Martínez ÁLO, Mena SK, Céspedes PM

Language: Spanish
References: 5
Page:
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ABSTRACT

Introduction: The first phase of the drug preformulation comprises the selection of excipients and the conduction of studies on chemical compatibility between pharmacologically active ingredient and the excipients. One of the quickest techniques is the differential scanning calorimetry and the supplementary technique called thermogravimetic analysis.
Objective: To conduct a chemical compatibility study of the pharmacologically active ingredient and of the preselected excipients by using differential scanning calorimentry (DSC) and thermogravimetric analysis (TG), in order to confirm the chemical interaction between them.
Methods: This study used the thermal analysis equipment TA 3000 Mettler, coupled with the DSC 20 cell and the TG50 oven. The pharmacologically active ingredient was Piracetam and the excipients were Aerosil Kollidon VA64, magnesium stearate, microcrystalline cellulose, Polyethylene glycol 20 000. The differential scanning calorimetry characterized the excipients and the pharmacologically active ingredient as well, whose physical fusion transition was determined. Some binary physical mixtures with a concentration ratio of 1:1 were prepared to study compatibility.
Results: Figure 1 showed the pharmacologically active ingredient´s fusion point detection. Two endothermal transitions were determined as well as the fusion transition by the TG equipment. Figure 2 showed the thermograms of mixtures between pharmacologically active ingredient and excipients.
Conclusions: The occurrence of new peaks was bit detected, so it was inferred from this study that there was no chemical incompatibility between the studied substances, and the excipients are recommended for the development of the final pharmaceutical formulation.

REFERENCES

1. Ford J.L., Timmis P. , Pharmaceutical Thermal Analysis, Techniques and applications, ed. John Wiley Sons, Ed.New York, 1988.

2. Girón, D, Thermal analysis in Pharmaceutical routine analysis. Acta Pharm. Jugosl, 1990; 40:95-157.

3. Martindale: The Complete Drug Reference, monografías en CD-ROM, Pharmaceutical Press, Ed. Sweetman SC. London 2007.

4. The Merck Index, An Encyclopedia of Chemicals and Drugs, Merck&CO., INC, Ed.11, Rahway, N.J., USA, 1989.

5. Pharmaceutical Excipients en CD-ROM, Handbook of Pharmaceuticals excipients, American Pharmaceuticals Association, Version 3.0, N.W., Washington, D.C., 200