Compatibility study of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in physical mixtures

G G G de Oliveira; A Feitosa; K Loureiro; A R Fernandes; E B Souto; P Severino

doi:10.1016/j.jsps.2016.05.001

Compatibility study of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in physical mixtures

Saudi Pharm J. 2017 Jan;25(1):99-103. doi: 10.1016/j.jsps.2016.05.001. Epub 2016 May 7.

Authors

G G G de Oliveira¹, A Feitosa², K Loureiro², A R Fernandes³, E B Souto⁴, P Severino²

Affiliations

¹ Department of Pharmacy, Faculty of Pharmaceutical Health, University of São Paulo, São Paulo 05508-900, Brazil.
² Laboratory of Nanotechnology and Nanomedicine (LNMED), University of Tiradentes (UNIT), Institute of Technology and Research (ITP), Av. Murilo Dantas, 300, 49010-390 Aracaju, Brazil.
³ Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra (FFUC), Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
⁴ Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra (FFUC), Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; REQUIMTE/LAQV, Group of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.

Abstract

Paracetamol (PAR), phenylephrine hydrochloride (PHE) and chlorpheniramine maleate (CPM) are commonly used in clinical practice as antipyretic and analgesic drugs to ameliorate pain and fever in cold and flu conditions. The present work describes the use of thermal analysis for the characterization of the physicochemical compatibility between drugs and excipients during the development of solid dosage forms. Thermogravimetric analysis (TGA) and Differential Scanning Calorimetry (DSC) were used to study the thermal stability of the drug and of the physical mixture (drug/excipients) in solid binary mixtures (1:1). DSC thermograms demonstrated reproducible melting event of the prepared physical mixture. Starch, mannitol, lactose and magnesium stearate influence thermal parameters. Information recorded from the derivative thermogravimetric (DTG) and TGA curves demonstrated the decomposition of drugs in well-defined thermal events, translating the suitability of these techniques for the characterization of the drug/excipients interactions.

Keywords: Chlorpheniramine maleate and phenylephrine hydrochloride; Differential Scanning Calorimetry (DSC); Paracetamol; Thermogravimetric analysis (TGA).