the range of about 0.025% w/w to about 10% w/w, preferably in the range of about 0.05% w/w to about 6% w/w;
- d) at least one lubricant is present in the range from about 0.05% w/w to about 10% w/w, preferably in the range from about 0.25% w/w to about 5% w/w;
- and
- e) at least one or more pharmaceutically acceptable excipients.
The Orally rapidly disintegrating tablet according to claim 23, wherein the tablet is more stable for at least three months and six months at 25° C./60% relative humidity and at 40° C./75% relative humidity in PVC/PVDC-Alu Film or HDPE Bottle with Child Resistant cap.
Dependencies are inferred from the claim text.