Novel Method

Abstract

The present invention is directed to a novel method for reducing intrapatient variability in pharmaceutically active agent which is suitably not absorbed in the stomach, such as paracetamol, containing formulations in patients having gastric dysmotility, or a method of improving analgesia in a diabetic patient, or improving absorption of an active agent is a patient with gastric dysmotility, which methods comprises administering orally to said patient in need thereof a pharmaceutical dosage form comprising a first active agent, calcium carbonate, at least one first binding agent, and at least one disintegrating agent as intragranular components in the form of a granulate, and as an extragranular component at least one hydrophilic colloid, an optionally a second binding agent, calcium carbonate, a super disintegrant, and a second active agent.

What is claimed is: 
     
         1 . A method for improving analgesia in a diabetic comprising administering to said patient in need thereof an orally administered pharmaceutical dosage comprising a first active agent which is paracetamol present in an amount of about 60 to about 80% by weight, calcium carbonate present in an amount of about 5 to about 20% by weight, at least one first binding agent, and at least one disintegrating agent as intragranular components in the form of a granulate, and as an extragranular component at least one hydrophilic colloid. 
     
     
         2 . A method for improving absorption of paracetamol in a patient with gastric dysmotility comprising administering to said patient in need thereof an orally administered pharmaceutical dosage comprising a first active agent which is paracetamol present in an amount of about 60 to about 80% by weight, calcium carbonate present in an amount of about 5 to about 20% by weight, at least one first binding agent, and at least one disintegrating agent as intragranular components in the form of a granulate, and as an extragranular component at least one hydrophilic colloid, an optionally a second binding agent, calcium carbonate, super disintegrant, and a second active agent. 
     
     
         3 . A method for improving analgesia in a diabetic comprising administering to said patient in need thereof an orally administered pharmaceutical dosage comprising
 a) paracetamol;   b) at least one agent which contributes to dissolution selected from sodium carbonate, ammonium carbonate, sodium bicarbonate, potassium bicarbonate, calcium carbonate, magnesium carbonate, disodium glycine carbonate, sodium glycine carbonate, lysine carbonate, arginine carbonate, or combinations of two or more of the above;   c) at least one water uptake agent selected from cross-linked polyvinylpyrrolidone (crospovidone), croscarmellose sodium, sodium starch glycolate, povidone, starch, starch derivatives, low substituted hydroxypropylcellulose, hydroxypropylcellulose, alginic acid, sodium alginate, calcium sulfate, calcium carboxymethylcellulose, microcrystalline cellulose, powdered cellulose, colloidal silicon dioxide, docusate sodium, guar gum, magnesium aluminum silicate, methylcellulose, polacrilin potassium, silicified microcrystalline cellulose, magnesium oxide, tragacanth, mannitol, sorbitol, xylitol, sucrose, lactose, fructose, maltose, polyethylene glycol, amino acids, cyclodextrin, urea and/or polyvinylpyrrolidone; and   wherein at least 70 of the paracetamol is dissolved from the formulation within 180 seconds in USP dissolution apparatus 2 with 900 ml of 0.05 N hydrochloric acid at 30 rpm and 37° C.