Comparative dissolution studies on granules with acetaminophen and caffeine using the basket and paddle methods with simultaneous spectrophotometric determination of active substances

Abstract

Acetaminophen and caffeine, popular therapeutic substances used to relieve pain or alleviate the symptoms of cold. The aims of the study were the comparison of granules, in terms of dissolution rate and moreover the development of spectrophotometric method to the simultaneous determination of both active pharmaceutical ingredients (APIs) in granules. The granules were tested by two pharmacopoeial methods of dissolution for solid dosage forms, and the dissolution profiles for each formulation were compared. A method of simultaneous determination of two medicinal substances by the double calibration method using derivative spectrophotometry was used. Considering the dissolution process carried out in the paddle apparatus, it was shown that more than 80% of acetaminophen and caffeine were released from each of the preparations in a clearly shorter time than 10 minutes. Carrying out the basket test, substances dissolved gradually, much slower than in the paddle method. The time required to release 80% of both active substances from majority of tested preparations was from 30 to 45 minutes. Application of the first derivative spectrophotometric method allows simultaneous determination of acetaminophen and caffeine in the mixture, without the need to separate them first.

Comparative in vitro dissolution studies of fixed-dose combination formulations: analgesic tablets of acetaminophen/caffeine

“…Some authors have studied the UV identi ication of ACE/CAF in granules (Szumilo et al, 2019), and in commercial tablets (Dinç, 1999;Vichare et al, ). These methods used simultaneous equations to quantify both drugs without mutual interference.…”

“…These methods used simultaneous equations to quantify both drugs without mutual interference. In granules, more than 80% of ACE and CAF were released in less than 10 min (Szumilo et al, 2019) and both analytical methods reported for commercial tablets can be used for quality control purposes. Especially in dissolution studies, controlled release of CAF tablets has been reported by some authors (Franek et al, 2014;Tan et al, 2019) and more than 80% of drug dissolved was found between 20-24 h. On the other hand, more than 80% of CAF at 20 min was found in immediaterelease formulations with a binary mixture of drugs and HPLC determination (Williams et al, 2010) as well as with a ternary mixture (Liu et al, 1999).…”