Study of formulation of pharmaceutical forms of paracetamol in medical practice.
It is a well-known fact that tablets are the most ordinary medicines in daily practice, which along with capsules represents about 70% of pharmaceutical preparations. Experimenting with paracetamol tablets of 500 mg dose was scope of this study. Study of formulation, preparation, quality control, and follow-up of the paracetamol stability in tablets was conducted. Carefully analyzing the physical--chemical properties of the paracetamol, in particular to the high number of excipients utilized in the preparation of tablets (diluting, connective, analyzing, and lubricant excipients), and by researching an considerable number of bibliographic sources, we have conceived four different formulations of the paracetamol tablets 500 mg. Preparation of tablets was realized by the humid method of granulation. Quality control of the paracetamol tablets was performed by implementing a series of trials and analyses forecasted in latest editions of most recognized pharmacopoeias. From these trials and analyses, we can mention as follows: reactions of identification, diameter, and average mass, time of analysis, velocity of dissolution and determination of 4-aminophenol. Requirements deriving from the abovementioned trials and analyses were accomplished, excluding the velocity of dissolution that was not accomplished in two of the last formulation (3 and 4). Since this trial is very important in regard to the quality of solid pharmaceutical forms, two of the abovementioned formulations are considered as inappropriate to be used in practice. From the four formulations of paracetamol tablets, results shows that 1st and 2nd are most appropriate formulations due to its simplicity in preparation and practice to be produced industrially. Defining of the timely depending content of the paracetamol in tablet was performed by the implementing of two contemporary methods of spectrophotometry in UV zone and chromatography in the liquid phase with high pressure (HPLC). Just as it was expected, results of these analyses showed that acting substance did not incur any alteration during the period of storage and that alterations of the analyses results in between these two methods are almost inconsiderable ones.
Department of Pharmacy, Faculty of Medicine, University of Prishtina, Clinical Centre, Prishtina, Kosovo.
Bedri
B
Abdullahu
Azem
A
Lajci
Vehbi
V
Shehu
Shaip
S
Krasniqi
Hilmi
H
Islami
D000082:Acetaminophen / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D013607:Tablets
D013607:Tablets; D000082:Acetaminophen