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Composition comprising acetaminophen, caffeine and optionally aspirin together with an alkiline agent for enhanced absorption

A technology of paracetamol and aspirin, applied in the field of compositions containing paracetamol, caffeine and optional aspirin and an alkaline agent for enhancing absorption, can solve problems such as reducing the rate of absorption

Inactive Publication Date: 2007-10-03
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The addition of 400 mg sodium bicarbonate to paracetamol tablets increased the rate of absorption relative to conventional paracetamol tablets, but did not differ in the rate of absorption compared to soluble paracetamol tablets
Sterbenz et al. referred to the results of Wojcicki et al., Zbl.Pharm., 118 (1979), Vol2-3, and they found that when 4g of calcium carbonate and 1g of APAP were administered, the measured t max values ​​showed a significantly reduced rate of absorption

Method used

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  • Composition comprising acetaminophen, caffeine and optionally aspirin together with an alkiline agent for enhanced absorption
  • Composition comprising acetaminophen, caffeine and optionally aspirin together with an alkiline agent for enhanced absorption
  • Composition comprising acetaminophen, caffeine and optionally aspirin together with an alkiline agent for enhanced absorption

Examples

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Embodiment 1-4

[0069] It should be noted that Examples 1-3 are intended to illustrate the fast-acting compositions of the present invention. Example 4 is a similar composition without the alkaline agent required by the present invention.

[0070] A preclinical pharmacokinetic (PK) study was performed with tablets prepared from the compositions of Examples 1-4.

[0071] A single-dose, four-sequence, four-phase, four-formulation crossover Williams design was used to differentiate the pharmacokinetic behavior between the compositions of Examples 1-3 and Example 4. Two naive Beagles were used per sequence. The cleaning period is one week. Serial blood samples were collected 12 h after oral administration. Plasma concentrations of caffeine, acetaminophen, and salicylic acid were determined by a validated HPLC method. One dog vomited after the second dose, and its blood sample was not analyzed.

[0072] Including the time to reach the peak blood level after taking the drug (T max ) an...

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Abstract

The onset of activity of a first analgesic / antipyretic composition containing an analgesic / antipyretic effective amount of acetaminophen, caffeine and, optionally, aspirin is shortened by incorporating in the first composition an onset of analgesic / antipyretic activity shortening amount of at least one alkaline agent whereby a second composition is produced. The second composition being bioequivalent to the first composition but having a shorter onset of analgesic / antipyretic activity than the first composition.

Description

Background of the invention [0001] Aspirin and acetaminophen (also known as paracetamol and APAP) are well known pain relievers and antipyretics. They are often used with caffeine. [0002] Buffered aspirin products that simultaneously release alkaline material and aspirin in the stomach are known in the art. The alkaline material is co-administered with aspirin to reduce the acidity of the stomach contents and reacts with aspirin to form its soluble salts. [0003] When co-administering a tablet containing basic material and aspirin, the basic material and aspirin are usually separated. One way of accomplishing this is by making a multilayer tablet formulation with one layer containing the alkaline material and the other layer containing aspirin. [0004] U.S. Patent No. 4,664,915 (the '915 patent) states that if citric acid and monobasic sodium phosphate are included as part of the basic layer in a multilayer compressed tablet, the rate at which the basic material reacts ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/167A61K47/02A61K31/616A61P29/00A61K31/522
CPCA61K9/2009A61K9/485A61K31/167A61K31/522A61K31/616A61P25/04A61P29/00A61K2300/00
Inventor R·刘M·科尔博J·德赛G·P·弗伦齐齐晓宏C·Y·乔伊R·R·甘地A·Z·布洛斯
Owner NOVARTIS AG
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